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Background Previous studies have found that patients with subclinical interstitial lung disease (ILD) are highly susceptible to developing radiation pneumonitis (RP) after thoracic radiation therapy. In the present study we aimed to evaluate the incidence of and risk factors for RP after thoracic intensity-modulated radiation therapy in lung cancer patients with subclinical ILD. Methods We retrospectively analyzed data from lung cancer patients with subclinical ILD who were treated with thoracic intensity-modulated radiation therapy with a prescribed dose of ≥ 50 Gy in our institution between January 2016 and December 2017. Results Eighty-seven consecutive lung cancer patients with subclinical ILD were selected for the study. The median follow-up period was 14.0 months. The cumulative incidence of grades ≥ 2 and ≥ 3 RP at one year was 51.0% and 20.9%, respectively. In the multivariate analysis, a mean lung dose ≥ 12 Gy was a significant risk factor for grade ≥ 2 RP (p = 0.049). Chemotherapy with gemcitabine in the past, V5 ≥ 50%, and subclinical ILD involving ≥ 25% of the lung volume were significantly associated with grade ≥ 3 RP (p = 0.046, p = 0.040, and p = 0.024, respectively). Conclusion Mean lung dose is a significant risk factor for grade ≥ 2 RP. Lung cancer patients who have received chemotherapy with gemcitabine in the past, V5 ≥ 50%, and those with subclinical ILD involving ≥ 25% of lung volume have an increased risk of grade ≥ 3 RP in lung cancer patients with subclinical ILD.

Background The optimal dose and fractionation scheme of stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma (HCC) remains unclear due to different tolerated liver volumes and degrees of cirrhosis. In this study, we aimed to verify the dose-survival relationship to optimize dose selection for treatment of HCC. Methods This multicenter retrospective study included 602 patients with HCC, treated with SBRT between January 2011 and March 2017. The SBRT dosage was classified into high dose, moderate dose, and low dose levels: SaRT (BED10 ≥ 100 Gy), SbRT (EQD2 > 74 Gy to BED10 2 Results The median tumor size was 5.6 cm (interquartile range [IQR] 1.1–21.0 cm). The median follow-up time was 50.0 months (IQR 6–100 months). High radiotherapy dose correlated with better outcomes. After classifying into the SaRT, SbRT, and ScRT groups, three notably different curves were obtained for long-term post-SBRT survival and intrahepatic control. On multivariate analysis, higher radiation dose was associated with improved OS, PFS, and intrahepatic control. Conclusions If tolerated by normal tissue, we recommend SaRT (BED10 ≥ 100 Gy) as a first-line ablative dose or SbRT (EQD2 ≥ 74 Gy) as a second-line radical dose. Otherwise, ScRT (EQD2

OBJECTIVES To validate stage nodal (N)3 of the 8th edition American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma (NPC). METHODS This retrospective cohort study extracted NPC patients from the Surveillance, Epidemiology, and End Results database between 2004 and 2016. Pathologically confirmed patients with complete data of level IV, N3a, and N3b lymph node metastasis were investigated. The included patients were divided into level IV, N3a, and N3b groups. Five-year overall survival (OS) and cancer-specific survival (CSS) were compared among the three groups. RESULTS A total of 693 patients were included: 285 (41.13%) patients in the level IV group, 124 (17.89%) patients in the N3a group, and 284 (40.98%) patients in the N3b group. The 5-year OS (57.1%, 55.0%, and 55.2%) and CSS (64.4%, 63.5%, and 64.4%) were not different among the level IV, N3a, and N3b groups. Multivariate regression analysis revealed that N stage was not an independent prognostic factor for OS (hazard ratio [HR] = 1.03, 95% confidence interval [CI]: 0.91-1.17; P = .65) or CSS (HR = 1.03, 95% CI: 0.89-1.19; P = .70). CONCLUSION Stage N3 of the 8th edition AJCC staging system for NPC is reasonable. LEVEL OF EVIDENCE III Laryngoscope, 131:535-540, 2021.

Background Child-Turcotte-Pugh (CTP) score extensively used to assess hepatic function, predicting postoperative outcome of hepatocellular carcinoma (HCC) patients. Lately, the albumin–bilirubin (ALBI) grade has been identified to be a predictor of overall survival of HCC patients. In this investigation, we compared the pre-SBRT ALBI and CTP scores with the prognosis of patients with HCC. Methods This cohort study included 594 HCC patients who treated with SBRT. Overall survival (OS) rates were measured from treatment date to death date or last follow-up. We compared ALBI score with the CTP score in predicting long-term survival. Results The average follow-up time was 21 months (1 to 82 months). The CTP and ALBI ratings have discriminatory for long-term survival across the groups. CTP class was significantly related to OS, with a median OS of 29.9 months in CTP-A, 11.5 in CTP-B (P 0.05). Conclusions To assess liver dysfunction in HCC patients before SBRT, traditional CTP classification is a necessary but imperfect tool for assessing HCC liver injury. The ALBI score is a more objective, discriminatory and evidence-based approach in CTP-A groups, and need to be validated in CTP ≥ B7 class.

BACKGROUND This study aimed to determine the value of the significant index in predicting symptomatic radiation pneumonitis (RP) in esophageal cancer patients, establish a nomogram prediction model, and verify the model. MATERIAL AND METHODS The patients enrolled were divided into 2 groups: a model group and a validation group. According to the logistic regression analysis, the independent predictors for symptomatic RP were obtained, and the nomogram prediction model was established according to these independent predictors. The consistency index (C-index) and calibration curve were used to evaluate the accuracy of the model, and the prediction ability of the model was verified in the validation group. Recursive partitioning analysis (RPA) was used for the risk stratification analysis. RESULTS The ratio of change regarding the pre-albumin at the end of treatment (P=0.001), platelet-to-lymphocyte ratio during treatment (P=0.027), and neutrophil-to-lymphocyte ratio at the end of treatment (P=0.001) were the independent predictors for symptomatic RP. The C-index of the nomogram model was 0.811. According to the risk stratification of RPA, the whole group was divided into 3 groups: a low-risk group, a medium-risk group, and a high-risk group. The incidence of symptomatic RP was 0%, 16.9%, and 57.6%, respectively. The receiver operating characteristic curve also revealed that the nomogram model has good accuracy in the validation group. CONCLUSIONS The developed nomogram and corresponding risk classification system have superior prediction ability for symptomatic RP and can predict the occurrence of RP in the early stage.

Background: It is unclear whether robotic stereotactic body radiotherapy (SBRT) is superior to intensity-modulated radiotherapy (IMRT) in advanced hepatocellular carcinoma (HCC). This study aimed to compare the long-term outcomes of SBRT with those of IMRT in HCCs with portal vein tumor thrombosis (PVTT). Methods: We retrospectively evaluated 287 HCC patients with PVTT who underwent radiotherapy between January 2000 and January 2017. Of them, 154 and 133 patients were treated with IMRT and SBRT, respectively. Overall survival (OS), progression-free survival (PFS), intrahepatic control (IC), and local control (LC) were evaluated in univariable and propensity-score matched analyses. Results: After matching, 102 well-paired patients were selected. There was no significant difference in the 6-, 12-, 24-, and 60-month cumulative OS (73.5, 42.9, 23.6, 7.6% vs. 72.4, 45.1, 29.8, 13.2%, P=0.151), PFS (53.9, 29.3, 21.8, 7.5% vs. 54.5, 19.3, 12.0, 9.6%, P=0.744) , IC (61.4, 45.7, 39.0, 26.8% vs. 75.1, 45.8, 35.9, 28.7%, P=0.144), and LC (85.2, 56.5, 52.1, 47.4% vs. 87.4, 65.2, 62.1, 62.1%, P=0.191) between the IMRT and SBRT groups. A biologically effective dose assumed at an a/b ratio of 10 (BED10) of ≥100 Gy was the optimal cutoff for predicting the OS, PFS, IC, and LC in the patients who received SBRT. Conclusions: When high-precision tracking technology is available, SBRT appears to be a safe and more time-efficient treatment, achieving comparable OS, PFS, IC and LC to IMRT for local advanced HCC with PVTT. A BED10≥100 Gy is recommended if tolerated by normal tissue.

