摘要
本文通过回顾中药注射剂研发的历史和安全性监测现状,分析了中药安全性事件的特点和风险因素,提出进一步严格注册审批制度,加强生产和质量环节的控制,规范中药注射剂的临床使用等风险控制措施。同时提出,药品生产企业建立全面系统的风险管理方案,通过实施重点监测积极探索主动监测方法学和体系建设、加强基础研究将是控制中药注射剂风险的有效方式。
After a systemic review of the research and developmental history and the current status of safety surveillance of traditional Chinese medicinal injections（TCMIs）,the authors analyzed the characteristics and risk factors of recent safety events of TCMIs and proposed to reinforce the approval procedure for drug registration,strengthen quality control in manufacturing,and standardize clinical applications,etc.In addition,the authors propose that the manufacturers should establish a standardized systemic risk management protocol to actively and voluntarily involve in safety evaluation and surveillance.Exploring the active monitoring methodology and system construction by implementing intensive surveillance and strengthening basic science research are crucial in the understanding and control of the risk of TCMIs.
出处
《世界科学技术-中医药现代化》
2010年第6期845-850,共6页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
关键词
中药注射剂
安全监测
风险管理
重点监测
主动监测
Traditional Chinese medicinal injections（TCMIs）
Safety monitoring
Risk management
Intensive surveillance
Active/ Voluntary surveillance
