经内镜黏膜下剥离术治疗胃肿瘤后预防人工溃疡出血的口服与静脉用兰索拉唑比较：一项前瞻性随机 II 期研究（KDOG 0802）。
Comparison of oral and intravenous lansoprazole for the prevention of bleeding from artificial ulcers after endoscopic submucosal dissection for gastric tumors: a prospective randomized phase II study (KDOG 0802).
机构信息
Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan.
Research and Development Center for New Frontiers, Kitasato University School of Medicine, Sagamihara, Japan.
出版信息
Surg Endosc. 2018 Jun;32(6):2939-2947. doi: 10.1007/s00464-017-6008-9. Epub 2017 Dec 22.
BACKGROUND
Very few studies have evaluated the effectiveness of oral proton-pump inhibitors for the prevention of bleeding after endoscopic submucosal dissection (ESD) for gastric tumors. The aim of our study was to establish the non-inferiority of lansoprazole orally disintegrating (OD) tablets to intravenous lansoprazole for the prevention of bleeding from artificial ulcers after ESD.
PATIENTS AND METHODS
Consecutive patients who underwent ESD for gastric tumors were randomly assigned to receive lansoprazole OD tablets (OD group) or intravenous lansoprazole (IV group). In the OD group, lansoprazole OD tablets (30 mg) were given orally once daily for 8 weeks (56 days), starting on the day before ESD. In the IV group, lansoprazole (30 mg) was given as a continuous intravenous infusion twice daily for 3 days, starting on the day before ESD, and lansoprazole OD tablets (30 mg) were given orally once daily on days 4-56. The primary endpoint was the incidence of bleeding events within 8 weeks after ESD.
RESULTS
Among 310 enrolled patients, 304 patients (152 in the OD group and 152 in the IV group) were included in the analysis. Endoscopic hemostasis was performed in 38 patients (19 in the OD group and 19 in the IV group). The incidence of bleeding events within 8 weeks after ESD did not differ significantly between the groups (p = 0.487). Endoscopic hemostasis was performed at second-look endoscopy in 17 patients (11.2%) in the OD group and 19 patients (12.5%) in the IV group (difference, 1.3 percentage points; 90% confidence interval, - 4.8-7.4%; non-inferiority, p < 0.001).
CONCLUSIONS
The effectiveness of lansoprazole OD tablets for the prevention of bleeding from artificial ulcers after ESD was similar to that of intravenous lansoprazole. Lansoprazole OD tablets are thus considered a treatment option in patients who undergo ESD.
背景
很少有研究评估质子泵抑制剂（PPI）口服制剂在预防内镜黏膜下剥离术（ESD）治疗胃肿瘤后出血的有效性。我们的研究旨在确定口服兰索拉唑分散片（OD 片）与静脉用兰索拉唑预防 ESD 后人工溃疡出血的非劣效性。
患者和方法
连续接受 ESD 治疗胃肿瘤的患者被随机分配接受兰索拉唑 OD 片（OD 组）或静脉用兰索拉唑（IV 组）治疗。在 OD 组中，兰索拉唑 OD 片（30mg）于 ESD 前 1 天开始，每日口服 1 次，共 8 周（56 天）。在 IV 组中，兰索拉唑（30mg）于 ESD 前 1 天开始，每日静脉滴注 2 次，共 3 天，然后于第 4-56 天给予兰索拉唑 OD 片（30mg）口服 1 次。主要终点是 ESD 后 8 周内出血事件的发生率。
结果
在 310 例入组患者中，有 304 例（OD 组 152 例，IV 组 152 例）患者纳入分析。38 例（19 例在 OD 组，19 例在 IV 组）患者进行了内镜止血。ESD 后 8 周内出血事件的发生率在两组间无显著差异（p=0.487）。在 OD 组中，17 例（11.2%）患者在第 2 次内镜检查时进行了内镜止血，而 IV 组中 19 例（12.5%）患者进行了内镜止血（差异，1.3 个百分点；90%置信区间，-4.8 至 7.4%；非劣效性，p<0.001）。
结论
兰索拉唑 OD 片预防 ESD 后人工溃疡出血的疗效与静脉用兰索拉唑相似。因此，兰索拉唑 OD 片被认为是接受 ESD 治疗的患者的一种治疗选择。
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