To investigate the follow-up strategy of stage II NPC based on event dynamics.Stage II NPC patients were retrospectively assessed from January 2007 to December 2014 at Guangxi Medical University Cancer Hospital. Event dynamics for patterns of recurrence and metastasis were calculated based on the hazard rates.A total of 251 patients were included. After treatment, 10 (4.0%) patients developed recurrence and 6 (2.4%) patients developed metastasis. The hazard rate curve of recurrence showed a bimodal recurrence pattern. The maximum hazard rates were 0.048 and 0.072 at the intervals of 36-42 and 90-96 months, respectively. The maximum hazard rate was 0.036 at the interval of 48-54 months in the hazard rate curve of metastasis.Follow-up strategies of stage II NPC should be performed based on currently recommended guidelines. In the future, it should be modified to meet the needs of individual patients.

PURPOSE To identify whether chemoradiotherapy improves survival in patients with stage T3-4N0M0 nasopharyngeal carcinoma (NPC). MATERIALS AND METHODS The data of patients with stage T3-4N0M0 NPC were extracted from the Surveillance, Epidemiology, and End Results database between 2004 and 2016. The patients were divided into radiotherapy and chemoradiotherapy groups. Overall survival (OS) and cancer-specific survival (CSS) were assessed using the Kaplan-Meier method and propensity score matching (PSM) analyses. RESULTS We examined 496 patients: 88 who received radiotherapy and 408 who received chemoradiotherapy. Before PSM, chemoradiotherapy was associated with a better 5-year OS (52.58% vs. 38.13%; P = .005) and similar CSS (63.62% vs. 59.26%; P = .196) compared to those associated with radiotherapy. However, chemoradiotherapy was not an independent prognostic factor for OS [hazard ratio (HR)=0.95, 95% confidence interval (CI): 0.68-1.32; P = .760] or CSS (HR = 1.02, 95% CI: 0.66-1.56; P = .935). After PSM, similar OS (45.15% vs. 42.78%; P = .626) and CSS (58.22% vs. 60.37%; P = .730) were found between the radiotherapy and chemoradiotherapy groups. CONCLUSION Radiotherapy and chemoradiotherapy are associated with similar OS and CSS in patients with stage T3-4N0M0 NPC.

This study aimed to evaluate whether the addition of oxaliplatin to a neoadjuvant chemoradiotherapy (CRT) regimen could improve survival benefit in locally advanced rectal cancer (LARC) patients. We retrospectively analysed 73 LARC patients (cT2-4 and/or cN1-2) who received preoperative CRT with capecitabine followed by surgery (arm A, 43 patients) or capecitabine plus oxaliplatin followed by surgery (arm B, 30 patients). The main endpoints of the study were pathologic complete response (pCR) rate, overall survival (OS) and disease-free survival (DFS). The secondary endpoints included the sphincter preservation rate and safety. The pCR for arms A and B were 28% and 17% (P = 0.267). In arms A and B, the mean OS was 84.287 months (95% CI 68.413–100.160) and 106.333 months (95% CI 99.281–113.386) (P = 0.185); the mean DFS was 72.812 months (95% CI 56.271–89.353) and 95.073 months (95% CI 83.392–106.754) (P = 0.310); and the sphincter preservation rates were 72% and 67%, respectively (P = 0.619). The incidence of grade 3 toxicity was much higher in arm B than in arm A (57% vs. 21%, P = 0.002). Adding oxaliplatin to a preoperative CRT regimen for LARC did not improve the survival benefits of patients or increase toxicity.

Background: Macroscopic vascular invasion (MVI) is a terminal manifestation of hepatocellular carcinoma (HCC) and carries an extremely poor prognosis. In Chinese and Korean HCC guidelines, transarterial chemoembolization (TACE), or/and radiotherapy (RT) is adopted for treatment of MVI. In the current study, we aimed to compare the long-term outcome of TACE + RT to that of RT alone in patients with local advanced HCC with MVI.Methods: In this retrospective study, 148 treatment-naive patients of HCC with MVI were enrolled. Of the patients enrolled, 49 received TACE + RT treatment, whereas 99 patients received RT alone as a monotherapy. Overall survival (OS), progression-free survival (PFS), and intrahepatic control were evaluated using univariable and propensity score–matched analyses.Results: During follow-up, 126 patients (85.1%) died. The median follow-up time was 55.0 months in the RT group and 57.0 months in the TACE + RT group. The TACE + RT group showed better OS and PFS than the RT group, but intrahepatic control was comparable in these two groups. Of 41 cases well-pairs after propensity score matching, the associations between TACE + RT and better OS and PFS remained (15.0 vs. 8.0 months, and 8.0 vs. 4.0 months, all P < 0.05). The 1-, 2-, 3-, and 5-years OS rates in the TACE + RT group were 56.1, 28.6, 20.8, and 15.7 vs. 31.5%, 13.1%, 9.8%, and 6.7% in the RT group, respectively (P = 0.017). The 6-, 12-, and 24-months rates in the TACE + RT group were 51.2, 39.0, and 23.1% vs. 36.6%, 13.9%, and 11.1% in the RT group, respectively (P = 0.04). Two patients (4.1%) experienced radiation-induced liver disease (RILD), and one (2.0%) experienced RT-related gastrointestinal (GI) bleed in the TACE + RT groups. Nine patients (9.1%) experienced RILD, and two (2.0%) experienced RT-related GI bleed in the RT groups.Conclusion: Transarterial chemoembolization + RT had well-complementarity with no more complications than RT alone, providing a better PFS and OS compared with RT-alone treatment for HCC with MVI.

Background: The value of maximal lymph nodal diameter in staging system of nasopharyngeal carcinoma (NPC) is not well established.Methods: NPC patients were extracted from SEER database between 2004 and 2016. Overall survival (OS) and cancer-specific survival (CSS) were compared among three groups based on the maximal lymph nodal diameter: ≤3.0 cm, >3.0-6.0 cm, and >6.0 cm. Included patients were randomly divided into training set and validated set with 1:1 ratio. In training set, X-tile plots were created by dividing maximal lymph nodal diameter into three populations. All possible divisions of the maximal lymph nodal diameter were assessed. Two cut-off values were calculated by the X-tile plots in training set. The two cut-off values were evaluated in validated set.Results: The 10-year OS and CSS were different between the three groups. Multivariate regression analysis revealed that maximal lymph nodal diameter >6.0 cm was an independent risk prognostic factor for OS (hazard ratio [HR]=1.91, 95% confidence interval [CI]: 1.51-2.43; PP5.0 cm was a risk prognostic factor for OS and CSS.Conclusions: The maximal lymph nodal diameter of 5.0 cm may be a reasonable cut-off value for N stage.

