中国药物警戒 ›› 2026, Vol. 23 ›› Issue (9): 1045-1049.
DOI: 10.19803/j.1672-8629.20260265

• 安全与合理用药 • 上一篇    下一篇

1115例草酸艾司西酞普兰片不良反应报告分析

潘恩1, 崔小康2, 徐滨1, 荣右明2, 范晓1, 马晓东1,*, 李霞2#   

  1. 1泰安市食品药品检验检测研究院,山东 泰安 271000;
    2山东省药品不良反应监测中心,山东 济南 250014
  • 收稿日期:2026-04-01 出版日期:2026-09-15 发布日期:2026-09-15
  • 通讯作者: *马晓东,男,硕士,副主任中药师,药品不良反应监测与评价。E-mail: xdma1990@163.com。#为共同通信作者。
  • 作者简介:潘恩,女,本科,高级工程师,药品不良反应监测与评价。
  • 基金资助:
    山东省药品不良反应监测科研课题（2025SDADRKY17）

1115 case reports of adverse drug reactions induced by escitalopram oxalate tablets

Pan En1, Cui Xiaokang2, Xu Bin1, Rong Youming2, Fan Xiao1, Ma Xiaodong1,*, Li Xia2#   

  1. 1Tai'an Institute for Food and Drug Control, Tai'an Shandong 271000, China;
    2Shandong Provincial Center for ADR Monitoring, Jinan Shandong 250014, China
  • Received:2026-04-01 Online:2026-09-15 Published:2026-09-15

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摘要： 目的 分析草酸艾司西酞普兰片致药品不良反应（ADR）的规律及特点,为临床安全用药提供参考。方法 对2010年1月1日至2025年12月31日山东省ADR数据库中的草酸艾司西酞普兰片ADR报告的患者一般情况、累及系统-器官和临床表现、严重ADR风险因素进行回顾性分析。结果 共收集到1 115例草酸艾司西酞普兰片ADR报告,其中新的一般报告83例（7.44%）,严重报告为232例（20.81%）。男女性别比为1∶1.75。年龄以45~64岁居多,占39.46%;年龄<18岁占5.11%,不符合说明书规定的适用人群。用药剂量以每日10 mg（45.29%）居多,剂量超过每日20 mg的占3.14%。ADR发生时间以用药1周内最多,占53.19%。ADR累及系统主要为胃肠系统损害、中枢及外周神经系统损害、肝胆系统损害、精神紊乱等。ADR表现主要为恶心、便秘、头晕、肝功能异常、嗜睡、心悸、皮疹、乏力、白细胞减少等。ADR结果以好转（55.25%）和痊愈（36.95%）为主。合并用药主要为劳拉西泮片、盐酸丁螺环酮片、奥氮平片、枸橼酸坦度螺酮胶囊等精神治疗药物。结论 草酸艾司西酞普兰片ADR累及多个系统-器官,白细胞减少、中性粒细胞减少是报告数量较多的新的ADR信号,患者性别、年龄、合并用药是严重ADR的风险因素。临床应加强对新的ADR信号的监测与有效处理。

关键词: 草酸艾司西酞普兰片, 白细胞减少, 胃肠系统损害, 中枢及外周神经系统损害, 肝胆系统损害, 精神紊乱, 药品不良反应

Abstract: Objective To analyze the regularity and characteristics of adverse drug reactions (ADRs) caused by escitalopram oxalate tablets in order to provide a reference for clinical medication. Methods Reports of ADRs caused by escitalopram oxalate tablets collected by an ADR database in 2010-2025 were retrieved before the basic data of patients, system and organs involved, clinical manifestations and risk factors for severe ADRs were analyzed. Results A total of 1 115 ADR reports were collected, 83 of which involved (7.44%) new and mild ADRs, and 232 (20.81%) involved severe ones. The ratio of males to females was 1∶1.75. Patients aged 45 to 64 accounted for 39.46%, compared with 5.11% among those under 18. The dosage was usually 10 mg per day (45.29%), and dosages exceeding 20 mg per day accounted for 3.14%. Most of these ADRs occurred within one week of treatment, accounting for 53.19%. The symptoms were mostly gastrointestinal damage, damage to central and peripheral nervous systems, damage to the hepatobiliary system, and mental disorders, manifested as nausea, constipation, dizziness, abnormal liver function, drowsiness, palpitations, rash, fatigue, and leukopenia. Most of the patients improved (55.25%) or recovered (36.95%) after treatment. The combined drugs included lorazepam tablets, buspirone hydrochloride tablets, olanzapine tablets, tandospirone citrate capsules, and other psychotropic drugs. Conclusion ADRs caused by escitalopram oxalate tablets involve multiple systems and organs. Leukopenia and neutropenia are new ADR signals with more reported cases. Patients' gender, age, and concomitant medication are risk factors for severe ADRs. Clinicians should devote more effort to monitoring and effective management of new ADR signals.

Key words: Escitalopram Oxalate Tablets, Leukopenia, Gastrointestinal Damage, Damage to Central and Peripheral Nervous Systems, Damage to the Hepatobiliary System, Mental Disorders, Adverse Drug Reaction

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