Miner Philip, Orr William, Filippone Joseph, Jokubaitis Leonard, Sloan Sheldon
Oklahoma Foundation for Digestive Research, University of Oklahoma Health Sciences Center, Oklahoma City, USA.
Am J Gastroenterol. 2002 Jun;97(6):1332-9. doi: 10.1111/j.1572-0241.2002.05769.x.
Clinical results to date suggest that antisecretory therapy may be less effective in providing symptom relief for patients with nonerosive gastroesophageal reflux disease (GERD) than for patients with erosive disease. This study was carried out to assess the efficacy and rapidity of once-daily rabeprazole (10 mg or 20 mg) in relieving symptoms in endoscopically negative patients with moderately severe GERD symptoms and to evaluate the safety of these doses over 4 wk.
This placebo-controlled, double blind study enrolled 203 men and women with moderately severe symptoms of GERD. After a 2-wk, single-blind placebo run-in phase, patients were randomized to receive 10 mg or 20 mg of rabeprazole or placebo once daily for 4 wk.
Rabeprazole rapidly and effectively relieved heartburn, with significant improvements on day 1 of dosing. It also improved most other GERD-related symptoms, including regurgitation, belching, bloating, early satiety, and nausea. Both rabeprazole doses were significantly superior to the placebo with respect to time to the first 24-h heartburn-free interval (2.5 and 4.5 days for 10 mg and 20 mg of rabeprazole, respectively, vs 21.5 days for the placebo) and first daytime or nighttime heartburn-free interval (1.5-3 days for rabeprazole groups vs 12.5-15 days for the placebo), as well as to percentage of time patients were heartburn-free and free of antacid use. Both rabeprazole doses were well tolerated.
Based on these findings and prior studies, rabeprazole reliably relieves GI symptoms equally well in both nonerosive GERD and erosive GERD.
迄今为止的临床结果表明，抗分泌治疗对非糜烂性胃食管反流病（GERD）患者缓解症状的效果可能不如糜烂性疾病患者。本研究旨在评估每日一次雷贝拉唑（10毫克或20毫克）缓解内镜检查阴性的中度严重GERD症状患者症状的疗效和速度，并评估这些剂量在4周内的安全性。
这项安慰剂对照、双盲研究纳入了203名有中度严重GERD症状的男性和女性。在为期2周的单盲安慰剂导入期后，患者被随机分配接受每日一次10毫克或20毫克雷贝拉唑或安慰剂，持续4周。
雷贝拉唑能迅速有效地缓解烧心症状，给药第1天就有显著改善。它还改善了大多数其他与GERD相关的症状，包括反流、嗳气、腹胀、早饱感和恶心。两种雷贝拉唑剂量在达到首个24小时无烧心间隔时间（10毫克和20毫克雷贝拉唑分别为2.5天和4.5天，而安慰剂为21.5天）以及首个白天或夜间无烧心间隔时间（雷贝拉唑组为1.5 - 3天，安慰剂组为12.5 - 15天）方面，以及在患者无烧心且无需使用抗酸剂的时间百分比方面，均显著优于安慰剂。两种雷贝拉唑剂量的耐受性都很好。
基于这些发现和先前的研究，雷贝拉唑在非糜烂性GERD和糜烂性GERD中均能可靠地缓解胃肠道症状。
