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达比加群酯致胃肠道出血的风险:与利伐沙班的直接比较研究

Risk of gastrointestinal bleeding with dabigatran: a head-to-head comparative study with rivaroxaban.

作者信息

Sherid Muhammed, Sifuentes Humberto, Sulaiman Samian, Samo Salih, Husein Husein, Tupper Ruth, Thiruvaiyaru Dharma, Spurr Charles, Sridhar Subbaramiah

机构信息

Section of Gastroenterology and Hepatology, Georgia Regents University, Augusta, Ga., USA.

出版信息

Digestion. 2014;90(2):137-46. doi: 10.1159/000365967. Epub 2014 Oct 1.

DOI:10.1159/000365967
PMID:25278002
Abstract

INTRODUCTION

The risk of gastrointestinal (GI) bleeding of dabigatran and rivaroxaban is relatively unexplored. The aim of our study was to compare this risk in both drugs.

METHODS

We examined the medical records of patients on either dabigatran or rivaroxaban from October 2010 to April 2013 in two hospitals.

RESULTS

A total of 374 patients (147 rivaroxaban vs. 227 dabigatran) were identified. GI bleeding occurred in 5.3% in the dabigatran when compared to 4.8% in the rivaroxaban group (p = 0.8215). Multivariate analysis showed that the odds of GI bleeding while on dabigatran for ≤40 days when compared to ≥40 days was 8.3 (p < 0.0001). In the rivaroxaban group, patients who were on the drug for ≤40 days had a higher incidence of bleeding when compared to those >40 days (OR = 2.8, p = 0.023). Concomitant use of antiplatelets (single or dual) or non-steroidal anti-inflammatory drugs was not associated with increased bleeding in the dabigatran group; however, the use of dual antiplatelet agents with rivaroxaban was associated with an increased risk of GI bleeding (OR = 7.4, p = 0.0378). Prior GI bleeding had a higher risk of bleeding in the rivaroxaban group (OR = 15.5, p = 0.0002).

CONCLUSION

Dabigatran was not associated with a higher incidence of GI bleeding. Both drugs had a higher bleeding risk in the first 40 days.

摘要

引言

达比加群和利伐沙班的胃肠道(GI)出血风险相对未被充分研究。我们研究的目的是比较这两种药物的该风险。

方法

我们检查了2010年10月至2013年4月期间在两家医院使用达比加群或利伐沙班的患者的病历。

结果

共识别出374例患者(147例使用利伐沙班,227例使用达比加群)。达比加群组胃肠道出血发生率为5.3%,而利伐沙班组为4.8%(p = 0.8215)。多变量分析显示,与使用达比加群≥40天相比,使用≤40天的胃肠道出血几率为8.3(p < 0.0001)。在利伐沙班组中,与使用药物>40天的患者相比,使用≤40天的患者出血发生率更高(OR = 2.8,p = 0.023)。在达比加群组中,联合使用抗血小板药物(单药或双药)或非甾体抗炎药与出血增加无关;然而,利伐沙班与双联抗血小板药物联合使用会增加胃肠道出血风险(OR = 7.4,p = 0.0378)。既往有胃肠道出血史的患者在利伐沙班组中出血风险更高(OR = 15.5,p = 0.0002)。

结论

达比加群与更高的胃肠道出血发生率无关。两种药物在开始的40天内出血风险都更高。

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