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首页> 外文期刊>Gastroenterology >Effects of lesogaberan on reflux and lower esophageal sphincter function in patients with gastroesophageal reflux disease.
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Effects of lesogaberan on reflux and lower esophageal sphincter function in patients with gastroesophageal reflux disease.

机译：莱索加贝兰对胃食管反流病患者反流和食管下括约肌功能的影响。

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BACKGROUND & AIMS: Transient lower esophageal sphincter relaxations (TLESRs) are a major mechanism behind reflux. This study assessed the effects of lesogaberan (AZD3355), a novel gamma-aminobutyric acid type B receptor agonist, on reflux and lower esophageal sphincter (LES) function when used as add-on treatment in patients with reflux symptoms despite proton pump inhibitor (PPI) treatment. METHODS: In this randomized, double-blind, placebo-controlled, crossover study, patients received lesogaberan (65 mg) or placebo twice on day 1 (morning/evening) and once on day 2 (morning), in addition to existing PPI treatment. Patients consumed a standardized meal 45-60 minutes after morning doses. Ambulatory impedance-pH monitoring was conducted for 24 hours after the first dose on day 1. Stationary manometry and impedance-pH monitoring was conducted for 4 hours after the third dose on day 2. RESULTS: Of 27 randomized patients, 21 were included in the per-protocol efficacy analysis. During the 24 hours after treatment start, lesogaberan reduced the mean number of reflux events by approximately 35% compared with placebo. During the 3 postprandial hours on day 2, lesogaberan reduced the geometric mean number of TLESRs by 25% and increased geometric mean LES pressure by 28% compared with placebo. The most common adverse events were headache (placebo: 11/27 patients; lesogaberan: 8/25 patients) and paresthesia (transient; placebo: 3/27 patients; lesogaberan: 5/25 patients). CONCLUSIONS: In patients with reflux symptoms despite PPI treatment, lesogaberan decreased the number of TLESRs and reflux episodes, and increased LES pressure compared with placebo. These findings support further evaluation of lesogaberan as an add-on treatment in patients partially responding to PPIs.
机译：背景与目的：短暂性食管下括约肌松弛（TLESRs）是反流背后的主要机制。这项研究评估了新型的γ-氨基丁酸B型受体激动剂lesogaberan（AZD3355）作为质子泵抑制剂（PPI）的反流症状患者的补充治疗时对反流和食管下括约肌（LES）功能的影响）治疗。方法：在这项随机，双盲，安慰剂对照的交叉研究中，除现有的PPI治疗外，患者在第1天（早晨/晚上）两次接受lesogaberan（65 mg）或安慰剂，第二天（早晨）接受一次安慰剂。 。早晨服药后45-60分钟，患者食用标准餐。在第1天的第1剂后24小时进行动态阻抗pH监测。在第2天的第3剂后4个小时进行静压和阻抗pH值监测。结果：在27例随机分组的患者中，有21例被纳入研究范围。协议疗效分析。在治疗开始后的24小时内，与安慰剂相比，莱索加贝兰使平均反流事件减少了约35％。与安慰剂相比，在第2天的餐后3小时内，莱索加贝兰使TLESR的几何平均数减少了25％，使LES平均几何压力增加了28％。最常见的不良事件是头痛（安慰剂：11/27例;莱索加仑：8/25例）和感觉异常（短暂性;安慰剂：3/27例;莱索加伯兰：5/25例）。结论：尽管采用PPI治疗，但仍存在反流症状的患者，与安慰剂相比，莱索加贝兰减少TLESR和反流发作的次数，并增加LES压力。这些发现支持对部分对PPI有反应的患者，将lesogaberan作为附加治疗进行进一步评估。

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