作　　者： ;

机构地区： 广州中医药大学

出　　处： 《国际中医中药杂志》 2018年第8期685-689,共5页

摘　　要： 传统医学在面对较复杂多变的疑难危重疾病时，往往对选用的处方进行必要加减、使用多样化的治疗措施。这反映了传统医学“辨证论治”原则性与灵活性的统一。但在临床试验过程中，对干预措施的变动，虽有更适合临床颇重而复杂疾病的优点，但这会导致多种干预成分共用，很难避免混杂偏倚的影响。本文针对疑难危重疾病的特点介绍一种新的临床治疗性试验设计方法，在疾病某阶段以相同症状为导向进行随机分组，再用综合干预措施进行处理，观察差异是否有统计学意义。这种以症状为导向的综合干预措施为传统医学的治疗性试验设计提供了可行方案，可解决当前传统医学试验设计中的一些问题。 Due to the characteristics of the complicated and critical deseases, therapeutic measures in the TCM clinical trials need to be multiple rather than single indexes. It is the flexibility and principle reflection of treatment based on syndrome differentiation. The advantage is more suitable for severe and complex diseases, but the adverse effect is mis-understood by the confounding bias. According to the characteristics of traditional medicine, a new method was proposed for the complicated and critical deseases. Firstly, the randomization with the inclusion criteria was made by the same symptom in a certain stage of disease; and secondly, the comprehensive intervention measures were adopted of processing; Eventually, the statistical difference was calculated. The symptom directed comprehensive interventions have provided the experimental design of the TCM therapeutic clinical trials.

关 键 词： 传统医学 疑难危重疾病 症状 综合干预 治疗性试验 方法设计

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