Seo Seungyeon, Jung Hye-Kyung, Gyawali C Prakash, Lee Hye Ah, Lim Hyung Seok, Jeong Eui Sun, Kim Seong Eun, Moon Chang Mo
Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, Korea.
Division of Gastroenterology, Washington University School of Medicine, St. Louis, MO, USA.
J Neurogastroenterol Motil. 2024 Jul 30;30(3):259-271. doi: 10.5056/jnm24024.
BACKGROUND/AIMS: Gastroesophageal reflux disease (GERD) is typically managed based on the clinical phenotype. We evaluated the efficacy and safety of potassium-competitive acid blockers (PCABs) in patients with various clinical GERD phenotypes.
Core databases were searched for studies comparing PCABs and proton pump inhibitors (PPIs) in clinical GERD phenotypes of erosive reflux disease (ERD), non-erosive reflux disease (NERD), PPI-resistant GERD and night-time heartburn. Additional analysis was performed based on disease severity and drug dosage, and pooled efficacy was calculated.
In 9 randomized controlled trials (RCTs) evaluating the initial treatment of ERD, the risk ratio for healing with PCABs versus PPIs was 1.09 (95% CI, 1.04-1.13) at 2 weeks and 1.03 (95% CI, 1.00-1.07) at 8 weeks, respectively. PCABs exhibited a significant increase in both initial and sustained healing of ERD compared to PPIs in RCTs, driven particularly in severe ERD (Los Angeles grade C/D). In 3 NERD RCTs, PCAB was superior to placebo in proportion of days without heartburn. Observational studies on PPI-resistant symptomatic GERD reported symptom frequency improvement in 86.3% of patients, while 90.7% showed improvement in PPIresistant ERD across 5 observational studies. Two RCTs for night-time heartburn had different endpoints, limiting meta-analysis. Pronounced hypergastrinemia was observed in patients treated with PCABs.
Compared to PPIs, PCABs have superior efficacy and faster therapeutic effect in the initial and maintenance therapy of ERD, particularly severe ERD. While PCABs may be an alternative treatment option in NERD and PPI-resistant GERD, findings were inconclusive in patients with night-time heartburn.
背景/目的：胃食管反流病（GERD）通常根据临床表型进行治疗。我们评估了钾离子竞争性酸阻滞剂（PCABs）在各种临床GERD表型患者中的疗效和安全性。
检索核心数据库，查找比较PCABs与质子泵抑制剂（PPIs）在糜烂性反流病（ERD）、非糜烂性反流病（NERD）、PPI难治性GERD和夜间烧心等临床GERD表型中的研究。基于疾病严重程度和药物剂量进行额外分析，并计算汇总疗效。
在9项评估ERD初始治疗的随机对照试验（RCTs）中，PCABs与PPIs相比，2周时愈合的风险比为1.09（95%CI，1.04 - 1.13），8周时为1.03（95%CI，1.00 - 1.07）。在RCTs中，与PPIs相比，PCABs在ERD的初始和持续愈合方面均有显著增加，尤其是在严重ERD（洛杉矶分级C/D）中。在3项NERD的RCTs中，PCAB在无烧心天数比例方面优于安慰剂。关于PPI难治性症状性GERD的观察性研究报告，86.3%的患者症状频率改善，而在5项观察性研究中，90.7%的PPI难治性ERD患者症状改善。两项针对夜间烧心的RCTs终点不同，限制了荟萃分析。接受PCABs治疗的患者出现明显的高胃泌素血症。
与PPIs相比，PCABs在ERD，尤其是严重ERD的初始和维持治疗中具有更好的疗效和更快的治疗效果。虽然PCABs可能是NERD和PPI难治性GERD的替代治疗选择，但在夜间烧心患者中的研究结果尚无定论。
