中国药物警戒 ›› 2010, Vol. 7 ›› Issue (12): 741-744.

• 管理及工作研究 • 上一篇    下一篇

骨伤科常用非处方外用中成药的安全性评价与合理使用

季原1,张力2   

  1. 1.北京中医药大学第三附属医院,北京100029；
    2.国家食品药品监督管理局药品评价中心,北京100045
  • 收稿日期:2010-08-01 修回日期:2016-03-09 出版日期:2010-12-08 发布日期:2016-03-09
  • 通讯作者: 张力,女,中药安全监测与评价。E-mail：zhangli@cdr.gov.cn
  • 作者简介:季原,男,骨伤科临床康复。

Safety Evaluation and Rational Use of External Application of Over the Counter Chinese Patent Medicines for Orthopedics

JI Yuan1 ,ZHANG Li2   

  1. 1.The Third Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100029;
    2.National Center for Drug Reevaluation, SFDA, Beijing 100045
  • Received:2010-08-01 Revised:2016-03-09 Online:2010-12-08 Published:2016-03-09

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摘要： 外用中成药在骨伤科疾病治疗过程中具有独特的优势,为充分发挥临床疗效规避风险,该类非处方药的安全性问题更应引起高度重视。通过对骨伤科常用非处方外用中成药安全性相关典型案例分析,总结了该类药物的风险特点和影响因素,提出遵循其常规使用原则及特殊使用原则是积极推行合理用药、发挥疗效减少用药风险的主要途径。

关键词: 骨伤科, 非处方, 中成药, 评价, 合理使用, 风险管理

Abstract: External application of Chinese patent medicines have unique advantages in the treatment of orthopedic diseases. However, more attention are needed to this category of medicine that are over the counter(OTC) to maximize the therapeutic effects and minimize medication risk. This article summarizes risk characteristics and the relevant factors by analysis of the typical safety case reports and put forward that it is an important measure to abide the conventional and special rules during medication.

Key words: Key word：orthopedics, over the counter(OTC), chinese patent medicine, evaluation, rational use, risk management

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