生脉胶囊治疗慢性心衰双盲随机对照试验中盲法的实施

Application of Blind Method in Double-Blind Randomized Controlled Trial of Shengmai Capsule for Chronic Heart Failure

[目的]以生脉胶囊治疗慢性心衰双盲随机对照试验为例,探讨盲法实施过程和盲法测试的意义。[方法]盲法实施参照GCP(good clinical practices)规范,盲法测试分别由10名测试者独立对安慰剂的外观、气味等做出评测,再由22名测试者模拟试验实际情况独立判断使用药物为何种。[结果]安慰剂在外观方面基本与生脉胶囊一致,但其气味、味道和口感则明显有别,当两者放在一起时容易辨别。但模拟试验情况的测试表明,试验实际实施中可能不易区分服用药物为何种。[结论]该安慰剂的制作技术有待进一步完善。双盲法的实施过程中,应强化实施过程的标准操作规范,由相对独立人员完成随机化、盲法编码和药物包装等过程,并应制定适宜的数据管理方法,以保证盲法实施的成功。

[Objective] Clinical trial of Shengmai Capsule (SC) for chronic heart failure was used as an example to explore the key technique for clinical trial of herbal medicine. [ Methods] According to the guidelines for good clinical practices (GCP), blinding procedures of the trial was designed. Placebo test was performed by 10 individuals and simulative test was perfomed by 22. [Results] The appearance of placebo was similar to SC but its odor and taste obviously differed from SC. This indicated that the pharmaceutical technique of placebo should be improved. [ Conclusion ] Standard operating procedure should be emphasized during the performance of blinding method. Randomization, blinded codes, drug packaging and drug allocation should be handled by independent persons and good data management is required for the blind trial to guarantee the successful implementation of blinding method.