中国药物警戒 ›› 2022, Vol. 19 ›› Issue (3): 325-327.
DOI: 10.19803/j.1672-8629.2022.03.21

• 安全与合理用药 • 上一篇    下一篇

385例茵栀黄制剂不良反应/事件分析

冯承阳1, 赵丽2, 刘东1,*   

  1. 1华中科技大学同济医学院附属同济医院药学部,湖北 武汉 430030;
    2湖北省药品（医疗器械）不良反应监测中心,湖北 武汉 430073
  • 收稿日期:2020-05-17 出版日期:2022-03-15 发布日期:2022-03-16
  • 通讯作者: *刘东,男,博士,教授·博导,药物流行病学。E-mail：ld2069@outlook.com
  • 作者简介:冯承阳,女,硕士,药师,药物流行病学。

385 cases of adverse drug reactions/adverse drug events caused by Yinzhihuang preparations

FENG Chengyang1, ZHAO Li2, LIU Dong1,*   

  1. 1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Hubei 430030, China;
    2Hubei Center for ADR Monitoring, Wuhan Hubei 430073, China
  • Received:2020-05-17 Online:2022-03-15 Published:2022-03-16

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摘要： 目的 通过对茵栀黄制剂导致的药品不良反应（ADR）进行分析,了解茵栀黄制剂ADR发生的特点,为规范临床合理用药提供参考。方法 收集2012年1月1日至2018年12月31日湖北省药品（医疗器械）不良反应监测中心数据库中385例茵栀黄制剂ADR/事件（ADE）报告,对报告中患者使用药物剂型、患者年龄、性别、原患疾病、使用剂量、发生时间、累及系统-器官以及临床表现等进行统计分析。结果 茵栀黄制剂所致ADR/ADE患者中,男女性别比为1.60∶1.00,多发生于40~59岁人群（42.86%）;其中有发生时间记录的报告301例,多在用药30 min内出现ADR/ADE;累及系统-器官主要为皮肤及附件损害,主要临床表现为瘙痒及皮疹等。结论 茵栀黄制剂可导致不同程度的ADR/ADE,一般经停药或对症处理后患者好转,临床上应给予足够重视,密切关注患者用药后状况,辨证施药,禁止超功能主治施药。

关键词: 茵栀黄制剂, 药品不良反应/事件, 安全性

Abstract: Objective To analyze adverse drug reactions (ADR) caused by Yinzhihuang preparations in order to grasp the characteristics of ADR of Yinzhihuang preparations and provide reference for rational clinical use. Methods A total of 385 reports of ADR/adverse drug events (ADE) of Yinzhihuang preparations were collected by Hubei Center for ADR Monitoring between January 1, 2012 and December 31, 2018. Dosage forms that patients used, patients' age and gender, preexisting diseases, dosages, times of occurrence, system-organs involved, and clinical manifestations were recorded and analyzed. Results Among these cases, the ratio of males to females was 1.60∶1.00, and the incidence was higher in patients aged 40 to 59 (42.86%). There were 301 reports that documented the time ADR occurred (mainly within 30min). The affected systems-organs were mostly the skin and its accessories while the main clinical manifestations were pruritus and rash. Conclusion Yinzhihuang preparations can cause ADR/ADE of varying degrees, but patients can generally improve after drug withdrawal or symptomatic treatment. Enough attention should be paid to the condition of patients after medication.

Key words: Yinzhihuang preparations, adverse drug reaction/adverse drug event, safety

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