Hirschowitz B I, Berenson M M, Berkowitz J M, Bright-Asare P, DeLuca V A, Eshelman F N, Font R G, Griffin J W, Kozarek R A, McCray R S
J Clin Gastroenterol. 1986 Jun;8(3 Pt 2):359-66. doi: 10.1097/00004836-198606002-00006.
Treatment of duodenal ulcer with the histamine H2-receptor antagonist, ranitidine, was assessed in a double-blind, randomized, multicenter trial in which patients were treated for two consecutive 4-week periods with ranitidine 150 mg b.i.d. or a placebo. All patients were allowed to take antacids as necessary for symptoms. Three hundred eighty-two patients were entered and 355 completed the first 4-week trial period. Ranitidine significantly improved healing at 2 weeks (37 versus 19%, p less than 0.01) and at 4 weeks (73 versus 45%, p less than 0.01), with better relief of pain and lower use of antacids. In the second 4-week trial period, 124 unhealed patients from the first 4 weeks were re-randomized. Ranitidine treatment resulted in a greater healing rate regardless of previous treatment (p less than 0.05). In this trial, side effects were uncommon and not different between placebo and the tested drug. One case of hepatitis in the ranitidine treated group was presumed on the evidence to be non-A non-B. Ranitidine is effective and appears to be safe in the treatment of duodenal ulcer and its symptoms.
在一项双盲、随机、多中心试验中，对使用组胺H2受体拮抗剂雷尼替丁治疗十二指肠溃疡进行了评估。在该试验中，患者连续两个4周疗程接受雷尼替丁150毫克每日两次或安慰剂治疗。所有患者可根据症状需要服用抗酸剂。共有382名患者入组，355名患者完成了第一个4周试验期。雷尼替丁在2周时（37%对19%，p<0.01）和4周时（73%对45%，p<0.01）显著提高了愈合率，疼痛缓解更好，抗酸剂使用量更低。在第二个4周试验期，对前4周未愈合的124名患者重新进行随机分组。无论先前治疗情况如何，雷尼替丁治疗的愈合率更高（p<0.05）。在该试验中，副作用不常见，安慰剂组和受试药物组之间无差异。雷尼替丁治疗组有1例肝炎病例，根据证据推测为非甲非乙型肝炎。雷尼替丁在治疗十二指肠溃疡及其症状方面有效且似乎安全。
