刘慧 刘源 黄宇涵 刘艳 蔡灯塔

中圖分类号 R969.3 文献标志码 A 文章编号 1001-0408（2021）16-2019-06

DOI 10.6039/j.issn.1001-0408.2021.16.17

摘 要 目的：探讨阿来替尼致不良反应（ADR）的发生规律和临床表现特点，为其临床安全使用提供参考。方法：检索中国知网、万方数据、维普网、PubMed、Web of Science和Embase数据库，检索时限均为建库/建站起至2021年3月1日，收集关于阿来替尼致ADR的个案报道，采用描述性统计方法，对纳入文献中患者的一般情况、ADR发生时间、累及器官/系统、临床表现、治疗和转归等进行归纳、分析。结果：共纳入文献17篇，涉及患者17例，其中男性4例（23.53%）、女性13例（76.47%）;平均年龄为（61.82±14.18）岁;患者来自5个国家/地区，以美国最多（41.18%）。ADR主要发生在用药后30 d内（52.94%），所致ADR主要累及皮肤及其附件系统（35.29%），其次为呼吸系统（23.53%）、泌尿系统（11.76%）、心血管系统（11.76%）、胃肠系统（11.76%）、血液系统（5.87%），其中脱发、胰腺炎和十二指肠穿孔均为药品说明书未记载的ADR。17例患者出现ADR后，2例患者没有停用阿来替尼;15例患者停用阿来替尼且部分患者给予对症及支持治疗，其症状均好转，其中10例症状好转后重启阿来替尼治疗，8例未再出现ADR。结论：女性患者及50岁以上患者使用阿来替尼更易发生ADR，且发生时间多在用药后1个月内。其ADR累及多个器官/系统，以皮肤及其附件系统和呼吸系统为主，应特别关注脱发、胰腺炎和十二指肠穿孔等ADR。

关键词 阿来替尼;不良反应;个案报道;文献分析

Literature Analysis of Adverse Drug Reactions Induced by Alectinib

LIU Hui1，LIU Yuan1，HUANG Yuhan2，LIU Yan3，CAI Dengta4（1. Dept. of Pharmacy， Shangqiu First Peoples Hospital， Henan Shangqiu 476900， China; 2. School of Pharmacy， Shangqiu Medical College， Henan Shangqiu 476900， China; 3. Dept. of Pharmacy， Henan Provincial Hospital， Zhengzhou 451161， China; 4. Dept. of Pharmacy， the First Affiliated Hospital of Henan University， Henan Kaifeng 475000， China）

ABSTRACT   OBJECTIVE： To explore the regularity and characteristics of adverse drug reactions （ADR） induced by alectinib， and to provide reference for rational drug use in clinic. METHODS： Retrieved from CNKI， Wanfang database， VIP， PubMed， Web of Science and Embase database during the inception to Mar. 1st，2021， case reports of alectinib-induced ADR were collected， summarized and analyzed with descriptive statistical analysis method in terms of general information， occurrence time of ADR， involved organ/system， clinical manifestations， treatment and outcome， etc. RESULTS： A total of 17 literatures were included， involving 17 patients. Among them， 4 cases （23.53%） were males， and 13 cases （76.47%） were females. The mean age of the patients was （61.82±14.18） years old. The patients were from 5 countries/regions， among which America took the largest ratio （41.18%）. Most ADR occurred within 30 days （52.94%） after therapy. ADR mainly involved skin and its appendants （35.29%）， followed by respiratory system （23.53%）， urinary system （11.76%）， cardiovascular system （11.76%）， gastrointestinal system （11.76%） and blood system （5.87%）; hair loss， pancreatitis and duodenal perforation belonged to ADRs not recorded in the drug instructions. After 17 patients suffered from ADR， 2 patients still continued to use aletinib， while 15 patients withdrew aletinib and some patients received symptomatic and supportive treatment， and their symptoms improved. Among them， 10 patients restarted aletinib treatment after their symptoms improved， and 8 patients did not suffered from ADR again. CONCLUSIONS： Female patients and patients over 50 years old are more likely to suffer from ADR after using aletinib， and most of ADR occur within 1 month after treatment. ADR involves many organs/systems， mainly skin and its appendants. Special attention should be paid to ADR such as hair loss， pancreatitis and duodenal perforation.

KEYWORDS   Alectinib; Adverse drug reaction; Case report; Literature analysis

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