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二肽基肽酶-4 抑制剂与首次使用后 3 个月内大疱性类天疱疮风险增加之间的关联:使用日本国家数据库进行的为期 5 年的基于人群的队列研究。

Association between dipeptidyl peptidase-4 inhibitors and increased risk for bullous pemphigoid within 3 months from first use: A 5-year population-based cohort study using the Japanese National Database.

机构信息

Department of Diabetes and Endocrinology, Nara Medical University, Kashihara, Japan.

Department of Public health, Health Management and Policy, Nara Medical University, Kashihara, Japan.

出版信息

J Diabetes Investig. 2022 Mar;13(3):460-467. doi: 10.1111/jdi.13676. Epub 2021 Oct 11.

DOI:10.1111/jdi.13676
PMID:34559464
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8902379/
Abstract

AIMS/INTRODUCTION: We assessed the association between dipeptidyl peptidase-4 inhibitors (DPP-4is) and bullous pemphigoid (BP) and time-dependent changes in the risk for developing BP after DPP-4i initiation.

MATERIALS AND METHODS

The present population-based, real-world study was carried out using the Japanese National Database dataset collected between 2013 and 2018. To assess independent correlations between DPP-4is and the development of BP, the self-controlled case series method was used.

RESULTS

Among the cohort followed up for a median of 1,540 days, 53,027 patients were likely to develop BP. The possible incidence rate of BP in all 150,328,339 patients was 10.4/100,000 person-years. Among the 9,705,814 patients with type 2 diabetes, 15,634 were likely to develop BP. The possible incidence rate of BP in patients with type 2 diabetes was 38.1/100,000 person-years, whereas that in patients with type 2 diabetes who did and did not use DPP-4is was 40.7 and 30.0/100,000 person-years, respectively. Analysis of the 28,705 patients with type 2 diabetes likely to develop BP after initial DPP-4i use showed a risk ratio of 2.15 (95% confidence interval [CI] 1.75-2.63), 1.70 (95% CI 1.37-2.11), 1.44 (95% CI 1.15-1.82), 1.25 (95% CI 0.98-1.59), 0.84 (95% CI 0.63-1.10), 0.84 (95% CI 0.64-1.11) and 1.05 (95% CI 0.92-1.20), for the risk period of ≤30, 31-60, 61-90, 91-120, 121-150, 151-180 and 181-365 days, respectively.

CONCLUSIONS

Although DPP-4is were associated with increased risk for BP, the risk was particularly significant within 3 months from first use.

摘要

目的/引言:我们评估了二肽基肽酶-4 抑制剂(DPP-4i)与大疱性类天疱疮(BP)之间的关联,以及 DPP-4i 起始后发生 BP 的风险随时间的变化。

材料和方法

本基于人群的真实世界研究使用了 2013 年至 2018 年期间收集的日本国家数据库数据集。为了评估 DPP-4i 与 BP 发展之间的独立相关性,使用了自我对照病例系列法。

结果

在随访中位数为 1540 天的队列中,有 53027 名患者可能发展为 BP。所有 150328339 名患者的 BP 可能发生率为 10.4/100000 人年。在 9705814 名 2 型糖尿病患者中,有 15634 名可能发展为 BP。2 型糖尿病患者的 BP 可能发生率为 38.1/100000 人年,而使用和未使用 DPP-4i 的 2 型糖尿病患者的发生率分别为 40.7 和 30.0/100000 人年。对 28705 名初始使用 DPP-4i 后可能发展为 BP 的 2 型糖尿病患者进行分析,结果显示风险比为 2.15(95%置信区间[CI]1.75-2.63)、1.70(95%CI1.37-2.11)、1.44(95%CI1.15-1.82)、1.25(95%CI0.98-1.59)、0.84(95%CI0.63-1.10)、0.84(95%CI0.64-1.11)和 1.05(95%CI0.92-1.20),风险期分别为≤30、31-60、61-90、91-120、121-150、151-180 和 181-365 天。

结论

虽然 DPP-4i 与 BP 风险增加相关,但风险在首次使用后 3 个月内尤其显著。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0b9/8902379/b440bc797e54/JDI-13-460-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0b9/8902379/b440bc797e54/JDI-13-460-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0b9/8902379/b440bc797e54/JDI-13-460-g001.jpg

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