构建注射用丹参多酚酸盐再评价证据体的研究

Systematic report on re-evaluating parenterally administered salvianolate

该文围绕着中药注射剂创新药"注射用丹参多酚酸盐"上市后的再评价进行了系统的证据综合:药品质量控制;上市后药理学文献评价研究、临床疗效文献评价研究、临床安全性报道文献评价;非临床安全性如毒性实验研究、群体药代动力学再评价;有效性和安全性的多中心Ⅳ期临床试验;来自20家医院共14191例医院HIS数据的分析;739份ADR病例来自国家SRS系统中的报告分析;目前正在开展的上市后临床安全性监测注册登记研究等7个方面进行了全面阐述,使得"注射用丹参多酚酸盐"从研发到上市后的临床有效性和安全性研究拥有一套较为完整的证据链,能为该药规范性地开展再评价工作提供有利依据和信息。

There are few articles or reports collecting evidence about parenterally administered salvianolate from premarketing and postmarketing research or studies systematically.This article is an exact miniature of a systematical report about parenterally administered salvianolate.We analyzed information from four aspects,such as quality control reports,non-clinical premarketing safety experiments,postmarketing research（efficacy studies,hospital information system data and national spontaneous reporting system data）and literature analysis.All the four aspects build an evidence body for Kudiezi Solution in order to inform its safety use in clinical practice and further study.