Sontag S, Robinson M, McCallum R W, Barwick K W, Nardi R
Arch Intern Med. 1987 Aug;147(8):1485-91.
In a multicenter, double-blind trial, 284 patients with gastroesophageal reflux disease were evaluated before, during, and after six weeks of treatment with either placebo or ranitidine (150 mg twice daily). Randomization resulted in two comparable patient groups. Ranitidine treatment was significantly more effective than placebo treatment in decreasing the frequency and the severity of heartburn during both daytime and nighttime assessment periods. There was a significant correlation between improvement in heartburn symptoms and decrease in antacid consumption; hence, patients receiving ranitidine consumed significantly fewer antacid tablets. Among patients with endoscopic esophagitis at baseline, the overall change in endoscopic classification after six weeks of therapy was significantly better for the ranitidine-treated patients. The ranitidine-treated group had less evidence of erosions and ulcerations as well as greater healing. There were no differences between the groups with respect to changes in esophageal mucosal sensitivity to acid perfusion or changes in histologic grading of esophageal mucosal biopsy specimens. The ranitidine safety profile was similar to that of previous studies. We conclude that, in patients with gastroesophageal reflux disease, ranitidine therapy, 150 mg twice daily, markedly reduced the heartburn symptoms of reflux disease and significantly improved the endoscopic appearance of the esophageal mucosa.
在一项多中心双盲试验中，对284例胃食管反流病患者在接受安慰剂或雷尼替丁（每日两次，每次150毫克）治疗的六周期间及治疗前后进行了评估。随机分组产生了两个具有可比性的患者组。在白天和夜间评估期间，雷尼替丁治疗在降低烧心频率和严重程度方面明显比安慰剂治疗更有效。烧心症状的改善与抗酸剂消耗量的减少之间存在显著相关性；因此，接受雷尼替丁治疗的患者服用的抗酸剂片明显更少。在基线时有内镜下食管炎的患者中，雷尼替丁治疗组在治疗六周后内镜分类的总体变化明显更好。雷尼替丁治疗组的糜烂和溃疡迹象更少，愈合情况更好。两组在食管黏膜对酸灌注的敏感性变化或食管黏膜活检标本的组织学分级变化方面没有差异。雷尼替丁的安全性与先前研究相似。我们得出结论，在胃食管反流病患者中，每日两次、每次150毫克的雷尼替丁治疗可显著减轻反流病的烧心症状，并显著改善食管黏膜的内镜表现。
