2014～2015年成都地区小牛血清去蛋白注射液不良反应报告分析

Analysis of Deproteinized Calf Blood Extractives Injection-induced Adverse Drug Reaction in Chengdu from 2014 to 2015

目的：统计分析成都地区2014—2015年度小牛血清去蛋白注射液的不良反应报告，提高小牛血清去蛋白注射液临床应用的安全性。方法：收集2014—2015年成都市药品不良反应监测中心数据库中小牛血清去蛋白注射液不良反应报告154例，并对患者的基本情况、ADR的合并用药、用法用量、发生时间、临床表现、新的和严重的ADR、预后进行统计分析。结果：154例小牛血清去蛋白注射液不良反应报告经因果关系评价，符合标准的有141例。ADR主要发生于成人和老年人；给药途径均为静脉滴注，日剂量均符合说明书推荐的用药剂量。ADR报告中涉及合并用药的25例，其中18例合并应用了中药注射剂。ADR大多发生在首次输液的1h内，临床表现涉及机体多个器官系统。发生严重的ADR共7例，新的不良反应共15例。结论：小牛血清去蛋白注射液新的不良反应和过敏反应的发生率应作为上市后评价的关注要点。还应加强对各医疗机构ADR报告质量的评估和管理。

Objective：To analyse the adverse reaction （ADR） of deproteinized calf blood extractives injection in Chengdu from 2014-2015, hoping to provide reference for rational use of deproteinized calf blood extractives injection. Methods： 141 reports of ADR induced by deproteinized calf blood extractives injection received by Chengdu drug adverse reaction monitoring center were collected and analyzed during the period 2014-2015. Information about demographic, combination medication, dosage, administration, occurring time, manifestation, new/serious ADR, prognosis were retrieved and analyzed. Results： Among the 154 cases of ADR reports of deproteinized calf blood extractives injection which evaluated causality, 141 cases met the standard. The ADR mainly occured in adults and the elderly. Drug delivery way was intravenous drip, daily dose all conformed to the specification＇ s recommended dosage. The ADR reports involved in 25 cases of drug combination, 18 cases combined with TCM injections. The ADRs were mainly happened within an hour through intra- venous infusion, the clinical manifestation involved different systems and organs. There were 7 serious ADRs, a total of 15 new ADR cases. Conclusion：The incidence of anaphylatic reaction and new ADR should be an important part of post-marketing safety surveillance. Moreover, the quality of ADR reports should be assessed and evaluated.