中国药物警戒 ›› 2020, Vol. 17 ›› Issue (7): 385-388.
DOI: 10.19803/j.1672-8629.2020.07.01

• 新型冠状病毒肺炎诊疗药品安全研究专栏 • 上一篇    下一篇

羟氯喹的药理学作用机制及安全性风险分析

王涛1, 刘继才2, 逄瑜1   

  1. 1国家药品监督管理局药品评价中心,北京 100022;
    2延安市药品检验所,陕西 延安 716000
  • 收稿日期:2020-05-17 修回日期:2020-06-22 出版日期:2020-07-15 发布日期:2020-06-22
  • 作者简介:王涛,男,博士,副研究员,神经药理学、药品不良反应监测与评价。
  • 基金资助:
    国家科技重大专项项目（2017ZX09101001-001-003）：药品再评价政策法规及实施策略研究

Pharmacologic Mechanism and Safety Risk Analysis of Hydroxychloroquine

WANG Tao1, LIU Jicai2, PANG Yu1   

  1. 1Center for Drug Reevaluation, NMPA, Beijing 100022, China;
    2Yan 'an Institute for Drug Control , Yan 'an Shaanxi 716000, China
  • Received:2020-05-17 Revised:2020-06-22 Online:2020-07-15 Published:2020-06-22

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摘要： 目的 分析羟氯喹的安全性风险,为临床合理用药提供参考。方法 对世界卫生组织药品不良反应监测数据库、我国药品不良反应监测数据库、国内文献数据库中的不良反应报告情况及国外药监机构风险控制措施等相关资料进行整理与分析。结果 检索世界卫生组织药品不良反应监测数据库,截至2020年4月26日,共有28 031例羟氯喹制剂不良反应/事件报告,其中严重报告13 498例,占48.2%;临床表现主要包括皮疹、恶心、过敏反应、疼痛、关节肿胀、疲劳、腹泻等。2004年1月~2019年12月,国家药品不良反应监测数据库共收到硫酸羟氯喹片不良反应/事件报告2 506例,其中,严重报告285例,占11.4%,累及系统-器官主要涉及皮肤及其附件损害、胃肠损害、神经系统损害、视觉损害、全身性损害等,不良反应主要表现为皮疹、瘙痒、头晕、头痛、恶心、视力异常、腹泻、呕吐等。结论 应重视羟氯喹临床使用中可能发生的涉及皮肤、消化系统、神经系统、视觉及心血管系统等不良反应。在对新型冠状病毒肺炎患者的治疗过程中,应加强对其心脏毒性等严重不良反应的安全性监测,促进药品的临床合理使用。

关键词: 新型冠状病毒肺炎, 羟氯喹, 不良反应

Abstract: Objective To analyze the safety risk of hydroxychloroquine so as to provide reference for clinical rational use of this drug. Methods The individual adverse drug reaction cases reported by WHO Vigilyze, China adverse drug reaction database, domestic literature and risk management plans of foreign regulatory agencies were analyzed. Results As of April 26, 2020, a total of 28 031 cases of hydroxychloroquine-caused ADRs were reported in the WHO Vigilyze database, 13 498 of which (48.2%) were serious ones. Clinical manifestations included skin rashes, nausea, allergic reactions, pain, joint swelling, fatigue and diarrhea. Between January 2004 and December 2019, 2 506 cases of ADRs associated with hydroxychloroquine sulfate tablets were reported to China adverse drug reaction database, 285 of which (11.4%) were serious, mainly related to skin and appendages disorders, gastrointestinal disorders, neurological disorders, vision disorders, and general disorders. The adverse reactions were mainly manifested as rashes, itching, dizziness, headache, nausea, abnormal vision, diarrhea and vomiting. Conclusion Attention should be paid to the possible adverse reactions caused by hydroxychloroquine in clinical use, such as cutaneous damage, gastrointestinal disorders, neurological disorders, visual damage and cardiovascular diseases. We should reinforce the safety monitoring of hydroxychloroquine, with special attention to such adverse reactions as cardiac toxicity, in order to promote the rational application of this medicine.

Key words: COVID-19, hydroxychloroquine, adverse reaction

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