30445例住院患者帕洛诺司琼相关心律失常临床特征及危险因素分析  

Clinical characteristics and risk factor analysis of 30445 inpatients with palonosetron-related arrhythmias

作　　者：李鹏 郭代红[2] 朱曼[2] 高奥[2] 郭海丽 伏安 赵安琪 LI Peng;GUO Daihong;ZHU Man;GAO Ao;GUO Haili;FU An;ZHAO Anqi(Chinese PLA Medical School,Beijing 100853,China;Department of Pharmacy,Medical Supplies Center,Chinese PLA General Hospital,Beijing 100853,China)

机构地区：[1]解放军医学院,北京100853 [2]解放军总医院医疗保障中心药剂科,北京100853

出　　处：《中国医院药学杂志》2023年第23期2666-2671,共6页Chinese Journal of Hospital Pharmacy

基　　金：2017年军事医学创新工程重点项目(编号:17CXZ010);中国研究型医院学会临床重点药品的使用监测和评价研究专项课题(编号:Y2022FH-YWPJ01)。

摘　　要：目的:通过大样本信息化真实世界研究,评价分析止吐药帕洛诺司琼致心律失常的发生率、临床特征和危险因素,为临床安全用药提供参考。方法:依托临床ADE主动监测与智能评估警示系统-Ⅱ(adverse drug event active surveillance and assessment system-Ⅱ,ADE-ASAS-Ⅱ)对2017年至2021年某院使用该药的住院患者开展回顾性自动监测,获取心律失常发生率和临床特征,通过Logistic回归分析确定危险因素。结果:纳入30445例患者,用药78232例次,最终确定165例次发生心律失常,发生率0.21%。使用该药患者发生心律失常的独立危险因素有合并心血管疾病、天冬氨酸氨基转移酶>40 U·L^(-1)和用药时间延长;此外,使用该药预防化疗后恶心、呕吐患者的独立危险因素还包括肌钙蛋白T>0.13μg·mL^(-1)、氨基末端脑钠肽前体>900 pg·mL^(-1)和联用环磷酰胺,预防术后恶心、呕吐患者的独立危险因素还包括钾<3.5 mmol·L^(-1)、静脉泵入给药、联用其他5-羟色胺3受体拮抗剂(5-hydroxytryptamine 3 receptor antagonists,5-HT3RA)或氟氧头孢。结论:帕洛诺司琼致心律失常与前述危险因素显著相关,发生率属偶见范围;ADE-ASAS-Ⅱ能够高效、精准、低成本获取目标用药人群风险信息。OBJECTIVE To evaluate and analyze the incidence,clinical characteristics and risk factors of arrhythmias caused by an antiemetic drug palonosetron by a large-sample informational real-world study in order to provide reference for clinical drug safety.METHODS A retrospective automatic monitoring of all inpatients treated with palonosetron in a hospital from 2017 to 2021 was performed by using the adverse drug event active surveillance and assessment system-Ⅱ(ADE-ASAS-II)to obtain arrhythmia incidence and clinical characteristics,and risk factors were identify by Logistic regression analysis.RESULTS The study enrolled 30445 patients with 78232 cases of medication,and finally identified 165 cases of arrhythmias,with an incidence of 0.21%.Independent risk factors for arrhythmias in patients using this drug included comorbid cardiovascular disease,aspartate aminotransferase>40 U·L~(-1)and prolonged medication duration;additional independent risk factors for patients aiming to prevent chemotherapy-induced nausea and vomiting were troponin T>0.13μg·mL~(-1),amino terminal brain natriuretic peptide precursor>900 pg·mL~(-1)and co-administration of cyclophosphamide,and those for patients aiming to prevent postoperative nausea and vomiting were potassium<3.5 mmol·L~(-1),intravenous infusion pump administration,and co-administration of other 5-hydroxytryptamine 3 receptor antagonists(5-HT3RA)or flomoxef.CONCLUSION Palonosetron-related arrhythmias is significantly associated with the aforementioned risk factors,and the incidence is within the occasional range.ADE-ASAS-II is an efficient,accurate and cost-effective way to obtain risk information of the target medication population.

关 键 词：5-HT3RA 帕洛诺司琼 心律失常 发生率 自动监测 危险因素 

分 类 号：R969.3[医药卫生—药理学]