Comparative efficacy and safety of traditional Chinese patent medicine for NAFLD in childhood or adolescence: A protocol for a Bayesian network meta analysis

Background:Nonalcoholic fatty liver disease is a common reason for chronic liver disease in children and adults. The increasing incidence of the disease has become one of the most critical public health problems in the 21st century, closely related to genetic and environmental factors. So far, apart from changing lifestyle and diet, modern medicine still lacks effective treatment measures. Chinese patent medicine has the advantages of apparent curative effect, overall regulation and fewer side effects. However, there is a lack of research on the simultaneous comparison of various Chinese patent medicines. Therefore, we used a reticular meta-analysis to indirectly compare the efficacy and safety of different oral Chinese patent medicines through standard reference.Method:We will conduct a comprehensive and systematic search of Chinese and English databases from the beginning to December 2020. All randomized controlled trials (RCTs) of oral Chinese patent medicine for NAFLD in children will be searched. The 2 researchers then independently filter the retrieved literature, extract the data according to the data extraction table and assess the risk of bias. We will perform a pair of meta-analyses and a Bayesian network meta-analysis. STATA and Win BUGS software will be used for data analysis.Results:This study will thoroughly compare and analyze the differences in the efficacy of all kinds of TCPM in NAFLD treatment in childhood or adolescence.Conclusion:This study will provide reference and evidence support for clinical drug selection optimization.Ethics and dissemination:This study does not require ethical approval.INPLASY registration number:2020120068.     

中成药中非法添加化学药品的现状与分析检测对策

简要综述了近年来中成药非法添加化学药品的现状,分析检测对策,为药品技术监督工作提供参考。     

HPLC-DAD-MS(n) analysis and HPLC quantitation of chemical constituents in Xian-ling-gu-bao capsules

In this study, a systematic method was established for the global quality control of Xian-ling-gu-bao capsules (XLGB), a popular six-herb Traditional Chinese Patent Medicine (TCPM) for the treatment of osteoporosis. Both qualitative and quantitative analyses were conducted. In qualitative analysis part, a fast and sensitive method based on high-performance liquid chromatography coupled with diode-array detection and electrospray ionization tandem mass spectrometry (HPLC-DAD-MS(n)) was established for rapid separation and sensitive identification. Samples were separated on a Waters Symmetry C(18) column (250mm×4.6mm, 5μm) by gradient elution using acetonitrile (A) and water-formic acid (B; 0.03%, v/v) as mobile phase at a flow rate of 1.0ml/min. Based on the mass spectra, UV spectra and retention time, 47 compounds were identified or tentatively characterized, including 27 flavonols (all from Epimedii Herba, the major component herb), 4 coumarins, 3 flavonones, 1 chalcone, 3 isoflavones, 1 coumestrol, 3 triterpenoid saponins, 1 iridoid, 3 steroidal saponins, and 1 phenolic acid. Among them, 18 compounds were confirmed by comparing with reference standards. In quantitative analysis part, 10 major compounds in 18 batches of XLGB were simultaneously determined by HPLC/UV detected at 270nm. The method was validated with respect to intra- and inter-day precision, repeatability and stability, with RSD less than 1.0%, 1.5%, 2.9% and 1.8%, respectively. All the 10 analytes showed good linearity in wide linear ranges (r(2)=0.9999), and their average recoveries varied between 97.8% and 104.9%.     

中成药致肝炎的病例分析

目的:探讨中成药所致肝损害的相关药物、发病机制及防治。方法:对本院1991-2003年收治的103例中成药所致肝炎进行统计,从发病趋势、相关药物、临床表现、治疗及预后几个方面进行分析。结果:中成药所致药物性肝炎,以治疗骨关节病药物占首位,其次为皮肤病用药。临床表现以肝细胞损害为主,也有表现为胆汁淤积型肝炎者。经西药或中西医结合治疗后,绝大部分痊愈和好转。结论:中成药所致肝损害集中发生于治疗骨关节病与皮肤病两类药物,表明该两类药物可能含有某些肝毒性成分或者与配伍等因素相关,确切机制有待于进一步研究。加强临床监测和信息交流有助于及时发现及预防肝损害的发生。