| 张科,孙璇,邵佳,等.基于FAERS 数据库的5 种二肽基肽酶Ⅳ抑制剂上市后关节不良事件研究[J].安徽医药,2022,26(9):1904-1908. |
| 基于FAERS 数据库的5 种二肽基肽酶Ⅳ抑制剂上市后关节不良事件研究 |
| Postmarketing study on joint adverse events of five dipeptidyl peptidase Ⅳ inhibitors based on the FAERS database |
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| DOI：10.3969/j.issn.1009-6469.2022.09.049 |
| 中文关键词: 二肽基肽酶Ⅳ抑制剂 美国食品药品监督管理局不良事件报告系统数据库 关节不良事件 关节痛 报告比值比 |
| 英文关键词: Dipeptidyl-peptidase Ⅳ inhibitors FAERS database Joint adverse events Arthralgia Report odds ratio |
| 基金项目:天津市自然科学基金项目(20JCQNJC01810)；天津市卫生健康科技项目(ZC20212) |
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| 中文摘要: |
| 目的基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库比较5种二肽基肽酶Ⅳ(DPP-4)抑制剂上市后的关节不良事件的情况。方法检索2006年10月16日至2021年12月31日FAERS数据库中所有DPP-4抑制剂的药品不良事件(ADE)报告数据，筛选出这些报告中与关节有关的不良事件，采用报告比值比(ROR)法对关节不良事件报告进行分析。结果最终得到阿格列汀3份，利格列汀186份，沙格列汀119份，西格列汀1 396份，维格列汀87份ADE报告。这些报告中女性多于男性，主要集中于>50~75岁年龄段病人，且美国地区的上报数最多，这些报告中(除阿格列汀外)以关节痛和关节肿胀上报数最多。经ROR法检测发现，仅关节痛(ROR=1.391)、关节肿胀(ROR=1.346)、多关节炎(ROR=2.321)在西格列汀中出现可疑信号，其他DPP-4抑制剂未检测出关节不良事件的可疑信号。结论虽然5种DPP-4抑制剂上市后的关节不良事件报告数量相对较少，而且经ROR法检测仅在西格列汀中发现可疑信号；但在临床使用这类药物时，如果出现严重和持续性的关节不良事件，应考虑将其视为可能的原因，同时医务人员应考虑终止该类药物的治疗，避免对病人造成损害。 |
| 英文摘要: |
| Objective Comparison of postmarketing joint adverse events for five dipeptidyl peptidase Ⅳ (DPP-4) inhibitors based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods Adverse drug event (ADE)report data for all DPP-4 inhibitors in the FAERS database from October 16, 2006, to December 31, 2021, were retrieved, and reported joint-related adverse events were screened using the reported odds ratio (ROR).Results Finally, 3 reports of alogliptin, 186 of linagliptin,119 of saxagliptin, 1 396 of sitagliptin and 87 of vildagliptin were obtained. There are more women than men in these reports,mainly concentrated in patients >50-75 years old, and the United States has the largest number of reports. Among these reports (except alogliptin), joint pain and joint swelling are reported the most. It was found by the ROR method that only joint pain (ROR=1.391), joint swelling (ROR=1.346) and polyarthritis (ROR=2.321) had suspicious signals in sitagliptin, and other DPP-4 inhibitors did not detect suspicious signals of joint adverse events.Conclusion Although the number of reports of postmarketing joint adverse events for five DPP-4 inhibitors was relatively small and only suspicious signals were found in sitagliptin by the ROR method; when these drugs are used clinically, serious and persistent joint adverse events should be considered as possible causes, and medical staff should consider terminating the treatment of such drugs to avoid harm to the patient. |
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