国内生物制品安全性问题的回顾与思考

Review and Reflection on Security Issues of Domestic Biological Products

目的:回顾国内生物制品出现的安全性问题,并思考对策。方法:参考国家食品药品监督管理局发布的《药品不良反应信息通报》以及在社会上造成严重影响的生物制品安全事件,根据时间顺序与问题的性质分析整理。结果:资料显示国内生物制品不良反应的临床后果一般都比较严重,且绝大多数可引起过敏反应;国内生物制品安全事件主要发生在病毒类疫苗、血液制品和细胞因子三类上,且该类事件近几年有愈演愈烈之势。结论:国内生物制品不良反应发生率虽然较低,但临床后果严重,通过改良生产工艺、临床严格使用等途径可尽量避免发生;国内生物制品安全事件的发生越来越频繁,事件原因复杂,关联到经济利益、管理制度等多个方面,很多亟待解决的问题应引起国内医疗卫生界的足够重视。

Objective：To review on the security issues of domestic biological products, and discuss on its countermeasures. Methods： Chinese Adverse Drug Reaction Information Bulletin issued by the State Food and Drug Administration and safety events of biological products which had serious social influence were referred to, analyzed and collated according to time sequence and nature of the problems. Results： Adverse reactions of domestic biological products generally induced serious clinical consequences, and most can cause allergic reactions; biological products security incidents mainly occurred in vaccines, blood products and cytokines, and such events have become increasingly rampant in recent years. Conclusions： Biological products, despite their lower incidence of adverse reactions, usually induce serious clinical consequences. Their adverse reactions can be avoided as much as possible through improved production technology and strict clinical use; security incidents of biological products have become more and more frequent, and their reasons are complex, related to the economic interests and management systems. Many problems to be solved should arouse enough attention from domestic medical and health departments.