我国医学期刊中RCT试验的随机质量调查  

Investigation on randomization quality of RCT in published medical periodicals of China

作　　者：李强[1] 陈宇[2] 吴淑金[1] 杜冠辉[1] 陈兵[1] 袁宁[1] 陈嘉伟[1] 

机构地区：[1]广东省医学情报研究所《实用医学杂志》编辑部,广州510180 [2]广东药学院,广州510240

出　　处：《中华医学科研管理杂志》2008年第6期339-342,共4页Chinese Journal of Medical Science Research Management

基　　金：广东省医学科研基金资助项目（B2007026）

摘　　要：目的探讨我国医药期刊中随机对照试验（RCT）论文的随机质量。方法设计了随机对照试验论文质量评价表，单纯随机抽取了1995、2000及2005年公开出版的我国医学期刊中137篇题目中出现“随机对照”字样的医学论文，其中符合纳入标准的103篇作为样本，并对被抽取的文献作相关分析。结果①随机化：在103篇的被调查RCT论文当中，96．1％没有详细地描述采取的随机方法，97．1％未介绍抽样方法。1995年的RCT报告完全没有对随机抽样和随机分组的具体方法加以说明，2000年和2005年在这方面显然优于1995年。②样本：63．1％的论文在文中有清楚描述的诊断标准，另外的36．9％没有。对研究纳入标准和排除标准两者都具体描述的论文仅占50．5％，有26．2％的论文甚至两者都没有写明，而剩余23．3％的论文则只是描述了两者中的任意一个。③分组：69．9％都对分组后组间的基线情况分开介绍，30．1％则未分开介绍；未对组间可比性进行分析的占28．2％。结论我国医学RCT论文存在随机化方法不够严谨，诊断标准、纳入标准和排除标准遗漏率较高，还有约三分之一的论文将组间的基线情况混在一起交代，说明我国RCT论文的随机质量还有待进一步提高。Objective To explore the quality of randomization of RCT in medical periodicals of China. Methods We designed a table of quality evaluation of RCT, and then randomly chose 137 articles entitled with ＂random control＂ , which were published in 1995, 2000, and 2005. Results Of the 137 articles, 103 meet the requirement of this research. Of the 103 articles, 99 didn＇t include the details of randomization （96.1%）, 100 didn＇t present the sampling methods （97.1%）. Articles published in 1995 totally didn＇t inelude the introduction of randomized sampling And grouping methods, but the situation got better in 2000 and 2005. There was 63. 1% included clear description of diagnostic criteria. Of remaining of 36.9%, 23.3% included either in drawing or excluding criteria, 50.5% included both, and 26.2% included none. For grouping, 69.9% included the introduction of the baseline of each group, and 30.1% didn＇t. Conclusions There were some problems in the RCT, such as lack of rigorous in randomization, incomplete in diagnostic, in drawing, and excluding criteria, and lack of clear introduction of the baseline, which revealed there were still much work needed to be done to improve the clinical research level in our country.

关 键 词：随机对照试验 医学论文 随机化临床试验 

分 类 号：GG[文化科学] G2[医药卫生] R