Suzuki Shinya, Yamashita Takeshi, Kato Takeshi, Fujino Tadashi, Sagara Koichi, Sawada Hitoshi, Aizawa Tadanori, Fu Long-Tai
The Cardiovascular Institute, Minato-ku, Tokyo, Japan.
Circ J. 2007 May;71(5):761-5. doi: 10.1253/circj.71.761.
During anticoagulation for prevention of stroke in patients with non-valvular atrial fibrillation (NVAF), bleeding is the most serious complication. In Western countries, the incidences of major bleeding and intracranial hemorrhages with low-dose warfarin are known to occur at a rate of 0.4-1.3% and 0.2% per year, respectively. The purpose of this study was to investigate the incidence and risk factors for major bleeding related with warfarin therapy in Japanese patients with NVAF.
From August 2004 to July 2005, 667 NVAF patients treated with warfarin for NVAF were followed-up. The target prothrombin time-international normalized ratio (PT-INR) value was set at 1.6-2.6 (low-dose warfarin). The exposure on warfarin was 503 patient-years (average PT-INR 2.00 +/-0.40). During the follow-up period, 12 major bleeding complications occurred (2.38% per patient-year), which included 3 intracranial hemorrhages (0.60% per patient-year). Among the patients' characteristics, average PT-INR > or =2.27 during the study was identified as an independent risk factor for major bleeding.
The incidence of major bleeding and intracranial hemorrhages in Japanese NVAF patients with low-dose warfarin therapy was 2.38% and 0.60% per patient-year, respectively, which is higher than in Westerners.
在非瓣膜性心房颤动（NVAF）患者中，为预防中风进行抗凝治疗期间，出血是最严重的并发症。在西方国家，已知小剂量华法林治疗时，每年主要出血和颅内出血的发生率分别为0.4%-1.3%和0.2%。本研究旨在调查日本NVAF患者中与华法林治疗相关的主要出血的发生率及危险因素。
2004年8月至2005年7月，对667例接受华法林治疗的NVAF患者进行随访。目标凝血酶原时间-国际标准化比值（PT-INR）设定为1.6-2.6（小剂量华法林）。华法林暴露时间为503患者年（平均PT-INR 2.00±0.40）。随访期间，发生12例主要出血并发症（每年每患者2.38%），其中包括3例颅内出血（每年每患者0.60%）。在患者特征中，研究期间平均PT-INR≥2.27被确定为主要出血的独立危险因素。
日本接受小剂量华法林治疗的NVAF患者中，主要出血和颅内出血的发生率分别为每年每患者2.38%和0.60%，高于西方人。
