李文婷 方鹏骞

    患者盲法在疼痛相关随机对照试验中重要性的meta分析

    李文婷 方鹏骞

    目的 通过对疼痛相关随机对照试验的meta分析，探讨患者盲法对结果偏倚的重要性，以期对完善我国临床试验中方法学方面的质量管理有所裨益。方法 检索MEDLINE、 EMBASE和the Cochrane Databases of Systematic Reviews这三大数据库，并筛选出有关慢性疼痛随机对照试验的meta分析。对于每个meta分析，使用随机效应模型计算下列干预的均差：①对患者采用盲法及不进行盲法；②分配隐匿和不进行分配隐匿。之后再合并各个meta分析的标准均差。 结果 最终有17篇meta分析纳入研究，包括了93个随机对照试验，其中57个汇报了不充分盲法，36个为充分盲法。合并的标准均差为0.09(95% CI ：-0.00～0.19)，说明对患者进行盲法的试验结果不佳。 结论 慢性疼痛临床试验结果会受到对患者是否采用了盲法的影响。

    疼痛；患者盲法；随机对照试验；meta分析

    【Abstract】Objective The paper discusses about the importance of patient blind method to bias of the results by carrying out meta analysis of pain related randomized controlled trial in order to assist in improving quality management with respect to methodology in clinical trials in China.Method Three databases including MEDLINE，EMBASE and the Cochrane Databases of Systematic Reviews are researched and meta analysis of chronic pain related randomized controlled trial is selected out.For each meta analysis，mean difference of the following interventions is calculated by using random effect model:blind method is carried out for the patients or not；allocation concealment and non-allocation concealment.After that ......