随机对照临床试验中盲法质量评价现状  

Blinding Assessment in Randomized Controlled Clinical Trials

作　　者：闫世艳[1] 何丽云[1] 刘保延[2] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院,北京100700

出　　处：《中国循证医学杂志》2014年第5期631-635,共5页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金青年基金资助项目(编号:81303149);中国中医科学院基本科研业务费自主选题项目资助(编号:Z0259);中央级公益性科研院所基本科研业务费专项资金资助(编号:ZZ070818);"十二五"国家科技重大专项(编号:2012ZX10005009)

摘　　要：正确使用盲法可以有效控制和减少临床试验过程中由于试验参与人员主观因素所引入的偏倚,但盲法失败时反而会引入更大偏倚。因此,对涉及盲法的临床试验,有必要对其进行盲法质量评价。笔者对目前国际上盲法质量评价的相关文献和方法进行了梳理总结,发现目前盲法质量评价尚未引起研究者的足够重视,相关研究报道较少;更缺乏全面综合的盲法评价方法和工具,对盲法评价时点也无统一意见。因此,有必要对盲法评价方法进行多方面的深入研究,并建议根据影响盲法实施的关键因素开发综合的盲法评价量表,通过评估各关键因素的执行情况,确定研究的盲法风险和等级,便于更好地解释和评估研究结果。Blinding is an effective measure to control and reduce the bias caused by the subjective factors of participants in a study, However, the failure of blinding results in more bias. Therefore, it is necessary to assess blinding quality in clinical trials involving blinding. The relevant international articles and methods of blinding assessment were summarized in this study. According to the present situation of blinding assessment, researchers don＇t pay enough attention to the assessment of blinding quality, relevant studies lack, comprehensive methods and tools for blinding quality, and researchers have discrepancy with time points in blinding quality. Therefore, it is necessary to conduct further studies in all aspects, and it is suggested that comprehensive blinding quality scales should be developed according to the key influencing factors of the implementation of blinding. Through the assessment of the implementation of key factors, the risk and degree of blinding should be confirmed in order to better interpret and assess researcher results.

关 键 词：盲法 盲法质量评价 随机对照试验 

分 类 号：R-03[医药卫生]