失眠症中药新药临床试验设计的考虑

Thoughts on clinical trial design of new compound Chinese medicine for insomnia

失眠症严重影响患者的情绪、社会功能以及生活质量,是抑郁症、心血管疾病以及糖尿病的独立预测因子。本文基于作者对失眠症中药新药临床试验审评工作的总结和思考,对失眠症中药治疗的特点、人用经验的相关考虑、临床试验设计中关疾病诊断、受试人群、对照组的设置、疗程及观察时点的设置、基础治疗与合并用药、疗效评价、安全性指标设置、受试者日志卡的设置以及质量控制等方面的问题进行探讨,希望能够为失眠症中药新药研发提供有益的参考。

Insomnia seriously affects the mood, social function and quality of life of patients,and is an independent predictor of depression,cardiovascular disease and diabetes. Based on the author’s summary and thinking of clinical trial review of new Chinese medicine drugs for insomnia,this paper discusses the characteristics of traditional Chinese medicine treatment for insomnia,the relevant considerations of human experience,the diagnosis of related diseases in clinical trial design,the setting of subjects and control groups,the setting of treatment courses and observation points, the setting of basic treatment and combined medication,curative effect evaluation,safety index setting,subject log card setting and quality control,hoping to provide useful reference for the research and development of new Chinese medicine drugs for insomnia.