中国药物警戒 ›› 2022, Vol. 19 ›› Issue (10): 1132-1135.
DOI: 10.19803/j.1672-8629.20201246

• 安全与合理用药 • 上一篇    下一篇

盐酸美西律引起口唇麻木药品不良反应分析与防范措施

张青霞1, 咸颖2,△, 董月鑫3, 闫素英1, 岳群英4,*   

  1. 1首都医科大学宣武医院药学部,国家老年疾病临床医学研究中心,北京 100053;
    2北京市昌平区中西医结合医院药剂科,北京 102208;
    3北京市普仁医院药剂科,北京 100062;
    4世界卫生组织乌普萨拉监测中心,瑞典 乌普萨拉 75140
  • 收稿日期:2020-12-31 出版日期:2022-10-15 发布日期:2022-10-17
  • 通讯作者: *岳群英,女,博士,信号挖掘与药物警戒。E-mail：qun-ying-yue@who-umc.org
  • 作者简介:张青霞,女,硕士,副主任药师,用药安全管理及心血管慢病合理用药。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2020YFC2008305）; 北京市科学技术委员会“北京老年人健康评估及维护关键技术研究”项目（D181100000218002）

Adverse drug reactions of oral and lip numbness caused by mexiletine hydrochloride and precautions

ZHANG Qingxia1, XIAN Ying2,△, DONG Yuexin3, YAN Suying1, YUE Qunying4,*   

  1. 1Department of Pharmacy, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disease, Beijing 100053, China;
    2Department of Pharmacy, Beijing Hospital of Integrated Traditional Chinese And Western Medicine , Beijing 102208, China;
    3Department of Pharmacy, Beijing Puren Hospital, Beijing 100062, China;
    4WHO Uppsala Monitoring Centre, Uppsala 75140, Sweden
  • Received:2020-12-31 Online:2022-10-15 Published:2022-10-17

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摘要： 目的 探讨美西律致口唇麻木不良事件的因果关系评价及可能的作用机制、影响因素,为制定针对性的防范措施提供依据。方法 分析互联网（百度和今日头条）、数据库（万方数据、中国知网、维普网、PubMed）和世界卫生组织个案安全报告全球数据库（VigiBase）中美西律的口唇麻木不良事件,因果关系评价包括个例和案例系列。结果 自建库/系统至2020年4月26日,美西律引起口唇麻木的不良事件报告共10例：其中互联网网络咨询3例、VigiBase 3例、数据库文献报道4例,因果关系评价（Naranjo评分）都支持因果关系。可能发生机制为美西律结构与利多卡因相似,有局部麻醉作用,从而导致口唇麻木;口唇麻木发生时间为服药后即刻至给药后5 d,停药可自行恢复,可能与服药方法有关。结论 美西律致口唇麻木与其局部麻醉相关,所以口服制剂应与饮料或食物同服、不得嚼碎,以避免不良反应的发生。

关键词: 美西律, 口唇麻木, 药品不良反应

Abstract: Objective To explore the causality, possible mechanism and influencing factors of such adverse events as oral and lip numbness associated with mexiletine so as to provide data for precautions. Methods Literature related to adverse events of oral and lip numbness caused by mexiletine were retrieved from such databases as Wanfang, CNKI, VIP, PubMed and VigiBase before being analyzed. The causality of single cases or a series of cases was explored. Results As of April 26, 2020, there were 10 cases of oral and lip numbness associated with mexiletine: 3 cases from online consultation, 3 cases from VigiBase, and 4 cases from literature. Causal analysis by Naranjo criteria delivered a causality score that supported causality between mexiletine and adverse reactions. The possible mechanism was that mexiletine was structurally similar to lidocaine, so it had a local anesthetic effect, which could cause oral and lip numbness. The onset time of oral and lip numbness ranged from shortly after administration to 5 days after administration, but the patients recovered after withdrawal. Routes of administration might play a role. Conclusion Mexiletine can cause oral and lip numbness, which is related to the local anesthetic effect. Therefore, oral preparations should be taken as a whole along with beverages or foods rather than being chewed to prevent adverse reactions.

Key words: mexiletine, oral and lip numbness, adverse drug reaction

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