中医药治疗冠心病的临床随机对照试验文献的质量分析

目的：评价中医药治疗冠心病的临床随机对照试验（RCT）文献的质量。方法：手工检索83种中医类杂志（1977-2002年6月）。纳入标准：中医药治疗冠心病的临床随机对照试验。结果：符合纳入标准的文献共675篇。（1）交待了随机分配方法的58篇（8.59%);(2)提到了诊断标准及研究纳入标准的637篇（94.37%);(3)无一篇提到分配隐匿；（4）使用了盲法的64篇（9.48%)。采用双盲的29篇（4.29%)。单盲的35篇（5.19%);(5)提到基线可比性的563篇（83.41%);(6)无一篇提到样本含量的估算依据；（7）12个临床研究中病人丢失，但无一在结果统计中进行intention-to-treat处理；（8）统计方法错误的24篇，占3.56%;有统计结果但没有说明方法的394篇。占58.37%；结论；迄今为止临床随机对照实试在有关中医药治疗冠心病的研究中还没有被广泛运用。我们在这一领域的临床随机对照实验中还很难见到分配隐匿，样本的估算依据。盲法与intention-to-treat的运用。一些文章还混淆了随机分配与随机抽样的概念，正确的统计学方法的运用率还比较低。总的看来，中医药治疗冠心病的RCT试验文献的质量亟待提高。

Quality Analysis of Literatures on Clinical Randomized Controlled Trial of Coronary Heart Diseases Treated with TCM

Objective: To assess the quality of literatures on clinical randomized controlled trial of coronary heart diseases (CHD) treated with TCM. Methods: Literatures of clinical randomized controlled trial of CHD treated with TCM, published in 83 Journals of TCM from 1977 to June 2002, were retrieved manually. Results: In the 675 articles that conformed to the including criteria, the method of randomized control was declared in 58 articles (8.59%), including and diagnostic criteria declared in 637 (94.37%), allocation concealment in none, baseline comparability in 563 (83.41%), account evidence of sample size in none; double-blinded method was adopted in 29 (4.29 % ) and single-blinded in 35 (5.19 % ); abscondence occurred in 12 but intention-to-treat in none in the results; wrong statistical method was used in 24 (3. 56% ) and 394 (58.37% ) had statistical result but the method used was not mentioned. Conclusion: The clinical randomized controlled trial has not yet been used widely in studies of TCM treating CHD so far. Latent distribution, the reliance of estimation on the sample, blind method and the application of intention-to-treat are hardly seen extensively in clinical randomized controlled trial (RCT) in this field. The concept of randomized distribution and randomized sampling in some articles. The adopting rate of accurate statistical methods is quite low. Generally speaking, the quality of RCT literatures on TCM treating coronary heart diseases needs to be further improved.