中医妇科临床试验标准化研究进展和思考  

Research progress and reflection on standardization of clinical trials of traditional Chinese medicine gynecology

作　　者：贾丽妍[1] 张跃辉[1] 沈文娟[1] 吴效科[1] JIA Li-yan;ZHANG Yue-hui;SHEN Wen-juan;WU Xiao-ke(First Affiliated Hospital,Heilongjiang University of Chinese Medicine,Harbin 150040,China)

机构地区：[1]黑龙江中医药大学附属第一医院,哈尔滨150040

出　　处：《中华中医药杂志》2020年第10期4820-4823,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重大科技专项-2015年度公益性中医药类行业专项(No.201507001);黑龙江省中医药管理局科研项目(No.ZHY2020-134)。

摘　　要：文章探讨中医妇科临床试验标准化研究进展,梳理国内外、中西医有关中医妇科学相关疾病标准化发展和存在的问题,并进行深入分析。提出了中医妇科临床试验标准化研究需有循证医学和补充替代医学依据,并从统一中医妇科常见疾病的名词和术语、更新已有病种的临床试验报告规范,扩展新病种的标准规范指南、培养标准化人才队伍等方面详细阐述其发展意义。指出建设全国中医妇科临床试验标准化研究中心是一项系统工程,合理设计和规划,必定促进中医药标准化建设及国际化的发展。This article discussed the research progress of standardization of clinical trials of traditional Chinese medicine(TCM)gynecology.Problems in the development and standardization of TCM gynecology related diseases in domestic,foreign,Chinese,TCM and western medicine were analyzed in-depth.It puts forward the standardization of TCM gynecology clinical trial research of evidence-based medicine and complementary alternative medicine basis.From the unity of department of gynecology of traditional Chinese medicine common disease of TCM terms and phrases,update existing diseases clinical trial report specification,extend new kinds of standard specification guidelines and standardization of cultivation talent,the significance of its development is expounded in detail.It is pointed out that the establishment of a national research center for the standardization of clinical trials of TCM gynecology is a systematic project,and the rational design and planning will surely promote the internationalization of the standardization of TCM.

关 键 词：中医妇科 标准化 研究进展 临床试验 思考 

分 类 号：R271[医药卫生—中医妇科学]