Background and Objective: It is unclear if stereotactic body radiation therapy (SBRT) or transarterial chemoembolization (TACE) is better for the treatment of inoperable early-stage hepatocellular carcinoma (HCC). This study aimed to retrospectively compare the efficacy of SBRT to TACE in patients with inoperable Barcelona Clinic Liver Cancer (BCLC)-A stage HCC. Materials and Methods: In this multi-institutional retrospective study, a total of 326 patients with inoperable BCLC-A stage HCC were enrolled. Totally, 167 patients initially received SBRT and 159 initially received TACE. Overall survival (OS), local control (LC), intrahepatic control (IC), and progression-free survival (PFS) were evaluated in univariable and propensity-score matched analyses. Results: There was a smaller median tumor size in the SBRT group than in the TACE group (3.4 cm vs. 7.2 cm, P < 0.001). After propensity score matching in the selection of 95 patient pairs, SBRT had better LC, IC, and PFS than TACE but showed comparable OS. The accumulative 1-, 3-, and 5-year OS rates were 85.7, 65.1, and 62.8% in the SBRT group and 83.6, 61.0, and 50.4% in the TACE group, respectively (P = 0.29). The accumulative 1-, 3-, and 5-year PFS were 63.4, 35.9, and 27.5% in the SBRT group and 53.5, 27.4, and 14.2% in the TACE group, respectively (P = 0.049). The accumulative 1-, 3-, and 5-year LC were 86.8, 62.5, and 56.9% in the SBRT group and 69.3, 53.3, and 36.6% in the TACE group, respectively (P = 0.0047). The accumulative 1-, 3-, and 5-year IC were 77.3, 45.9, and 42.4% in the SBRT group and 57.3, 34.1, and 17.7% in the TACE group, respectively (P = 0.003). On multivariate analysis, treatment (SBRT vs. TACE) was a significant covariate associated with local and intrahepatic control (HR = 1.59; 95% CI: 1.03–2.47; P = 0.04; HR = 1.61; 95% CI: 1.13–2.29; P = 0.009). Conclusions: SBRT was an alternative to TACE for inoperable BCLC-A stage HCC with better local and intrahepatic control. Controlled clinical trials are recommended to evaluate the actual effects of this novel regimen adequately.

Background: Several epidemiological studies have been performed to evaluate the association of dietary intake of vitamin C-oriented foods (DIVCF) with risk of fracture and bone mineral density (BMD) loss, but the results remain controversial. Therefore, we conducted a systematic meta-analysis to assess this correlation. Methods: We searched EmBase, PubMed, Web of Science, and the Chinese database CNKI for relevant articles published up to August 2019. Pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated using the random- or fixed-effects model. Discrepancies were resolved by consultation with a third expert. Results: A total of 13 eligible articles (including 17 studies) with 19,484 subjects were identified for the present meta-analysis. The pooled RR of hip fracture for the highest vs. lowest category was 0.66 (95% CI, 0.47–0.94) for DIVCF, i.e., people with a greater frequency of Vitamin C uptake had a 34% (95% CI, 6%−53%) lower prevalence of hip fracture. In subgroup analyses stratified by study design, gender, and age, the negative associations were statistically significant. Furthermore, the statistical analysis of the association between DIVCF and risk of osteoporosis (RR, 0.66; 95% CI, 0.48–0.92), BMD at the lumbar spine (pooled r, 0.15; 95% CI, 0.09–0.23), and BMD at the femoral neck (pooled r, 0.20; 95% CI, 0.11–0.34) showed beneficial effects of DIVCF. Conclusion: Our meta-analysis indicates that DIVCF is negatively associated with the risk of hip fracture, osteoporosis, and BMD loss, suggesting that DIVCF decreases the risk of hip fracture, osteoporosis, and BMD loss.

e16117 Combining radiation therapy with anti-PD-1 for patients with advanced hepatocellular carcinoma: an open-label, single-center, single-arm clinical study Jian-Xu Li, Ting-Shi Su, Xiao-Feng Lin, Yi-Tian Chen, Shi-Xiong Liang, Bang-De Xiang; Guangxi Medical University Cancer Hospital, Nanning, China Abstract Research Funding: Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. Guangxi Medical and Health Appropriate Technology Development and Application Project (No. S2019039), Guangxi, China. Background: Based on the results of recent studies, the PD-1 monoclonal antibodies have been approved to treat the patients with advanced hepatocellular carcinoma (HCC) by the FDA. Radiation therapy (RT) can enhance responsiveness to PD-1 monoclonal antibody by potential mechanisms. A phase Ⅱa study was conducted to assess the safety and the efficacy of combining RT with anti-PD-1 for patients with advanced hepatocellular carcinoma. Methods: Patients with advanced HCC were eligible. Stereotactic body radiation therapy (SBRT) were adopted, and the dose of radiation were Dt-PGTV 30-50 Gy/10fractions. Camrelizumab (200mg) were given intravenously every 3 weeks since the first day of RT until disease progression, or intolerable toxicity. Adverse events (AEs) and objective response rate (ORR) were summarized to assess the safety and efficacy. Results: From April 2020 to November 2020, 17 patients were enrolled (median age 54, range 32-69). 15 (88%) patients were male. 14 (82%) had ECOG performance score of 0. All the patients had Child-Pugh score A. 16 patients staged as Barcelona Clinic Liver Cancer staging C or China Liver Cancer staging Ⅲ. Extrahepatic metastases were identified in 11 (65%) patients. 13 (77%) patients were Hepatitis B virus infected. 15 (88%) patients had previously 2 lines or more chemotherapy. 9 (53%) patients had Alpha-fetoprotein level≥400 ng/ml. The ORR was 47%. The best response assessed by RECIST 1.1 was partial response (8 patients). Four patients had grade 3 immune-related adverse events (irAEs), including increased aspartate aminotransferase and alanine transaminase (n =1)，decreased hemoglobin (n =1)，decreased platelet count (n =1)，decreased neutrophil count (n =1). All grade 3 irAEs were mitigated with proper treatment. None treatment-related deaths occurred. Conclusions: In this study, RT combined with anti-PD-1 had an acceptable safety profile and indicated an effective treatment option in patients with unresectable HCC. Clinical trial information: NCT04193696. Clinical trial information: NCT04193696.

e16155 Background: External beam radiation therapy has been used as a palliative to radical treatment of hepatocellular carcinoma (HCC) depending on different tumor status, liver function and patient's general state of health. The existing models of HCC staging cannot perfectly predict the prognosis of radiotherapy. In this study, we aimed to set up a new staging system for radiotherapy-based treatment by incorporating bilirubin-albumin (ALBI) grade and tumor status for the prognostic classifications of HCC. Methods: This multicenter cohort study included 878 HCC patients who received radiotherapy-based treatment. A new staging system was established: stage I, solitary nodule without macrovascular invasion or 2-3 nodules with no more than 3.0 cm each other and PS 0-2 (Ia: ALBI-1 grade; Ib: ALBI-2 or 3 grade); stage II: 2-3 nodules with anyone more than 3.0 cm or ≥4 nodules and PS 0-2 (IIa: ALBI-1 grade; IIb: ALBI-2 grade); stage III: macrovascular invasion or regional lymph node metastasis or distant metastasis and PS 0-2 (IIIa: ALBI-1 grade; IIIb:ALBI-2 grade); stage IV: ALBI-3 grade without stage I patient or/and PS score 3-4. The new modified staging system and the existing staging systems, such as the BCLC, TNM, CNLC staging systems were used for prognostic analysis. All patients were separated into different stages and substages. The long-term overall survival outcomes and time-dependent receiver operating characteristic (ROC) were analyzed. Results: A training cohort of 595 patients underwent stereotactic body radiotherapy (SBRT) from 2011 to 2017 and an external validation cohort of 283 patients underwent intensity-modulated radiotherapy (IMRT) from 2000 to 2013 were included into establishing and validating the new staging system. In the training cohort, the median follow-up time was 55 months (range, 6–100 months), and the new staging system had a good discriminatory ability to separate patients into different stages with 4 notably different curves and substages with 7 notably different curves. BCLC staging could not differentiate stage 0 to A, and stage C to D in these selected patients. TNM staging could not completely distinguish stage IIIb to IV, but also stage Ia to Ib. CNLC staging could not differentiate among stage IIIa, IIIb, and IV. In the external validation, the median follow-up time was 95 months (range, 9–120 months), and the new staging system also had a good discriminatory ability to separate patients into different stages with 4 notably different curves and substages with 7 notably different curves. The new staging system had a better area under curve of time-dependent ROC than BCLC, TNM and CNLC staging in both SBRT and IMRT cohorts. Conclusions: The new modified (Su’s) staging system could provide a good discriminatory ability to separate patients into different stages and substages after radiotherapy treatment. It may be used to supplement the other HCC staging systems.

