从系统综述看中国随机对照试验的质量

Quality and validity of randomized controlled trials in China from the perspective of systematic reviews

随机对照试验是系统综述的证据来源,系统综述结论的可靠性与原始文献的质量息息相关。目前,中国的随机对照试验质量的现状尚不令人满意,导致系统综述在评价干预措施的疗效时难以得到确定的结论,仍需要进一步的高质量的随机对照试验研究加以证实。本文从中国随机对照研究文献质量的现状出发,探讨低质量临床研究文献的纳入对系统综述结论的影响,以及在此条件下如何进行系统综述,并介绍了评价随机对照试验质量的方法,最后提出提高中国临床随机对照试验质量的策略,包括培养诚信的科研环境和社会氛围,加强对临床医生的方法学培训,实施临床试验注册制度,重视临床研究的质量控制以及医学期刊对论文质量的把关。

A systematic review is based on randomized controlled trials（RCTs）,and the reliability of its conclusion is closely related to the quality of original literature.The low quality of existing RCTs in China leads to the failure of conclusive findings in systematic reviews when evaluating the effectiveness of interventions.It is almost universal for systematic reviews to draw the conclusion that ＂further well-designed multicenter and large-scale RCTs are still required to confirm the beneficial effects of interventions＂.This paper analyzed the current status of RCTs in China,discussed the influence of including trials of low quality in a systematic review and assessed how a systematic review should be carried out under such circumstances.Furthermore,the methods to evaluate the quality of RCTs were introduced and evaluated.Finally,several strategies were proposed to improve the quality of RCTs in China：foster an honest academic and social environment,enhance the training of doctors on clinical research methodology,promote the implementation of clinical registration systems and strengthen the quality control of clinical research and the medical journals regulations on the quality of submitted papers.