对推拿等中医外治疗法临床试验方案撰写要求的分析

Analysis on the requirements for clinical trial protocol writing of external treatment of TCM such as tuina

根据《标准方案条目:用于干预性试验的建议》《临床试验报告统一标准》《适用于非药物疗法的临床试验报告统一标准扩展版》以及国内现行的《药品临床试验管理规范》,分类总结其对临床试验方案撰写、报告以及实施过程的具体要求,结合推拿等中医外治疗法临床试验的实际情况,分析并提炼出中医外治疗法临床试验方案撰写要求,为提高推拿等中医外治疗法临床试验方案质量,进而对规范中医临床试验实施与研究结果报告提供参考。

According to Standard Protocol Items：Recommendations for Interventional Trials,Consolidated Standard of Reporting Trials 2010 Statement（CONSORT）,CONSORT Extension for Non-Pharmacologic Treatment Interventions（CONSORT for NPT）and Good Clinical Practice,the detailed requirements for protocol writing,reporting,and practicing of clinical trial were classified and summarized in this article.By combining the practical situation of clinical trial of external treatment of TCM such as tuina,the requirements for clinical trial protocol writing of external treatment of TCM were analyzed and acquired,which could improve the quality of clinical trial protocol of external treatment of TCM,thus to provide references for standardized execution of TMC clinical trial and reports of research results.