e16115 Background: In the past clinical practice of radiotherapy for liver cancer, liver regeneration (LR) which is beneficial to the prevention or recovery of radiation-induced liver injury, has not received enough attention. In current study, we aimed to build and validate multivariate model for liver regeneration after radiation therapy for hepatocellular carcinoma (HCC) based on data from 2 prospective studies. Methods: Thirty patients treated with preoperative downstaging radiotherapy were prospectively included in the training cohort, and 21 patients treated with postoperative adjuvant radiotherapy were included in the validation cohort. Liver regeneration was defined as an increase of more than 10% of normal liver volume in the areas of the protected hepatic segment or lobe, without Child-Pugh class decreased and tumor progression compared to pre-radiotherapy. Model and nomogram of liver regeneration after radiotherapy were developed and validated. The cut-off points of each optimal predictors were obtained using receiver-operating characteristic analysis. Risk stratification based on the cut-off point was conducted to compare the proportion of patients with liver regeneration between subgroups. Results: After radiotherapy, 12 (40%) cases in the training cohort and 13 (61.9%) cases in the validation cohort experienced liver regeneration. The model and nomogram of liver regeneration based on SVs20 (standard residual liver volume spared from at least 20 Gy) and alanine aminotransferase (ALT) showed good prediction performance (AUC = 0.759) in training cohort and performed well (AUC = 0.808) in the validation cohort. The risk stratification according to the cutoffs of SVs20 with 303.4 mL and ALT with 43 U/L demonstrated clear differentiation in risk of liver regeneration between the training(P = 0.049) and entire cohort (P = 0.032). The proportion of patients with liver regeneration decrease progressively with 88.9% in high-probability group (ALT＜43 U/L and SVs20＜303.4 mL), 60% in high-intermediate probability group (ALT ≥43 U/L and SVs20＜303.4 mL), 43.75% in low-intermediate probability group (ALT＜43 U/L and SVs20≥303.4 mL) and 33% in low- probability group (ALT≥43 U/L and SVs20≥303.4 mL). Conclusions: SVs20 and ALT are optimal predictors for liver regeneration. This simple-to-use nomogram is beneficial to the constraints of normal liver outside the radiotherapy target area and make prognosis-based decision without complex calculations. Clinical trial information: ChiCTR1800015350. [Table: see text]

// Zhi-Rui Zhou 1,2,3,* , Min Liu 3,* , Hui-Rong Lu 3 , Ye-Fei Li 3 , Shi-Xiong Liang 3,4 and Chun-Yan Zhang 5 1 Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, P.R. China 2 Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R. China 3 Department of Radiation Oncology, Cancer Hospital of Guangxi Medical University, Nanning, Guangxi Zhuang Autonomous Region, P.R. China 4 Department of Radiation Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, P.R. China 5 Department of Experimental Research, Cancer Hospital of Guangxi Medical University, Nanning, P.R. China * These authors have contributed equally to this work Correspondence to: Shi-Xiong Liang, email: // Chun-Yan Zhang, email: // Keywords : hepatocellular carcinoma, radiotherapy, cancer staging Received : September 20, 2016 Accepted : January 16, 2017 Published : January 28, 2017 Abstract There is no consensus on predicting prognosis for hepatocellular carcinoma patients undergoing radiotherapy. This study aims to evaluate the validity of different staging systems. Overall, 249 hepatocellular carcinoma patients were evaluated retrospectively. All patients were classified by different staging systems. The cumulative survival rates were calculated using the Kaplan-Meier method, and survival curves were compared using the log-rank test. Harrell’s concordance index (c-index) was calculated. The 1-, 3-, and 5-year overall survival rates were 58%, 31% and 20%, respectively. Significant differences in overall survival were observed between stages I and II of the Okuda staging system ( p =0.004), between scores of 3 and 4 of Cancer of the Liver Italian Program prognostic score ( p =0.009), between Chinese University Prognostic Index low-risk and intermediate-risk groups ( p =0.01), between 1 and 2 points of the Japan Integrated Staging score ( p =0.037), between stages III and IV of American Joint Committee on Cancer 1997 TNM staging system ( p =0.011), between stages II and III of American Joint Committee on Cancer 2002 TNM staging system ( p =0.026) and between stages I and II of Guangzhou 2001 staging system ( p =0.000). In conclusion, the Okuda staging system, Chinese University Prognostic Index, and Chinese Guangzhou 2001 staging system were more discriminative than the other staging systems in the prognostic stratification for hepatocellular carcinoma patients undergoing radiotherapy.

Fei-Xiang Wu,1–3,* Hui-Rong Lu,4,* Shao-Liang Zhu,1,* Zi-Hui Li,1 Ling Zou,1 Tao Bai,1 Jie Chen,1 Tian-Bo Yang,1 Shi-Xiong Liang4,51Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, 2Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, 3Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor, Ministry of Education, Shanghai, 4Department of Radiation Oncology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, 5Department of Radiation Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China*These authors contributed equally to this workObjective: The current study aimed to evaluate the efficacy and outcomes of three-dimensional conformal radiotherapy (3DCRT) combined with transarterial chemoembolization (TACE) for treating patients with hepatocellular carcinoma involving portal vein tumor thrombus.Methods: During 2000 and 2013, a total of 182 hepatocellular carcinoma patients with portal vein tumor thrombus were retrospectively analyzed: 68 patients were treated by 3DCRT alone (group A), 74 by TACE alone (group B), and 40 by a combination of 3DCRT + TACE (group C). The overall survival (OS) of the three groups was compared using the Kaplan–Meier method. The independent predictors of survival were identified using multivariate analysis.Results: The total effective rate (complete response + partial response) among all patients was 44% (80/182). The objective response rate (complete response + partial response) was higher in group C than in group A or B, but the differences were not significant. OS rates at 1, 2, and 3years were significantly higher in group C than in group A or B (P

Current evidence demonstrated certain beneficial effects of medicinal herbs as an adjuvant therapy for post-stroke depression (PSD) in China; Chai-hu (Chinese Thorowax Root, Radix Bupleuri) is an example of a medicinal plant for Liver-Qi regulation (MPLR) in the treatment of PSD. Despite several narrative reports on the antidepressant properties of MPLR, it appears that there are no systematic reviews to summarize its outcome effects. Therefore, the aim of this review was to assess the effectiveness and safety of MPLR adjuvant therapy in patients with PSD. Seven databases were extensively searched from January 2000 until July 2016. Randomized control trials (RCTs) involving patients with PSD that compared treatment with and without MPLR were taken into account. The pooled effect estimates were calculated based on Cochrane Collaboration's software RevMan 5.3. Finally, 42 eligible studies with 3612 participants were included. Overall, MPLR adjuvant therapy showed a significantly higher effective rate (RR = 1.23; 95% CI = 1.19, 1.27; p

