循证医学与中药上市后的再评价

Evidence-Based Medicine and Reassessment of Post-Marketed Chinese Herbs

目前 ,我国已逐渐开展对上市后药物的不良反应监测 ,并开始重视其对患者生存质量、患者死亡率等指标的影响。已获上市批准的中药中 ,有很多在不良反应的发现和管理上存在时滞现象 ,且在临床有效性和安全性方面存在一定问题。对中药上市后的再评价 ,需要有效、规范的评价体系。循证药物评价运用循证医学的理念 ,结合临床流行病学、系统评价、卫生技术评估等手段 ,评价新药和上市后药物的临床有效性、安全性、经济性和适用性 ,对我国中药的现代化与国际化进程具有重要作用。

Assessment on adverse drug reactions (ADR) that directly affects the quality of life and mortality and an important part of the post-marketed reassessment are developing gradually in China. Many problems have been identified in clinical validity and safety for the authorized Chinese herbs. An effective and standardized system is needed in the post-marketed drug reassessment. Evidence-based drug evaluation,which mainly includes clinical epidemiology,systematic review and health technology,will be used to assess the clinical validity,safety and cost of post-marketed drug and play an important role in the process of modernization and internationalization of Chinese herbs.