Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.
Am J Gastroenterol. 2020 Apr;115(4):548-554. doi: 10.14309/ajg.0000000000000584.
The optimal duration of fasting after endoscopic hemostasis in patients with peptic ulcer bleeding has not yet been determined. We investigated the appropriate timing of feeding after endoscopic hemostasis in patients with high-risk peptic ulcer bleeding.
This study was a randomized, single center, noninferiority trial. Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding were randomized to resume feeding either 24 or 48 hours after successful endoscopic hemostasis. A total of 209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis. The primary outcome measure was recurrent bleeding within 7 days of hemostasis. Noninferiority testing was performed in the PP population, and the noninferiority margin was set at 10%. Secondary outcomes included 30-day rebleeding and mortality, transfusion requirements, and length of hospital stay.
Recurrent bleeding rates at 7 days were 7.9% in the 24-hour group and 4.0% in the 48-hour group in the PP analysis; tests for noninferiority did not reach statistical significance (difference: 3.9%, 95% confidence interval [CI]: -2.7 to 10.5, P value for noninferiority = 0.034). The recurrent bleeding rates within 30 days were 10.9% and 4.0% in the 24- and 48-hour groups (difference: 6.9%, 95% CI: -0.5 to 14.2), and the 30-day mortality rates were 5.9% and 14.1%, respectively (difference: -8.2%, 95% CI: -16.5 to 0.1) in the PP analysis. The transfusion requirement and the length of hospital stay were similar between the 2 groups.
Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding. Our results do not allow a recommendation of refeeding at 24 hours, rather than later refeeding in this population.
内镜止血后禁食的最佳时间尚未确定。我们研究了高危消化性溃疡出血内镜止血后喂养的适宜时机。
这是一项随机、单中心、非劣效性试验。2014 年 2 月至 2019 年 3 月，连续纳入消化性溃疡出血患者，随机分为内镜止血后 24 小时或 48 小时恢复喂养。共有 209 例符合条件的患者纳入意向治疗分析，200 例纳入符合方案（PP）分析。主要结局指标为止血后 7 天内再出血。在 PP 人群中进行非劣效性检验，非劣效性边界设定为 10%。次要结局包括 30 天再出血和死亡率、输血需求和住院时间。
PP 分析中，24 小时组和 48 小时组 7 天内再出血率分别为 7.9%和 4.0%；非劣效性检验未达到统计学意义（差异：3.9%，95%置信区间：-2.7 至 10.5，非劣效性检验 P 值=0.034）。24 小时组和 48 小时组 30 天内再出血率分别为 10.9%和 4.0%（差异：6.9%，95%置信区间：-0.5 至 14.2），30 天死亡率分别为 5.9%和 14.1%（差异：-8.2%，95%置信区间：-16.5 至 0.1）。两组输血需求和住院时间相似。
高危消化性溃疡出血患者内镜止血后 24 小时早期喂养并不优于 48 小时后再喂养，再出血率无差异。我们的研究结果不支持在该人群中推荐 24 小时内喂养，而不是更晚再喂养。