Xerostomia is a common radiation-induced late complication after radiotherapy. Identifying predictive factors for xerostomia will lead to better treatments and improve the quality of life. This study was conducted to establish an effective predictive nomogram for xerostomia by assessing stage I-IVb (AJCC 7th edition) NPC patients between September 2015 and March 2016. Xerostomia was evaluated via the RTOG/EORTC system. The primary endpoint was grade 2-3 xerostomia 1 year after treatment. The predictive factors for xerostomia were analysed using logistic regression analysis. A nomogram was constructed based on combining the predictors and clinical variables. In total, 102 patients with grade 0-1 xerostomia and 93 patients with grade 2-3 xerostomia were included. The independent predictive factors for xerostomia were V25, V30, V35, and V45 of the ipsilateral parotid gland and mean dose of the contralateral parotid gland. The calibration plot for the probability of xerostomia showed good agreement between prediction by the nomogram and actual observation. The concordance index of the nomogram for predicting xerostomia was 0.796 (95% CI: 0.735-0.857, P

Purpose Chemotherapy use remains controversial for stage II nasopharyngeal carcinoma (NPC). This retrospective study was conducted to identify whether chemoradiotherapy was associated with better survival compared to radiotherapy. Materials and methods The Surveillance, Epidemiology, and End Results (SEER) database was queried for stage II NPC patients between 2004 and 2015. Patients were divided into radiotherapy and chemoradiotherapy groups. Overall survival (OS) and cancer-specific survival (CSS) were examined using the Kaplan-Meier method, Cox proportional hazards models, and propensity score matching analyses. Results This study examined 908 patients, including 102 receiving radiotherapy and 806 receiving chemoradiotherapy. Chemoradiotherapy was associated with 5-year OS (78.01% vs. 75.12%; p = 0.22) and CSS (78.92% vs. 78.26%; p = 0.40) rates comparable to those of radiotherapy. Propensity score matching analyses demonstrated similar OS (HR: 0.63, 95% CI: 0.36–-1.10; p = 0.10) and CSS (HR: 0.77, 95% CI: 0.41–1.48; p = 0.44) rates with radiotherapy. Age >60 years and non-Asian patients were associated with worse survival. Conclusion This study revealed that chemoradiotherapy showed similar survivals to stage II NPC patients compared with radiotherapy. Due to the limitations of SEER database, further studies should be performed to verify the results.

Background: Several epidemiological articles have reported the correlations between anti-osteoporosis medication and the risks of fractures in male and female subjects, but the specific efficacy of anti-osteoporosis medication for male subjects remains largely unexplored. Objective: The aim of this study was to evaluate the correlation between anti-osteoporosis medication and the risk of fracture in relation to low bone mass [including outcomes of osteoporosis, fracture, and bone mineral density (BMD) loss] in male subjects analyzed in studies within the updated literature. Methods: Randomized controlled trials (RCTs) that analyzed the effectiveness of a treating prescription for male subjects with osteoporosis (or low BMD) and that focused on the outcomes of fracture were included. Relevant studies from Embase, Web of Science, PubMed, and Chinese database of CNKI were retrieved from inception to January 30th, 2019. Two staff members carried out the eligibility assessment and data extraction. The discrepancies were settled by consultation with another researcher. We calculated the pooled relative risks (RRs) based on 95% confidence intervals (CIs). Results: Twenty-seven documents (28 studies) with 5,678 subjects were identified. For the category of bisphosphonates, significant results were observed in pooled analyses for decreased risk of the vertebral fracture domain (RR, 0.44 [95% CI, 0.31–0.62]), nonvertebral fracture domain (RR, 0.63 [95% CI, 0.46–0.87]), and clinical fracture domain (RR, 0.59 [95% CI, 0.48–0.72]) compared with those of controls. Participants with bisphosphonates had a 56% (95% CI = 38–69%) lower risk of vertebral fractures, 37% (95% CI = 13–54%) lower risk of nonvertebral fractures, and 41% (95% CI = 28–52%) lower risk of clinical fractures. Furthermore, meta-analyses also demonstrated a decreased risk of the vertebral fracture domain via treatment with risedronate (RR, 0.45 [95% CI, 0.28–0.72]) and alendronate (RR, 0.41 [95% CI, 0.23–0.74]), but not with calcitriol, calcitonin, denosumab, ibandronate, monofluorophosphate, strontium ranelate, teriparatide, or zoledronic acid, compared with that of controls. Conclusions: This systematic review confirms that bisphosphonates were connected with a decreased risk of vertebral fractures, nonvertebral fractures, and clinical fractures for male subjects with osteoporosis. Future research is needed to further elucidate the role of nonbisphosphonates in treating fractures of osteoporosis subjects.

Objective The Dengzhan Shengmai (DZSM) capsule is a commercially available type of Chinese herbal medicine frequently administered to improve neurological impairment after stroke. Its ability to prevent recurrent stroke, however, has not been determined. This study therefore evaluated the ability of DZSM as an add-on to conventional secondary preventive agents to prevent recurrent ischemic stroke. Methods In this randomised, double-blind, placebo-controlled trial, conducted at 83 hospitals in Mainland China, 3143 patients in 14–180 days after the initial onset of ischemic stroke, were randomly allocated to the DZSM (0.36 g, twice daily for 12 months) or the placebo group. All patients in both groups received standard secondary preventive medications. The primary outcome was the 1-year incidence of stroke. Between group differences were assessed using the Cox proportional hazards model. Results Intent-to-treat analysis showed that 58 (3.8%) participants in the DZSM group and 82 (5.4%) in the placebo group experienced new stroke events (hazard ratio = 0.70, 95% confidence interval = 0.50–0.98, P = 0.036). The type and incidence of adverse events were similar in the DZSM and placebo groups. Conclusions The addition of DZSM capsules to standard secondary preventive agents provides additional benefits after the initial onset of ischemic stroke, reducing recurrent stroke without increasing severe adverse events. However, further study is needed to elucidate the role of DZSM on the updated practice of conventional secondary prevention for ischemic stroke.

The aim of this research was to study the pharmacokinetic characteristics of a slow-release 5-fluorouracil implant as well as to evaluate the clinical drug activity of this preparation in pancreatic cancer patients. Pharmacokinetic characteristics of the slow-release 5-fluorouracil implant were evaluated by examining the half-life time (T1/2) and apparent volume of distribution (Vd) in pancreatic cancer patients; the slow-release 5-fluorouracil implant was administered through interstitial chemotherapy (tumor interstitium implantation). In the drug activity study, 36 locally advanced unresectable pancreatic cancer patients were divided randomly into an experimental treatment group (n=18) and a standard treatment group (n=18). The experimental treatment group was treated with interstitial chemotherapy of a slow-release 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine; the standard treatment group was treated with systemic chemotherapy of gemcitabine. An internal drainage procedure was used when biliary and/or gastrointestinal tract obstruction occurred in the two groups. Clinical benefit response, including pain (visual analogue scale), analgesic drug use, general conditions (Karnofsky performance score), weight changes, and survival status, was observed. T1/2 of the slow-release 5-fluorouracil implant was 5475.8±136.4 min, whereas Vd was 45275.0±1028.6 l. Clinical benefit response in the experimental treatment group was better than that in the standard treatment group. The experimental treatment group had longer median survival time compared with the standard treatment group. The slow-release 5-fluorouracil implant could deliver drugs mainly in the regional area of the tumor and prolong the drug action time; interstitial chemotherapy of a 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine could improve the quality of life and survival status of pancreatic cancer patients. The method was promising and worthy of in-depth investigations.

