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随机临床试验:Vonoprazan 与兰索拉唑治疗糜烂性食管炎患者烧心的初始缓解。

Randomised clinical trial: vonoprazan versus lansoprazole for the initial relief of heartburn in patients with erosive oesophagitis.

机构信息

Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.

Department of Internal Medicine, Nishinomiya Kyoritsu Neurosurgical Hospital, Nishinomiya, Hyogo, Japan.

出版信息

Aliment Pharmacol Ther. 2019 Jan;49(2):140-146. doi: 10.1111/apt.15062.

Abstract

BACKGROUND

Proton pump inhibitors (PPIs) are widely used to treat gastro-oesophageal reflux disease (GORD). However, the onset of action is considered slow and PPIs cannot completely block acid secretion at night. A new potassium-competitive acid blocker (P-CAB) can rapidly block acid secretion. However, whether this P-CAB can relieve GORD symptoms quickly and adequately soon after starting treatment is unknown.

AIM

To determine how rapidly vonoprazan and lansoprazole provide heartburn relief.

METHODS

Patients (n = 32) with endoscopically confirmed erosive oesophagitis who experienced heartburn at least once a week were randomised in a double-blind manner to receive either daily vonoprazan (20 mg) or lansoprazole (30 mg) before breakfast for 14 days. Day time and night time heartburn were assessed daily throughout the study using a five-point Likert scale. The primary endpoint was the first day of complete day and night heartburn relief for at least seven consecutive days. The ethics committees of the participating institutions approved the study protocol.

RESULTS

Heartburn was relieved sooner with vonoprazan than with lansoprazole (P < 0.05, log-rank test). Heartburn was completely relieved in 31.3% and 12.5% of patients on day 1 with vonoprazan and lansoprazole, respectively. Significantly more patients achieved complete nocturnal heartburn relief with vonoprazan than lansoprazole (P < 0.01). Both regimens were well tolerated.

CONCLUSIONS

Complete sustained heartburn relief was achieved sooner with vonoprazan than with lansoprazole during the first week of therapy. (UMIN000018776).

摘要

背景

质子泵抑制剂(PPIs)被广泛用于治疗胃食管反流病(GORD)。然而,其作用起效较慢,并且 PPIs 不能在夜间完全抑制胃酸分泌。一种新的钾竞争性酸阻滞剂(P-CAB)可以快速抑制胃酸分泌。然而,这种 P-CAB 在开始治疗后是否能迅速且充分地缓解 GORD 症状尚不清楚。

目的

确定 vonoprazan 和兰索拉唑缓解烧心症状的速度。

方法

将 32 例经内镜证实的糜烂性食管炎患者随机分为两组,每组 16 例,均接受每日早餐前服用 vonoprazan(20mg)或兰索拉唑(30mg),连续 14 天。在整个研究过程中,使用 5 分制 Likert 量表每天评估白天和夜间的烧心情况。主要终点是第 1 天至少连续 7 天完全缓解白天和夜间烧心的时间。参与机构的伦理委员会批准了该研究方案。

结果

与兰索拉唑相比,vonoprazan 能更快缓解烧心(P<0.05,log-rank 检验)。服用 vonoprazan 和兰索拉唑的患者中,分别有 31.3%和 12.5%在第 1 天完全缓解烧心,差异具有统计学意义(P<0.05)。与兰索拉唑相比,服用 vonoprazan 的患者能更快达到完全夜间烧心缓解(P<0.01)。两种方案均耐受良好。

结论

在治疗的第 1 周内,vonoprazan 比兰索拉唑更快地实现持续完全缓解烧心症状。(UMIN000018776)。

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