中医药治疗失眠临床试验中结局指标的选择与报告

Selection and Reporting of Outcome Measures in Clinical Trials on Insomnia Treated with TCM Therapy

针对当前中医药临床试验关于结局测量指标应用不统一、与国际不接轨等迫切需要改善的现状,以中医药治疗失眠为例剖析了疗效评价中涉及结局指标选择的相关注意事项,给出了具体的国际化标准及规范要求。结合具体的实例分析,以求改进国内目前对疗效指标选择应用较为混乱的局面,使中医药临床试验在结局测量和结果报告方面逐步达到国际统一规范,促进中医药临床研究质量的提高。

Because of the disunity use of the outcome measures in traditional Chinese medicinal clinical trials, we explain the application of outcome measures in clinical trials on insomnia, provide the international criteria and guideline on outcome reporting. According to analysis of the concrete cases, we in order to improve the misuse of outcome measures of insomnia, to make the selection and reporting of outcome measures follow with the international practices and, to accelerate the development of traditional Chinese medicine.