Many publications have reported the growing application of complementary and alternative medicine, particularly the use of Chinese herbal medicine (CHM) in combination with routine pharmacotherapy (RP) for senile vascular dementia (SVD), but its efficacy remains largely unexplored. The purpose of this study is to evaluate the efficacy of CHM adjunctive therapy (CHMAT), which is CHM combined with RP, in the treatment of SVD. Publications in seven electronic databases were searched extensively, and 27 trials with a total of 1961 patients were included for analysis. Compared with RP alone, CHMAT significantly increased the effective rate [odds ratio (OR) 2.98, 95% confidence interval (CI) 2.30, 3.86]. In addition, CHMAT showed benefits in detailed subgroups of the Mini-Mental State Exam (MMSE) score from time of onset to 4 weeks (WMD 3.01, 95% CI 2.15, 3.87), 8 weeks (weighted mean difference (WMD) 2.30, 95% CI 1.28, 3.32), 12 weeks (WMD 2.93, 95% CI 2.17, 3.69), and 24 weeks (WMD 3.25, 95% CI 2.61, 3.88), and in the activity of daily living scale score from time of onset to 4 weeks (WMD -4.64, 95% CI -6.12, -3.17), 8 weeks (WMD -4.30, 95% CI -6.04, -2.56), 12 weeks (WMD -3.89, 95% CI -4.68, -3.09), and 24 weeks (WMD -4.04, 95% CI -6.51, -1.57). Moreover, CHMAT had positive effects on changes in the Hasegawa dementia scale, National Institutes of Health Stroke Scale, Clinical Dementia Rating, and Montreal Cognitive Assessment scores, as well as blood fat levels (total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and apolipoprotein E), platelet aggregation rate (1-min platelet aggregation rate, 5-min platelet aggregation rate, and maximal platelet aggregation rate), and blood rheology (whole-blood viscosity and hematocrit). No serious or frequently occurring adverse effects were reported. Weaknesses of methodological quality in most trials were assessed using the Cochrane risk of bias tool, while the quality level of Grades of Recommendations Assessment Development and Evaluation (GRADE) evidence classification indicated 'very low'. This systematic review suggests that CHM as an adjunctive therapy can improve cognitive impairment and enhance immediate response and quality of life in SVD patients. However, because of limitations of methodological quality in the included studies, further research of rigorous design is needed.

Background Extranodal natural killer/T-cell lymphoma (ENKTL) is a rare lymphoid malignancy with diverse clinical features and prognoses. The aims of this study were to explore the pretreatment prognostic factors of ENKTL and develop a new individual prognostic model. Patients and Methods We retrospectively enrolled 81 ENKTL patients with newly diagnosed disease between June 2006 and August 2017 at the Affiliated Cancer Hospital of Guangxi Medical University. Survival analysis was used to assess the prognostic value of various factors. A nomogram was developed to predict overall survival (OS) based on the Cox proportional hazards model. Results The median survival time of the patients was 48 months, and the 5-year OS rate was 47.5%. Cox regression analysis showed that the prognostic factors of OS for ENKTL patients included Eastern Cooperative Oncology Group performance status, Ann Arbor stage, pretreatment albumin-to-globulin ratio, and platelet count. A prognostic nomogram was developed to predict the OS rate for ENKTL patients based on these factors. The calibration curve showed that the nomogram was able to predict OS accurately. The concordance index of the nomogram for OS prediction was 0.807. Conclusion Our proposed nomogram based on Eastern Cooperative Oncology Group performance status, Ann Arbor stage, albumin-to-globulin ratio, and platelet count provides an individualized risk estimate of OS in patients with ENKTL.

// Ling-Feng Zeng 1,2,* , Ye Cao 3,* , Wei-Xiong Liang 2,* , Wen-Hu Bao 4 , Jian-Ke Pan 2 , Qi Wang 2 , Jun Liu 2 , Hao-Dong Liang 2 , Hui Xie 2 , Yan-Ting Chai 1 , Zi-Tong Guan 4 , Qian Cao 2 , Xiao-Yan Li 2 , Lei Yang 1 , Wei-Hua Xu 1 , Sui-Qing Mi 1 and Ning-Sheng Wang 1 1 Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, China 2 The 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China 3 Department of Clinical Research/National Clinical Trials Institute, Sun Yat-sen University Cancer Center, Guangzhou, China 4 World Federation of Chinese Medicine Societies, Beijing, China * These authors have contributed equally to this work Correspondence to: Jun Liu, email: // Qi Wang, email: // Keywords : cognitive disorders; dementia of Alzheimer type; fish-oriented dietary intake; risk factors; meta-analysis Received : November 10, 2016 Accepted : February 07, 2017 Published : March 17, 2017 Abstract Epidemiological studies have presented inconsistent evidence of the correlation between a fish-oriented dietary intake (FDI) and the risk of cognitive decline. To address these controversies, we performed this systematic review of prospective studies published in December 2016 and earlier using PubMed, Embase, and Web of Science. Two independent researchers conducted the eligibility assessment and data extraction; all discrepancies were solved by discussion with a third researcher. The pooled relative risks (RRs) focused on the incidence of events were estimated with 95% confidence intervals (CIs). Overall, nine studies containing 28,754 subjects were analyzed. When the highest and lowest categories of fish consumption were compared, the summary RR for dementia of Alzheimer type (DAT) was 0.80 (95%CI = 0.65–0.97); i.e., people with a higher intake of fish had a 20% (95%CI = 3–35%) decreased risk of DAT. Additionally, the dose-response synthesized data indicated that a 100-g/week increase in fish intake reduced the risk of DAT by an additional 12% (RR = 0.88, 95%CI = 0.79–0.99). Non-significant results were observed for the risk of dementia of all causes (DAC) and mild cognitive impairment (MCI). Limited evidence involving heterogeneity was found within subgroups or across studies. In conclusion, this review confirmed that a higher intake of fish could be correlated with a reduced risk of DAT. Further research, especially prospective studies that specifically quantify FDI, will help find a more accurate assessment of the different levels of dietary intake.

Background: Xingnaojing injection (XNJ) sharpen the mind and induce consciousness and are widely used in acute phases of intracerebral hemorrhage (ICH). Naloxone hydrochloride injection (NX) performs equally well and replace the effects of morphine-like substances to promote conscious awareness. The applications of XNJ combined with NX for ICH show some advantages compared with NX applied individually. The aim of this systematic review is to evaluate the effectiveness and safety of XNJ combined with NX for ICH. Methods: Comprehensive searches were conducted in 8 medical databases (PubMed, Cochrane Library, Web of Science, Embase, CNKI, VIP, CBM and Wanfang database) from inceptions to October 2017 for randomized controlled trials (RCTs) that compared the applications of XNJ and NX with NX applied individually in ICH. Literature screening, assessing risk of bias and data extraction were conducted by 2 reviewers independently. According to the Cochrane Collaboration's RevMan5.3 software to perform the data analysis. Results: 32 RCTs (3068 cases) were selected and the quality of studies were low. All trials compared XNJ and NX with NX applied individually. The overall meta-analysis results showed that XNJ combined with NX have significant effect on clinical efficacy (OR 3.78, 95% CI: 3.03–4.73; P

BACKGROUND Medical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association. OBJECTIVE The purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs. METHODS Four medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software. RESULTS Among those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009. CONCLUSION Compared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.

