恩沃利单抗临床应用评价和安全性分析  

Clinical application evaluation and safety analysis of envolizumab

作　　者：陈美玲 汪国玉 朱文靖 曹然 黄光耀 王君萍 CHEN Meiling;WANG Guoyu;ZHU Wenjing;CAO Ran;HUANG Guangyao;WANG Junping(Center of Pharmacy,Hefei Cancer Hospital,Chinese Academy of Sciences,Hefei 230031,China)

机构地区：[1]中国科学院合肥肿瘤医院药学中心,合肥230031

出　　处：《中国临床保健杂志》2024年第4期485-491,共7页Chinese Journal of Clinical Healthcare

基　　金：安徽省卫生健康科研项目(AHWJ2023BAa20074)。

摘　　要：目的对恩沃利单抗临床应用合理性和安全性进行评价,为临床使用和管理免疫检查点抑制剂提供参考。方法收集2023年4—12月中国科学院合肥肿瘤医院使用恩沃利单抗治疗的所有住院患者病历,统计其基本资料、用药情况以及药物不良反应等进行临床用药评价和安全性分析。结果共纳入使用恩沃利单抗的患者63例,既往治疗后出现疾病进展的晚期实体瘤占比82.54%,临床应用存在超适应证和用法用量不适宜情况。恩沃利单抗免疫相关不良反应(irAE)发生率为68.25%,主要包括血液毒性(41.27%)、消化系统症状(23.81%)和肝脏毒性(20.63%)等。患者的性别、年龄、基础疾病、吸烟史、饮酒史、放疗史及肿瘤类型与恩沃利单抗不良反应发生率均无相关性(P>0.05),不良反应在200 mg和400 mg的发生率差异有统计学意义(P<0.05)。结论在真实世界恩沃利单抗存在不合理使用情况,临床应用免疫检查点抑制剂应依据循证医学证据用药,关注irAE的发生,药学部门应加大处方审核和处方点评力度,共同保障患者安全用药。Objective To evaluate the rationality of clinical application and safety of envolizumab,so as to provide reference for the clinical use and management of immune checkpoint inhibitors(ICI).Methods The basic information,medication status,and occurrence of adverse drug reactions of the patients treated with envolizumab from April 2023 to December 2023 in Hefei Cancer Hospital,Chinese Academy of Sciences were collected for clinical application and safety analysis.Results A total of 63 patients were treated with envolizumab,82.54%of advanced solid tumors showed disease progression after previous treatment,and there wre some problems of off-label drug use on indication and inappropriate usage and dosage in clinical applications.The incidence of immune related adverse reactions(irAE)with envolizumab was 68.25%,mainly included blood toxicity(41.27%),digestive system symptoms(23.81%),and liver toxicity(20.63%).There was no significant correlation between the incidence of adverse reactions to envolizumab and the patient′s gender,age,underlying disease,smoking history,drinking history,radiotherapy history and tumor type(P>0.05),and the irAE′incidence of different drug doses of 200 mg and 400 mg was statistically significant(P<0.05).Conclusions There are widespread of unreasonable use of envolizumab in the real world.The clinical application of ICI should be based on evidence-based medicine and pay attention to the irAE,and the department of pharmacy should enhance prescription audit and prescription comment to jointly ensure safe medication for patients.

关 键 词：处方不当 药物相关性副作用和不良反应 恩沃利单抗 免疫检查点抑制剂 临床研究 

分 类 号：R979.1[医药卫生—药品]