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[中华中医药学会《中成药临床应用指导原则》技术规范]

[Technical specification for Instructions for Clinical Application of Chinese Patent Medicines in China Association of Chinese Medicine].

作者信息

Zhang Xiao-Meng, Sa Ri-Na, Zhang Bing, Zhang Dan, Lyu Jin-Tao, Duan Xiao-Jiao, Lin Zhi-Jian, Guo Yu-Bo

机构信息

Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine Beijing 100029, China.

Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine Beijing 100029, China Department of Pharmacy, Gansu Provincial Hospital Lanzhou 730000, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 Sep;46(17):4563-4568. doi: 10.19540/j.cnki.cjcmm.20201223.501.

Abstract

In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.

摘要

为解决中成药临床用药混乱、说明书不完善等问题,中国中药协会标准化部门与北京中医药大学中药不良反应监测与合理用药研究中心联合编写了《中成药临床应用指南》。作为药品说明书信息的解读与补充,旨在指导中成药临床安全合理使用。此外,还制定了中成药临床应用描述的技术规范,涵盖“梳理说明书、临床调研、数据检索、数据筛选、证据分级、路径转化、撰写格式”七个流程。这将使《中成药临床应用指南》的读者了解编写背后的工作。

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