中医药治疗风湿病的多中心随机对照试验研究概况

Research Situation in Multi-center Randomized Controlled Trial of Traditional Chinese Medicine in Treating Rheumatism

目的:评价中医药治疗风湿病的多中心随机对照试验(randomized controlled trial, RCT)的文献质量,为临床研究提供参考。方法:检索PubMed、Cochrane Library、维普(VIP)、中国知网(CNKI)、万方(WanFang)等数据库的多中心RCT研究,采用Cochrane偏倚风险评估工具对纳入文献进行质量评价。结果:共纳入RCT文献37篇,包含类风湿关节炎16篇、骨关节炎8篇、痛风4篇、强直性脊柱炎2篇、原发性干燥综合征3篇、风湿性关节炎2篇、系统性红斑狼疮1篇、纤维肌痛综合征1篇;质量评价发现偏倚风险主要集中于随机序列的产生、分配隐藏、受试者与研究者盲法,结局评价盲法方面。结论:目前中医风湿病的多中心RCT研究除试验设计不足外,存在缺少中医疗效评价标准、统计分析不够系统等问题。文章系统综述了中医风湿病的多中心RCT研究,发现严谨的试验设计是获得高质量循证依据的关键,并展望通过大数据来提高多中心RCT的研究质量。

Objective To evaluate the literature quality of Multi-center RCT research of Rheumatism in traditional Chinese medicine(TCM),and to provide reference for clinical research.Methods The multi-center RCT studies were retrieved in databases such as PubMed,Cochrane Library,VIP,CNKI and Wanfang,and the quality of literature was evaluated by Cochrane bias risk assessment tool.Results 37 articles were included,including 16 rheumatoid arthritis,8 osteoarthritis,4 gout,2 ankylosing spondylitis,3 Sjogren syndrome,2 rheumarthritis,1 systemic lupus erythematosus,1 fibromyalgia syndrome.The quality evaluation found that the risk of bias was mainly focused on random sequences generation,allocation concealment,blinding of participants and personnel and blinding of outcomes assessment.Conclusion At present,in addition to the insufficient experimental design,there are some problems such as lack of evaluation standard of TCM curative effect and insufficient statistical analysis in the study of multi-center RCT of rheumatism in TCM.In this paper,the Multi-center RCT research of Rheumatism in TCM is systematically reviewed,and it is found that rigorous experimental design is the key to obtain high quality evidence-based basis,and look forward to improving the research quality of multi-center RCT through big data.