PDF(Pubmed)
Abstract：
Background: Lansoprazole, a proton-pump inhibitor (PPI), is the primary therapy for peptic ulcers (PU). Potassium competitive acid blockers (P-CAB) offer an alternative for acid suppression. However, the efficacy and safety of P-CABs versus lansoprazole in the management of PU has not been evaluated. Methods: Five databases were searched for randomized clinical trials in English until 31 August 2023. Data extraction provided outcome counts for ulcer healing, recurrent NSAID-related ulcer, and adverse events. The pooled effect, presented as rate difference (RD), was stratified by ulcer location, follow-up time, and the types of P-CAB, along with their corresponding 95% confidence intervals (95% CI). Results: The pooled healing rates of peptic ulcers were 95.3% (1,100/1,154) and 95.0% (945/995) for P-CABs and lansoprazole, respectively (RD: 0.4%, 95% CI: -1.4%-2.3%). The lower bounds of the 95% CI fell within the predefined non-inferiority margin of -6%. In subgroup analyses base on ulcer location, and follow-up time also demonstrated non-inferiority. The drug-related treatment-emergent adverse events (TEAEs) did not differ significantly among groups (RR: 0.997, 95% CI: 0.949-1.046, p = 0.893). However, P-CAB treatment was associated with an increased risk of the serious adverse events compared to lansoprazole (RR: 1.325, 95% CI: 1.005-1.747, p = 0.046). Conclusion: P-CABs demonstrated non-inferiority to lansoprazole in the management of peptic ulcer. The safety and tolerability profile are comparable, with similar TEAEs rates. However, P-CABs appear to have a higher risk of serious adverse events. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=458361 Identifier: PROSPERO (No. CRD42023458361).
摘要：
背景：兰索拉唑，质子泵抑制剂（PPI），是消化性溃疡（PU）的主要治疗方法。钾竞争性酸阻滞剂（P-CAB）为抑酸提供了替代方案。然而,尚未评估P-CABs与兰索拉唑在PU治疗中的疗效和安全性.方法：在2023年8月31日之前，在五个数据库中搜索英语的随机临床试验。数据提取提供了溃疡愈合的结果计数，复发性NSAID相关溃疡，和不良事件。集合效应，表示为比率差(RD)，根据溃疡位置分层，随访时间,以及P-CAB的类型,以及它们相应的95%置信区间(95%CI)。结果：P-CAB和兰索拉唑的消化性溃疡的合并治愈率分别为95.3％（1,100/1,154）和95.0％（945/995）。分别(RD：0.4%，95%CI：-1.4%-2.3%）。95%CI的下限落在-6%的预定非劣效性范围内。在基于溃疡位置的亚组分析中，随访时间也证明了非劣效性。与药物相关的治疗引起的不良事件（TEAE）在组间没有显着差异（RR：0.997，95％CI：0.949-1.046，p=0.893）。然而,与兰索拉唑相比，P-CAB治疗与严重不良事件风险增加相关(RR:1.325,95%CI:1.005-1.747,p=0.046)。结论：P-CAB在消化性溃疡的治疗中显示出与兰索拉唑相比的非劣效性。安全性和耐受性是可比的，具有相似的TEAE率。然而,P-CAB出现严重不良事件的风险较高。系统审查注册：https://www。crd.约克。AC.uk/PROSPERO/display_record。php?RecordID=458361标识符：PROSPERO(No.CRD42023458361)。
