对受试者在急性缺血性脑卒中的药物临床试验中排除标准的考虑

Consideration on the exclusion criteria of subjects in clinical trial of drugs for acute ischemic stroke

基于3项临床研究资料:白蛋白用于急性缺血性脑卒中、Rt-PA经典给药方案与较长时间给药方案用于急性缺血性脑卒中的比较、诱导性高血压对急性缺血性脑卒中疗效与安全性,本文对急性缺血性脑卒患者的药物临床试验中如何确定排除标准进行了简要介绍。希望对有关临床试验的设计有所助益。

Based on three studies, Albumin in acute ischemic stroke trial, fralyse trial： Comparison of the classical rt- PA procedure with a longer procedure in acute ischemie stroke and Induced hypertension for acute ischemic stroke, this article gives a brief introduction about how to make the exclusion criteria of subjects in clinical trial of drugs for acute ischemic stroke. Wish it is helpful to the design of related clinical trials.