大型双盲临床试验中药安慰剂制备方法及效果评价研究  

Preparation of Chinese Herbal Medicine Placebos and Efficacy Evaluation in Large-scale Double-blind Clinical Trails

作　　者：王云飞[1] 阮新民[1] 吴焕林[1] 欧爱华[1] 曹炳君[2] 穆启运[1] 李晓庆[1] 马柳玲[1] 

机构地区：[1]广州中医药大学第二临床医学院,广州510120 [2]江苏省江阴天江药业有限公司,江苏江阴214434

出　　处：《中药新药与临床药理》2011年第3期255-258,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：十一五国家科技支撑计划课题(2006BAI04A01)

摘　　要：目的客观评价大型双盲中医药临床试验中研制的盲法中药安慰剂的效果,为中医药临床试验的中药安慰剂的研制提供参考。方法以"十一五"国家支撑计划《冠心病血运重建后中医干预的临床研究》临床研究用药"冠心病方(协定)(免煎颗粒)"的安慰剂研制为例,运用盲法测试,由测试者独立对安慰剂的外观、颜色和气味进行评价,再模拟临床试验进行评价打分。结果安慰剂与冠心病方主要在气味上有一定差别,而颗粒溶解前后外观、颜色、混浊度等基本达到一致,尝试口味也基本一致。模拟临床试验及大型双盲中医药临床试验具体实施均表明安慰剂不易破盲。结论该安慰剂的制作技术有待进一步改善和提高。双盲试验的实施过程中,要求设计良好的试验以及盲法的评价规范,以保证双盲法的成功实施。Objective To objectively evaluate the efficacy of Chinese herbal medicine placebos in large-scale double-blind traditional Chinese medical（TCM） clinical trials,and to offer a reference for placebo preparation of TCM clinical trials.Methods Taking Guanxinbing Recipe as the placebo,which was used in Clinical Researches of TCM Intervention After Revascularization in Coronary Artery Diseases supported by the national project during the eleventh five-year plan,we carried out the blind trial in which the appearance,color and smell of placebos were assessed by conners individually.The results of the mimic clinical trials were scored.Results The placebos were different from the testing drugs in smell,but were parallel in the appearance,color,turbidity and taste before and after the dissolving of particles.However,results of the mimic clinical trial and the operation of large-scale double-blind TCM clinical trials showed that the placebos were not easy to be exposed.Conclusion The production technology of placebos needs further improvement and modification.Well-designed trial and evaluation standardization of blind trial are required to ensure the feasibility of the double-blind study.

关 键 词：临床试验 中药安慰剂 制备方法 盲法 评价 

分 类 号：R285.5[医药卫生—中药学]