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EPREX®/ERYPO®/PROCRIT® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as per the recommendation provided by European Medicines Agency. EPIAO® is a biosimilar formulation of EPREX®, and making it a 1:1 dose conversion from EPREX® according to recommendation of European Medicines Agency. This study evaluated the clinical efficacy and safety of EPIAO® in subjects with end-stage renal disease receiving hemodialysis after intravenous administration.This study was a multicenter, prospective, randomized, double-blind, parallel-group, 2-cohort, maintenance phase, therapeutic equivalence study to evaluate a 1:1 dose conversion from EPREX® to EPIAO® in terms of clinical efficacy and safety that was conducted at 20 sites in 2 countries in patients with end-stage renal disease on hemodialysis. Eligible subjects were treated with EPREX® (reference product of epoetin) for a period of at least 3 months before the treatment period, and then were randomly assigned to the group of EPREX® or EPIAO®. Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO®/EPREX® in parallel groups.A total of 200 people received the random intervention and were included in the safety set. After 6, 9, and 12 months of treatment with EPIAO® or EPREX®, there were no significant differences in the hemoglobin levels of the 2 groups compared with baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. There were no significant differences in the incidence of adverse events between the EPIAO® and EPREX® groups. Most adverse events were mild to moderate and were reverted/resolved.EPIAO® demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis.

Laryngeal injury is common after endotracheal intubation, presenting with varying degrees of edema, ulceration, granulation, and limited vocal cord movement, usually resulting in lumen narrowing. In these cases, laryngeal edema is a common complication after intubation, usually caused by direct pressure and inflammatory reaction caused by endotracheal intubation on the contact surface.A 71-year-old female was scheduled to undergo open reduction and internal fixation of femoral neck. On admission, she was diagnosed with femoral neck fracture. Tracheal intubation induced by general anesthesia was successful, but the tracheal catheter was difficult to remove after the operation. After 2 days of detumescence in ICU, the extubation was successful under the condition of complete recovery of spontaneous breathing.Patients undergoing general anesthesia may have laryngeal or glottic edema due to operation time, operation and other reasons, resulting in difficulty in extubation after general anesthesia. The extubation action shall be gentle. In case of obvious resistance, it shall not be forcibly extubated to prevent serious dyspnea after extubation.

Rationale: Hematopoietic stem cell transplantation (HSCT) is the most effective treatment for the majority of patients who have malignant haemolytic disease. Although the success rate of HSCT has increased, the increasing number of cases suffering from secondary solid malignancies after HSCT has attracted more interest recently. Patient concerns: A 16-year-old female patient from China presented with a crusty and painful lesion on the left buccal mucosa with a history of chronic graft-versus-host disease following allogeneic HSCT for acute myeloid leukaemia. Diagnosis: An incisional biopsy of the lesion showed stratified squamous epithelium mucosa with severe dysplasia (carcinoma in situ). Subsequently, a wide local excision was performed and histological examination revealed early infiltrating squamous epithelial mucosa (carcinoma in situ). Interventions: She was being treated in the oral and maxillofacial surgery clinic with an incisional biopsy of the left buccal mucosa. She also received a wide local excision. Outcomes: Follow-up for 4 years showed no recurrence. Lessons: This case helps raise awareness of the diagnosis of oral symptoms in young patients after HSCT. Due to the increasing application of HSCT, raising awareness in oral and dental physicians may be required to improve long-term clinical outcome of patients who underwent HSCT.

Background: As the gold standard for imaging sinus disease, the main disadvantage of computed tomography (CT) of the pediatric paranasal sinus is radiation exposure. Because of this, 1 protocol for CT should reduce radiation dose while maintaining image quality. The aim of this study is to evaluate the image quality of dose-reduced paranasal sinus computed tomography (CT) using an ultralow tube voltage (70 kVp) combined with iterative reconstruction (IR) in children. Methods: CT scans of the paranasal sinus were performed using different protocols [70 kVp protocols with IR, Group A, n = 80; 80 kVp protocols with a filtered back projection algorithm, Group B, n = 80] in 160 pediatric patients. Then, the volume-weighted CT dose index, dose-length product, and effective dose were estimated. Image noise, the signal-to-noise ratio and the diagnostic image quality were also evaluated. Results: For the radiation dose, the volume-weighted CT dose index, dose-length product and effective dose values were significantly lower for the 70 kVp protocols than for the 80 kVp protocols (P

