近期国内吉非替尼致药品不良反应49例  

49 cases of adverse drug reactions caused by gefitinib in China recently

作　　者：王文联 赵霞[2] 糜怡珺 WANG Wenlian;ZHAO Xia;MI Yijun(Wuxi Drug Safety Inspection and Testing Center,Jiangsu Province,Wuxi 214000,China;不详)

机构地区：[1]江苏省无锡市药品安全检验检测中心,214000 [2]江苏省无锡市第二人民医院,214000

出　　处：《临床合理用药杂志》2022年第8期35-38,共4页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的 分析吉非替尼致药品不良反应(ADR)的相关因素,为临床安全用药提供参考。方法 检索2020年1—12月无锡市上报国家ADR监测系统吉非替尼致ADR报告,记录患者性别、年龄、原患疾病、用药情况、ADR发生时间、累及的系统/器官及临床表现、转归和关联性评价等信息进行统计分析。结果 共提取49例报告,其中男16例,女29例,4例患性别不详;年龄24~85(60±13)岁;主要ADR累及胃肠系统损害24例次,表现为呕吐、腹泻、便秘等,皮肤及其附属器损害19例次,主要为皮疹、痤疮、瘙痒等,呼吸系统损害18例次,表现为间质性肺炎、肺部感染、鼻咽炎;49例吉非替尼片致不良反应患者中痊愈10例,好转21例,未好转12例,死亡1例,其他5例转归信息不详。结论 通过对49例吉非替尼致不良反应分析可知,严重甚至危及生命的不良反应发生比例较高。故应加强吉非替尼在抗肿瘤治疗中的不良反应监测和处理,加强其上市后的安全性研究工作。Objective To analyze the related factors of adverse drug reactions( ADR) caused by gefitinib,so as to provide reference for clinical safe drug use. Methods Search the ADR report from gefitinib reported to the national ADR monitoring system in Wuxi from January to December 2020. The patient’s gender,age,primary disease,medication,occurrence time of ADR,involved systems/organs,clinical manifestations,prognosis and correlation evaluation were recorded for statistical analysis. Results A total of 49 cases were extracted,including 16 males and 29 females. The sex of 4 cases was unknown. The age of the patients ranged from 24 to 85( 60 ± 13) years. The main ADR involved 24 cases of gastrointestinal system damage,manifested as vomiting,diarrhea,constipation and so on. Skin and its appendages were damaged in 19 cases,mainly skin rash,acne,pruritus and so on. There were 18 cases of respiratory damage,including interstitial pneumonia,pulmonary infection and nasopharyngitis. Among the 49 patients with adverse reactions caused by gefitinib tablets,10 cases were cured,21 cases were improved,12 cases were not improved,1 case died,and the outcome information of the other 5cases was unknown. Conclusion Through the analysis of 49 cases of adverse reactions caused by gefitinib,it can be seen that the incidence of serious and even life-threatening adverse reactions is high. Therefore,we should strengthen the monitoring and treatment of adverse reactions of gefitinib in antitumor treatment,and strengthen the safety research after its listing.

关 键 词：肺癌 吉非替尼 药品不良反应 临床监测 

分 类 号：R969[医药卫生—药理学]