Ohmori Hiromitsu, Kada Akiko, Nakamura Mashio, Saito Akiko M, Sanayama Yoshitami, Shinagawa Tomoe, Fujita Hiroshi, Wakisaka Akiko, Maruhashi Keiko, Mizukami Akiko, Takizawa Noboru, Murata Hiroaki, Inoue Michiko, Kaneko Hideo, Taniguchi Hidekazu, Sano Nozomi, Tanuma Naoyuki, Kumode Masao, Takechi Tomoki, Koretsune Yukihiro, Sumimoto Ryo, Miyanomae Takeshi
Department of Pediatrics, National Hospital Organization Yanai Medical Center, Yanai, Yamaguchi, Japan.
Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan.
Ann Vasc Dis. 2019 Sep 25;12(3):372-378. doi: 10.3400/avd.oa.19-00040.
: Patients with severe motor and intellectual disabilities (SMID) often develop complications, including paralysis of the extremities due to abnormal muscular tonicity. Furthermore, the incidence of sudden death, which may be caused by pulmonary thromboembolism (PTE), is approximately 4.2%. Deep vein thrombosis (DVT) is attracting attention as an embolic source. In this study, DVT was confirmed in SMID patients by lower extremity venous ultrasound. The oral anticoagulant, warfarin, and novel oral anticoagulant, edoxaban tosilate hydrate, were administered, and their efficacies and safeties were evaluated. : DVT patients were randomly allocated to warfarin and edoxaban groups. The frequency of hemorrhagic events and incidence of adverse events were investigated to evaluate efficacy and safety. : DVT was detected in 14 (8.4%) out of 167 patients. Four (0.067/person-month) hemorrhagic events occurred in the warfarin group from subcutaneous hemorrhage due to bruises caused by postural changes. Three (0.042/person-month) events occurred in the edoxaban group due to nasal hemorrhage caused by tracheal aspiration. There was no significant difference (p=0.5383) between groups. : No significant differences were observed in hemorrhagic events between SMID patients with DVT treated with warfarin and edoxaban.
重度运动和智力残疾(SMID)患者常出现并发症,包括因异常肌张力导致的肢体麻痹。此外,可能由肺血栓栓塞(PTE)引起的猝死发生率约为4.2%。深静脉血栓形成(DVT)作为栓子来源正受到关注。在本研究中,通过下肢静脉超声在SMID患者中确诊了DVT。给予口服抗凝剂华法林和新型口服抗凝剂甲苯磺酸依度沙班水合物,并评估它们的疗效和安全性。
DVT患者被随机分配到华法林组和依度沙班组。调查出血事件的发生频率和不良事件的发生率以评估疗效和安全性。
167例患者中有14例(8.4%)检测到DVT。华法林组因体位改变引起的瘀伤导致皮下出血发生了4例(0.067/人月)出血事件。依度沙班组因气管抽吸导致鼻出血发生了3例(0.042/人月)事件。两组之间无显著差异(p = 0.5383)。
使用华法林和依度沙班治疗的DVT的SMID患者在出血事件方面未观察到显著差异。