一清胶囊临床研究文献质量评价

目的：对一清胶囊临床研究文献进行质量评价。方法：收集国内1990-2005年6月公开发表的一清胶囊相关论文，按照牛津循证医学中心证据标准和临床试验的设计原则，对文献进行质量评价。结果：推荐级别为B级的占68．4％，C级占31．6％；证据水平为2b级占26．3％，3b级占42．1％，4级占31．6％：随机对照试验文献占68．4％，临床对照占5.3％。随机双盲占3．8％；说明组间基线可比性的占11．5％，有诊断标准的占26．9％，有纳入和排除标准占11．5％，说明统计学方法的占19．2％，有客观疗效评价指标占50．0％，说明药物不良反应占3．8％。结论：一清胶囊的临床研究较为活跃，但随机对照试验质量偏低，临床研究设计需进一步规范，论文撰写水平有待提高。

Quality Evaluation of References about Clinical Study of Yiqing Capsules

Objective:To evaluate the quality of references about clinical study of Yiqing capsules.Methods:Related references published during 1990~2005 were collected and their quality evaluated according to the standard for evidence degree provided by Oxford Evidence-based Medicine Center and design principles in clinical trials.Results:68.4% references were recommended as B degree and 31.6% as C degree.For evidence level,26.3% were 2b level,42.1% were 3b level and 31.6% were 4 degree.68.4% references were about randomized contrasted trials.5.3% were about clinical contrasted trials.And 3.8% were about randomized doubleblind.References containing intergroup baseline comparisons,diagnosis standard,standard for patient inclusion and exclusion,statistical method,and objective efficacy evaluation were 11.5%,26.9%,11.5%,19.2% and 50%.Side effects were reported in 3.8% references.Conclusion:The clinical effect of Yiqing capsules has been widely studied.However,ratio of randomized contrasted trials was low.Design of clinical research should be standardized and the level of references be improved.