中医药治疗急性心肌梗死临床研究文献中的病死率分析

目的:了解我国中医药治疗急性心肌梗死(AMI)临床研究文献中有关病死率的情况.方法:①电子检索1994-2005年CNKI中国学术期刊全文数据库中的中医药治疗AMI临床研究文献.②逐一阅读检出文献,按规定标准筛检出病死率明确的中医药治疗AMI临床研究文献.③提取相关数据,SPSS 11.0统计分析软件进行观察总结和描述性分析.结果:符合要求的95篇文献中总病例数6 540例,总死亡人数626例,总病死率为9.57%.设对照组的文献共47篇,病例数为4 197例,病死率为10.22%,其中治疗组病死率为6.19%,对照组为15.09%,两组比较差异有显著性(P＜0.01).未设对照组的文献48篇,病例数为2 343例,病死率为8.41%.全部病例中,使用中医药治疗的病例4 638例,死亡339例,病死率7.31%,低于设对照组文献中的对照组(P＜0.01).结论:中医药治疗AMI在降低病死率方面可能具有一定作用,但不能排除在临床研究的实验设计、规范治疗、病例选取等方面可能存在一定缺陷;目前仍需要设计规范、样本合理、多中心的随机对照中医药临床研究证据.

Fatality rate analysis of traditional Chinese medicine treatment on acute myocardial infarction from clinical research literatures of China

Objective: To analyze fatality rate of traditional Chinese medicine (TCM) treatment on acute myocardial infarction(AMI) from clinical research literatures in China.Methods: Useful data were extracted from the clinical research literatures of TCM treatment on AMI with identifiable fatality rate on CNKI,which were retrieved from Chinese academic periodical full-text database during 1994-2005 based on some standards,and described and analyzed by statistical analysis software SPSS 11.0.Results: Ninety-five literatures wereretrieved,containing 6 540 cases in total and 626 fatal cases,the fatality rate being 9.57%.There were 47 literatures setting up control group with 4 197 cases,the fatality rate being 10.22%,the rate of fatal cases of the treatment group was 6.19%,while that of the control group was 15.09%,the difference of the two groups was statistically significant(P<0.01).There were 48 literatures that did not include the control group,containing 2 343 cases,and the fatality rate was 8.41%.Four thousand six hundred and(thirty-eight) cases used TCM treatment in total,339 cases died,and the fatality rate was 7.31%,which was also below the rate of the control group,the difference being statistically significant(P<0.01).Conclusion: TCM treatment may have some effects on decreasing the fatality rate of AMI,but it still needs more(multi-centric) randomized controlled clinical trials with normative design and rational sample size in order to get more evidence on the(validity) of TCM treatment on AMI.