摘要
为改进中药临床试验报告质量,本文在《草药随机对照临床试验的报告:CONSORT声明细则》的基础上,结合中医药的特点,制定了中药临床试验报告的参考条目。本条目沿用了草药CONSORT声明的22项要求,对其中11项的部分内容根据中医药特点进行了细化和增减,并根据中成药和汤药两大类临床试验的特点,分别对参考条目进行细化;条目突出了受试者(participant)、干预措施(intervention)、对照(control)和结局(outcome)四个方面的内容。制定中药临床试验报告的参考条目旨在提高中药临床试验报告的质量,并为杂志编辑和审稿人员提供参考。
In order to improve the quality of reporting Chinese herbal medicine （CHM） trials, an elaborated checklist was developed according to the basic characteristics of traditional Chinese medicine （TCM） and on the basis of the Reporting Randomized Controlled Trials of Herbal Interventions： An Elaborated CONSORT Statement. This checklist adopted the 22 items of the Herbal CONSORT Statement with some necessary elaboration and modification in the detailed contents of 11 items, among which, the items of Participants. Intervention, Control group and Outcomes were elaborated and modified accordingly to adapt TCM characteristics. Since the design and reporting of trials on Chinese proprietary medicine and herbal decoctions are different in some aspects, the checklist provided two sets of elaborated item 4 （interventions）. We hope that authors, journal editors and peer reviewers find this checklist instructive.
出处
《中西医结合学报》
CAS
2008年第3期233-238,共6页
Journal of Chinese Integrative Medicine
基金
国家重点基础研究发展计划(973计划)资助项目(No.2006CB504602)
关键词
中药
临床试验
试验报告
临床试验报告统一标准
Chinese herbal drugs
clinical trials
trial report
Consolidated Standards of Reporting Trials
