对《中国新药杂志》发表的随机对照试验文献的统计分析

Assessment of the randomized clinical trials articles published in Chinese Journal of New Drugs

目的:统计《中国新药杂志》11年来发表的文献,从中筛选出符合纳入标准的文章,统计其中随机对照试验(RCT)文献的数量以及试验设计方案的质量,从而了解我国新药临床试验方面的科研设计水平。方法:对《中国新药杂志》1992年创刊至2002年共11卷91期(包括增刊)进行手工检索,逐期逐页筛选新药临床试验文献并加以记录、评价和统计学分析。结果:11年间共发表699篇新药临床试验文献,其中RCT 358篇(双盲RCT共51篇),占51.2％;临床对照试验(CCT)93篇,占13.3％;其他临床研究248篇,占35.5％。结论:《中国新药杂志》所发表的新药临床试验文章水平较高,其中RCT和CCT文献所占比例呈逐年上升趋势。

Objective: To assess the scientific standard of design in new drug clinical trials through statistical analysis of articles published in 《Chinese Journal of New Drugs》 during past 11 years. Methods:Randomized clinical trial articles published in 《Chinese Journal of New Drugs》 during past 11 years were collected and evaluated by statistical analysis. Results:Totally 699 articles of clinical trials including 358 (51.2%) randomized clinical trials (contained 51 double-blind clinical trials),93 (13.3%) controlled clinical trials,and 248 (35.5%) other clinical trials were obtained. Conclusion: Articles of clinical trials published in《Chinese Journal of New Drugs》 are of high quality and the proportions of RCT (randomized clinical trials) and CCT (controlled clinical trials) are increased as time passing.