中国药物警戒 ›› 2013, Vol. 10 ›› Issue (9): 563-566.

• 药械安全性研究 • 上一篇    下一篇

37例二甲双胍致不良反应报告分析

史洪波*, 蔡强   

  1. 山东电力中心医院,山东济南250001
  • 收稿日期:2013-07-02 修回日期:2016-03-09 出版日期:2013-09-08 发布日期:2016-03-09
  • 作者简介:史洪波,女,主治医师,内科学。

Analysis of 37 Cases of Adverse Drug Reaction Reports by Metformin

SHI Hong-bo*, CAI Qiang   

  1. Shandong Electric Power Center Hospital, Shandong Jinan 250001, China
  • Received:2013-07-02 Revised:2016-03-09 Online:2013-09-08 Published:2016-03-09

摘要: 目的 通过对37 例二甲双胍致不良反应事件报告进行分析,探讨其引起不良反应的规律和原因,为安全合理用药提供参考。方法 对1979 年~2013 年中国期刊全文数据库文献进行检索,对其中涉及二甲双胍致临床药品不良反应的32 篇文献中报道的37 例病例报告进行统计与分析。结果37 例二甲双胍所致报告中,男性明显多于女性,30~39 岁患者例数最多;所用二甲双胍涉及普通片剂、肠溶片剂和缓释片剂3种剂型,普通片剂为临床常用主要剂型,占全部病例的89.19%;不良反应发生时间最快为第1 次用药30min 后出现,最长为长期服用数年后出现,其中服药1d 内发生不良反应的患者最多;不良反应可累积多个系统、器官,主要以皮肤及附件损害、全身性损害和内分泌系统为主,其次为神经系统、胃肠道系统等,大部分ADR 多轻微,即使有症状较重或严重者,及时停药或对症治疗处理,大多数症状可好转消失,但2 例发生乳酸酸中毒,经抢救无效死亡。结论 临床应重视二甲双胍所致ADR 的发生,根据病情严格控制服药剂量,加强用药监测,以减少不良反应的发生。

关键词: 二甲双胍, 药品不良反应, 文献分析

Abstract: Objective Through analysing 37 cases of adverse drug reaction(ADR) by metformin to explore the rules and causes of adverse reactions, provide a reference for clinical rational use of drugs. Methods By searching literature in Chinese Journal Full-text Database from 1979 to 2013, 32 ADR literatures of metformin involving 37 cases, were statistically analyzed. Results In the 37 cases of adverse drug reaction by metformin, the adverse reaction incidence of men was more than that of women, the 30-39 years old patients with the highest incidence; the used formulation of metformin involved tablet formulation,enteric-coated tablet and sustained-release tablet. The tablet formulation was the ordinary formulation, accounting for 89.19%; the fastest appearing time of adverse reaction was 30 minutes after administration, the longest time was a few years after administration, and most adverse reactions happpened within 1 day after administration. The ADRs involved many systems and organs, mainly manifested as skin and appendage damage, systemic damage and endocrine system damage followed by nervous system and gastrointestinal system disorders. Most adverse reactions were slight, even if some symptoms were severe, most symptoms could be improved and disappeared after timely drug withdraw or symptomatic drug treatment, but2 cases died of lactic acidosis after rescue. Conclusion The doctors and pharmacists should pay attention to the adverse reactions caused by metformin, and understand the rules and characteristics of adverse reactions, the dosages should be strictly controlled according to the diseases, and the clinical care should be strengthened so as to prevent the occurrence of adverse reactions.

Key words: metformin, adverse drug reaction, literature analysis

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