摘要
目的:利用系统综述、流行病学方法和不良反应评价法评价丹红注射液的安全性,为丹红注射液的安全、合理应用提供科学依据。方法:搜集2004年1月至2011年12月有关静脉滴注丹红注射液产生不良反应的文献资料,将文献分为同期对照临床研究或观察报告、不良反应监测或病案系列报告、不良反应个案或典型病例报告三类,进行归类整理、量化分析;计算并统计丹红注射液不良反应的发生率、发生类型,以及各类型的发生率和构成比。结果:同期对照临床研究或观察报告不良反应发生率为1.89%,不良反应类型以心脑血管系统损害为主;不良反应监测或病案系列报告不良反应发生率为0.58%,不良反应发生类型以Ⅰ型变态反应为主;不良反应个案或典型病例报告主要表现为过敏反应,大多为速发型不良反应;另外还发现了丹红注射液说明书描述以外的不良反应。结论:丹红注射液发生不良反应较常见,临床使用时需引起注意。
OBJECTIVE：To evaluate the safety of Danhong injection by the method of system review,epidemiologic methods and ADR evaluation,so as to provide scientific basis for safe and reasonable application of Danhong injection.METHODS：Literatures about intravenous infusion of Danhong injection-induced ADR were collected from Jan.2004 to Dec.2011.Those literatures were divided into period controlled clinical study or observation and reports,ADR monitoring or case reporting,ADR cases or typical cases.The data were classified and organized.The incidence and types of Danhong injection-induced ADR were calculated,and the incidence and constituent ratio of various types of ADR were also analyzed statistically.RESULTS：The incidence of ADR in period controlled clinical study or observation and report was 1.89%,and main types of ADR were cardiovascular or cerebral system injury;the incidence of ADR in ADR monitoring or case reporting was 0.58%,and typeⅠallergic reactions were dominant type;main type of ADR case or typical cases was allergic reaction,mainly being anaphylactic type ADR.Simultaneously,it was found that some adverse reactions were not included in the package inserts of Danhong injection.CONCLUSIONS：Danhong injection-induced ADR is more common,and it should be seriously noticed when using.
出处
《中国药房》
CAS
CSCD
2013年第35期3328-3333,共6页
China Pharmacy