This study aimed to evaluate the onset characteristics of patients with uremia undergoing maintenance hemodialysis complicated with COVID-19, so as to improve the understanding, diagnosis, and treatment.26 cases were confirmed cases of COVID-19. Confirmed patients with COVID-19 undergoing maintenance hemodialysis in the blood purification center were recruited. The general data of patients, including age, sex, duration of dialysis, and basic diseases, were analyzed. The clinical features included fever, respiratory symptoms, and gastrointestinal symptoms. The items for laboratory tests included blood routine examination, liver function, C-reactive protein, procalcitonin, creatine kinase, creatine kinase-MB, markers of myocardial injury, B-type natriuretic peptide, D-dimer, and so forth. The imaging examinations referred mainly to computed tomography imaging findings of the lungs.Twenty-one cases were complicated with chronic basic diseases, such as hypertension or diabetes. In terms of clinical manifestations, 13 cases had fever, which was close to the number of cases without fever (13 cases). The respiratory symptoms included dry cough (19 cases), shortness of breath (9 cases), fatigue (11 cases), and so forth. Further, 15 patients had hypoxemia, indicating more severe patients. Sore throat (2 cases) was not significant, and a few patients reported gastrointestinal symptoms (3 cases). The results of blood routine examination showed decreased absolute lymphocyte count (0.7 ±â€Š0.4 × 10∼9/L), lower hemoglobin level (105.2 ±â€Š20 g/L), and normal absolute neutrophil count 4.2 (3.0, 5.9) × 10∼9/L. Of the inflammatory indexes, procalcitonin was 0.69 (0.24, 2.73) ng/mL; C reactive protein was 17.2 (5.2, 181.6) mg/L, which was higher than normal. Blood biochemistry revealed lower albumin level (38.0 ±â€Š4.0 g/L) and higher troponin 0.11(0.035, 6.658) ng/mL and myoglobin levels (538.5 ±â€Š240.5 ng/mL), suggesting myocardial injury.The patients with uremia and confirmed COVID-19 undergoing maintenance hemodialysis are more common in males. Although the proportion of fever patients is 50%, the proportion of hypoxemia patients is high (58%). With poor cardiac function. They were prone to respiratory failure complicated with heart failure. According to the onset characteristics of this population, early diagnosis and treatment could help reduce the risk of developing a critical illness and control the spread of the COVID-19 epidemic.

The main purpose of this study was to build a prediction model for patients with contralateral breast cancer (CBC) using competing risks methodology. The aim is to help clinicians predict the probability of CBC in breast cancer (BC) survivors. We reviewed data from the Surveillance, Epidemiology, and End Results database of 434,065 patients with BC. Eligible patients were used to quantify the association between the development of CBC and multiple characteristics of BC patients using competing risk models. A nomogram was also created to facilitate clinical visualization and analysis. Finally, the stability of the model was verified using concordance index and calibration plots, and decision curve analysis was used to evaluate the clinical utility of the model by calculating the net benefit. Four hundred thirty-four thousand sixty-five patients were identified, of whom 6944 (1.6%) developed CBC in the 10 years follow-up. The 10-year cumulative risk of developing CBC was 2.69%. According to a multivariate competing risk model, older patients with invasive lobular carcinoma who had undergone unilateral BC surgery, and whose tumor was better differentiated, of smaller size and ER-negative/PR-positive, had a higher risk of CBC. The calibration plots illustrated an acceptable correlation between the prediction by nomogram and actual observation, as the calibration curve was closed to the 45° diagonal line. The concordance index for the nomogram was 0.65, which indicated it was well calibrated for individual risk of CBC. Decision curve analysis produced a wide range of risk thresholds under which the model we built would yield a net benefit. BC survivors remain at high risk of developing CBC. Patients with CBC have a worse clinical prognosis compared to those with unilateral BC. We built a predictive model for the risk of developing CBC based on a large data cohort to help clinicians identify patients at high risk, which can then help them plan individualized surveillance and treatment.

