302例丹参注射液临床不良反应分析  

Analysis of 302 ADR Cases Caused by Danshen Injection

作　　者：王之羽[1] 王友群[1] 李明 

机构地区：[1]中国药科大学,南京市210009 [2]江苏省食品药品监督管理局,南京市210000

出　　处：《中国药房》2010年第32期3035-3037,共3页China Pharmacy

摘　　要：目的:分析丹参注射液临床不良反应的类型和可能原因。方法:根据各医院上报的第一怀疑药品以及不良反应描述,对2003～2008年江苏省丹参注射液不良反应报告中明确为丹参注射液不良反应的302例有效病例进行分析,对各种不良反应进行统计归类,尝试分析出可能由丹参注射液有效成分导致的不良反应。结果:302例丹参注射液临床不良反应中0.66%为疑似丹参注射液有效成分所致;96.36%为与有效成分可能无关的过敏反应;2.32%为制剂不良反应;0.66%为无法确定原因的不良反应。结论:丹参注射液有90%以上可能为过敏反应,应与其主要有效成分无关。其有效成分可能导致出血等不良反应。OBJECTIVE： To analyze the types and the potential causes of Danshen injection inducing ADR cases. METHODS： 302 ADR cases induced by Danshen injection were collected from ADR cases reported in Jiangsu province from 2003 to 2008 according to reported primarily susceptive drug and the description of the ADR. All cases were analyzed statistically to find out possible reason that ADR was induced by active components of Danshen injection. RESULTS： Of total 302 ADR cases, 0.66% was likely to be caused by the active components of Danshen injection; 96.36% allergic reaction were not possibly related to active components; 2.32% was caused by the drug preparation; 0.66% was caused by unclear reason. CONCLUSION： More than 90% ADR cases induced by Danshen injection manifests as allergic reaction, which isn’t possibly related to main active components. The active components could induce the hemorrhage.

关 键 词：丹参注射液 有效成分 不良反应 

分 类 号：R932[医药卫生—生药学] R969.3[医药卫生—药学]