人体耐受性试验中不良事件与药物关系分析探讨

Discussion between adverse events and drug in Human tolerance test

目的:探讨如何结合实际分析不良事件与试验药物的因果关系。方法:以螺旋藻多糖胶囊人体耐受性试验为例,对试验中出现的不良事件进行分析判断。结果:在人体耐受性试验中常常会出现症状体征方面的不适或理化检查数据的异常这两个类型的不良事件。结论:中药新药临床试验中应特别重视安全性考察,真实、完整、准确地提供新药的临床试验数据。

Objective：To explore how to combine the pratical analysis method to analyse the relationship of adverse event and test drug.Methods：Through the human tolerance test of PSP,analysed the adverse events appeared in the test.Rusults： There had two types of adverse event in the human tolerance test that symptoms and signs in discomfort or unusual physical and chemical inspection data.Conclusion：Clinical trials of new drugs in traditional Chinese medicine should pay special attention to the safety inspection,true,complete and accurate delivery of new drug clinical trial data.