Ohmori Hiromitsu, Nakamura Mashio, Kada Akiko, Saito Akiko M, Sanayama Yoshitami, Shinagawa Tomoe, Fujita Hiroshi, Wakisaka Akiko, Maruhashi Keiko, Okumura Akiko, Takizawa Noboru, Murata Hiroaki, Inoue Michiko, Kaneko Hideo, Taniguchi Hidekazu, Kawasaki Masayuki, Sano Nozomi, Akaboshi Shinjiro, Tanuma Naoyuki, Sone Sui, Kumode Masao, Takechi Tomoki, Koretsune Yukihiro, Sumimoto Ryo, Miyanomae Takeshi
Department of Pediatrics, National Hospital Organization Yanai Medical Center.
Clinical Research Center, National Hospital Organization Nagoya Medical Center.
Kurume Med J. 2018 Dec 21;65(1):11-16. doi: 10.2739/kurumemedj.MS651003. Epub 2018 Aug 30.
Sudden death in patients with severe motor and intellectual disabilities (SMID) is sometimes caused in part by pulmonary thromboembolism (PTE), and deep venous thrombosis (DVT) has drawn attention as a possible embolic source. Warfarin, which is a conventional therapeutic agent, is not easy to control appropriately, and daily management can be especially difficult in SMID patients. On the other hand, edoxaban tosilate hydrate, which has been newly approved for insurance coverage for the treatment of DVT, is not listed in the Guidelines for the Diagnosis, Treatment and Prevention of Pulmonary Thromboembolism and Deep Vein Thrombosis (DVT-PTE guidelines). The aim of this study is to evaluate the efficacy and safety of anticoagulation therapy (warfarin vs. edoxaban) in DVT treatment in SMID patients by means of an open-label, randomized controlled trial. The primary endpoint is the incidence of hemorrhagic events during 12 months of follow up.
重度运动和智力残疾（SMID）患者的猝死有时部分由肺血栓栓塞症（PTE）引起，深静脉血栓形成（DVT）作为可能的栓子来源已受到关注。华法林作为一种传统治疗药物，难以适当控制，对于SMID患者而言日常管理尤其困难。另一方面，已新获批用于DVT治疗且纳入医保的托西酸依度沙班未被列入《肺血栓栓塞症和深静脉血栓形成诊断、治疗及预防指南》（DVT-PTE指南）。本研究的目的是通过一项开放标签、随机对照试验评估抗凝治疗（华法林与依度沙班）在SMID患者DVT治疗中的疗效和安全性。主要终点是随访12个月期间出血事件的发生率。
