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This study explored the preparation process of the placebo of Jiawei Ermiao Granules and evaluated the placebo effect, aiming to provide qualified placebo samples for clinical trials of Jiawei Ermiao Granules and a reference for the preparation and quality evaluation of placebos of traditional Chinese medicine granules. On the basis of the comprehensive analysis results of Jiawei Ermiao Granules, the orthogonal experiment was conducted to optimize the flavoring agents and colorants. After manual evaluation, the placebo formula was determined as dextrin 10 g, Codonopsis Radix extract 5.0 g, bitter melon extract 1.6 g, Mume Fructus extract 0.3 g, stevioside 0.1 g, sucrose octaacetate 0.004 g, indigo 0.004 g, lemon yellow 0.003 1 g, sunset yellow 0.001 8 g, bitter tea powder 0.001 8 g, caramel 0.001 3 g. Pilot trials were conducted on the placebo formula. The simulation effect of placebo was evaluated independently and comparatively, and the objectively evaluated by electronic nose and electronic tongue. The results showed that the independent manual evaluation of the placebo formula had higher error rate, and the placebo and Jiawei Ermiao Granules showed the similarity of 99.61% in the comparative manual evaluation. The smell similarity between the placebo and Jiawei Ermiao Granules was 99.19%, and the electronic tongue test showed little difference in the taste. In conclusion, the placebo prepared in this study shows a high similarity to Jiawei Ermiao Granules, which is not easy to break the blindness when being applied to clinical trials. This study provides a reference for the preparation and quality evaluation and promotes the large-scale production of placebos of traditional Chinese medicine granules, playing a role in improving the persuasiveness and acceptance of the efficacy of traditional Chinese medicines.

Objective: To determine IgG antibody levels of measles, rubella, mumps in healthy population in Shanghai from 2010 to 2020 and analyze the trend of antibody changes in different age groups. Methods: 10 828 healthy people without measles, rubella and mumps in Shanghai were included in the study from 2010 to 2020. Serum samples were collected from 12 age groups, and the serum IgG antibody of measles, rubella and mumps were detected by ELISA. The difference of antibody positive rates and antibody levels were analyzed. Results: The median age M ( Q 1 , Q 3 ) of 10 828 objects were 8 years old (9 months old, 20 years old). Males accounted for 48.34% (5 234/10 828) and females accounted for 50.92% (5 514/10 828). Unknown gender information accounted for 0.74% (80/10 828), and 27.03% (2 927/10 828) of participants had unknown MMR immunization history. The total positive rates of measles, rubella and mumps IgG antibody were 76.78%, 64.46% and 64.29% and their GMCs were 541.45 mIU/ml, 31.76 IU/ml and 133.73 U/ml respectively. There were significant differences in serum IgG antibody GMC of measles, rubella and mumps in each year ( F measles =180.74, P <0.001; F rubella =189.95, P <0.001; F mumps =122.40, P <0.001). The positive rate of measles antibody was higher than that of rubella and mumps, and the difference was statistically significant (χ²=518.09, P <0.001). Conclusion: The level of measles IgG antibody in healthy people in Shanghai is higher, while the level of rubella and mumps IgG antibody is slightly lower.

This study aimed to explore the triterpenic acid components in leaves of Ilex hainanensis. Alkaline water extraction, macroporous resin adsorption, and high performance liquid chromatography were used to separate and purify the triterpenic acid components in leaves of I. hainanensis. The physical and chemical property analysis, MS, NMR spectroscopy, and literature comparison were performed to identify the structures, and a new triterpene acid compound was discovered:(3S, 4R, 5R, 8R, 9R, 10R, 14S, 17S, 18S, 19R)-3,19-dihydroxyursa-12,20(30)-diene-24,28-dioic-acid, and named ilexhainanin F. In addition, according to its structural characteristics, the ~(19)F-NMR Mosher method was further employed to study its absolute configuration. By comparison of the ~(19)F-NMR chemical shifts of Mosher esters, it was determined that the absolute configuration of the 3-position chiral center of the compound was the S configuration.

