中国药物警戒 ›› 2023, Vol. 20 ›› Issue (12): 1415-1420.
DOI: 10.19803/j.1672-8629.20230077

• 安全与合理用药 • 上一篇    下一篇

953例口服降糖药不良反应/事件报告分析

魏安华1, 漆建军2, 王璐1, 曾露1, 贡雪芃1, 江莹2*   

  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 430033;
    2武汉市药品不良反应监测中心，湖北 武汉 430000
  • 收稿日期:2023-02-13 出版日期:2023-12-15 发布日期:2023-12-15
  • 通讯作者: *江莹,女,硕士,主管药师,药品不良反应。E-mail: 40273494@qq.com
  • 作者简介:魏安华,女,博士,副主任药师,药品临床综合评价。
  • 基金资助:
    湖北省卫生健康委科研项目（WJ2023F004）

Adverse drug reaction/ event caused by oral antidiabetic drugs

WEI Anhua1, QI Jianjun2, WANG Lu1, ZENG Lu1, GONG Xuepeng1, JIANG Ying2,*   

  1. 1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Hubei 430033, China;
    2Wuhan Center for ADR/ADE Monitoring, Wuhan Hubei 430000, China
  • Received:2023-02-13 Online:2023-12-15 Published:2023-12-15

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摘要： 目的 探讨口服降糖药品不良反应/事件（ADR/ADE）发生的一般规律和特点,为临床合理用药提供依据。方法 采用回顾性研究方法,收集2012年1月1日至2022年12月31日武汉市ADR/ADE自发呈报系统数据库中10种口服降糖药ADR/ADE报告,采用描述性方法对报告信息、患者人口学特征、用药情况和累及系统-器官分布及临床表现等进行分析。结果 共纳入口服降糖药ADR/ADE报告953例,涉及1 405例次,数量呈逐年上升趋势,程度以“一般”为主（88.67%）,“严重”占11.33%;以胃肠系统损害、皮肤及其附件损害和代谢与营养障碍最为多见,频次排序前3位的药物类别为α-糖苷酶抑制剂、噻唑烷二酮类和双胍联合噻唑烷二酮复方制剂。不同类别药物所致ADR/ADE的累及系统-器官和临床表现各具特点,钠-葡萄糖共转运蛋白2抑制剂以尿路损害和生殖器瘙痒为主,二肽基肽酶Ⅳ抑制剂以皮肤及皮肤附件疾病损害为主,格列奈类所致低血糖居多,其他类别最常见胃肠道不适,基本与药品说明书相符。结论 口服降糖药的ADR/ADE涉及系统广泛,且呈逐年增多趋势,特别需关注新型口服降糖药,通过多方位药学服务,提升患者自我管理能力,加强ADR/ADE风险防范意识,及时识别并处理ADR/ADE,保障患者用药安全。

关键词: 口服降糖药, 药品不良反应/事件, α-糖苷酶抑制剂, 噻唑烷二酮类, 双胍联合噻唑烷二酮, 钠-葡萄糖共转运蛋白2抑制, 二肽基肽酶Ⅳ抑制, 格列奈类

Abstract: Objective To study the characteristics and regularity of adverse drug reaction / adverse drug event (ADR/ADE) caused by oral antidiabetic drugs, and to provide reference for rational use of these drugs in clinic. Methods A retrospective study was conducted to retrieve all ADR/ADE reports involving 10 types of oral antidiabetic drugs from the database of Wuhan ADR/ADE spontaneous reporting system that were submitted between 2012 and 2022. The demography of the users, usage of drugs, organs and systems involved in ADR/ADE and clinical manifestations were analyzed using the descriptive statistical methods. Results A total of 953 ADR/ADE reports and 1 405 cases related to oral antidiabetic drugs were included in this study. The number of reports trended up. Mild cases and serious ones accounted for 88.67% and 11.33% respectively. The most common ADR/ADE were gastrointestinal, skin, and metabolic disorders while drugs involved most frequently were α-glycosidase inhibitors, thiazolidinediones (TZD) and biguanide combined with TZD. Meanwhile, the ADR/ADE caused by different types of oral antidiabetic drugs varied in terms of system -organ distribution and clinical manifestations. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) were most likely to induce urinary tract damage and genital pruritus, dipeptidyl peptidase-IV inhibitors (DPP4i) tended to lead to skin or skin accessory disorders, glinides were mainly associated with hypoglycemia, and other drugs were mainly linked to gastrointestinal damage. Conclusion The ADR/ADE due to oral antidiabetic drugs involve a wide range of systems and keep increasing each year. The ADR/ADE caused by new oral antidiabetic drugs deserve more attention. In order to ensure the safety of oral antidiabetic drugs in clinical use, potential risks need to be prevented, users need to improve their self-control, and related ADR/ADE have to be detected and handled quickly.

Key words: oral antidiabetic drugs, adverse drug reaction/event, α-glycosidase inhibitors, thiazolidinediones (TZD), biguanide combined, sodium-glucose cotransporter-2 inhibitors (SGLT2i), dipeptidyl peptidase-IV inhibitors (DPP4i), glinides

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