糖尿病中药临床试验方案设计的几个问题

Discussion on clinical study conceptual design of diabetes treatment by TCM

根据多年的实践与教训,笔者就糖尿病中药临床试验方案设计中容易出现的问题谈个人体会,从临床研究方案设计的研究目的、设计方法、入组标准及疗效评价标准的确定、对照药的选择、安全性指标评价等方面进行了讨论,为中医药治疗糖尿病的临床研究设计提出了具体的思路和方法,也为中医药的疗效评价及临床研究方法提供借鉴和思考。

The author discusses some problems about protocol design of clinical study of diabetes treatment by TCM. Based on the practices and lessons in many years, the design ideas and concrete ways of how to design the protocol, which offer reference and thinking on evaluation of clinical therapeutic effect and research methods of TCM are brought up.