一清胶囊临床研究文献质量评价

Quality Evaluation of References about Clinical Study of Yiqing Capsules

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。

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 double-blind. 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.