基于日本不良事件报告系统的萘莫司他不良事件分析  

Analysis of adverse drug events of nafamostat by using Japanese adverse drug event report database

作　　者：顾董事 纪文卉 熊伟根 王之舟 陈君 方忠宏 方欢 GU Dongshi;JI Wenhui;XIONG Weigen;WANG Zhizhou;CHEN Jun;FANG Zhonghong;FANG Huan(Department of Pharmacy,Jinshan Hospital,Fudan University,Shanghai 201508,China)

机构地区：[1]复旦大学附属金山医院药剂科,上海201508

出　　处：《中国临床药学杂志》2024年第3期221-227,共7页Chinese Journal of Clinical Pharmacy

摘　　要：目的分析萘莫司他(NM)在日本的药物不良事件发生情况及特点,以促进临床安全合理用药。方法在日本不良反应JADER数据库中下载2012年1月到2023年7月的NM所有药物不良事件(ADE),统计发生ADE病例的性别、年龄、原发病种类、给药原因、给药剂量、转归等信息,对超适应证ADE和其他ADE的转归进行分析。结果剔除重复病例和无因果关系病例后,共有762例ADE,其中男性489例,60岁以上581例,多数病例有基础性疾病,主要用药目的是体外循环抗凝治疗。单次给药剂量占比最多的为10~49 mg,其次为100~199 mg。给药途径以静脉给药和血液透析为主,主要的转归结果为恢复和好转。在死亡病例中,有11例在JADER数据库中被判定为与ADE有因果关系,其余25例可能无关或无法判定。常见ADE为过敏性休克和类过敏性休克,速发严重过敏反应、类过敏反应和超敏反应,休克和血压降低。主要涉及的系统器官分类(SOC)为免疫系统疾病。怀疑仅为NM单药的病例,剔除了给药途径为静脉给药的体外循环的病例后,发现超适应证ADE和其他ADE的转归差异无统计学意义(P>0.05)。结论NM引起ADE最常见的症状是过敏相关症状,建议用药前询问过敏史,必要时可进行皮试。此外,需注意血压降低出现频次较多,超过以往文献较多报道的高血钾。AIM For clinical safety and rational use of nafamostat(NM),the state and characteristics of adverse events of NM in Japan were analyzed and reported.METHODS The NM adverse drug event(ADE)received from the first quarter of 2012 to July 2023 were downloaded from the Japanese adverse drug event report(JADER)database,and the repeated and non-causal cases were removed.The gender,age,type of primary disease,reason for administration,drug dose of administration,recovery and other information were recorded and analyzed to compare the differences between off-label indication ADE and other ADE outcomes.RESULTS After excluding the repeated and non-causal cases,a total of 762 ADEs were obtained.489 cases were male,and 581 cases were over 60 years old,most of whom had underlying diseases and the main purpose of medication was anticoagulation for extracorporeal circulation.A single dose of 10-49 mg was the largest proportion followed by 100-199 mg.Routes of administration were mainly intravenous and hemodialysis.The main outcomes were recovery and improvement.Among the deceased patients,11 cases were determined to have a causal relationship with ADE in the JADER database,while the remaining 25 cases were possibly unrelated or inconclusive.The most common ADEs were anaphylactic shock,anaphylactoid shock,anaphylactic reaction,anaphylactoid reactions and hypersensitivity reactions,shock and low blood pressure The system organ class mainly involved was immune system disease,In cases suspected to involve only NM as a single drug,after excluding cases of cardiopulmonary extracorporeal circulation with intravenous administration,there was no statistical difference in outcomes between offlabel indication ADEs and other ADEs(P>0.05).CONCLUSION The most common symptom of ADE caused by NM is allergy-related symptoms,and it is recommended that skin test should be considered besides asking about allergic history before medication.In addition,the frequent occurrence of hypotension should be noted,which exceeds the frequency of hyperkalemia

关 键 词：萘莫司他 药物不良事件 JADER数据库 类过敏反应 过敏反应 

分 类 号：R975[医药卫生—药品]