Supplemental Digital Content is available in the text, Evidence on the prescription patterns of antihypertensive drug use in children and adolescents in China is scarce. A descriptive analysis of the Beijing Medical Claim Data, which covered over 95% of the urban residents, was conducted to investigate antihypertensive prescribing patterns and trends in children and adolescents aged under 18 from 2009 to 2014 in Beijing, China. An additional meta-analysis of trends in hypertension prevalence was conducted to compare trends with antihypertensive medications. A total of 11,882 patients received at least 1 prescription for antihypertensive drugs from 2009 to 2014. The number of annual antihypertensive users increased from 2009 to 2012, then declined steadily until 2014, which was consistent with the trend of the hypertension prevalence estimated from the meta-analysis. β-receptor blockers, thiazide diuretics, and angiotensin-converting enzyme inhibitors were the 3 most commonly prescribed antihypertensive drugs. More boys took the antihypertensive drugs than girls. For users aged under 3 years, thiazide diuretics, α-receptor blockers, and angiotensin-converting enzyme inhibitors were the most prescribed drugs, while β-receptor blockers, thiazide diuretics were the most used drugs for users above 3 years. In conclusion, antihypertensive drug prescribing for children and adolescents increased from 2009 to 2014, with different characteristics in different subgroups.

To explore the relationship between baseline information, personal factors, working characteristics and job performance among nurses in emergency department in northern Taiwan. Two-hundred twenty-two nursing staff were interviewed repeated with structured questionnaires for data collection in 3 time points (From August to September, 2008, from February to March, 2009, and from November to December, 2009). The generalized estimating equation (GEE) is used to test the relationship between the domains of independent variables (baseline information, personal factors, working characteristics) and dependent variables (task performance, contextual performance). The mean age of participants is 30.1 ± 5.1 years. 50.0% are junior college or bachelor degrees. From the GEE model, biological protection (β = 0.17, P value = .002) and safety climate (β = 0.24, P value

Supplemental Digital Content is available in the text, The purpose of this study was to describe the prescription pattern of initial treatment for type 2 diabetes (T2DM) in Beijing from 2011 to 2015. We selected 790,339 newly diagnosed outpatients with T2DM from the Beijing Medical Claim Data for Employees database between January 2011 and December 2015. The percentages of different treatments and agents were calculated from the patients’ 1st prescriptions. Subgroup analyses were conducted for primary, secondary, and tertiary hospital settings. The initial treatments given to 57.7%, 30.7%, and 11.7% of patients were oral hypoglycemic agent (OHA) monotherapy, OHA polytherapy, and insulin, respectively. Alpha-glucosidase inhibitors (AGIs) (43.0%) were the most commonly used agents for monotherapy, followed by metformin (35.5%) and sulfonylureas (14.9%). AGIs were most commonly used in primary hospitals (52.0%), while metformin was prescribed most often in secondary (37.6%) and tertiary (41.8%) hospitals. From 2011 to 2015, there were increases in the use of AGIs (40.1–41.1%, P

To assess the mental health of nurses and to find the post responsibility and psychological status of clinical nurses. A total of 447 nursing staff at different levels in a teaching hospital was assessed by nursing post responsibility scale and mental symptom checklist (SCL-90) then compared with each other. The study period was from April 1, 2018 to April 30, 2018. There was a positive correlation between the responsibility of post and interpersonal relationship (r = 0.11, P

Diagnosis of Crigler-Najjar syndrome type II (CNS-II) and Gilbert syndrome (GS) based on the serum bilirubin concentration is difficult, because this parameter can fluctuate under certain conditions. The aim of this study was to explore differences in UGT1A1 gene mutations, which cause both CNS and GS, and pathological changes between CNS-II and GS. Ninety-five Chinese patients with hereditary unconjugated hyperbilirubinemia were enrolled in this study. Peripheral blood samples obtained from patients were used to evaluate bilirubin levels and for UGT1A1 gene testing. Percutaneous needle biopsy of the liver and staining of tissue samples with hematoxylin and eosin, Masson trichrome, reticulin, and Perl Prussian blue were performed for 59 patients. The Ishak scoring system was used to assess inflammatory activity and the extent of fibrosis. One hundred ninety-two UGT1A1 mutations at 6 sites were detected in the 95 patients; the most common mutation in GS was c.-3279T>G in the phenobarbital response enhancing motif of the UGT1A1 promoter, whereas the most common mutation in CNS-II was p.G71R. The frequency of heterozygous p.G71R mutations in CNS-II was significantly higher than that in GS (P = .001); however, the frequency of homozygous c.-3279T>G mutations in CNS-II was markedly lower than that in GS (P = .032). Among all patients with multiple mutations, the frequency of p.Y486D was significantly higher in CNS-II than in GS (P = .007). The frequency of compound c.-3279T>G, A(TA)7TAA, and p.G71R mutations in CNS-II was significantly higher than that in GS (P = .001). Among the 59 patients who underwent percutaneous needle biopsy, 20 had iron deposition in the liver. The frequency of hepatic iron deposition in CNS-II was significantly higher than that in GS (P = .002). The linked polymorphic mutations, A(TA)7TAA and c.-3279T>G in UGT1A1, were most strongly associated with GS, whereas mutations in the coding region, especially p.G71R and p.Y486D, were more strongly associated with CNS-II. Iron deposition was more common in liver biopsies from patients with CNS-II than in those with GS.

