基于国家药品不良反应监测系统数据库的琥珀酰明胶注射液不良反应报告分析  

Analysis of adverse reactions caused by succinylated gelatin injection based on database of the National Adverse Drug Reaction Monitoring System

作　　者：王力剑 樊若曦 朱旭 关瑜 李雷 Wang Lijian;Fan Ruoxi;Zhu Xu;Guan Yu;Li Lei(Jilin Province Drug Safety Monitoring Center,Changchun 130033,China)

机构地区：[1]吉林省药品安全监测中心,长春130033

出　　处：《药物不良反应杂志》2024年第3期145-149,共5页Adverse Drug Reactions Journal

摘　　要：目的分析琥珀酰明胶注射液不良反应的一般规律及特点,为临床安全合理用药提供参考。方法收集国家药品不良反应监测系统数据库2004年1月至2021年8月上报的琥珀酰明胶注射液不良反应报告,回顾性分析涉及患者的性别、年龄、原患疾病、用药原因、合并用药,用药后发生不良反应的时间、临床表现、严重程度和转归等信息,参考《国际医学用语词典》的系统器官分类(SOC)进行分类统计。结果共纳入3036例琥珀酰明胶注射液不良反应报告,其中严重不良反应710例(23.39%),涉及的SOC居前5位者依次为免疫系统疾病、全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病、血管与淋巴管类疾病和呼吸系统/胸及纵隔疾病,主要症状为过敏性休克、类速发严重过敏反应、寒战、发热等速发型严重过敏反应的表现。3036例患者中1543例痊愈,1480例好转,3例未好转,2例有后遗症,2例死亡,6例结果不详。说明书以外不良反应涉及的SOC包括眼器官疾病、各种肌肉骨骼及结缔组织疾病、代谢及营养类疾病和肾脏及泌尿系统疾病等。结论琥珀酰明胶注射液ADR多与过敏反应有关,严重不良反应符合速发型严重过敏反应的特征,但可能存在说明书中未涉及的相关风险。Objective To analyze the general rules and characteristics of adverse reactions of succinylated gelatin injection and provide reference for safe and rational clinical use.Methods Adverse reaction reports related to succinylated gelatin injection in National Adverse Drug Reaction Monitoring System database from January 2004 to August 2021 were collected.Retrospective analysis of patients′gender,age,primary disease,reason for drug use,combined drugs,and time of adverse reaction occurrence from drug use,clinical manifestations,severity and patient outcomes were performed,and classified statistics were performed according to systematic organ class(SOC)and preferred terms of Medical Dictionary for Regulatory Activities.Results A total of 3036 adverse reaction reports of succinylated gelatin injection were entered,including 710 serious cases(23.39%),and the top 5 SOCs involved diseases of the immune system,systemic diseases and various reactions at the administration site,skin and subcutaneous tissue diseases,vascular and lymphatic diseases,and respiratory/thoracic and mediastinal diseases.The main symptoms were anaphylactic shock,similar rapid severe allergic reaction,chills,fever,and other rapid severe allergic reactions.Among the 3036 patients,1543 were cured,1480 were improved,3 were not improved,2 had sequelae,2 died,and 6 had unknown results.The SOCs involved in adverse reactions and not recorded in labels included ocular organ diseases,various musculoskeletal and connective tissue diseases,metabolic and nutritional diseases,kidney and urinary system diseases,etc.Conclusions The adverse reactions related to succinylated gelatin injection are mostly associated with anaphylaxis.Severe adverse reactions are consistent with the characteristics of rapid severe anaphylaxis,but there may be related risks not covered in labels.

关 键 词：药物相关副作用和不良反应 药物不良反应报告系统 数据分析 琥珀酰明胶 

分 类 号：R969[医药卫生—药理学]