D'Angelo A
Dipartimento di Gastroenterologia e Endoscopia Digestiva, Ospedale di Dolo, Venezia, Italy.
Ital J Gastroenterol. 1994 Jan-Feb;26(1 Suppl 1):16-8.
A multicenter open-labelled study was conducted in 286 patients with acute benign gastric ulcer in order to evaluate the safety and efficacy of nizatidine 300 mg given at bedtime. Endoscopy was performed on entry, at 4 weeks and, if the ulcer had not healed, at 8 weeks. Seven patients dropped out (four withdrawals due to adverse drug events and three lost to follow up). The endoscopic healing rates at 4 and 8 weeks were 53.8% and 86.7%, respectively. Age, sex, ulcer symptoms, alcohol consumption, smoking, ulcer location and duration of ulcer history were all found not to influence healing. Only the ulcer size significantly influenced the healing rate. The results of this trial confirmed the efficacy of a single dose of nizatidine at bedtime for 8 weeks in healing gastric ulcer.
为评估睡前服用300毫克尼扎替丁的安全性和疗效,对286例急性良性胃溃疡患者进行了一项多中心开放标签研究。在入组时、4周时进行内镜检查,若溃疡未愈合,则在8周时进行内镜检查。7例患者退出研究(4例因药物不良事件退出,3例失访)。4周和8周时的内镜愈合率分别为53.8%和86.7%。研究发现,年龄、性别、溃疡症状、饮酒、吸烟、溃疡部位及溃疡病史时长均不影响愈合。只有溃疡大小显著影响愈合率。该试验结果证实了睡前单次服用尼扎替丁8周治疗胃溃疡的疗效。