Gibinski K, Nowak A, Gabryelewicz A, Szalaj W, Hasik J, Klincewicz H, Pokora J, Radwan P, Kosecki P, Pachlewski J
Dtsch Z Verdau Stoffwechselkr. 1982;42(2-3):64-9.
One hundred and seventy seven duodenal ulcer and eighty-one gastric ulcer patients were treated with either ranitidine or placebo in a prospective double-blind study. Groups treated with active drug and placebo were comparable and ulcer healing was assessed by weekly endoscopic examinations. Ranitidine was shown to accelerate the rate of spontaneous ulcer healing in both duodenal and gastric ulcer. This acceleration is significant after one week of treatment in duodenal ulcer and from three weeks onwards in gastric ulcer. The ulcer healing rate after three weeks treatment with ranitidine was 85.5% in duodenal ulcer, and 72.5% in gastric ulcer which was significantly higher than in the placebo group where it was 51.7% and 41.5% respectively (P less than 0.005 and P less than 0.01). Treatment with ranitidine for a maximum of six weeks healed 97.1% of duodenal ulcer patients (172 out of 177) and 96.5% of gastric ulcer patients (77 out of 81). Out of total of 258 patients only 9 failed to heal. No adverse events were seen with ranitidine and it would appear free of the side effects that have been seen with cimetidine. In addition there were no significant changes in blood haematology or clinical chemistry parameters. Ranitidine is also given in a more convenient regimen, 150 mg daily as compared to 200 mg three times daily and 400 mg nocte with cimetidine.
在一项前瞻性双盲研究中,177例十二指肠溃疡患者和81例胃溃疡患者接受了雷尼替丁或安慰剂治疗。接受活性药物和安慰剂治疗的组具有可比性,并通过每周的内镜检查评估溃疡愈合情况。结果显示,雷尼替丁可加速十二指肠溃疡和胃溃疡的自然愈合速度。在十二指肠溃疡中,治疗1周后这种加速效果显著;在胃溃疡中,从第3周起加速效果显著。雷尼替丁治疗3周后,十二指肠溃疡的愈合率为85.5%,胃溃疡为72.5%,显著高于安慰剂组,安慰剂组的愈合率分别为51.7%和41.5%(P<0.005和P<0.01)。雷尼替丁治疗最长6周后,97.1%的十二指肠溃疡患者(177例中的172例)和96.5%的胃溃疡患者(81例中的77例)愈合。在总共258例患者中,只有9例未愈合。雷尼替丁未出现不良事件,且似乎没有西咪替丁所出现的副作用。此外,血液学和临床化学参数也没有显著变化。雷尼替丁的给药方案也更方便,每日150mg,而西咪替丁为每日3次,每次200mg,夜间400mg。