【作者】 王云飞； 阮新民； 吴焕林； 欧爱华； 曹炳君； 穆启运； 李晓庆； 马柳玲；

【Author】 WANG Yunfei1, RUAN Xinmin1, WU Huanlin1, OU Aihua1, CAO Bingjun2, MU Qiyun1, LI Xiaoqing1, MA Liuling3 (1.TCM Hospital of Guangdong Province 2.Jiangyin Tianjiang pharmaceutical Co. Ltd. 3.graduate student of Guangzhou University of Chinese Medicine )

【机构】 广东省中医院； 江苏省江阴天江药业有限公司； 广州中医药大学；

【摘要】 目的:客观评价"十一五"国家支撑计划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:本文以"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。更多还原

【Abstract】 Objective: To objectively evaluate the efficacy of placebos in large-scale double-blind TCM clinical trials ,supported by the country’s eleventh five-year plan ,and to offer a reference for placebo Preparation of TCM clinical trials. Method: The article took the placebos researches of "drugs for treating coronary artery diseases " in Clinical Researches of TCM Intervention after Revascularization in Coronary Artery Diseases ,which was supported by the country’s eleventh five-year plan, for example, used blind trial in which the appearance, color and smell of placebos were assessed by conners individually.The results were also marked in mimesis clinical trials. Results: The placebos were different from the testing drugs in smell, but parallel in the appearance,colour, turbidity and taste no matter before or after the particles were solved. However, results of the clinical trial and the operation of the large-scale double-blind traditional Chinese medicine(TCM) clinical trials showed that the placebos were not easy to expose. Conclusion: The production technology of placebos needs further improvement and modification. Well-designed trial and the appropriate method of data management are required to make sure the feasibility of the double-blind study.更多还原