富马酸伏诺拉生与雷贝拉唑联合黏膜保护剂对内镜黏膜下剥离术后人工溃疡疗效的随机对照研究

Comparison of the efficacy between vonoprazan fumarate and rabeprazole combined with mucosal protectors for artificial ulcers after endoscopic submucosal dissection: a prospective randomized controlled study

摘要:

目的 比较富马酸伏诺拉生与雷贝拉唑治疗内镜黏膜下剥离术（endoscopic submucosal dissection，ESD）后人工溃疡的疗效。方法 纳入2021年12月至2023年8月间在江苏省人民医院接受胃ESD治疗的患者进行前瞻性随机对照研究，将其随机分为两组，分别在ESD术后第4天起服用富马酸伏诺拉生联合瑞巴派特（富马酸伏诺拉生组）或雷贝拉唑联合瑞巴派特（雷贝拉唑组），8周后复查内镜，比较两组手术创面愈合情况。结果 最终纳入91例患者，其中富马酸伏诺拉生组51例，雷贝拉唑组40例。服药8周后，通过内镜观察到富马酸伏诺拉生组受试者的溃疡面积缩小率比雷贝拉唑组显著提高（92.86%±3.80%比90.04%±4.28%，t=3.281，P=0.001），完全愈合率与雷贝拉唑组比较差异无统计学意义［15.69%（8/51）比7.50%（3/40），χ2=1.414，P=0.234］。两组不良事件发生情况差异无统计学意义（P>0.05）。结论 富马酸伏诺拉生在不增加不良事件风险的前提下可以达到更好的溃疡治疗效果。

Abstract:

Objective To compare the efficacy between vonoprazan fumarate and rabeprazole for the treatment of artificial ulcers after endoscopic submucosal dissection (ESD). Methods In this prospective randomized controlled study, patients who underwent ESD between December 2021 and August 2023 at Jiangsu Province Hospital were enrolled and randomly divided into two groups. Vonoprazan fumarate combined with rebamipide (vonoprazan group) or rabeprazole combined with rebamipide (rabeprazole group) were given respectively from the 4th day after ESD. After 8 weeks, the healing of the ulcers was compared. Results Ninety-one patients were enrolled in the study, including 51 in the vonoprazan group and 40 in the rabeprazole group. The ulcer area reduction rate of the vonoprazan group was significantly higher than that of the rabeprazole group (92.86%±3.80% VS 90.04%±4.28%, t=3.281, P=0.001), but there was no significant difference in the healing rate [15.69% (8/51) VS 7.50% (3/40), χ2=1.414, P=0.234] or the adverse event occurrence (P>0.05) between the two groups. Conclusion Vonoprazan fumarate can achieve better ulcer treatment without increasing the risk of adverse events.