Background: Guillain–Barré syndrome (GBS) is the most common acute paralytic neuropathy. Many clinical trials indicate acupuncture provides a good effect as a complementary therapy of Western medicine for GBS. The objective of this systematic review protocol is to provide the evidence to evaluate the effectiveness and safety of acupuncture on the treatment of GBS. Methods: We will search relevant randomized controlled trials investigating the effect of acupuncture for GBS in following databases from start to October 2019: PubMed, Embase, the Cochrane Library, CINAHL Complete, National Digital Science Library, China National Knowledge Infrastructure, and Wanfang Database without language restriction. For articles that meet our inclusion criteria, 2 researchers will extract the data information independently, and assess the risk of bias and trial quality by the Cochrane collaboration's tool. All data will be analyzed by RevMan V.5.3.3 statistical software. Results: According to the Barthel index of Activities of Daily Living (ADL) and the Medical Research Council (MRC) muscle scale, the efficacy and safety of acupuncture for GBS will be determined in this study. Conclusion: This systemic review will provide high quality evidence to judging whether acupuncture provides benefits to treat GBS. Prospero registration number: CRD42019158710.

Background Non-pharmacological treatments (education, exercise, and physical therapy) are remain basic approaches to long-term management of ankylosing spondylitis (AS) patients. As an important part of non-pharmacological treatments, Health Qigong is widely used for AS treatment. We will perform the systematic review to confirm the safety and efficacy of Health Qigong for AS. Methods Systematical search of 6 electronic databases will be done, including English and Chinese, until December 2019. All randomized controlled trials (RCTs) involving Health Qigong in combination with conventional therapy for AS will be included. Study selection, data extraction, and validation were performed independently by 2 reviewers. RevMan (V.5.3) will be used for mata-analysis. Results This systematic review will identify the safety and efficacy of Health Qigong in the treatment of AS and update evidence summaries of Health Qigong. At the end of the treatment, the primary outcome is Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) with a range of 0 to 10,and the secondary outcomes will include functional ability that measured by Bath Ankylosing Spondylitis Functional Index (BASFI), mobility measured by Bath Ankylosing Spondylitis Metrology Index (BASMI), chest expansion, night spinal pain, adverse reactions, laboratory measures such as erythrocyte sedimentation rate (ESR) and C protein response (CRP). Conclusion This study will provide evidence that whether Health Qigong can benefit patients with ankylosing spondylitis by reducing disease activity, alleviating pain to support the application of Health Qigong in the AS treatment. Registration number CRD42019159126.

Rationale Condyloma acuminatum (CA) is a benign tumor primarily caused by infection with human papillomavirus (HPV) type-6 or type-11, lesions of which are most frequently found on the genital and perianal squamous mucosa and skin. CA outside the genitals is not common. Patient concerns A 29-year-old male presented with lesions on the left nipple and coronary sulcus after heterosexual contact. Diagnoses Histopathological examination and HPV detection made a definite diagnosis of CA. Intervention The patient was treated with microwave and topical imiquimod cream. Outcomes After 6 months follow-up, there was no sign of recurrence. Lessons This case shows that we should pay more attention to CA outside the genitals in the process of diagnosis and treatment.

