This study enrolled patients who had peptic ulcer bleeding between March 2022 and February 2023. After undergoing standard endoscopic therapy, the patients were randomly assigned to either the TXA group or the standard group. In the TXA group, an additional 1.25 g of TXA powder was sprayed endoscopically on the ulcer. Both groups then received 3 days of high-dose (8 mg/h) continuous infusion proton pump inhibitor therapy. Second-look endoscopy was conducted on days 3 to 4. The primary end point of early treatment failure was defined as ulcer recurrent bleeding within 4 days or major stigmata of recent hemorrhage on the second-look endoscopy.
Sixty patients (30 in each group) with peptic ulcer bleeding and balanced baseline characteristics were randomly assigned to a treatment group. The early treatment failure rate was lower in the TXA group (6.7%) than in the standard group (30%) (P = .042). The freedom from treatment failure periods for 4 and 28 days was significantly longer in the TXA group than in the standard group (P = .023). No adverse events from TXA were recorded.
The precise delivery of topical TXA alongside standard endoscopic hemostasis reduced the early treatment failure rate in patients with bleeding peptic ulcers. (Clinical trial registration number: NCT05248321.).
方法:本研究纳入了2022年3月至2023年2月之间发生消化性溃疡出血的患者。在接受标准内镜治疗后,患者被随机分为TXA组和标准组.在TXA组中,将另外1.25g的TXA粉末通过内窥镜喷涂在溃疡上。两组均接受3天大剂量(8mg/h)持续输注质子泵抑制剂治疗。在第3至4天进行第二次内窥镜检查。早期治疗失败的主要终点定义为4天内溃疡复发性出血或第二次内窥镜检查中近期出血的大柱头。
结果:60例消化性溃疡出血且基线特征平衡的患者(每组30例)被随机分配到治疗组。TXA组的早期治疗失败率(6.7%)低于标准组(30%)(P=0.042)。TXA组4天和28天的无治疗失败期明显长于标准组(P=0.023)。没有记录到来自TXA的不良事件。
结论:局部TXA与标准内镜止血的精确递送降低了消化性溃疡出血患者的早期治疗失败率。(临床试验登记号:NCT05248321。).