新型抗肿瘤药物药品不良反应及危险因素分析  

Adverse Drug Reactions of Novel Antitumor Drugs and Their Risk Factors

作　　者：陈春燕[1] 单慧亭[1] 伊力亚斯·买买提艾力 朱青梅[1] 赵海霞[1] 熊代琴[1] CHEN Chunyan;SHAN Huiting;Yiliyasi·MAIMAITIAILI;ZHU Qingmei;ZHAO Haixia;XIONG Daiqin(The First Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China 830011;Xinjiang Medical University,Urumqi,Xinjiang,China 830054)

机构地区：[1]新疆医科大学第一附属医院,新疆乌鲁木齐830011 [2]新疆医科大学,新疆乌鲁木齐830054

出　　处：《中国药业》2023年第1期107-110,共4页China Pharmaceuticals

基　　金：新疆医科大学大学生创新训练计划项目[CX2021044];新疆维吾尔自治区药品监督管理局科研项目[新药监20210002(科)]。

摘　　要：目的分析新型抗肿瘤药物药品不良反应(ADR)的发生规律及危险因素,为临床安全用药提供参考。方法收集某三甲医院2020年1月至2021年12月使用新型抗肿瘤药物致ADR的有效报告151份,涉及患者151例。通过Logistic回归分析,识别使用利妥昔单抗发生ADR的危险因素。结果151例发生ADR的患者中,男88例,女63例,男女比例为1.40∶1;以≥70岁老年患者为主,共39例(25.83%);ADR共涉及24种新型抗肿瘤药物,其中利妥昔单抗致ADR例数最多;ADR累及系统/器官以皮肤黏膜及全身性损害为主,临床主要表现为皮疹(46例次)、瘙痒(25例次)、发热(32例次)、寒战(25例次)等;发生严重ADR 15例次,新的ADR 6例次;转归均良好。Logistic多因素回归分析显示,用药前淋巴细胞水平高[RR=9.24,95%CI(3.21,26.61),P=0.00]是使用利妥昔单抗致ADR的危险因素。结论使用新型抗肿瘤药物时需加强ADR及疗效监护,特别是使用利妥昔单抗且合并淋巴细胞水平高的患者应予以密切关注。Objective To analyze the characteristics and risk factors of adverse drug reactions(ADR)of novel antitumor drugs,and to provide a reference for the safe drug use in the clinic.Methods A total of 151 effective reports of ADR induced by the novel antitumor drugs from January 2020 to December 2021 in a grade-A tertiary hospital were collected,involving 151 patients.The risk factors of ADR induced by rituximab were analyzed by the Logistic regression analysis.Results Among the 151 patients with ADR,there were 88 males and 63 females,with the ratio of male to female of 1.40∶1,and most of them were 70 years old or older,accounting for 25.83%(39 cases).A total of 24 novel antitumor drugs involved in ADR,of which rituximab induced most cases having ADR.The systems/organs involved in ADR were mainly mucocutaneous and systemic damages,and the main clinical manifestations of ADR were rash(46 case times),pruritus(25 case times),fever(32 case times),chills and so on.Among the 151 patients with ADR,there were 15 case times of severe ADR and six case times of new ADR.The outcomes of all patients with ADR was good.The result of Logistic multivariate regression analysis showed that high level of lymphocyte before the medication[RR=9.24,95%CI(3.21,26.61),P=0.00]was a risk factor of ADR induced by rituximab.Conclusion ADR and efficacy monitoring should be strengthened when using the novel antitumor drugs,especially in patients who use rituximab and have a high level of lymphocyte.

关 键 词：新型抗肿瘤药物 药品不良反应 利妥昔单抗 危险因素 

分 类 号：R95[医药卫生—药学] R979.1