中药注射剂说明书中药物警戒表述的分析

An Analysis of the Pharmacovigilance Expression in the Directions of Traditional Chinese Medicine Injections

目的:分析我院中药注射剂说明书中关于药物警戒的表述,以指导临床用药。方法:根据《药品说明书和标签管理规定》及《中药、天然药物处方药说明书格式》中有关药物警戒项目对我院中药注射剂说明书中关于药物警戒的表述进行统计、分析。结果:调查28份中药注射剂说明书中不良反应、禁忌、注意事项、药物相互作用4项标注良好,标注率89.3%～100%,其他项目缺项较多。结论:中药注射剂说明书中药物警戒的表述存在内容简单、项目不全的情况,需要规范及完善。

Objective：To investigate the pharmacovigilance expression of traditional Chinese medicine injections （TCMI） in the directions in our hospital. Methods： The related pharmacovigilance items were collected and analyzed according to Provisions Governing Pharmaceutical Directions and Labels and The Directions Format of Traditional Chinese Medicine, Natural medicine, Prescription Drugs. Results： The marks of 4 items （Adverse reactions, contraindications, precautions, drug interactions） were good in 28 TCMI directions, accounting for 89.3% - 100%, the other items were not fully marked. Conclusions： It is necessary to further regulate pharmacovigilance expressions of TCMI directions to fulfill the domestic need.