癃闭舒制剂安全性风险分析及思考

doi:10.19803/j.1672-8629.2021.09.15

摘要/Abstract

摘要： 目的分析癃闭舒制剂安全性风险,特别是致肝功能异常风险,为临床安全用药提供参考。方法对国家药品不良反应监测数据库、国内文献癃闭舒制剂相关不良反应进行整理与分析。结果癃闭舒制剂在临床使用时可能引起恶心、呕吐、腹痛、腹泻、胃不适、头晕、口渴、乏力、肝功能异常等不良反应。结论在临床使用癃闭舒制剂过程中应关注其致肝功能异常等风险,药品上市许可持有人应及时完善产品说明书中安全性提示信息,促进其在临床的安全使用,以保证公众用药安全。

关键词: 癃闭舒, 说明书, 肝功能异常, 不良反应, 安全性

Abstract: Objective To analyze the risk of Longbishu preparations, especially the liver injury risk, in order to provide reference for clinical safe drug use. Methods Individual adverse drug reaction cases in China retrieved from the adverse drug reaction database and domestic literature were analyzed. Results Longbishu preparations could possibly cause nausea, vomiting, abdominal pain, diarrhea, stomach discomfort, dizziness, thirst, fatigue, liver dysfunction and other adverse reactions. Conclusion The monitoring of clinical use of Longbishu preparations should be upgraded. Marketing authorization holders are expected to update the drug label information and promote the safe use of medicineto ensure the safety of drug users.

Key words: Longbishu, labeling, liver injury, adverse reaction, safety

中图分类号:

R994.11

逄瑜, 朱兰, 王涛, 于洪礼, 邵波, 刘博. 癃闭舒制剂安全性风险分析及思考[J]. 中国药物警戒, 2021, 18(9): 869-871.

PANG Yu, ZHU Lan, WANG Tao, YU Hongli, SHAO Bo, LIU Bo. Analysis of Risks of Longbishu Preparation[J]. Chinese Journal of Pharmacovigilance, 2021, 18(9): 869-871.

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