甲磺酸奥希替尼不良反应文献分析

目的:分析甲磺酸奥希替尼不良反应(ADR)的临床表现和特点,为其临床安全用药提供参考。方法:计算机检索自建库起至2018年8月PubMed、万方数据、中国知网和维普网上收录的甲磺酸奥希替尼ADR的案例报道,对案例中患者年龄、性别、国籍,甲磺酸奥希替尼的用法用量,ADR发生的时间分布、临床表现、治疗措施及转归情况等进行回顾性分析。结果:共纳入案例报道20篇,合计21例患者。患者年龄32～82岁,其中57～79岁患者所占比例最大(80.9%);女性(14例)多于男性;患者来自5个国家,其中日本最多(13例,61.9%)。1例患者用量为160 mg/d,其余均为80 mg/d的常规推荐剂量;用药3个月内出现ADR的例数最多(16例,76.2%),尚无用药12个月以上发生ADR的报道;ADR累及器官/系统以呼吸系统(11例次,45.8%)和消化系统(6例次,25.0%)为主,此外还包括心血管系统、血液系统、全身性反应、皮肤和眼部。在21例患者中,3例较轻微而继续以原剂量和频次给药;1例患者出现间质性肺炎,调整用药频次为隔日1次并给予对症治疗后症状减轻;剩余17例通过停药及对症治疗后症状减轻,但其中2例因肿瘤进展死亡。结论:临床应用甲磺酸奥希替尼前3个月应特别注意ADR的发生,尤其应注意呼吸、消化系统的ADR。

Literature Analysis of Adverse Drug Reactions Induced by Osimertinib Mesylate

OBJECTIVE:To analyze the clinical manifestations and characteristics of adverse drug reactions(ADR)induced by osimertinib mesylate,and to provide reference for clinical safe use of drugs.METHODS:Retrieved from PubMed,Wanfang database,CNKI and VIP during database establishment-Aug.2018,ADR cases of osimertinib mesylate were analyzed retrospectively in respects of patient’s age,gender,nationality,usage and dosage of osimertinib mesylate,occurrence time of ADR,clinical manifestations,treatment measures and outcome,etc.RESULTS:A total of 20 articles were included,involving 21 patients.The age of the patients was 32-82 years old,and the proportion of patients aged 57-79 was the largest(80.9%).The female with ADR(14 cases)were more than the male.The patients were from 5 countries,in which Japan took the most ratio(13 cases,61.9%).The dose of osimertinib mesylate was 160 mg/d in a patient and commonly recommended dose 80 mg/d for other patients.The most ADR cases(16 cases,76.2%)occurred within 3 months,and no reports of ADR occurred more than 12 months.Organs/systems involved in ADRs were mainly respiratory system(11 case times,45.8%)and digestive system(6 cases,25.0%),in addition,ADR also occurred in cardiovascular system,hematological system,systemic reactions,skin and eyes.Among 21 patients,3 cases were mild ADR so that they were given same dose with same frequency.A patient suffered from interstitial pneumonia and was given medicine every other day and symptomatic treatment;the symptoms of the patient were relieved.Other 17 cases were relieved after drug withdrawal and symptomatic treatment,but 2 patients died of tumor progression.CONCLUSIONS:In clinical application of osimertinib mesylate,attention should be paid to ADR monitoring,especially short-term ADR,especially ADR of respiratory,digestive system.