Wesdorp I C, Dekker W, Klinkenberg-Knol E C
Gut. 1983 Oct;24(10):921-4. doi: 10.1136/gut.24.10.921.
The efficacy of ranitidine was evaluated using a two-staged trial in patients with endoscopically moderate or severe reflux oesophagitis. The results of a six week double blind placebo controlled trial (stage I) in 36 patients shows that ranitidine (150 mg bd) is superior to placebo in the acute treatment with significant symptomatic improvement concerning heartburn and regurgitation, and in healing or improvement of endoscopic lesions. Prolonged treatment with ranitidine for another six weeks (stage II) proved to be effective in more resistant cases. No clinical side effects or significant biochemical changes were noted during this trial.
使用两阶段试验评估雷尼替丁对内镜检查显示为中度或重度反流性食管炎患者的疗效。对36例患者进行的为期六周的双盲安慰剂对照试验(第一阶段)结果表明,雷尼替丁(150毫克,每日两次)在急性治疗中优于安慰剂,在缓解烧心和反流症状方面有显著改善,在内镜下病变的愈合或改善方面也有效果。在另外六周内对雷尼替丁进行延长治疗(第二阶段),结果证明对更具抗药性的病例有效。在该试验期间未观察到临床副作用或显著的生化变化。