证型变化随机对照试验的盲法技术

A Blind Technique Used in Randomized Controlled Trials of Treatment Based on Changes of Syndromes

辨证论治是中医诊疗的一个基本特征,基于证型变化随机对照试验的干预措施具有复杂性,给盲法的实施带来一定困难。本文介绍了一种双盲实现技术,在证型变化、改变用药情况下的随机对照试验中,通过两级药物编号、分阶段药物编号的方法,实现双盲。该方法既保证了研究者和研究对象处于盲态,又可实现患者不同证型条件下的用药变化,且不造成药物的浪费,具有科学性和可操作性。

Treatment based on syndrome differentiation is an essential feature of traditional Chinese medical diagnosis. The interventions based on changes of syndrome types in randomized controlled trials are complicated, leading to the difficulty of blind method enforcement. This article described a double-blind method. It could be used in randomized controlled trials under the condition of different syndrome types and different medications. It numbered drugs in two stages, and in two phases to achieve doubleblind. This method not only guaranteed investigators and subjects to be in blinded conditions, but also achieved using different medications for patients of different syndromes. It also caused no drug waste. It was scientific and feasible.