Department of Health Statistics, The Fourth Military Medical University, Xi'an, Shaanxi, China.
J Clin Gastroenterol. 2011 Apr;45(4):322-9. doi: 10.1097/MCG.0b013e3181e88515.
To investigate the efficacy and safety of a new proton pump inhibitor (PPI), ilaprazole (IY-81149) in the treatment of duodenal ulcers and provide some characteristics of the dose-response relationship for later studies.
PPIs have been used therapeutically for many years, and shown great efficacy in accelerating ulcer healing. Currently researches are focused on more potent PPIs. Some preclinical studies have shown that ilaprazole might be such a new substitute.
235 patients with at least 1 endoscopically diagnosed active duodenal ulcer were enrolled in a randomized trial. Patients were randomized into 4 groups (5, 10, and 20 mg/d ilaprazole, with 20 mg/d omeprazole as positive control) and treated for up to 4 weeks. Forty patients accepted continuous 24-hour pH measurements after the fifth dose. The primary endpoint was ulcer healing rate at week 4.
The efficacy analyses were based on 235 patients. At week 4, 86.4%, 93.1%, 86.4%, and 89.8% patients treated with 5 mg ilaprazole, 10 mg ilaprazole, 20 mg ilaprazole, and 20 mg omeprazole once daily, respectively had ulcers healed (P=0.59). The majority of patients (>70%) became asymptomatic after 4 weeks treatment. Both drugs with stipulated dosages exhibited similar efficacy and safety profiles. Gastric acid suppression increased with increasing dose of ilaprazole in pH study.
Ilaprazole is as tolerable, safe, and efficacious as omeprazole in the treatment of duodenal ulcers, especially at a lower dose (10 mg/d ilaprazole vs. 20 mg/d omeprazole). (ClinicalTrials.gov ID: NCT00953381).
研究新型质子泵抑制剂（PPI）依普拉唑（IY-81149）治疗十二指肠溃疡的疗效和安全性，并为进一步研究提供剂量-反应关系的特征。
质子泵抑制剂已被广泛应用于临床多年，在加速溃疡愈合方面疗效显著。目前的研究重点是更有效的质子泵抑制剂。一些临床前研究表明，依普拉唑可能是一种新的替代药物。
235 例至少有 1 例内镜诊断为活动性十二指肠溃疡的患者被纳入一项随机试验。患者被随机分为 4 组（5、10 和 20 mg/d 依普拉唑，以 20 mg/d 奥美拉唑作为阳性对照），治疗时间最长为 4 周。40 例患者在第 5 次给药后接受了连续 24 小时 pH 值测量。主要终点为第 4 周时的溃疡愈合率。
疗效分析基于 235 例患者。第 4 周时，5 mg 依普拉唑、10 mg 依普拉唑、20 mg 依普拉唑和 20 mg 奥美拉唑组的溃疡愈合率分别为 86.4%、93.1%、86.4%和 89.8%（P=0.59）。大多数患者（>70%）在 4 周治疗后症状消失。两种药物在规定剂量下具有相似的疗效和安全性。在 pH 研究中，随着依普拉唑剂量的增加，胃酸抑制作用增强。
依普拉唑在治疗十二指肠溃疡方面与奥美拉唑一样耐受良好、安全有效，特别是低剂量（10 mg/d 依普拉唑与 20 mg/d 奥美拉唑）。（临床试验注册号：NCT00953381）。
