克唑替尼不良反应文献分析

Literature analysis of adverse drug reactions of Crizotinib

目的分析克唑替尼致不良反应(ADR)的发生及预后等,为合理用药提供依据。方法在PubMed、Embase、Web of Science、Sinomed、中国知网、维普资讯、万方数据库检索建库至2021年12月发表的克唑替尼药物不良反应的个案报道并进行汇总分析。结果克唑替尼引起ADR的病例报道共70例:男性29例(41.4%),女性41例(58.6%),41~70岁患者居多(52例,74.3%);ADR多发生在用药后90 d内(59例,84.3%);累及的器官或系统主要有消化系统(28.1%)、肝胆系统(17.5%)和全身性反应(13.2%)等。其中,导致患者死亡的严重ADR为间质性肺炎2例(2.8%)、肝衰竭1例(1.4%);并发现说明书中未提及的ADR剥脱性皮炎及手足综合征。结论克唑替尼所致的不良反应涉及多个系统,且严重程度不同,临床应用应结合患者个体情况,加强用药ADR监测,保证用药的安全。

Objective To analyze the occurrence,characteristic and treatment outcome of adverse drug reactions(ADR)caused by crizotinib and to provide reference for rational drug use in clinical practice.Methods Case reports of crizotinib ADR were retrieved from PubMed,Embase,Web of Science,CNKI,Wanfang and VIP databases until December 2021,and the ADR was summarized and analyzed.Results A total of 70 cases of ADR caused by crizotinib were reported,including 29 males(41.4%)and 41 females(58.6%),the majority of patients aged 41~70 years old(52 cases,74.3%);ADR mostly occurred within 90 days after medication(59 cases,84.3%).The organs or systems involved mainly include digestive system(28.1%),hepatobiliary system(17.5%)and systemic reaction(13.2%).Severe ADR which led to the death of patients were liver failure,long Q-T interval syndrome and interstitial pneumonia.It is found that the new ADR not mentioned in the manual are exfoliative dermatitis and hand-foot syndrome.Conclusion The adverse reactions caused by crizotinib involve multiple systems with different severity.The clinical application should be combined with the individual situation of patients,and the monitoring of adverse reactions should be strengthened to ensure the drug safety of patients.