176例单克隆抗体和脂质体抗肿瘤药物引发的输液反应分析  

Analysis of 176 cases of infusion reactions caused by monoclonal antibodies and liposome antineoplastic agents

作　　者：黄焕均 余柱立 张云惠 郭晨晨 陈浩云 石凤 董心仪 梁蔚婷[1] HUANG Huanjun;YU Zhuli;ZHANG Yunhui;GUO Chenchen;CHEN Haoyun;SHI Feng;DONG Xinyi;LIANG Weiting(State Key Laboratory of Oncology in South China,Guangdong Provincial Clinical Research Center for Cancer,Department of Pharmacy,Sun Yat-sen University Cancer Center,Guangzhou 510060,China;School of Pharmaceutical Sciences,Sun Yat-sen University,Guangzhou 510006,China)

机构地区：[1]华南恶性肿瘤防治全国重点实验室-广东省恶性肿瘤临床医学研究中心-中山大学肿瘤防治中心药学部,广州510060 [2]中山大学药学院,广州510006

出　　处：《中国临床药学杂志》2024年第11期807-812,共6页Chinese Journal of Clinical Pharmacy

基　　金：广东省药品临床综合评价项目(编号2022-1115-28)。

摘　　要：目的分析单克隆抗体与脂质体抗肿瘤药物引发输液反应(IR)的特征,为IR的管理和药学监护路径的完善提供参考。方法收集202l年1月1日至2024年6月30日某院上报至国家药品不良反应监测系统的单克隆抗体与脂质体抗肿瘤药物IR报告176例,并对数据进行统计和分析。结果176例IR报告共涉及19个抗肿瘤药物,其中51~60岁的病例占37.50%,多柔比星脂质体引发IR的病例占比(26.14%)最高。在第1程化疗发生IR的有使用多柔比星脂质体(占91.67%)、利妥昔单抗(占64.86%)和奥妥珠单抗(占92.31%)的病例。多柔比星脂质体在给药后30 min内发生IR的病例占67.39%;使用利妥昔单抗的病例中在给药后61~240min发生IR的占72.41%。80.68%的发生IR的病例经对症处理后2h内缓解。IR临床表现为皮肤潮红、瘙痒、皮疹、寒战和胸闷的病例占比较高。结论使用单克隆抗体和脂质体抗肿瘤药物发生IR的病例年龄多在51~70岁,IR多发生在给药4 h内,在第1程化疗即发生IR的病例占比较高,临床表现以皮肤潮红、瘙痒、皮疹、寒战和胸闷为主。建议首次使用药品说明书明确记载有IR的抗肿瘤药物时,用药期间全程监测不良反应发生情况。在IR高发的化疗疗程和用药时间段内增加监测次数,以早期预防IR的发生。AIM To analyze the characteristics and patterns of infusion reaction(IR)triggered by antineoplastic agents with monoclonal antibodies and liposomes,and to provide reference for managing the IR and improving the pharmaceutical monitoring pathway.METHODS A total of 176 cases of IR reports of monoclonal antibodies and liposome antineoplastic agents reported to the National Adverse Drug Reaction Monitoring System were collected by a hospital from January 1,202l to June 30,2024,and the data were statistically analyzed.RESULTS Of the 176 IR reports,37.50%were in patients aged 51-70 years.Among the 19 antineoplastic agents,doxorubicin liposome had the highest incidence of IRs at 26.14%.After the first administration,IR occurred in doxorubicin liposome,rituximab,and otolizumab,accounting for 91.67%,64.86%,and 92.31%,respectively.IR occurred in 67.39%of patients 30 minutes after doxorubicin liposome infusion and in 72.41%of patients 1-4 h after rituximab administration.It was found that 80.68%of patients with IR resolved within 2 h after symptomatic treatment.The proportion of cases with immune-related IR clinical manifestations such as skin flushing,itching,rashes,chills,and chest tightness was relatively high.CONCLUSION Most patients with IR using monoclonal antibodies and liposomal antineoplastic agents are from 51 to 70 years old,and IR mostly occurs within 4 h of administration.A significant proportion of these reactions occur during the first cycle of chemotherapy.The clinical manifestations primarily include skin flushing,itching,rashes,chills,and chest tightness.When using a drug for the first time that has a documented incidence of IR specified in the instructions,it is recommended to monitor vital signs throughout the infusion.Early infusion reactions can be prevented by increasing the number of inspections during dosing regimens with a high incidence of IR and during the period of IR appearance.

关 键 词：输液反应 抗肿瘤药物 单克隆抗体 药品稳定性 静脉用药安全 

分 类 号：R979.1[医药卫生—药品]