中药注射剂安全性医院集中监测研究的标准化建设  

Standardized Construction in Hospital Centralized Monitoring for the Safety of Traditional Chinese Medical (TCM) Injections

作　　者：曹红波[1] 张俊华[1] 翟静波[1] 刘春香[1] 郑文科[1] Cao Hongbo Zhang Junhua Zhai Jingbo Liu Chunxiang Zheng Wenke(Evidence Based Medicine Center / Institute of Clinical Evaluation, Tianjin University of Trational Chinese Medicine, Tianjin 300193, China)

机构地区：[1]天津中医药大学循证医学中心/临床评价研究所,天津300193

出　　处：《世界科学技术-中医药现代化》2016年第12期2093-2096,共4页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：天津市教育委员会"131"创新型人才第二层次人选(ZX160123):中医药临床评价;负责人:曹红波;国家自然基金项目委青年科学基金项目(81202849):体现患者重要结局的中成药临床效应个性化比较效果评价方法;负责人:曹红波

摘　　要：目前,安全性问题是制约中药注射剂发展的重要瓶颈。医院集中监测是中药注射剂安全性评估的重要方法,但该方法经常因设计、过程质量控制等系列问题而导致监测结果与实际情况有所偏离。近年来,本课题组承担了多项中药注射剂集中监测项目,基于前期的研究经验,本文着重论述中药注射剂医院集中监测过程中标准化现状、重要性及具体方法,以期提高中国中药注射剂医院集中监测研究的质量,为充分认识中药注射剂的安全性提供技术支撑。Safety is a critical link restricting the development of TCM injections. Hospital centralized monitoring is of importance in the safety evaluation of TCM injections. However, the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality. Our research team have completed several projects over centralized monitoring in recent years. Based on the previous research experience, this paper mainly discussed the current statuation, the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections, in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.

关 键 词：中药注射剂 医院集中监测 真实世界 安全性评价 

分 类 号：R288[医药卫生—中药学]