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新型钾离子竞争性酸阻滞剂 Vonoprazan 治疗质子泵抑制剂难治性酸反流的疗效。

Efficacy of Vonoprazan, a Novel Potassium-Competitive Acid Blocker, in Patients with Proton Pump Inhibitor-Refractory Acid Reflux.

机构信息

Division of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Tokyo, Japan,

Department of Medicine and Molecular Science, Gunma University, Maebashi, Japan,

出版信息

Digestion. 2020;101(2):174-183. doi: 10.1159/000497775. Epub 2019 Mar 21.

Abstract

BACKGROUND/AIM: We evaluated the efficacy of vonoprazan (VPZ), a novel potassium-competitive acid blocker, in patients with proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD), exhibiting continued pathological esophageal acid exposure (EAE).

METHODS

Despite ≥8 weeks of appropriate PPI therapy, patients with -persistent reflux symptoms and pathological EAE times (EAETs ≥4%) were invited to switch to VPZ treatment. After an 8-week-course of once-daily VPZ (20 mg), multichannel intraluminal impedance-pH (MII-pH) monitoring was repeated to compare gastric acid exposure times (GAETs), EAETs, and other reflux parameters relative to the baseline values. Before each MII-pH study, reflux symptom severities were scored using the Gastrointestinal Symptom Rating Scale; erosive esophagitis and fasting plasma gastrin levels were also assessed.

RESULTS

From among the 124 patients undergoing MII-pH monitoring, 13 patients (median age, 69 years; females, 64%) were monitored at baseline (while on PPI therapy) and after VPZ therapy. The median GAET associated with VPZ treatment (23.8%) was less than that for PPI treatment (41.1%; p = 0.01), including both daytime and nighttime measurements. VPZ therapy resulted in better median EAET values (4.5%) than did PPI therapy (10.6%) during the 24-h monitoring period (p = 0.055). EAE normalization was achieved in 46% of VPZ-treated patients and was associated with complete gastric acid suppression (p = 0.005). After switching to VPZ, reflux symptoms (p < 0.01) and erosive esophagitis (p = 0.01) improved.

CONCLUSION

In patients with PPI-refractory GERD, VPZ provides more potent gastric acid suppression, more effective EAE control, enhanced symptom improvement, and better esophagitis healing than PPIs.

摘要

背景/目的:我们评估了新型钾竞争性酸阻滞剂沃诺拉赞(VPZ)在质子泵抑制剂(PPI)难治性胃食管反流病(GERD)患者中的疗效,这些患者表现为持续的病理性食管酸暴露(EAE)。

方法

尽管接受了≥8 周的适当 PPI 治疗,但仍有持续性反流症状和病理性 EAE 时间(EAETs≥4%)的患者被邀请转为 VPZ 治疗。在接受为期 8 周的每日一次 VPZ(20mg)治疗后,重复进行多通道腔内阻抗-pH(MII-pH)监测,以比较胃酸暴露时间(GAETs)、EAETs 和其他反流参数与基线值的关系。在每次 MII-pH 研究之前,使用胃肠道症状评分量表(Gastrointestinal Symptom Rating Scale)评估反流症状严重程度;还评估了糜烂性食管炎和空腹血浆胃泌素水平。

结果

在接受 MII-pH 监测的 124 例患者中,有 13 例(中位年龄 69 岁;女性 64%)在基线时(接受 PPI 治疗时)和 VPZ 治疗后进行了监测。VPZ 治疗时的中位 GAET(23.8%)低于 PPI 治疗时的 GAET(41.1%;p=0.01),包括日间和夜间测量。在 24 小时监测期间,VPZ 治疗的中位 EAET 值(4.5%)优于 PPI 治疗(10.6%)(p=0.055)。VPZ 治疗组有 46%的患者 EAE 正常化,与完全抑制胃酸有关(p=0.005)。转换为 VPZ 后,反流症状(p<0.01)和糜烂性食管炎(p=0.01)得到改善。

结论

在 PPI 难治性 GERD 患者中,VPZ 提供了比 PPI 更强的胃酸抑制作用、更有效的 EAE 控制、更显著的症状改善和更好的食管炎愈合效果。

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