Protection of individual rights and vulnerable groups is critical, and it is increasingly recognized that all countries wishing to engage with the international scientific community must set high standards, have robust regional ethical committees (RECs), and ensure genuine and complete compliance [1–3]. Despite raising concerns over the protection of subjects, over 90% of the included articles did not mention the reporting of REC approval [4]. These results are unexpected, because most journals request authors to report REC approval or ethical considerations. In views of this, Dr. Rosenberg’s paper [5]

Objective To evaluate the feasibility of laparoscopic vaginal reconstruction using an ileal segment in patients with vaginal atresia, male-female transsexual patients, or patients who had vaginal cancer. Methods A retrospective review of the records of 80 patients who underwent laparoscopic vaginoplasty between 2004 and 2007 at Beijing Anzhen Hospital, China. Results Nineteen (23.8%) patients underwent total laparoscopic vaginoplasty and 61 (76.3%) underwent laparoscope-assisted vaginoplasty. There were 64 (80.0%) primary operations and 16 (20.0%) secondary operations. All of the surgeries were completed successfully and no intraoperative complications occurred. Mean follow-up time was 14 months. Postoperatively, 5 women had vaginal stenosis, while 4 women had no sexual partner during the follow-up period which meant that they could not be assessed completely. The remaining 71 patients were satisfied with their sexual lives after surgery. Conclusion Vaginal reconstruction performed via total laparoscopic vaginoplasty or a laparoscope-assisted technique using an ileal segment has a high success rate for a functional vagina and patient satisfaction.

OBJECTIVE To test the reliability and validity of Health Scale of Traditional Chinese Medicine (HSTCM) by means of questionnaires. METHODS A cross-sectional survey was conducted at Liwan Community of Guangzhou, Old People's Home in Guangzhou and Outpatient Department of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 652 Chinese individuals (over 18 years old) were assessed with the 88-item version of HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF), which were randomly delivered to them. Some socioeconomic characteristics were registered. RESULTS A test-retest reliability (15-day interval) was found among the 76 persons who completed the questionnaires by themselves. Intra-class correlation coefficient (ICC) was 0.93. Associated 95% confidence interval (CI) was 0.89-0.96. Split-half reliability was 0.79. Inter-investigator reliability (0.93) was also good, and the ICC of HSTCM was 0.90 (95%CI 0.67-0.97). The correlation between HSTCM and WHOQOL-BREF was -0.66. The correlations of HSTCM and questionnaire deliver order, investigator, interview date and interview time were 0.06, -0.12, -0.17 and 0.20 respectively. The correlation between HSTCM and self-rated health (0.46) was greater than that between HSTCM and chronic illness (0.28). Divided by individuals with or without chronic illness, area under the ROC (receiver operator characteristic) curve for HSTCM was 0.67 (95%CI 0.63-0.71). CONCLUSION It indicates that the HSTCM is conceptually valid with satisfactory psychometric properties and forms a basis for further applications in clinical research of traditional or integrative medicine.

The members of guideline development of traditional Chinese medicine and integrative medicine were not chosen according to strict standards at present. The major problems in clinical guideline development include the insufficiency of evidence and the missing recommendation according to evidence reliability. In order to establish a clinical guideline for the treatment, we should abide by the principle for guideline development in this field. Firstly, a guideline development group must be set up and the evidences are needed to be classified correctly. To facilitate the clinical practice, the recommendations in the treatment guideline should be divided into different classes and the referring recommendation reasons should be given at the same time. Only when the guideline development principles and procedures are strictly followed can a clinical guideline for the treatment suitable to the situation in China be established.

Objectives To assess if the maternal pre-pregnancy weight status (MPWS) alters the association of early infant feeding pattern (at one and third months) with infant body mass index (BMI) in the first two years of life. Methods A cohort of 2,220 neonates were recruited in a community-based study conducted in China. Body weight and length were measured at birth, at age one and two, with BMI calculated accordingly. The BMI z-scores (BMI-Z) were computed according to the World Health Organization Growth Standard (2006). Feeding patterns were classified as exclusive breastfeeding (EBF), mixed feeding (MF), and formula feeding (FF). General linear models (GLM) were employed to estimate main and interaction effects of EBF and MPWS on children’s BMI-Z. Results No main effect of MPWS was found on child BMI-Z at ages one and two, nor the feeding patterns. An interaction between MPWS and feeding patterns was detected (p

Purpose: To identify risk factors relevant to radiation-induced liver disease (RILD) and to determine the hepatic tolerance to radiation. Methods and Materials: The data of 109 primary liver carcinomas (PLC) treated with hypofractionated three-dimensional conformal radiation therapy (3D-CRT) were analyzed. Seventeen patients were diagnosed with RILD and 13 of 17 died of it. Results: The risk factors for RILD were late T stage, large gross tumor volume, presence of portal vein thrombosis, association with Child-Pugh Grade B cirrhosis, and acute hepatic toxicity. Multivariate analyses demonstrated that the severity of hepatic cirrhosis was a unique independent predictor. For Child-Pugh Grade A patients, the hepatic radiation tolerance was as follows: ( 1 ) Mean dose to normal liver (MDTNL) of 23 Gy was tolerable. ( 2 ) For cumulative dose–volume histogram, the tolerable volume percentages would be less than: V 5 of 86%, V 10 of 68%, V 15 of 59%, V 20 of 49%, V 25 of 35%, V 30 of 28%, V 35 of 25%, and V 40 of 20%. ( 3 ) Tolerable MDTNL could be estimated by MDTNL (Gy) = −1.686 + 0.023 * normal liver volume (cm 3 ). Conclusion: The predominant risk factor for RILD was the severity of hepatic cirrhosis. The hepatic tolerance to radiation could be estimated by dosimetric parameters.

BACKGROUND Adjunctive treatment with medication of liver-soothing-oriented method (MLSM) is one of the most commonly used approaches for subjects with depression after cerebrovascular accident (DCVA) in China. The purpose of this meta-analysis was to evaluate the outcome of MLSM treatment in subjects with DCVA using relevant published literature. METHODS The PubMed, Cochrane Library, Embase, Chinese databases of China National Knowledge Infrastructure, WanFang, Sinomed, and VIP were used to collect all publications until March 2016. Randomized controlled trials comparing treatments with and without MLSM for subjects with DCVA were included. The quality of each publication was assessed based on the recent Handbook (5.1 version) for Cochrane Reviewers. Cochrane Collaboration's software RevMan 5.3 software was applied for data analysis. RESULTS Thirty studies, including 2599 cases, were identified and collected. Adjunctive treatment with MLSM noticeably enhanced total effective rates (odds ratio 3.76; 95% confidence interval [CI] 2.92-4.85, I = 0%, P = 0.96) in comparison to non-MLSM conventional pharmacotherapy. Compared to non-MLSM treatment, the changes of Hamilton Depression Scale in adjunctive treatment with MLSM, respectively, decreased and showed beneficial effects after 3 weeks (weighted mean difference [WMD] -4.83; 95% CI -6.82 to -2.83; I = 86%, P

