鱼精蛋白注射液致毒性反应机制分析与措施  

The Mechanism of Toxicity Reaction Induced by Protamine Sulfate Injection

作　　者：范燕 王丹 王春婷 FAN Yan;WANG Dan;WANG Chunting(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100022

出　　处：《中国药物警戒》2021年第12期1159-1161,1165,共4页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项2017年度(2017ZX0910-1001-001-003)。

摘　　要：目的分析鱼精蛋白注射液致毒性反应的发病机制和风险因素,为临床安全使用鱼精蛋白注射液、有效防范与控制其风险提供参考。方法对鱼精蛋白注射液致毒性反应的临床分型和发病机制分析,探讨其导致毒性反应的各种风险因素。结果鱼精蛋白注射液临床使用中给药速度、给药途径、特殊人群和认识不足等均是毒性反应发生的风险因素。结论采取有效的控制措施,加强用药时监测、选择合理的给药速度、给药途径、使用超滤、特殊人群的处理以及有效的信息干预,能降低和控制其风险。Objective To analyze the pathogenesis of and risk factors for toxic reactions induced by protamine sulfate injection so as to provide reference for clinical safe use.Methods The clinical classification and pathogenesis of toxic reactions induced by protamine sulfate injection were analyzed,while a wide range of risk factors leading to toxic reactions was discussed.Results Risk factors for toxic reactions in clinic included the speed of administration,routes of administration,insufficient knowledge,and special populations.Conclusion It is recommended that effective control measures be taken,including the monitoring of medication,selection of a proper speed and route of administration,use of ultrafiltration,control over special populations,and effective information intervention.

关 键 词：鱼精蛋白 注射液 毒性反应 发病机制 风险控制 

分 类 号：R994.11[医药卫生—毒理学]