中医药治疗咳嗽变异型哮喘随机对照研究文献的质量评价

Systematic Evaluation of Randomized Controlled Trials of Traditional Chinese Medicine for Cough Variant Asthma

【目的】对中医药治疗咳嗽变异型哮喘（CVA）的随机对照试验的文献质量进行分析，以客观评价中医药治疗CVA的疗效。【方法】按照临床流行病学／DME和循证医学的原则，采用统一编制的《中医药治疗性文献系统质量评价及信息采集表》，对1980～2006年发表的CVA中医药治疗性文献进行质量评价。【结果】检索到符合纳入标准的随机对照试验文献38篇，虽均有提及“随机对照”、“随机分组”，但只有4篇说明了具体的随机分配方法；较少采用盲法；所有文献均未说明样本含量的估算及失访、退出病例；有不良反应观察的9篇；有随访的10篇；在组间均衡性分析及疗效评价、结论推导等方面还存在一定的不足，影响了中医药随机对照试验的质量。【结论】中医药治疗CVA临床研究文献质量虽较以前有明显提高，但在科研设计和实施方面仍存在着一些问题；应提倡开展高质量的多中心前瞻性随机对照试验，以提高中医药治疗CVA研究文献的质量。

[Objective] To investigate the quality of the randomized controlled trials （RCT） of traditional Chinese medicine （TCM） for cough variant asthma （CVA）, thus to evaluate the therapeutic effect of Chinese herbal medicine for CVA. [ Methods ] Subjecting to the principles of evidence-based medicine, clinical epidemiology, and design, measurement and evaluation （DME） for clinical research, Table of Systematic Evaluation of Quality and Information Collection for TCM Clinical Research Literature was used to evaluate the literatures of TCM for CVA that was published from 1980 to 2006. [Results] There were 38 RCT subjecting to the inclusion criteria. Although ＂random control ＂ and ＂random allocation＂ were referred in all of RCT, there were only 4 describing the definite method of randomized allocation. Blind method was less used. None of them mentioned the estimation of sample size and withdrawal cases. Adverse reaction was mentioned in 9 RCT. Follow-up was mentioned in 10 RCT. There existed insufficiency in analysis of interclass balance, evaluation of therapeutic effect, conclusion deduction, etc, which decreased the quality of RCT of TCM. [Conclusion] The quality of clinical study of TCM for CVA has been improved in recent years, but there is still a lot of inadequacy in research design and implements. High-quality multi-central prospective trials are expected to increase the quality of TCM for CVA. We should advocate to develop randomized controlled trails which are high quality and multicentre.