OBJECTIVE Due to the differences between Chinese and Western cultures, Chinese version of foreign research instruments may not be totally applicable for use in evaluating the therapeutic effect of traditional Chinese medicine (TCM). Great efforts have been made by Chinese researchers to develop scales for evaluation of the therapeutic effects of TCM. This study aims to understand the current situation of research in the development of evaluation instrument in TCM. METHODS Database searches of Chinese Biomedical Literature Database, China Academic Journal Network Publishing Database and Chinese Scientific Journals Database were undertaken to identify published studies with the purpose of developing instruments in assessing the effectiveness of TCM, including papers regarding the construction of conceptual framework of instrument, item generation and selection and the evaluation of measurement properties. RESULTS A total of 60 pieces of literature involving 36 instruments were included. The first article on the development of each of the instruments was published between 2005 and 2011 and the instruments were used in many kinds of medical conditions, including cardiocerebrovascular, respiratory, digestive and infectious diseases. The number of items ranged from 10 to 52. Of the 36 instruments, 13 (36.1%) defined the hypothesized concepts measured by the instrument, 30 (83.3%) reported the domains of the questionnaires before measurement property testing and all of them were multidomain. Of 32 studies regarding item selection and the instrument's property evaluation, 14 (43.8%) articles reported the administration mode, 24 (75%) reported response option types, and 10 (31.5%) provided scoring algorithm for the scale, but none of these 32 studies specified the recall period. In 29 studies aiming at testing instrument's measurement property, 28 articles tested the Cronbach's α coefficient of the full scale and/or subscales, and retest reliability was also detected in 15 studies. Twenty-seven studies evaluated the construct validity by exploratory factor analysis and among them there were two studies applying confirmatory factor analysis. Content validity, responsiveness and feasibility of instruments were assessed in 11, 16 and 16 studies, respectively. CONCLUSION This study shows that in recent years many instruments have been developed in an attempt to evaluate the therapeutic effects of TCM, but some problems still exist in their practical implementation, including negligence in outlining the hypothesized concepts of the TCM instruments and in the reporting of instrument's content validity such as administration mode, scoring and recall period. Some instrument attributes and testing methods were misunderstood and/or misused. Revision of instruments is rarely carried out, though the development of an instrument is an iterative process. Researchers should have a thorough understanding of the general procedure and steps before starting to develop an instrument.

As one of the significant parts of medical science research in China, the research on Chinese medicine (CM) reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture. Therefore, in the practice of ethics review on CM research protocols, besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study, we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values. In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics, and then attempted to summarize the key points for the bioethics review to CM researches in China, so as to serve as reference for the bioethics review to traditional and alternative medicine researches.

Purpose Radiation-induced liver disease (RILD) is the most severe complication in liver cancer treatment. The aim of this study was to identify dosimetric predictors for RILD in primary liver carcinoma (PLC) patients with Child–Pugh Grade A cirrhosis after hypofractionated conformal radiotherapy (CRT). Methods and materials A total of 114 eligible patients (mean age 45years old) were enrolled and treated. The mean gross tumor volume (GTV) was (378.3±308.1) cm 3 . A median dose of 53Gy was delivered to the PLC by hypofractionated CRT (three fractions/week) with a median fraction size of 4.6Gy (range: 4–6Gy). Results Patients were followed up for 1–79months (median 19months) after the completion of irradiation. RILD was diagnosed in nine (7.9%) patients. Univariate analyses revealed that GTV and the percentage of normal liver volume receiving more than 5–40Gy irradiations (V 5–40 ) were related to the risk of developing RILD. Multivariate analyses demonstrated that only GTV and V 20 were independent predictors. Using V 20 as the predictor for RILD, the accuracy, sensitivity, and specificity was 76.3%, 88.9%, and 75.2%, respectively. Conclusions Our data suggest that V 20 is the unique significant dosimetric predictor for RILD risks in PLC patients with Child–Pugh Grade A cirrhosis after hypofractionated CRT.

To explore the composition characteristics of traditional Chinese medicine (TCM) syndromes in patients with acute ischemic stroke of yin or yang syndrome by investigating the characteristics of TCM syndromes at different periods after onset.One thousand two hundred and forty-six patients with acute ischemic stroke were admitted in twenty hospitals. According to the "diagnostic criteria of syndrome differentiation of stroke", the characteristics of syndromes in the patients were investigated at the periods of 1-3 days, 4-10 days and 11-30 days after they had ischemic stroke. General distribution of six basic syndromes was compared between the patients with yin syndrome and the patients with yang syndrome at the three periods. The six basic syndromes were wind syndrome, pathogenic fire syndrome, phlegm syndrome, blood stasis syndrome, qi deficiency syndrome, and syndrome of yin deficiency and yang hyperactivity.The percentages of wind, pathogenic fire, and phlegm syndromes in the patients were decreased at the period of 11-30 days as compared with the period of 1-3 days (87.1% vs 79.3%, 52.1% vs 38.7% and 67.1% vs 57.4% respectively, P0.01). However, the percentages of the syndromes of blood stasis, qi deficiency, and yin deficiency and yang hyperactivity were similar at the three periods (P0.05). There were no differences in the distribution of yin and yang syndromes among the three periods (P0.05). The percentages of syndromes of wind, pathogenic fire, phlegm, and yin deficiency and yang hyperactivity were higher (P0.01), and the percentages of syndromes of blood stasis and qi deficiency were lower (P0.05, P0.01) in patients with yang syndrome than in patients with yin syndrome. The complex of three syndromes was the most frequent composition pattern in the patients at the three periods. The percentages of complex syndromes of four or five syndromes were higher, and the percentages of single-syndromes and complex syndromes of two syndromes were lower in patients with yang syndrome than in patients with yin syndrome (P0.05, P0.01). The most frequent complex syndromes in patients with yin syndrome were complex syndrome of wind, phlegm, blood stasis and qi deficiency, and complex syndrome of wind, phlegm and qi deficiency; while the most frequent complex syndromes in patients with yang syndrome were complex syndrome of wind, pathogenic fire, phlegm and qi deficiency, and complex syndrome of wind, pathogenic fire and phlegm.The main discrimination between the yin and yang syndromes is that the yang syndrome is characterized by pathogenic fire. The syndromes of phlegm, qi deficiency, and blood stasis are not associated with the diagnosis of yin or yang syndrome.

BACKGROUND The purpose of the current study was to evaluate the tolerance and efficacy of hypofractionated three-dimensional conformal radiotherapy (3DCRT) with or without transarterial chemoembolization (TACE) for technically unresectable or medically inoperable primary liver carcinoma (PLC). METHODS Between April 1999 and August 2003, 128 patients with a clinical diagnosis of PLC received hypofractionated 3DCRT at Cancer Hospital, Guangxi Medical University. Both hypofractionated 3DCRT and TACE were used to treat 48 of these 128 patients. Liver cirrhosis of Child–Pugh Grade A was found in 108 patients, and Grade B was found in 20 patients. The mean gross tumor volume (GTV) was 459 ± 430 cm3. A mean total irradiation dose of 53.6 ± 6.6Gy was delivered at an average fraction of 4.88 ± 0.47Gy, 3 times a week using 8-MV photons. RESULTS The median follow-up time after 3DCRT was 12 months (range, 2–56 mos.). The immediate response rate was 55%. The overall survival rates at 1, 2, and 3 years were 65%, 43%, and 33%, respectively, with a median survival of 20 months (range, 7–31 mos.). Radiation Therapy Oncology Group (RTOG) Grade 2 acute gastrointestinal complications developed in 8 patients, whereas 4 patients developed Grade 3 late gastrointestinal complications. Radiation-induced liver disease (RILD) developed in 19 (15%) patients, of which 12 had Child–Pugh Grade B liver cirrhosis, and 7 had Grade A. GTV and associated liver cirrhosis were identified by Cox regression analysis as independent predictors for survival (P = 0.044 and 0.015). CONCLUSIONS Hypofractionated 3DCRT is effective in carefully selected patients with PLC. Gastrointestinal complications and RILD were the most distinct complications. Cancer 2005. © 2005 American Cancer Society.