136例小分子激酶抑制剂不良反应分析  

Analysis of 136 reports of adverse reactions related to small molecule kinase inhibitors

作　　者：贾贝 王伟华 杨靓 戴媛媛 JIA Bei;WANG Weihua;YANG Liang;DAI Yuanyuan(Department of Pharmacy,National Cancer Center,National Clinical Research Center for Cancer,Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Department of Pharmacy,National Cancer Center,National Clinical Research Center for Cancer,Cancer Hospital Langfang Campus,Chinese Academy of Medical Sciences,Langfang Hebei 065001,China)

机构地区：[1]国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院药剂科,北京100021 [2]国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院肿瘤医院廊坊院区药剂科,河北廊坊065001

出　　处：《中国药物警戒》2023年第10期1163-1167,共5页Chinese Journal of Pharmacovigilance

基　　金：中国医学科学院肿瘤医院管理研究课题(LC2021D04)。

摘　　要：目的 分析小分子激酶抑制剂(SMKI)药品不良反应(ADR)的发生特点,为临床合理用药提供参考。方法 对本院2011年1月1日至2022年12月31日监测到的136例SMKI相关ADR进行分析,从患者基本情况、药品使用情况、ADR发生情况等方面探讨SMKI所致ADR的特点和风险。结果 136例患者共发生例次ADR,涉及21种SMKI,患者平均年龄(57.75±12.74)岁,肺癌患者占54.41%。34例ADR存在超说明书使用药品情况。ADR累及系统-器官以胃肠系统为主,其次为皮肤及皮下组织。54.41%的ADR患者未调整SMKI的用药剂量,16.91%为严重ADR病例,56.62%的ADR经过治疗好转。结论 SMKI相关ADR多数患者可耐受,部分患者需要减少给药剂量及对症处理,ADR可累及多个系统-器官。应指导患者开展针对性的ADR监测和管理,提高患者药物治疗的安全性和依从性。Objective To analyze the characteristics of adverse drug reactions(ADR) of small molecule kinase inhibitors(SMKI),and provide reference for rational use of drugs in clinic.Methods The data on 136 cases of SMKI-related ADR monitored in our hospital between 2011 and 2022 was analyzed while the characteristics and risks of ADR caused by SMKI were studied in terms of patients,drug use,and occurrence of ADR.Results One hundred and thirty-six cases of ADR involved 21 types of SMKI.The average age of the patients was 57.75±12.74,and patients with lung cancer accounted for 54.41%.There were 34 cases of off-label use of drugs.The systems-organs implicated in ADR were mainly the gastrointestinal system,followed by the skin and subcutaneous tissue.54.41% of the patients with ADR did not have the dosage of SMKI adjusted,16.91% were severe ADR cases,and 56.62% improved after treatment.Conclusion SMKIrelated ADR are tolerable for most of the patients.Some patients require dose reduction and symptomatic treatment.ADR can implicate multiple systems-organs.Patients should be assisted in targeted ADR monitoring and management to improve the safety and compliance of medication.

关 键 词：小分子激酶抑制剂 药品不良反应 口服靶向药物 肺癌 胃肠系统 皮肤 皮下组织 表皮生长因子受体 

分 类 号：R994.11[医药卫生—毒理学] R979.1[医药卫生—药学]