Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.
Dexlansoprazole MR, a modified-release formulation of dexlansoprazole, an enantiomer of lansoprazole, effectively heals erosive oesophagitis.
To assess dexlansoprazole MR in maintaining healed erosive oesophagitis.
Patients (n = 451) with erosive oesophagitis healed in either of two dexlansoprazole MR healing trials randomly received dexlansoprazole MR 60 or 90 mg or placebo once daily in this double-blind trial. The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods. Secondary endpoints were percentages of nights and of 24-h days without heartburn based on daily diaries.
Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing (P < 0.0025). Maintenance rates were 87% and 82% for the 60 and 90 mg doses, respectively, vs. 26% for placebo (life table), and 66% and 65% vs. 14%, respectively (crude rate). Both doses were superior to placebo for the percentage of 24-h heartburn-free days (60 mg, 96%; 90 mg, 94%; placebo, 19%) and nights (98%, 97%, and 50%, respectively). Diarrhoea, flatulence, gastritis (symptoms) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo, but were not dose-related.
Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo, and was well tolerated.
地氯雷他定 MR 是地氯雷他定的一种缓释制剂，地氯雷他定是雷氯拉唑的对映异构体，能有效治愈糜烂性食管炎。
评估地氯雷他定 MR 对维持糜烂性食管炎愈合的效果。
在两项地氯雷他定 MR 愈合试验中愈合的糜烂性食管炎患者（n = 451），在这项双盲试验中随机接受地氯雷他定 MR 60 或 90 mg 或安慰剂，每日一次。使用寿命表和粗率法分析第 6 个月时维持愈合的患者比例。次要终点为基于每日日记的无烧心夜数和 24 小时无烧心天数的百分比。
地氯雷他定 MR 60 和 90 mg 与安慰剂相比，维持愈合的效果更好（P < 0.0025）。地氯雷他定 MR 60 和 90 mg 的维持愈合率分别为 87%和 82%，安慰剂为 26%（寿命表）；66%和 65%，安慰剂为 14%（粗率）。与安慰剂相比，两种剂量均可显著提高 24 小时无烧心日的比例（地氯雷他定 MR 60 组为 96%，地氯雷他定 MR 90 组为 94%，安慰剂组为 19%）和无烧心夜的比例（地氯雷他定 MR 60 组为 98%，地氯雷他定 MR 90 组为 97%，安慰剂组为 50%）。地氯雷他定 MR 组比安慰剂组更常发生腹泻、气胀、胃炎（症状）和腹痛，但与剂量无关。
与安慰剂相比，地氯雷他定 MR 能有效维持糜烂性食管炎愈合和缓解症状，且具有良好的耐受性。
