中药不良反应监测发展状况与案例分析

背景中药临床应用的安全性受到社会越来越广泛的关注,如何有效加强中药不良反应监测是卫生主管部门、制药企业及医疗机构无法回避的课题。目的剖析中药不良反应监测的现状,并探讨中药不良反应监测今后的发展方向。方法综合涉及中药不良反应监测的数据和文献报告,并以香雪抗病毒口服液不良反应/事件监测研究作为范例进行分析。结果中药不良反应监测有了明显进步,但中药注射制剂与口服制剂之间存在巨大反差,企业对于口服中药制剂临床用药的风险防范意识薄弱,缺乏主动性。结论中药口服制剂的不良反应监测应得到充分重视,而制药企业应加强产品的不良反应监测研究,切实提高社会卫生保障能力和水平。

Progression in Monitoring of Adverse Reactions on TCM Products and A Case Study

Background Since more and more concern is raised regarding clinical safety of TCM products,effective and enhanced monitoring on adverse reactions of TCM products has become an inevitable subject for health authorities,pharmaceutical companies and medical institutes.Objective To analyze current status and to explore the future of monitoring on adverse reactions of TCM products.Methods data and literature reports concerning adverse reactions monitoring of TCM products were reviewed and summarized,and an adverse reactions/events monitoring study as conducted by Guangzhou Xiangxue Pharmaceutical was analyzed as a paradigm. Results Significant progress has been made in the monitoring of adverse reactions to TCM products.There is,however,huge difference between injectable and oraly administered products in the monitoring.Pharmaceutical companies are hardly aware of the clinical risks with oraly administered TCM products and thus are not initiative.Conclusion Adequate attention should be given to the monitoring of adverse reactions to oraly administered TCM products,while pharmaceutical companies should strengthen adverse reactions monitoring study on their products,so as to substantialy improve protection for public health.