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随机临床试验:胃肠道危险因素筛查及预防性质子泵抑制剂治疗对接受双联抗血小板治疗患者的影响

Randomized clinical trial: the impact of gastrointestinal risk factor screening and prophylactic proton pump inhibitor therapy in patients receiving dual antiplatelet therapy.

作者信息

Jensen Berit E S, Hansen Jane M, Larsen Kasper S, Junker Anders B, Lassen Jens F, Jensen Svend E, Schaffalitzky de Muckadell Ove B

机构信息

Departments of aMedical Gastroenterology bCardiology, Odense University Hospital cDepartment of Public Health, University of Southern Denmark, Odense dDepartment of Cardiology, Aarhus University Hospital, Skejby eDepartment of Cardiology, Aalborg University Hospital, Aalborg, Denmark.

出版信息

Eur J Gastroenterol Hepatol. 2017 Oct;29(10):1118-1125. doi: 10.1097/MEG.0000000000000934.

DOI:10.1097/MEG.0000000000000934
PMID:28678044
Abstract

OBJECTIVE

Dual antiplatelet therapy reduces the risk of ischemic complications after acute coronary syndrome, but increases the risk of bleeding including upper gastrointestinal bleeding (UGIB).The aim of this study was to examine the effect of screening for risk of UGIB and prophylactic proton pump inhibitor (PPI) treatment in dual-antiplatelet-treated patients at risk of UGIB and to assess the significance of dual antiplatelet therapy compliance for cardiovascular events.

PATIENTS AND METHODS

In a register-based randomized-controlled trial, 2009 patients were included at the time of first percutaneous coronary intervention and randomized to either screening or control. Screened high-risk patients were prescribed pantoprazole 40 mg during the 1-year after percutaneous coronary intervention.

RESULTS

The incidence of UGIB was 0.8 versus 1.3% in screened patients and controls, respectively (P=0.381).Significantly fewer screened patients (5.4%) than controls (8.0%) underwent upper gastrointestinal endoscopy (P=0.026). Screened patients (2.9%) had significantly fewer events of unstable angina pectoris than controls (4.7%) (P=0.036) and a higher compliance to dual antiplatelet therapy (88.3 vs. 85.0%) (P=0.035), but no statistically difference was observed in the incidences of myocardial infarction and all-cause mortality (1.0 vs. 1.5%) (P=0.422).

CONCLUSION

Screening for risk factors for UGIB and subsequent prophylactic PPI treatment did not significantly reduce the incidence of UGIB. Prescription of PPI was associated with a higher compliance with dual antiplatelet therapy and decreases the risk of recurrent cardiovascular events.

摘要

目的

双联抗血小板治疗可降低急性冠脉综合征后缺血性并发症的风险,但会增加包括上消化道出血(UGIB)在内的出血风险。本研究旨在探讨对有UGIB风险的双联抗血小板治疗患者进行UGIB风险筛查及预防性使用质子泵抑制剂(PPI)治疗的效果,并评估双联抗血小板治疗依从性对心血管事件的意义。

患者与方法

在一项基于登记的随机对照试验中,2009例患者在首次经皮冠状动脉介入治疗时被纳入,并随机分为筛查组或对照组。筛查出的高危患者在经皮冠状动脉介入治疗后的1年内服用泮托拉唑40毫克。

结果

筛查组患者和对照组的UGIB发生率分别为0.8%和1.3%(P = 0.381)。接受上消化道内镜检查的筛查组患者(5.4%)明显少于对照组(8.0%)(P = 0.026)。筛查组患者(2.9%)不稳定型心绞痛事件明显少于对照组(4.7%)(P = 0.036),双联抗血小板治疗的依从性更高(88.3%对85.0%)(P = 0.035),但心肌梗死和全因死亡率的发生率无统计学差异(1.0%对1.5%)(P = 0.422)。

结论

筛查UGIB危险因素并随后进行预防性PPI治疗并未显著降低UGIB的发生率。PPI的使用与双联抗血小板治疗的更高依从性相关,并降低了心血管事件复发的风险。

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