Objective: To summarize the different teaching models and their effects in evidence-based medicine at home and abroad by qualitative method and systematic review. Methods: We searched the following databases (from inception to 13 May, 2019): PubMed, Embase, Proquest, Cochrane, Web of Science database and the Chinese databases (CNKI, Wanfang, SinoMed and VIP). To assess data strength and validity, risk of bias assessments were undertaken. Results: A total of 52 literatures were included in this study, including 21 Chinese-language literature and 31 English-language literature. PBL teaching model, mixed teaching model and workshop teaching model were the three teaching models with the largest number of studies in 20 teaching models. Conclusion: The evidence-based medicine teaching effect was closely related to the teaching models, so it is necessary to explore more suitable teaching models for the evidence-based medicine to improve the teaching effects.

This paper introduces the tools related to Quality In Prognosis Studies (QUIPS) to assess the risk of bias in studies of prognostic factors and the relevant points of assessment and to illustrate the application of QUIPS in published prognostic research. The QUIPS tool identified 6 important areas to consider when evaluating validity and bias in studies of prognostic factors including participation, attrition, measurement on prognostic factors, outcomes, confounding factors, statistical analysis and reporting. It also provided a new method for evaluation on bias in the areas of prognostic research.

Objective: Based on the medical records and follow-up records of hospitalized patients who received anti-tuberculosis therapy in the Third People's Hospital of Zhenjiang in Jiangsu province from 2006 to 2012, we investigated the incidence and outcome of anti-tuberculosis drug induced hepatotoxicity(ATDH)and provided evidence for the prevention of ATDH., Methods: According to tuberculosis patients' medical information and liver function test records, ATDH patients were diagnosed according to the criteria of International Consensus Meeting and American Thoracic Society respectively, then the related factors and outcomes were analyzed., Results: A total of 1 967 hospitalized tuberculosis patients were reviewed retrospectively, in which 1 403(71.3%)were men, 1 790(91.0%)were pulmonary tuberculosis patients, 1 528(77.8%)were patients receiving initiative treatment, 979(49.8%)were sputum smear-positive patients, and 1 297(65.9%)had other complicated diseases. According to the criterion of International Consensus Meeting, the incidence of ATDH was 16.5%, the median time of onset was 25 days. According to the criterion of American Thoracic Society, the incidence of ATDH was 8.3%, the median time of onset was 23 days. The incidence of ATDH was significantly higher in males and HRZE therapy group(P<0.05). Under the two liver criteria, 69.5% and 70.1% of the patients changed primary therapy respectively after ATDH occurred. 89.8% and 88.4% patients' liver function returned to normal range after changing or stopping therapy., Conclusion: According to two liver injury criteria, the incidences of ATDH were 16.5% and 8.3% in hospitalized tuberculosis patients respectively, and ATDH mainly occurred in the first month of anti-tuberculosis treatment. The monitoring of liver function should be strengthened in males and HRZE therapy group to reduce the incidence of ATDH.

Objective: To investigate the association between the polymorphisms of genes involving in drug metabolism and transport as well as immunological reaction and the risk of anti-tuberculosis drug-induced liver injury(ATLI)in Chinese., Methods: This 1∶4 matched case-control study was conducted by using the data from a cohort study of Anti-tuberculosis Drugs Induced Adverse Reactions in National Tuberculosis Prevention and Control Progtam of China. Genes involving in three phase of drug metabolism and transport as well as related immunological reaction were chosen and single nucleotide polymorphisms(SNPs)were genotyped by TaqMan allele discrimination technology. Lasso regression and multivariate conditional logistic regression analysis were used to select susceptible genes., Results: A total of 33 genes with 75 SNPs were tested. The combined results of Lasso and regression logistic regression analysis showed that genetic polymorphism of SLCO1B1 rs4149014, HSPA1L rs2227956, STAT3 rs1053023 and IL-6 rs2066992 were significantly associated with the risk of ATLI(P<0.05)., Conclusion: SLCO1B1, HSPA1L, STAT3 and IL-6 might be the susceptibility genes of drug induced liver injury in patients receiving anti-tuberculosis treatment.

To explore the gene-based logistic kernel-machine regression model and its application in genome-wide association study(GWAS). Using the simulated genome-wide single-nucleotide polymorphism(SNPs)genotypes data, we proposed a practical statistical analysis strategy-named 'the logistic kernel-machine regression model', based on the gene levels to assess the association between genetic variations and complex diseases. The results from simulation showed that the P value of genes in related diseases was the smallest among all the genes. The results of simulation indicated that not only it could borrow information from different SNPs that were grouped in genes and reducing the degree of freedom through hypothesis testing, but could also incorporate the covariate effects and the complex SNPs interactions. The gene-based logistic kernel-machine regression model seemed to have certain statistical power for testing the association between genetic genes and diseases in GWAS.

