2018-2023年北京市注射用曲妥珠单抗不良反应统计分析  

Statistical analysis of adverse drug reactions of Trastuzumab for injection from 2018 to 2023 in Beijing

作　　者：刘红[1] 白羽[1] 王啸洋 张文思[1] 张本静[2] 张艳华[1] LIU Hong;BAI Yu;WANG Xiaoyang;ZHANG Wensi;ZHANG Benjing;ZHANG Yanhua(Dept.of Pharmacy,Beijing Cancer Hospital&Beijing Institute for Cancer Research/Key Laboratory of Carcinogenesis and Translational Research,Ministry of Education,Beijing 100142,China;Beijing Drug Adverse Event Monitoring Center,Beijing 101117,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所药剂科/恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [2]北京市药品不良反应监测中心,北京101117

出　　处：《中国药房》2024年第21期2663-2667,共5页China Pharmacy

基　　金：北京市属医院科研培育计划项目(No.PZ2021025);北京大学肿瘤医院教育教学研究课题(No.2023-JY-09)。

摘　　要：目的为注射用曲妥珠单抗的临床安全应用提供依据。方法收集北京市2018年6月至2023年5月上报的注射用曲妥珠单抗相关的药品不良反应(ADR)报告,运用SPSS 25.0软件进行统计,分析出现ADR的患者性别、年龄、转归情况、所患癌症种类和ADR发生时间、严重程度、累及器官/系统等,并对患者发热及ADR预后情况进行单因素Logistic回归分析。结果共有195例患者累计318例次ADR纳入研究。女性(87.69%)和60~69岁年龄段(33.85%)患者出现ADR的情况较多;在癌症种类分布上,乳腺癌占据主导位置(86.67%);从转归情况来看,大多数患者(67.69%)表现出好转,部分患者(27.69%)实现痊愈。68.72%的ADR主要在用药当天出现,95.38%的ADR严重程度为“一般”。出现ADR最多的器官/系统是全身性疾病及给药部位各种反应(40.57%),以寒战(18.87%)和发热(18.24%)最为常见。单因素Logistic回归分析结果显示,发热多出现在用药后1 d内(OR=5.63,95%CI为2.26~14.02,P<0.001);ADR发生时间≥1 d是ADR预后差的危险因素(OR=20.08,95%CI为2.45~164.43,P=0.005),多表现为骨髓抑制和肝功能异常。粒细胞增多症、心脏呼吸骤停和混合性肝损伤为该药说明书未记录的新的ADR。结论女性和≥60岁患者为注射用曲妥珠单抗ADR的高发人群;寒战和发热是该药最常见的ADR,且多在用药后1 d内出现,但预后较好。在输注该药当天应密切关注患者的体温变化,适时干预;用药后应定期监测患者的血液学指标,关注其是否存在骨髓抑制和肝功能异常。OBJECTIVE To provide evidence for the safe clinical application of Trastuzumab for injection.METHODS Reports of adverse drug reaction(ADR)related to Trastuzumab for injection submitted in Beijing from June 2018 to May 2023 were collected.Statistical analyses were performed using SPSS 25.0 software.The gender and age of patients with ADRs,outcome,types of cancer,and the time of onset,severity,affected organs/systems of ADRs were included for analyses.The univariate Logistic regression analysis was conducted on patient fever and ADR prognosis.RESULTS A total of 195 patients with 318 instances of ADRs were included in the study.Women(87.69%)and patients aged 60-69(33.85%)were more likely to experience ADRs.Breast cancer dominated(86.67%)in terms of cancer types;in terms of outcomes,most patients(67.69%)showed improvement,and some patients(27.69%)achieved full recovery.Overall,68.72%of ADRs mainly occurred on the day of medication,and 95.38%of ADRs were of“moderate”severity.The most affected organs/systems were general diseases and various reactions at the administration site(40.57%),with chills(18.87%)and fever(18.24%)being the most common.Univariate Logistic regression analysis showed that fever mostly occurred within 1 day of medication(OR=5.63,95%CI was 2.26-14.02,P<0.001).The time of onset of ADR greater than 1 day was a risk factor for poor ADR prognosis(OR=20.08,95%CI was 2.45-164.43,P=0.005),mainly manifesting as bone marrow suppression and liver function abnormalities.Neutrophilia,cardiorespiratory arrest,and mixed liver damage were new ADRs not recorded in the drug’s instructions.CONCLUSION Women and patients aged≥60 are high-risk groups for ADRs of Trastuzumab for injection.Chills and fever remain the most common ADRs of this drug,and these symptoms mostly occur within 1 day of medication,which have better prognoses.Close attention should be paid to the patient’s temperature changes on the day of drug infusion,with timely intervention.Regular monitoring of the patient’s hematological indicators

关 键 词：注射用曲妥珠单抗 药品不良反应 寒战 发热 预后 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]