抗新型冠状病毒肺炎药物磷酸氯喹的安全性分析

doi:10.19803/j.1672-8629.2021.02.03

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 110-114.
DOI: 10.19803/j.1672-8629.2021.02.03

• 新型冠状病毒肺炎治疗药品安全研究专栏 • 上一篇下一篇

抗新型冠状病毒肺炎药物磷酸氯喹的安全性分析

吕强^1,2, 阎嘉阳¹, 张旺喆麒¹, 叶小飞^3,*, 郭晓晶^3,△

¹海军军医大学基础医学院,上海200433;
²解放军92608部队医院,上海200940;
³海军军医大学卫生勤务学系军队卫生统计学教研室,上海200433

收稿日期:2020-07-14 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
通讯作者: ^*叶小飞,男,博士,副教授,药物流行病学。E-mail: yexiaofei@smmu.edu.cn。^△为共同通信作者。
作者简介:吕强,男,本科,临床合理用药。
基金资助:
国家自然科学基金（81703296）:药品不良反应监测中多重性检验和低频数膨胀问题的研究; 国家十三五科技重大专项（2017ZX09304016)：病毒感染性疾病与肝病新药临床评价和药物肝脏安全性转化研究技术平台建设; 上海市卫计委优秀青年医学人才培养计划（2018YQ47）; 上海市自然科学基金（18ZR1449500）:疾病风险评分模型研究及在药品不良反应主动监测中的应用

Safety of an Anti-novel Coronavirus Pneumonia Drug：Chloroquine Phosphate

LYU Qiang^1,2, YAN Jiayang¹, ZHANG Wangzheqi¹, YE Xiaofei^3,*, GUO Xiaojing^3,△

¹Basic Medical College, Naval Medical University, Shanghai 200433, China;
²92608 Militang Hospital of PLA, Shanghai 200940, China;
³Department of Health Statistics,Faculty of Health Services, Naval Medical University, Shanghai 200433, China

Received:2020-07-14 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

摘要/Abstract

摘要： 目的基于美国FDA不良反应事件报告系统（FAERS）和加拿大Canada Vigilance数据库挖掘磷酸氯喹导致的可疑不良反应信号,为临床治疗新型冠状病毒肺炎安全用药提供参考。方法利用报告比值比法（ROR）和信息成分法（IC）对FAERS自2015年至2019年和Canada Vigilance自1965年至2019年的数据进行信号检测。结果 FAERS和Canada Vigilance数据库中分别提取出药品不良反应报告126例和54例,基于上述两个数据库ROR和IC法分别获得可疑信号58/32个和9/2个。FAERS中报告数最多的系统器官分类（SOC）是各类损伤、中毒及手术并发症（85例,16.2%）,信号最强的不良反应（PT）是限制性心肌病（n=9,ROR=18.92,IC=4.24）。Canada Vigilance中报告数最多的SOC是皮肤及皮下组织类疾病（23例,18.7%）,信号最强的PT是光敏性反应（n=9,ROR=17.01,IC=4.08）。结论临床长期使用磷酸氯喹可致严重ADR,应谨慎用于心脏基础疾病和神经系统基础疾病患者,并着重关注磷酸氯喹用法用量及磷酸氯喹的心脏毒性。

关键词: 磷酸氯喹, 新型冠状病毒肺炎, 药品不良反应, 信号检测

Abstract: Objective To analyze safety signals of chloroquine phosphate based on the data of the US FAERS and Canada Vigilance in order to provide reference for safe and rational medication against novel coronavirus pneumonia. Methods The reporting odds ratio method (ROR) and the information component method (IC) were adopted to detect ADR signals of the data of the FAERS from 2015 to 2019 and of Canada Vigilance from 1965 to 2019. Results From FAERS and Canada Vigilance, a total of 126 cases and 54 cases of adverse drug reactions were obtained respectively, and a total of 58/32, 9/2 ADR signals were detected by ROR and IC from FAERS and Canada Vigilance. The SOC with the largest number of reports of ADR signals in FAERS was injury, poisoning and procedural complications (85 cases, 16.2%), while PT with the strongest signal was restrictive cardiomyopathy (n=9, ROR=18.92, IC=4.24), compared with skin and subcutaneous tissue disorders (23 cases, 18.7%) and photosensitivity reaction (n=9, ROR=17.01, IC=4.08) respectively in Canada Vigilance. Conclusion Long-term clinical use of chloroquine phosphate can cause severe ADRs, so this drug should be used with caution in patients with heart-based diseases and nervous system-based diseases.

Key words: chloroquine phosphate, novel coronavirus pneumonia, adverse drug reaction, signal detection

中图分类号:

R978.7

吕强, 阎嘉阳, 张旺喆麒, 叶小飞, 郭晓晶. 抗新型冠状病毒肺炎药物磷酸氯喹的安全性分析[J]. 中国药物警戒, 2021, 18(2): 110-114.

LYU Qiang, YAN Jiayang, ZHANG Wangzheqi, YE Xiaofei, GUO Xiaojing. Safety of an Anti-novel Coronavirus Pneumonia Drug：Chloroquine Phosphate[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 110-114.

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抗新型冠状病毒肺炎药物磷酸氯喹的安全性分析

Safety of an Anti-novel Coronavirus Pneumonia Drug：Chloroquine Phosphate

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