中西医结合治疗严重急性呼吸综合征的随机对照试验质量调查

Quality of Randomized Controlled Trials of Traditional Chinese Medicine Integrated with Western Medicine for Severe Acute Respiratory Syndrome

目的 调查中西医结合治疗严重急性呼吸综合征 (severeacuterespiratorysyndrome ,SARS)的随机对照试验的真实性。 方法 通过电子检索、手工检索并无语种限制地检索全世界中西医结合治疗SARS的随机对照试验 (randomizedcontrolledtrial,RCT)。借鉴Cochrane的质量分级法 ,调查RCT的方法学质量 ,并从样本量、基线资料、结局指标等方面分析RCT质量。 结果 共检索到 7篇中西医结合治疗SARS的RCTs,1篇质量等级为B ,其余 5篇质量等级皆为C。没有一篇RCT进行样本量估计 ;仅 1篇RCT的基线资料经统计学检验无差异 ;1篇文献结局指标包括了生活质量 ;没有 1篇文献报告副性事件。 7篇RCTs共纳入SARS病人 5 0 1例。另有 3篇因未发表尚未获得全文。 讨论 目前所获得的RCTs真实性不够高 ,不能为临床实践提供充分、可靠的证据。

Objective To investigate the quality of the randomized controlled trials(RCTs) of traditional Chinese medicine(TCM) integrated with western medicine for severe acute respiratory syndrome(SARS). Method All the randomized controlled trials of traditional Chinese medicine integrated with western medicine for SARS worldwide were gained by electronic searching and hand searching. The quality of the RCTs was analyzed by the quality grade evaluation used in Cochrane handbook. The sample size, the baseline data, the results indexes were also analyzed. Results Seven RCTs included 501 SARS cases were identified. The quality grade of one RCT is B, the other six RCTs were graded C. None pre-specified sample size. One RCT tested the differences of the baseline data by statistic method. One RCT reported quality of life as result index. None reported the adverse events. Conclusions Current RCTs of TCM integrated with western medicine can't provide strong evidence for clinical practice because of the poor quality.