285例新型抗肿瘤药物不良反应分析

doi:10.19803/j.1672-8629.20230358

摘要/Abstract

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。

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

Abstract: 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, systems-organs 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.

Key words: new antineoplastic drugs, adverse drug reaction, off-label medication, national medical insurance negotiation, macromolecular monoclonal drugs, digestive system, blood and hematopoietic system

中图分类号:

徐伟佳, 彭崎, 黄海渝, 张磊姣, 肖华, 吴雪. 285例新型抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2024, 21(2): 199-203.

XU Weijia, PENG Qi, HUANG Haiyu, ZHANG Leijiao, XIAO Hua, WU Xue. 285 cases of adverse drug reaction related to new antineoplastic drugs[J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 199-203.

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