285例新型抗肿瘤药物不良反应分析  

285 cases of adverse drug reaction related to new antineoplastic drugs

作　　者：徐伟佳 彭崎 黄海渝 张磊姣 肖华[2] 吴雪[1] XU Weijia;PENG Qi;HUANG Haiyu;ZHANG Leijiao;XIAO Hua;WU Xue(Department of Pharmacy,the 924th Hospital of Joint Logistic Support Force,Guilin Guangxi 541002,China;Department of Oncology,the 924th Hospital of Joint Logistics Support Force,Guilin Guangxi 541002,China)

机构地区：[1]中国人民解放军联勤保障部队第924医院药剂科,广西桂林541002 [2]中国人民解放军联勤保障部队第924医院肿瘤科,广西桂林541002

出　　处：《中国药物警戒》2024年第2期199-203,210,共6页Chinese Journal of Pharmacovigilance

基　　金：广西药学会医院药学科研项目(GXYXH1-202212)。

摘　　要：目的 研究新型抗肿瘤药物的药品不良反应(ADR)的发生规律及特点,为临床安全用药提供参考。方法 对某三甲综合医院2018年1月1日至2023年3月31日新型抗肿瘤药物致ADR共285例,对患者性别、年龄、超说明书用药、ADR累及系统-器官和临床表现、ADR分级与转归、关联性评价等进行回顾性统计分析。结果 285例ADR男性155例(54.39%),女性130例(45.61%),平均年龄(54.98±13.175)岁;临床表现426例次,累及系统-器官12个,最常见的为消化系统(44.13%)、血液及造血系统(19.01%);严重ADR 51例,新的ADR 6例。涉及新型抗肿瘤药物33种,其中国家医保谈判药物28种,共266例次,大分子单体克隆药物特别是免疫检查点抑制剂的ADR较多,ADR例数最多的是卡瑞利珠单抗(66例)。涉及超说明书用药118例,超说明书用药的ADR发生率为63.10%。结论 新型抗肿瘤药物相关的ADR可发生于各个年龄,累及多个器官-系统,严重ADR较多,新的ADR较少,超说明书用药相关ADR较多;建议通过多学科联合会诊(MDT)、超说明书备案等措施严格管理超说明书用药,加强用药教育和药学监护,提高用药的安全性和有效性。Objective To study the patterns and characteristics of adverse reaction(ADR)related to new antineoplastic drugs,and provide reference for clinical medication.Methods A total of 285 cases of ADR caused by new antineoplastic drugs were collected in a tertiary general hospital from January 2018 to March 2023.The data on the gender,age,systemsorgans involved in ADR,clinical manifestations,off-label medication,grading and outcomes of ADR and correlations was analyzed via the Microsoft Excel and SPSS software.Results Among the 285 cases of ADR,155(54.39%)involved males and 130(45.61%)involved females,and the average age was(54.98±13.175)years.There were 426 cases of clinical manifestations and 12 systems-organs were involved.The digestive system(44.13%)and blood and hematopoietic system(19.01%)were more vulnerable.There were 51 cases of severe ADR,and 6 cases of new general ADR.There were 33 new anti-tumor drugs involved.Macromolecular monoclonal drugs,especially immune checkpoint inhibitors,caused more ADR,among which carrelizumab caused the largest number of cases(66 cases).One hundred and eighteen of these cases involved off-label medication,and the rate was as high as 63.10%.Conclusion ADR associated with novel antineoplastic drugs can occur among patients of any age,and involve multiple organs-systems.New antineoplastic drugs induce more serious ADR than new ADR,and many of these ADR are related to off-label drug use.It is recommended that off-label drug use be adopted,pharmaceutical care provided,and the safety and effectiveness of drug use improved for patients.

关 键 词：新型抗肿瘤药物 药品不良反应 超说明书用药 国家医保谈判 大分子单体克隆药 消化系统 血液及造血系统 

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