Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Department of Medicine, MetroHealth Medical Center, Case Western Reserve University, Cleveland, USA.
Dig Dis Sci. 2024 Oct;69(10):3863-3874. doi: 10.1007/s10620-024-08593-5. Epub 2024 Sep 18.
Although Vonoprazan, a potassium-competitive acid blocker, is superior to proton pump inhibitors (PPIs) in treating Helicobacter pylori and erosive esophagitis, its efficacy for treating gastric and/or duodenal ulcers remains controversial. This meta-analysis summarizes the efficacy and safety of Vonoprazan vs. PPI for treating and preventing gastric and/or duodenal ulcers.
Only randomized controlled trials randomizing gastric and/or duodenal ulcer patients, regardless of etiology, into Vonoprazan or any PPI and indexed in Embase, Medline, and CENTRAL until March 2, 2024 were searched. Primary outcomes were ulcer healing rates at Weeks 2, 4, 6, and 8 and recurrence rates at Week 24. Other outcomes included shrinkage rates, any adverse events (AEs), serious AEs (SAEs), and risks of delayed bleeding and perforation. The overall risk ratio (RR) and mean difference were pooled using the random-effects model. The risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB2) Tool.
Fifteen studies comprising 43 reports were included in the analysis. Healing rates of gastric and/or duodenal ulcers were similar in both Vonoprazan and PPI groups at all weeks (Week 2 RR 1.02 [95% CI 0.89-1.16]; Week 4 0.99 [95% CI 0.95-1.04]; Week 6 1.00 [95% CI 0.96-1.03]; Week 8 0.99 [95% CI 0.95-1.03]). The recurrence prevention of peptic ulcers was not different in Vonoprazan 10 mg (RR 0.48; 95% CI 0.18-1.27) or 20 mg (0.60; 95% CI 0.28-1.30) to PPI. Shrinkage rates, any AEs, SAEs, and risks of delayed bleeding and perforation were similar in both groups.
Vonoprazan is not significantly better than PPI in treating and preventing gastric and/or duodenal ulcers.
尽管钾竞争性酸阻滞剂 Vonoprazan 在治疗幽门螺杆菌和糜烂性食管炎方面优于质子泵抑制剂（PPIs），但其治疗胃和/或十二指肠溃疡的疗效仍存在争议。本荟萃分析总结了 Vonoprazan 与 PPI 治疗和预防胃和/或十二指肠溃疡的疗效和安全性。
仅检索 Embase、Medline 和 CENTRAL 中截至 2024 年 3 月 2 日索引的、将胃和/或十二指肠溃疡患者随机分配至 Vonoprazan 或任何 PPI 的随机对照试验，无论病因如何。主要结局为第 2、4、6 和 8 周时的溃疡愈合率和第 24 周时的复发率。其他结局包括缩小率、任何不良事件（AE）、严重不良事件（SAE）以及延迟出血和穿孔的风险。使用随机效应模型汇总总风险比（RR）和均数差。使用 Cochrane 风险偏倚评估工具 2（RoB2）评估风险偏倚。
纳入的 15 项研究包含 43 份报告。在所有周，胃和/或十二指肠溃疡的愈合率在 Vonoprazan 和 PPI 组之间相似（第 2 周 RR 1.02 [95% CI 0.89-1.16]；第 4 周 0.99 [95% CI 0.95-1.04]；第 6 周 1.00 [95% CI 0.96-1.03]；第 8 周 0.99 [95% CI 0.95-1.03]）。Vonoprazan 10 mg（RR 0.48；95% CI 0.18-1.27）或 20 mg（0.60；95% CI 0.28-1.30）与 PPI 相比，预防消化性溃疡复发的效果无差异。两组的缩小率、任何 AE、SAE 以及延迟出血和穿孔的风险均相似。
Vonoprazan 在治疗和预防胃和/或十二指肠溃疡方面并不明显优于 PPI。