Background: The diagnostic criteria for active infectious syphilis in the clinic are important matter of controversy and debate. So far, clinicians habitually do use the negative results of the nontreponemal and/or the specific antitreponemal IgM as the evidences of disease-free or active infection-free status. Method: We present a case study involving a patient who was admitted to Zhongshan Hospital because of cerebral infarct. Clinical examination indicated he had a history of latent syphilis with negative nontreponemal and specific antitreponemal IgM tests. The cerebrospinal fluid sample from the patient was inoculated into seronegative New Zealand rabbit. Results: Motile Treponema pallidum was detected by a rabbit infectivity test in the patient's cerebrospinal fluid. This syphilis strain was confirmed by DNA subtyping form of “centers for disease control subtype/tp0548 sequence type”, and the strain type was 14d/f. Treatment with benzathine penicillin provided no apparent benefit, but treatment with aqueous crystalline penicillin G, especially recommended for neurosyphilis, led to disease regression. No evidence of cerebral infarct was observed during a 2-year follow-up period. Conclusion: The definitive differential diagnosis of active infectious syphilis should be reconsidered. Moreover, selecting the appropriate penicillin preparation is important because T pallidum can reside in sequestered sites. It is necessary to treat a patient with known invasion of the central nervous system with aqueous crystalline penicillin G, if previous treatment for syphilis failed and patients had some clinical neurological presentation that is otherwise unexplained, but that could represent neurosyphilis. Additional studies are needed to confirm the results in other syphilis patients.

It is difficult to diagnose brucellar spondylitis because of its nonspecific clinical, radiological, and histological characteristics. This study aimed to determine whether real-time polymerase chain reaction (PCR) using formalin-fixed paraffin-embedded (FFPE) tissues was superior to conventional serum-based methods for diagnosing brucellar spondylitis. This retrospective study included 31 patients with brucellosis and a control group of 20 people with no history of brucellosis or exposure to Brucella spp. Samples from all patients with brucellar spondylitis were evaluated using Giemsa staining, the standard tube agglutination (STA) test, blood culture, and real-time PCR. The brucellar spondylitis was acute in 7 patients (22.6%), subacute in 15 patients (48.4%), and chronic in 9 patients (29%). Serological assays provided positive results for 25 patients (80.1%), real-time PCR provided positive results for 29 patients (93.5%), and blood cultures provided positive results for 11 patients (35.5%). The real-time PCR provided sensitivity of 93.5%, specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 100%. The corresponding values for the STA test were 80.1%, 100%, 100%, and 76.9%, respectively. Real-time PCR provided better sensitivity than Giemsa staining, the STA test, and blood culture, although the difference between PCR and STA was not statistically significant (P = .22). B melitensis was the only pathogen that was detected in patient with brucellar spondylitis using real-time PCR. These results suggest that real-time PCR provides a high sensitivity for diagnosing brucellar spondylitis. Furthermore, the real-time PCR results indicate that B melitensis was the causative pathogen in these cases.

Background:Water immersion delivery is a non-pharmacological approach to ease labor pain. This paper aims to investigate the effect of water immersion delivery on increasing strength of pelvic floor muscle (PFM) and relieving pelvic floor disorders (PFDs) during postpartum period.Methods:A t

Rationale: Ruptured sinus of Valsalva aneurysm is rare and dangerous in parturients. Few cases of ruptured SVA in pregnancy are reported, and the anesthetic management for cesarean delivery has scarcely been described. Patient concerns: A parturient at 37-week gestation complained of a sore throat and cough that started 3 days before admission, followed 1 day later by fever, dizziness, breathlessness, and palpitation on exertion. Case two at 36-week gestation complained of a 1-day history of bloating in the lower abdomen. Diagnoses: Full term and preterm parturients with ruptured sinus of Valsalva aneurysm. Interventions: Cesarean deliveries were performed with incremental epidural anesthesia technique under invasive monitoring. Surgical correction of the ruptured sinus of Valsalva aneurysms and ventricular septal defect were performed uneventfully 13 days and 7 days postpartum, respectively, for the 2 cases. Outcomes: No complications were observed in the intra- or postoperative period for both mothers and babies. Lessons: We reviewed the pertinent literature and reached the following conclusions: use of a multidisciplinary team to guide anesthetic management is helpful and necessary; and both general anesthesia and incremental epidural anesthesia can be safely used in parturients with ruptured sinus of Valsalva aneurysm.