中国药物警戒 ›› 2018, Vol. 15 ›› Issue (7): 398-403.

• 甲巯咪唑安全风险分析专栏 • 上一篇    下一篇

甲巯咪唑致粒细胞减少不良反应分析

文晓玲1, 高云娟1,*, 张海浪1, 阳洁1, 兰姗2, 李亚梅2, 李岚3   

  1. 1南充市药品不良反应监测中心,四川 南充 637000;
    2四川省药品不良反应监测中心,四川 成都 610031;
    3国家药品不良反应监测中心,北京 100045
  • 收稿日期:2018-08-08 修回日期:2018-08-08 出版日期:2018-07-20 发布日期:2018-08-08
  • 通讯作者: *高云娟,女,硕士,中药师,药品不良反应监测。E-mail：844026255@qq.com
  • 作者简介:文晓玲,女,本科,副主任药师,药品不良反应监测。
  • 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

Analysis of Granulocytopenia Induced by Thiamazole

WEN Xiaoling1, GAO Yunjuan1,*, ZHANG Hailang1, YANG Jie1, LAN Shan2, LI Yamei2, LI Lan3   

  1. 1Nanchong Center of Adverse Drug Reaction Monitoring, Sichuan Nanchong 637000, China;
    2Sichuan Center of Adverse Drug Reaction Monitoring, Sichuan Chengdu 610031, China;
    3National Center for ADR Monitoring, Beijing 100045, China
  • Received:2018-08-08 Revised:2018-08-08 Online:2018-07-20 Published:2018-08-08

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摘要： 目的 分析甲巯咪唑致粒细胞减少不良反应的发生特点,为临床安全合理用药提供参考。方法 采取回顾性研究方法,对国家药品不良反应监测中心数据库2004年1月1日-2016年6月30日收到的甲巯咪唑致粒细胞减少不良反应报告进行统计分析。结果 1 358例怀疑使用甲巯咪唑致粒细胞减少相关不良反应报告中,严重不良反应报告构成比为48.53%,女性患者数量为男性的3.93倍,15~44岁青壮年期患者居多,发生时间在12周内的占87.56%,不良反应发生疑似有剂量相关性趋势,相关不良反应表现主要涉及血液系统损害、全身性损害及呼吸系统损害等。结论 甲巯咪唑致粒细胞减少的不良反应不容忽视,临床上应注意用法用量,加强患者用药教育宣传,加强用药前后血象监护,对粒细胞减少的患者积极采取对症治疗,防止或减少严重不良反应的发生。

关键词: 甲巯咪唑, 粒细胞减少, 药品不良反应, 分析

Abstract: Objective To analyze the characteristics of granulocytopenia induced by thiamazole, so as to provide reference for clinical safe and rational drug use. Methods Retrospective study was conducted on the statistical analysis of granulocytopenia induced by thiamazole that received by the national adverse drug reactions monitoring database from January 1, 2004 to June 30, 2016. Results Among 1 358 cases of granulocytopenia induced by thiamazole, the proporation of the serious adverse drug reactions(ADRs) was 48.53%, female patients were 3.93 times that of male patients, the most of patients were 15 to 44 years old, it occurred within 12 weeks accounting for 87.56%, and there may be a dose correlation in the occurrence of ADRs. Clinical manifestations were mainly the blood system damage, systemic damage and respiratory damage. Conclusion Granulocytopenia induced by thiamazole can't be ignored. The clinic should pay attention to usage and dosage. The education of patients, the blood monitoring before and after treatment should be strengthened. Doctors should actively take treatment measures to reduce the injury if it happened, so as to prevent or reduce the occurrence of serious adverse drug reactions.

Key words: thiamazole, granulocytopenia, adverse drug reactions(ADRs), analysis

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