2019—2020年度中成药临床证据分析报告

Review of reports of clinical evidence of Chinese patent medicines in 2019—2020

关键词:  中成药  随机对照试验  循证医学

Key words:  Chinese patent medicine  randomized controlled trial  evidence-based medicine

摘要:

[目的] 随着循证医学理念的推广应用，中医药临床试验数量快速增长，为促进相关研究证据的转化应用，对2019—2020年度研究情况进行总结和评估并提出合理建议。[方法] 基于中医药循证评价证据库系统（EVDS），辅以文献数据库补充检索，获取2019—2020年度发表的中成药随机对照试验文献并进行统计分析。[结果] 共纳入文献2 463篇，其中中文2 439篇，英文24篇，中文核心期刊收录149篇（6.11%），中国科学引文数据库（CSCD）收录91篇（3.73%）。共涉及547种中成药，其中注射剂77种，口服/外用中成药470种。研究的热点病种为循环系统疾病、神经系统疾病、呼吸系统疾病等。单中心研究占98.29%，多中心研究仅占1.71%。56.23%的研究样本量小于100例。方法学方面，44.18%的研究存在随机方法描述不清或者应用错误的情况；分配隐藏、盲法、其他偏倚等条目的低风险率均不足5%。此外伦理审查和方案注册问题依旧突出。[结论] 虽然有大量的临床随机对照试验发表，但普遍存在方法学问题，欠缺有国际影响力的期刊论文。未来需要对研究者加强方法学培训，促进高质量研究数据的产出，推动研究数据向诊疗指南、专家共识、药品说明书等产品的转化应用，为科学决策提供依据。

Abstract:

[Objective] The application and popularization of evidence-based medicine have led to the explosion of clinical trials of traditional Chinese medicine. This study summarized and evaluated the relevant studies in 2019-2020 and made reasonable suggestions,aiming to promote the transformation and application of research evidence.[Methods] Based on the Evidence-Based Evaluation of Chinese Medicine Evidence Database System(EVDS),supplemented by the supplementary search of the literature database,the literatures of randomized controlled trials of Chinese patent medicines published in 2019-2020 were obtained and statistically analyzed.[Results] A total of 2 463 articles (2 439 in Chinese and 24 in English) were included for analysis. Among them,149 (6.11%) articles were published in Chinese core journals,and 91 (3.73%) articles in thejournals listed in CSCD. A total of 547 Chinese patent medicines were involved,including 77 injections and 470 oral/topical medicines. The research hotspots involved circulatory system diseases,nervous system diseases,and respiratory disorders. Among the randomized controlled trials (RCTs),single-center studies accounted for 98.29%,and multi-center studies accounted for only 1.71%. In terms of sample size,56.23% RCTs involved fewer than 100 cases. About methodology evaluation,44.18% RCTs had unclear descriptions of randomization methods or incorrect applications,and the low-risk rates of the items such as allocation concealment,blinding,and other biases were all less than 5%. In addition,the issues in ethical review and program registration still existed.[Conclusion] Although a large number of RCTs have been published,there are common methodological problems and insufficient papers published in high-impact journals. In the future,methodological training should be enhanced for researchers to improve the output of high-quality research data and promote the transformation and application of research data,so as to provide a basis for reasonable decision-making.