Department of Clinical Pharmacology and Therapeutics, Chungbuk National University College of Medicine and Hospital, Cheong-ju, Republic of Korea.
Chungbuk National University College of Medicine, Cheong-ju, Republic of Korea.
Clin Ther. 2024 Aug;46(8):622-628. doi: 10.1016/j.clinthera.2024.06.013. Epub 2024 Jul 20.
Gastritis, one of the most common clinically diagnosed conditions, is defined as the infiltration of inflammatory cells into the gastric mucosa. Drugs for gastritis include histamine-2 receptor antagonists and proton pump inhibitors (PPIs), which reduce acidity in the stomach, and antacids, which neutralize acid. Esomeprazole is a PPI for gastroesophageal reflux disease and gastric and duodenal ulcers that has been shown to be safe and effective at a 10 mg dose. Dual-release drugs have not yet been approved for the treatment of gastritis domestically or internationally. In this study, a dual delayed-release (DR) esomeprazole (10 mg), was compared to famotidine (20 mg) to determine its effectiveness in the treatment of gastritis.
This study was a randomized, open-label, multiple-dose, 2-treatment, 2-period, 2-sequence crossover study with a 7-day washout between periods. In each period, the subjects were administered one dose of esomeprazole (10 mg) or famotidine (20 mg) for 7 days at each period. The 24-hour gastric pH was recorded after single and multiple doses. The percentage of time (duration%) that the pH was maintained above 4 in the 24 hours after 7 days of repeated dosing was evaluated.
The mean percentages of time that the gastric pH was above 4 after multiple doses over 7 days of a dual DR esomeprazole (10 mg) and famotidine (20 mg) was 47.31% ± 14.85% and 23.88% ± 10.73%.
Multiple doses of a dual DR esomeprazole (10 mg) showed effective gastric acid secretion suppression compared to famotidine with comparable safety and tolerability. These results provide evidence supporting the clinical use of a dual DR esomeprazole (10 mg) to treat gastritis.
gov identifier: NCT04967014.
胃炎是最常见的临床诊断疾病之一，其定义为炎症细胞浸润胃黏膜。治疗胃炎的药物包括组胺 2 受体拮抗剂和质子泵抑制剂（PPIs），它们可降低胃酸，抗酸剂可中和胃酸。埃索美拉唑是一种用于治疗胃食管反流病、胃溃疡和十二指肠溃疡的 PPI，已证明其在 10mg 剂量下安全有效。双重释放药物尚未在国内外批准用于治疗胃炎。在这项研究中，比较了双重延迟释放（DR）埃索美拉唑（10mg）与法莫替丁（20mg），以确定其治疗胃炎的疗效。
这是一项随机、开放标签、多剂量、2 种治疗、2 个周期、2 个序列交叉研究，每个周期之间有 7 天的洗脱期。每个周期中，受试者连续 7 天每天服用一次埃索美拉唑（10mg）或法莫替丁（20mg）。单次和多次给药后记录 24 小时胃 pH 值。评价重复给药 7 天后 24 小时内 pH 值维持在 4 以上的时间百分比（持续时间%）。
双重 DR 埃索美拉唑（10mg）和法莫替丁（20mg）连续 7 天多次给药后 24 小时内 pH 值大于 4 的平均时间百分比分别为 47.31%±14.85%和 23.88%±10.73%。
与法莫替丁相比，多次服用双重 DR 埃索美拉唑（10mg）可有效抑制胃酸分泌，且安全性和耐受性相当。这些结果为临床使用双重 DR 埃索美拉唑（10mg）治疗胃炎提供了证据。
gov 标识符：NCT04967014。
