151例阿帕替尼致药品不良反应国内文献分析

Domestic Literature Analysis of 151 Cases of Adverse Drug Reaction Events Caused by Apatinib

目的:探讨阿帕替尼致药品不良反应(ADR)的一般特点和规律,为临床安全用药提供参考。方法:检索2015~2018年《中国期刊全文数据库》、维普中文期刊数据库,对收集到的阿帕替尼致ADR的文献报道从患者性别、年龄、原患疾病、给药途径、给药剂量、合并基础疾病、联合用药、以及ADR发生的时间、临床表现及转归等情况进行统计分析。结果:共纳入文献11篇,涉及151例ADR病例。ADR多发生在46~60岁的患者(41.72%)。151例ADR中,给药剂量250 mg·d-126例,500 mg·d^-1 64例,750 mg·d^-1 7例,850 mg·d^-1 54例;联合用药18例。发生ADR时间最短的为用药后3 d,最长的为用药后10个月;大部分ADR发生在用药后1~3个月。ADR累及器官-系统最多的是全身性损害(46.35%),主要表现为高血压,其次为皮肤黏膜系统(19.20%),主要表现为手足综合征,第三是消化系统(17.23%),主要为消化道出血、恶心、呕吐。急性左心衰竭、快速性房颤、甲状腺功能减退为阿帕替尼新的ADR。结论:重视阿帕替尼所致新的,严重的ADR,加强用药监测,以确保患者用药安全。

Objective:To investigate the general characteristics and regularity of adverse drug reactions(ADRs)induced by apatinib and provide reference for clinical safe drug use.Methods:CNKI and VIP databases were searched for ADRs induced by apatinib from 2015 to 2018.The literatures on 151 cases of apretinib-induced ADR s were reported and statistically analyzed on the gender,age,primary diseases,route of administration,dose of administration,combined underlying diseases,combination,time of adverse reactions,clinical manifestations and outcomes of adverse reactions.Results:A total of 11 articles were included in the literature,involving 151 cases of ADRs.ADRs caused by apatinib occurred in 46-60-year old patients(41.72%);Among the 151 cases of ADRs,26 ones were with the dose of 250 mg·d^-1,64 ones were with 500 mg·d^-1,7 ones were with 750 mg·d^-1,and 54 were with 850 mg·d^-1.Totally 18 cases were with combined drug use.The shortest occurrence time of ADRs was 3 days after the administration,the longest occurrence time of ADRs was 10 months after the administration,and the most of ADRs appeared within 1-3 months after the administration.The top three clinical manifestations of ADRs were systemic damage(46.35%),mainly hypertension,skin mucosa system(19.20%),mainly for the hand-foot syndrome,and digestive system(17.23%),mainly for gastrointestinal bleeding,nausea and vomiting.To compare with the drug descriptions,some adverse reactions were associated with insufficient risk warning,such as acute left heart failure,rapid atrial fibrillation and hypothyroidism,etc.Conclusion:Attention should be paid to the new and severe ADRs caused by apatinib,and drug monitoring should be strengthened to ensure the drug safety of patients.