Yamaoka Minoru, Imaeda Hiroyuki, Hosoe Naoki, Yoneno Kazuaki, Kanno Ryu, Mitsufuji Takashi, Sasaki Takahiro, Akiyama Yuji, Ohgo Hideki, Morohoshi Yuichi, Kanai Takanori, Yamamoto Toshimasa, Mimura Toshihide, Ogata Haruhiko, Araki Nobuo, Yamamoto Keiji, Nakamoto Hidetomo
Department of General Internal Medicine, Saitama Medical University, Japan.
Department of Gastroenterology, Saitama Medical University, Japan.
Gastroenterol Res Pract. 2020 Aug 11;2020:7125642. doi: 10.1155/2020/7125642. eCollection 2020.
This study was a prospective, open-label, nonblinded, multicenter, and observational study. From September 2013 to March 2017, patients taking DOACs were enrolled. Patients underwent VCE. The type and location of small-bowel lesions were registered. Also, (1) the proportion of lesions detected between types of DOAC was evaluated and (2) the hemoglobin (Hb) and serum ferritin levels were compared between patients with and without small-bowel lesions.
33 patients were enrolled, but 4 patients withdrew their consent, and VCE was performed on 29 patients. Eight, 13, and 8 patients received dabigatran, rivaroxaban, and apixaban, respectively. Small-bowel transit was complete in 27 of 29 patients (93.1%). Small-bowel lesions were detected in 23 (79.3%), redness in 12 (41.4%), erosions in 14 (48.3%), and angioectasia in 3 (10.3%) patients, and 6 patients (20.7%) had no abnormalities. Redness and erosions were detected in the upper, middle, or lower portions, but erosions tended to be less frequent in the middle portion ( = 0.25, 0.06). Angioectasia was not detected in the lower portion. No patients had active bleeding. The findings did not differ according to the drug. The relationships between the endoscopic findings and the Hb and serum ferritin levels were not significant.
Many patients taking DOACs had small-bowel lesions; however, most lesions were relatively mild. Observing small-bowel lesions over longer periods may be necessary in patients taking DOACs. This trial is registered with UMIN000011527.
本研究为前瞻性、开放标签、非盲法、多中心观察性研究。2013年9月至2017年3月,纳入服用直接口服抗凝剂(DOACs)的患者。患者接受了小肠胶囊内镜检查(VCE)。记录小肠病变的类型和位置。此外,(1)评估不同类型DOAC之间检测到的病变比例,(2)比较有和没有小肠病变的患者之间的血红蛋白(Hb)和血清铁蛋白水平。
共纳入33例患者,但4例患者撤回同意,29例患者接受了VCE。分别有8例、13例和8例患者接受了达比加群、利伐沙班和阿哌沙班治疗。29例患者中有27例(93.1%)小肠通过完整。23例(79.3%)患者检测到小肠病变,12例(41.4%)患者有发红,14例(48.3%)患者有糜烂,3例(10.3%)患者有血管扩张,6例(20.7%)患者无异常。上、中、下部分均检测到发红和糜烂,但糜烂在中部的发生率往往较低(=0.25,0.06)。下部未检测到血管扩张。无患者出现活动性出血。研究结果在不同药物之间无差异。内镜检查结果与Hb和血清铁蛋白水平之间的关系不显著。
许多服用DOACs的患者有小肠病变;然而,大多数病变相对较轻。对于服用DOACs的患者,可能需要更长时间观察小肠病变。本试验已在UMIN000011527注册。