Lashen Sameh A, Shamseya Mohammed M, Shamseya Ayman M, Hablass Fahmy H
Department of Internal Medicine (Hepatology & Gastroenterology Division), Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Department of Clinical and Experimental Internal Medicine, Medical Research Institute, Alexandria University, Alexandria, Egypt.
J Clin Exp Hepatol. 2023 Nov-Dec;13(6):962-971. doi: 10.1016/j.jceh.2023.05.008. Epub 2023 May 19.
Up-to-date data about the role of acid suppression therapy e.g. proton-pump inhibitors; to reduce post-endoscopic variceal ligation (EVL) ulcer-bleeding are conflicting. Vonoprazan; a recently introduced potassium-competitor acid blocker, has not been studied to prevent post-EVL ulcer/bleeding. The aim was to evaluate the efficacy of vonoprazan vs. pantoprazole or non-acid suppression to prevent post-EVL ulcer/bleeding in portal hypertension patients.
We enrolled 275 portal hypertension patients undergoing EVL in a three-arm randomized, single-blind, controlled study. A clinico-laboratory baseline evaluation was performed. Following EVL, patients were randomly and equally assigned to receive vonoprazan 20mg once daily, pantoprazole 40 mg once daily, or no acid suppression therapy. Post-EVL ulcer bleeding, ulcer dimensions, odynophagia as well as vonoprazan safety were evaluated after 2 weeks of EVL.
Post-EVL ulcer bleeding occurred among 2.15% of vonoprazan, 8.7% of pantoprazole, and 14.2% of the non-acid suppression groups ( < 0.001). Post-ligation ulcer frequency and dimensions were higher among non-acid suppression and pantoprazole groups vs. vonoprazan ( < 0.05). Chest pain and odynophagia were encountered among 73.6% and 54.9% of the non-acid suppression group vs. 39.6% and 45.1% in pantoprazole, and 17.2% and 21.5% in vonoprazan groups, respectively ( < 0.05). There were no vonoprazan-related adverse events. Non-use of vonoprazan was the strongest independent predictor for post-EVL bleeding.
Short course of vonoprazan 20 mg/day is safe and superior to pantoprazole 40 mg/day in the reduction of post-EVL ulcer dimensions at 2 weeks post-EVL, and prevention of ulcer-related bleeding. Acid suppression is superior to no acid suppression to prevent post-EVL complications.
关于抑酸治疗（如质子泵抑制剂）在减少内镜下静脉曲张结扎术（EVL）后溃疡出血方面的最新数据存在矛盾。沃克奥美拉唑（Vonoprazan）是一种最近引入的钾竞争性酸阻滞剂，尚未被研究用于预防EVL后溃疡/出血。目的是评估沃克奥美拉唑与泮托拉唑或不进行抑酸治疗相比，在预防门静脉高压患者EVL后溃疡/出血方面的疗效。
我们纳入了275例接受EVL的门静脉高压患者，进行一项三臂随机、单盲、对照研究。进行了临床实验室基线评估。EVL后，患者被随机且等分为三组，分别接受每日一次20mg沃克奥美拉唑、每日一次40mg泮托拉唑或不进行抑酸治疗。在EVL 2周后评估EVL后溃疡出血、溃疡大小、吞咽痛以及沃克奥美拉唑的安全性。
沃克奥美拉唑组、泮托拉唑组和非抑酸治疗组的EVL后溃疡出血发生率分别为2.15%、8.7%和14.2%（P<0.001）。与沃克奥美拉唑组相比，非抑酸治疗组和泮托拉唑组的结扎后溃疡发生率和大小更高（P<0.05）。非抑酸治疗组分别有73.6%和54.9%的患者出现胸痛和吞咽痛，泮托拉唑组分别为39.6%和45.1%，沃克奥美拉唑组分别为17.2%和21.5%（P<0.05）。未发生与沃克奥美拉唑相关的不良事件。未使用沃克奥美拉唑是EVL后出血的最强独立预测因素。
在EVL后2周，每日20mg的沃克奥美拉唑短疗程治疗在减少EVL后溃疡大小及预防溃疡相关出血方面安全且优于每日40mg的泮托拉唑。抑酸治疗在预防EVL后并发症方面优于不进行抑酸治疗。