Objective: To study the effects of Tongxinluo ultramicro-pulverization (TXLU) on experimental myocardial infarction and platelet aggregation of rats, investigate its mechanisms on ischemia heart disease and offer a reference to clinical usage., Method: Rats were separated randomly into 7 groups: sham, model, diltiazem (0.15 mg x kg(-1)), TXL(1.2 g x kg(-1)), TXLU (1.2, 0.6, 0.3 g x kg(-1)). The experimental myocardial infarction was induced with ligating the left anterior descending branch of the coronary of rats. The infarction size was determined after myocardium tissue was stained with 2,3,5-triphenyltetrazolium chloride (TTC). And the serum of rats was separated to analyze CK, LDH, SOD, MDA. Another 60 rats were separated randomly into 6 groups: control, aspirin (0.15 mg x kg(-1)), TXL (1.2 g x kg(-1)), TXLU (1.2 ,0.6,0.3 g x kg(-1)). The rat platelet aggregation was induced with adenosine diphosphate (ADP) and collagen to observe the inhibitory effects of TXLU., Result: TXLU could relieve the myocardial infarction size and weight stained with TTC significantly, the myocardial infarction size of the three groups of TXLU were (2.7 +/- 2.1)%, (3.4 +/- 1.2)%, (2.8 +/- 1.8)%, compared with model group (8.9 +/- 5.9)%, P < 0.05 or P < 0.01. The myocardial infarction weight of the three groups of TXLU were (8.4 +/- 3.5)%, (8.7 +/- 4.1)%, (9.7 +/- 4.1)%, compared with model group (l2.2 +/- 3.6)% P < 0.05 or P < 0. 01. And the content of MDA and the activities of CK and LDH in rats subjected with ligation of coronary artery were inhibited obviously too, compared with model group P < 0.05 or P < 0.01, then the activity of SOD increased. TXLU could inhibit the maximum percentage of rats platelet aggregation induced with ADP and collagen, the maximum percentage of platelet aggregation induced with ADP were (26.9 +/- 9.2)%, (24.4 +/- 13.4)%, (30.6 +/- 12.2)%, compared with control group (44.3 +/- 15. 7)% P < 0.05 or P < 0.01; The maximum percentage of platelet aggregation induced with collagen were (33.8 +/- 6.9)%, (32.1 +/- 8.3)%, (41.5 +/- 7.8)%, compared with control group (49.2 +/- 15.9)%, P < 0.05 or P < 0.01., Conclusion: The experiment results indicated that TXLU could protect myocardial tissue of rats from ischemic injury and the mechanism may be related with antioxidation and inhibiting platelet aggregation, and the results also suggested TXLU could lower clinical dosage.

Objective: To prepare a peroral thymopentin-loaded N-trimethyl chitosan chloride-nanoparticle (Tp5-TMC-NP) ,and observe the pharmacodynamic action when the Tp5-TMC-NP is taken by way of the mouth., Methods: N-trimethyl chitosan chloride was first synthesized, and then Tp5-TMC-NP was prepared with the formulation technology optimized by the Central Composite Design. The influence of Tp5-TMC-NP on the ratio of CD4+/CD8+ of T-lymphocytes were determined by flow cytometer., Results: The regular global Tp5-TMC-NP prepared with the optimized formulation craft had the mean diameter of 110.6 nm and got the entrapment efficiency of 78.8%. The ratio of lymphocyte CD4+/CD8+ of Wistar rat administered with Tp5-TMC-NP perfusing stomach had 2.59 times higher than that with Tp5., Conclusion: Taken orally the Tp5-TMC-NP has much higher efficiency than Tp5.

Objective: To explore the risk factors on relapsing tuberculosis related to smear positive pulmonary tuberculosis which had been cured for five years., Methods: Patients with smear positive pulmonary tuberculosis registered in 1995 from ten countries in Hubei province were studied and logistic regression was used for data analysis., Results: The 5-year relapse rate of smear positive pulmonary tuberculosis was 3.85 percent. Risk factors related to relapse would include being non-modeled county, negative smear after treated for three months, the class of retreatment, management of non-DOTS, method of chemotherapy and patients that did not get treated by the tuberculosis institute, with odds ratios of 0.15, 4.62, 3.68, 5.88 and 6.47, respectively., Conclusion: Effect standard, regulation DOTS and the centralized management measure might have had effects on decreasing the relapse rate.