中药注射剂不良反应的研究进展

Progress on cause of adverse reaction of traditional Chinese medicine

目的探讨中药注射剂不良反应(ADR)发生的一般规律及特点,为临床合理用药提供参考。方法采用回顾性研究方法,对不良反应的现状、类型、原因以及防治对策进行系统梳理。结果不良反应表现为过敏反应,对呼吸系统、心血管系统和消化系统等器官、组织的损害。不良反应的发生主要与药材成分与质量、制备工艺、质量标准、辅料、溶媒、个体差异等因素有关。结论提高质量标准,规范药品说明书,做好上市后再评价工作,以减少不良反应的发生。

Objective To provide the references information in clinical application by discussing the incidence general pattern and feature of traditional Chinese medicine （TCM） injections adverse reactions.Methods The present situation,types,causes and countermeasures of adverse reactions were systematically reviewed by retrospective study.Results Adverse reactions were allergic reactions,respiratory system,cardiovascular system and digestive system,such as organ damage.The main adverse reactions were related to medicinal ingredients and quality, manufacturing process,quality standards, materials,solvents,individual differences, etc.Conclusion Improving quality standards,standardized package insert and listed after the evaluation work to reduce the incidence of adverse reactions.