根据CONSORT HARMs声明评价雷公藤制剂相关肾毒性RCT的报告质量  

Evaluation of reporting quality of RCT on nephrotoxicity of Tripterygium wilfordii preparations according to CONSORT HARMs statement

作　　者：冯雪[1] 方赛男 高雨鑫 刘建平[1] 陈薇[1] FENG Xue;FANG Sai-nan;GAO Yu-xin;LIU Jian-ping;CHEN Wei(Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China;Department of Sociology, Acadia University, Wolfville B4P2R6, Canada)

机构地区：[1]北京中医药大学循证医学中心,北京100029 [2]阿卡迪亚大学社会学系,沃尔夫威尔市B4P2R6

出　　处：《中国中药杂志》2018年第3期440-445,共6页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金青年基金项目(81603451)

摘　　要：根据CONSORT HARMs声明评价以雷公藤中成药为干预或对照措施的RCT关于肾毒性的报告情况。根据CONSORT HARMs声明对纳入的雷公藤制剂相关肾毒性RCT研究进行报告质量评价,计算每个研究符合CONSORT HARMs声明的条目,评价雷公藤制剂相关RCT中其肾毒性相关不良反应的报告质量,总结国内研究肾毒性相关不良反应报告的问题。共纳入16项RCT,平均每个研究符合7个条目,雷公藤制剂相关肾毒性RCT研究的报告质量较差,报告的最不重复的条目为：使用已验证过的工具报告不良反应、提及不良反应的编码采用的标准、在方法中描述如何及何时收集不良反应的数据、描述不良反应是如何归因于雷公藤的、明确的提出是谁报告的不良反应、描述不良反应的分析方法、描述收集复发不良反应数据的方法、描述与危害相关的任何亚组分析和探索性分析。建议将来中药不良反应的相关研究,严格按照CONSORT HARMs建议的条目对研究进行详细报告。此外,也应考虑到中药自身的特点,详细的报告中药的组成、剂量、服用时间、联合用药及研究对象的辨证分型。To evaluate the quality of randomized controlled trials（ RCT） on nephrotoxicity of Tripterygium wilfordii preparations according to the CONSORT HARMs statement. The report quality of each included study was evaluated according to the CONSORT HARMs statement,and the number of entries that comply with CONSORT HARMs statement was calculated in each study to evaluate the report quality on nephrotoxicity-related adverse reactions of T. wilfordii preparations and summarize the problems in domestic studies on nephrotoxicity-related adverse reactions. A total of 16 RCTs were included,with an average of 7 entries complying with CONSORT HARMs statement per study. The report of the nephrotoxic-associated RCT of T. wilfordii preparations was of poor quality and the most non-repeating entries included the following ones： using validated tools to report adverse effects,standards for coding of the adverse reactions,describing how and when to collect data on adverse reactions in Method,describing how adverse reactions are attributed to T. wilfordii,clearly stating who has reported the adverse reactions,describing the analysis method of adverse reactions,describing the method of collecting recurrent adverse reaction data,describing any subgroup analysis and exploratory analysis associated with the hazard. We suggest that the studies on adverse reactions of traditional Chinese medicine should strictly report the entries according to the CONSORT HARMs statement,and take the characteristics of traditional Chinese medicine into account to report the details of the Chinese medicine like compositions,dose,taking time,combined medication and the dialectical typology of research objects.

关 键 词：CONSORT HARMs声明 雷公藤制剂 肾毒性 报告质量 随机对照试验 

分 类 号：R285.1[医药卫生—中药学]