Shirai Tsuguru, Yamamoto Takatsugu, Kawasugi Kazuo, Kuyama Yasushi, Kita Hiroto
Int J Clin Pharmacol Ther. 2016 Nov;54(11):841-846. doi: 10.5414/CP202607.
Although several non-vitamin K oral anticoagulants have been developed to prevent cardiogenic thrombosis, the status of hemorrhagic complications in the clinical setting among Asian populations, including Japan, remains unclear. We conducted this retrospective cohort study to clarify the current status of hemorrhagic events during antithrombotic therapy with non-vitamin K oral anticoagulants, with particular focus on gastrointestinal bleeding.
Medical charts of 475 patients prescribed dabigatran, rivaroxaban, or apixaban between April 2011 and September 2014 were reviewed to examine whether any hemorrhagic events occurred, compared with 135 patients who received warfarin between April 2009 and March 2011.
Incidences of total and actionable hemorrhage in patient taking non-vitamin K oral anticoagulants were 13.8% per year and 4.6% per year, respectively, showing no significant differences from those in warfarin users (9.3% per year and 5.0% per year, respectively). In addition, actionable gastrointestinal hemorrhage occurred at similar rates in non-vitamin K oral anticoagulants users (2.1% per year) and warfarin users (1.5% per year). Most hemorrhages were from the lower gastrointestinal tract, and considerable events involved perianal bleeding. Multiple regression analysis showed that age, concomitant dual antiplatelet therapy, and concomitant nonsteroidal anti-inflammatory drug therapy were significant factors related to actionable gastrointestinal bleeding.
CONCLUSIONS: Risk of gastrointestinal hemorrhage in patients taking non-vitamin K oral anticoagulants was similar to that in patients taking warfarin. The dominant bleeding site was the lower gastrointestinal tract. .
尽管已经研发出多种非维生素K口服抗凝药来预防心源性血栓形成,但在包括日本在内的亚洲人群临床环境中,出血并发症的情况仍不明确。我们开展这项回顾性队列研究,以阐明使用非维生素K口服抗凝药进行抗栓治疗期间出血事件的现状,尤其关注胃肠道出血。
回顾了2011年4月至2014年9月期间475例服用达比加群、利伐沙班或阿哌沙班患者的病历,以检查是否发生任何出血事件,并与2009年4月至2011年3月期间接受华法林治疗的135例患者进行比较。
服用非维生素K口服抗凝药患者的总出血和可处理出血发生率分别为每年13.8%和每年4.6%,与服用华法林的患者(分别为每年9.3%和每年5.0%)相比无显著差异。此外,非维生素K口服抗凝药使用者(每年2.1%)和华法林使用者(每年1.5%)发生可处理胃肠道出血的发生率相似。大多数出血来自下消化道,相当一部分事件涉及肛周出血。多元回归分析表明,年龄、联合双重抗血小板治疗以及联合非甾体抗炎药治疗是与可处理胃肠道出血相关的重要因素。
服用非维生素K口服抗凝药患者发生胃肠道出血的风险与服用华法林的患者相似。主要出血部位是下消化道。