Department of Pharmacotherapy and Pharmaceutical Care, University of Groningen, Groningen, The Netherlands.
J Clin Pharm Ther. 2010 Apr;35(2):213-7. doi: 10.1111/j.1365-2710.2009.01089.x.
BACKGROUND/AIMS: Antiplatelet therapy with aspirin and clopidogrel is an important component of the management of acute coronary syndrome, but it also increases the risk of bleeding. There are no formal guidelines about the use of a proton pump inhibitor (PPI) for gastroprotection in patients on clopidogrel. This study assessed how many patients in the Royal Darwin Hospital (RDH) and the Royal Hobart Hospital (RHH) prescribed clopidogrel and at risk of bleeding were co-prescribed PPIs.
We conducted a retrospective cohort study using a pharmacy database to select all patients commenced on clopidogrel in a 1-year period. We identified all patients newly prescribed clopidogrel and determined the proportion that had a risk factor for bleeding and also received a PPI. We also assessed the effect of the use of PPIs on the number of reported bleeds.
The final study cohort consisted of 385 patients who had been newly prescribed clopidogrel. Of all patients discharged on clopidogrel, 95.6% (368/385) had >or=1 risk factor for bleeding. One hundred and twenty-eight of these patients [128/368, (34.8%)] were discharged on a PPI. Patients on dual antiplatelet therapy with an additional risk factor for bleeding and not discharged on a PPI were more likely to develop a major bleed than patients on dual antiplatelet therapy without a risk factor for bleeding not discharged on a PPI (11.1% vs. 1.8%; P < 0.01). Patients on dual antiplatelet therapy with an additional risk factor for bleeding not discharged on a PPI had a higher probability (borderline significance) of major bleeding, compared with patients on dual antiplatelet therapy with an additional risk factor for bleeding discharged on a PPI [PPI: 1/60, (1.7%) vs. no PPI: 6/54, (11.1%); P = 0.05].
Our results indicate that PPIs may only lower the probability of major bleeding in patients treated with dual antiplatelet therapy, who possess additional risk factor(s) for bleeding.
背景/目的：阿司匹林和氯吡格雷的抗血小板治疗是急性冠状动脉综合征治疗的重要组成部分，但也会增加出血风险。目前尚无关于氯吡格雷治疗患者使用质子泵抑制剂（PPI）进行胃保护的正式指南。本研究评估了在皇家达尔文医院（RDH）和皇家霍巴特医院（RHH）开具氯吡格雷处方的患者中有多少人存在出血风险，并同时开具了 PPI。
我们进行了一项回顾性队列研究，使用药房数据库选择了一年内开始使用氯吡格雷的所有患者。我们确定了所有新开具氯吡格雷的患者，并确定了有出血风险因素且同时接受 PPI 治疗的患者比例。我们还评估了使用 PPI 对报告出血数量的影响。
最终的研究队列包括 385 名新开具氯吡格雷的患者。所有出院时服用氯吡格雷的患者中，有 95.6%（368/385）有 >或=1 个出血风险因素。其中 128 名患者[128/368，（34.8%）]出院时开具了 PPI。同时接受双联抗血小板治疗且存在额外出血风险因素但未开具 PPI 的患者比同时接受双联抗血小板治疗且无出血风险因素但未开具 PPI 的患者更有可能发生大出血（11.1% vs. 1.8%；P < 0.01）。同时接受双联抗血小板治疗且存在额外出血风险因素但未开具 PPI 的患者发生大出血的概率（边缘显著）高于同时接受双联抗血小板治疗且存在额外出血风险因素且开具了 PPI 的患者[PPI：1/60，（1.7%） vs. 无 PPI：6/54，（11.1%）；P = 0.05]。
我们的结果表明，PPI 可能仅降低同时接受双联抗血小板治疗且存在额外出血风险因素的患者发生大出血的概率。
