目的:探讨注射用丹参引起出血事件的风险,为临床提供可靠的安全性数据。方法:检索中国生物医学文献数据库(CBM),检索式为"注射用丹参or丹参粉针和不良反应or不良事件or副作用or出血or凝血or血凝",检索1979年1月至2009年8月,检索有注射用丹参不良反应报告的文献。结果:①检索到1 659篇文献,纳入统计文献86篇。其中共报道有不良反应病例7 900例,涉及注射用丹参不良反应病例395例(0.05%)。不良反应病例原发疾病以心脑血管病为主(58.1%)。②不良事件类型:出血16篇(18.6%)、皮疹14篇(16.3%)、休克、死亡各7篇(8.1%)。结论:病例报告注射用丹参引起不良事件及出血事件比例较低。
Objective: To investigate bleeding risk induced by Danshen injection,and to provide safety data for clinical treatment.Method: Chinese biological medical disc(CBM) was searched by the formulae of 'Salvia miltiorrhiza injection' or 'injection powder' and 'side effects' or 'adverse events' or 'bleeding' or 'blood clotting' or 'coagulation',with duration from 1979.01-2009.08 for the literatures with Danshen injection adverse reaction case report.Result: ① A number of 1659 documents is retrieved and 86 medical reports are selected.Among them,86 cases in the literature reported 7 900 cases of adverse reactions,involving 395 cases of Danshen injection cases(0.05%).The primary diseases of adverse reaction cases are mainly cardiovascular disease and cerebrovascular disease(58.1%).②Adverse events include bleeding 16 records(18.6%),rash 14 records(16.3%) and shock and death each 7 records(8.1%).Conclusion: The reports indicates that the ratio of adverse events and bleeding events induced by Danshen injection is low.