Cho Yu Kyung, Choi Myung-Gyu, Park Hyojin, Kim Ji Won, Lee Dong Ho, Ko Kwang Hyun, Kim Sang Gyun, Jung Hwoon-Yong, Hong Su Jin, Lee Yong Chan, Lee Si Hyung
Department of Internal Medicine, The Catholic University of Korea, College of Medicine, Seoul, Korea.
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
J Neurogastroenterol Motil. 2021 Apr 30;27(2):223-230. doi: 10.5056/jnm19053.
BACKGROUND/AIMS: S-isomer (S) pantoprazole is more bioavailable and less dependent on cytochrome 2C19 than is racemic pantoprazole. We aim to evaluate the efficacy and safety of 10 mg S-pantoprazole for treatment of non-erosive reflux disease (NERD).
In this phase 3, double-blind, randomized placebo controlled, multicenter study, 174 NERD patients were randomized to one of both treatment groups: 10 mg S-pantoprazole, or placebo once daily for 4 weeks. Symptoms and safety were assessed. The efficacy endpoints were complete relief of symptoms, > 50% improvement of all reflux symptoms and recurrence.
Eighty-eight patients were assigned to the S-pantoprazole group (25 males, mean 43.7 years old) and 86 to the placebo group (32 males, mean 43.0 years old), and 163 patients were subjected to full Analysis Set. A higher proportion of patients in the S-pantoprazole group had complete symptom relief (42.0 % [34/81] vs 17.1% [14/82], < 0.001) and > 50% symptom responses (66.0% vs 50.0%, = 0.010 for heartburn; 64.2% vs 28.0%, = 0.010 for acid regurgitation; and 51.9% vs 30.5%, = 0.03 for epigastric discomfort) compared to the placebo group. The factors associated with poor responsiveness to PPI were older age, female, greater body mass index, and severe baseline symptoms.
Low dose of S-pantoprazole (10 mg) for 4 weeks was more efficacious than placebo in providing reflux symptom relief in patients with NERD, especially acid regurgitation. More doses or longer periods of treatment with S-pantoprazole would be needed to completely eliminate symptoms.
背景/目的：S-异构体（S）泮托拉唑比消旋泮托拉唑具有更高的生物利用度，且对细胞色素2C19的依赖性更低。我们旨在评估10毫克S-泮托拉唑治疗非糜烂性反流病（NERD）的疗效和安全性。
在这项3期、双盲、随机、安慰剂对照、多中心研究中，174例NERD患者被随机分为两个治疗组之一：10毫克S-泮托拉唑组或安慰剂组，每日一次，共4周。评估症状和安全性。疗效终点为症状完全缓解、所有反流症状改善>50%以及复发情况。
88例患者被分配至S-泮托拉唑组（25例男性，平均年龄43.7岁），86例患者被分配至安慰剂组（32例男性，平均年龄43.0岁），163例患者纳入全分析集。与安慰剂组相比，S-泮托拉唑组有更高比例的患者症状完全缓解（42.0%[34/81]对17.1%[14/82]，<0.001）以及症状缓解>50%（烧心：66.0%对50.0%，P = 0.010；反酸：64.2%对28.0%，P = 0.010；上腹部不适：51.9%对30.5%，P = 0.03）。与质子泵抑制剂反应不佳相关的因素为年龄较大、女性、体重指数较高以及基线症状严重。
低剂量（10毫克）S-泮托拉唑治疗4周在缓解NERD患者的反流症状方面比安慰剂更有效，尤其是反酸症状。需要更多剂量或更长疗程的S-泮托拉唑治疗以完全消除症状。
