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钾竞争性酸阻滞剂与质子泵抑制剂在双重抗血小板治疗患者中的比较疗效:一项全国性队列研究。

Comparative effectiveness of potassium-competitive acid blockers and proton pump inhibitors in dual antiplatelet therapy patients: a nationwide cohort study.

作者信息

Lee Yu Jeong, Je Nam Kyung

机构信息

College of Pharmacy, Pusan National University, Busandaehakro 63 Bungil 2, Geumjeong-Gu, Busan, 46241, Republic of Korea.

Department of Pharmacy, Pusan National University Hospital, Busan, Republic of Korea.

出版信息

Int J Clin Pharm. 2025 Mar 21. doi: 10.1007/s11096-025-01895-2.

Abstract

BACKGROUND

Proton pump inhibitors (PPIs) are widely used in combination with dual antiplatelet therapy (DAPT) to reduce the risk of gastrointestinal bleeding; however, some PPIs may interfere with clopidogrel metabolism through CYP2C19 inhibition. Potassium-competitive acid blockers (P-CABs) have emerged as alternatives to PPIs, although their effectiveness in patients receiving DAPT have not been sufficiently explored.

AIM

This study aimed to compare the effectiveness of PPIs and P-CABs in preventing cardiovascular events and gastrointestinal bleeding among patients receiving DAPT after coronary stent implantation.

METHOD

A retrospective cohort design was employed using nationwide claim data from South Korea. The study included patients who received aspirin-clopidogrel DAPT with PPI or P-CAB for a minimum of 60 days. After applying propensity score matching (PSM) at a 1:1 ratio, survival analysis was conducted. The primary outcome was a composite of acute myocardial infarction, ischemic stroke, revascularization, and in-hospital mortality. Secondary outcomes involved the individual components of the composite outcome and gastrointestinal bleeding.

RESULTS

The initial cohort included 39,234 patients in the PPI group and 3,434 in the P-CAB group. After 1:1 PSM, 3,434 patients were included in each group. No statistically significant differences were observed between the PPI and P-CAB groups for the primary outcome (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.68-1.07; p = 0.167) and gastrointestinal bleeding (HR, 1.36; 95% CI, 0.76-2.42; p = 0.3).

CONCLUSION

Both PPIs and P-CABs appear to be viable options for acid suppression in patients undergoing DAPT, with no significant differences in cardiovascular or gastrointestinal outcomes.

摘要

背景

质子泵抑制剂(PPIs)广泛与双联抗血小板治疗(DAPT)联合使用以降低胃肠道出血风险;然而,一些PPIs可能通过抑制CYP2C19干扰氯吡格雷代谢。钾竞争性酸阻滞剂(P-CABs)已成为PPIs的替代药物,尽管其在接受DAPT患者中的有效性尚未得到充分研究。

目的

本研究旨在比较PPIs和P-CABs在冠状动脉支架植入术后接受DAPT患者中预防心血管事件和胃肠道出血的有效性。

方法

采用回顾性队列设计,使用韩国全国范围的索赔数据。该研究纳入了接受阿司匹林-氯吡格雷DAPT联合PPI或P-CAB治疗至少60天的患者。按1:1比例应用倾向评分匹配(PSM)后,进行生存分析。主要结局为急性心肌梗死、缺血性卒中、血运重建和住院死亡率的复合结局。次要结局包括复合结局的各个组成部分以及胃肠道出血。

结果

初始队列中,PPI组有39234例患者,P-CAB组有3434例患者。经过1:1 PSM后,每组纳入3434例患者。PPI组和P-CAB组在主要结局(风险比[HR],0.85;95%置信区间[CI],0.68 - 1.07;p = 0.167)和胃肠道出血(HR,1.36;95% CI,0.76 - 2.42;p = 0.3)方面未观察到统计学显著差异。

结论

PPIs和P-CABs似乎都是接受DAPT患者胃酸抑制的可行选择,在心血管或胃肠道结局方面无显著差异。

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