中国药物警戒 ›› 2022, Vol. 19 ›› Issue (1): 91-94.
DOI: 10.19803/j.1672-8629.2022.01.20

• 安全与合理用药 • 上一篇    下一篇

229例克咳片不良反应分析

乔卫林1, 李海燕2   

  1. 1中山市中智药业集团有限公司,广东 中山 528437;
    2中山市恒生药业有限公司,广东 中山 528411
  • 收稿日期:2020-02-28 出版日期:2022-01-15 发布日期:2022-01-20
  • 作者简介:乔卫林,男,本科,高级工程师,药品质量研究、不良反应监测。
  • 基金资助:
    2017年中山市战略性新兴产业创新平台建设专项资金（中发改高技术 [2017]543号）

229 cases of adverse drug reactions caused by Keke tablets

QIAO Weilin1, LI Haiyan2   

  1. 1Zhongshan Zhongzhi Pharmaceutical Group Co., Ltd., Zhongshan Guangdong 528437, China;
    2Zhongshan Hengsheng Pharmaceutical Co., Ltd., Zhongshan Guangdong 528411, China
  • Received:2020-02-28 Online:2022-01-15 Published:2022-01-20

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摘要： 目的 分析克咳片引起的药品不良反应（adverse drug reaction, ADR）,为临床安全合理用药提供参考。方法 对2017年1月1日至2018年12月31日收集到的克咳片不良反应229例进行回顾性分析。结果 男性患者123例,女性患者106例,男女性别比为1.16∶1;15~44岁患者占比最高（54.15%）;一般ADR病例报告数量最多,162例（70.74%）,其次为新的一般65例（28.38%）;ADR主要表现在皮肤系统,主要症状为皮疹（44.59%）,其次是瘙痒（19.75%）。结论 明确了克咳片ADR的特点,建议规范临床使用,修订说明书,有助于减少或避免严重ADR的发生,促进临床安全合理用药。

关键词: 克咳片, 药品不良反应, 皮疹, 瘙痒, 说明书, 合理用药

Abstract: Objective To analyze the characteristics of 229 cases of adverse drug reactions (ADR) induced by Keke tablets, and provide reference for rational use of drugs in clinic. Methods The clinical data of ADR caused by Keke tablets between January 1, 2017 and December 31, 2018 was retrospectively analyzed. Results Among the 229 cases of ADR, there were 123 males and 106 females (1.16∶1). Most of the patients were 15 to 44 years old (54.15%). Common ADR (n=162) were the most prevalent, accounting for 70.74% of the total, followed by new common ADR (n=65) that accounted for 28.38%. Most of the ADR occurred in the skin system. The main symptoms were rash (44.59%) and by pruritus (19.75%). Conclusion The characteristics of ADR induced by Keke tablets have been confirmed in this analysis, which can help standardize the clinical use of Keke tablets and revise the drug instructions so as to reduce or prevent serious ADR and to ensure safe and rational drug use.

Key words: Keke tablets, adverse drug reaction, rash, pruritus, instructions, rational drug use

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