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雷尼替丁与安慰剂治疗胃食管反流病的双盲交叉研究

Double-blind crossover study of ranitidine and placebo in gastro-oesophageal reflux disease.

作者信息

Johansson K E, Boeryd B, Johansson K, Tibbling L

出版信息

Scand J Gastroenterol. 1986 Sep;21(7):769-78. doi: 10.3109/00365528609011116.

DOI:10.3109/00365528609011116
PMID:3535004
Abstract

The effect of 150 mg ranitidine twice daily was compared with placebo by the double-blind crossover technique (8 weeks twice) in patients with gastro-oesophageal reflux (paired comparison in 38 patients). Ranitidine was superior to placebo with regard to effect on symptoms, improvement of oesophagitis as assessed by endoscopy and biopsy, and decrease of oesophageal acid hypersensitivity. The symptomatic response to ranitidine was, however, unsatisfactory in more than half of the cases. When symptomatic responders taking ranitidine (R) were compared with non-responders (NR), there was no difference with regard to the severity of oesophagitis or frequency of positive acid perfusion tests before or after the 8-week treatment. NR were younger and more often had endoscopic signs of incompetence of the cardia and gastric prolapse. Ranitidine is an efficient drug in patients with reflux disease. It cannot be expected that mechanical problems in the hiatal region will be influenced by ranitidine, which is probably why half the patients did not respond.

摘要

采用双盲交叉技术(8周,两次),将150毫克雷尼替丁每日两次的疗效与安慰剂在胃食管反流患者中进行比较(38例患者配对比较)。在症状改善、内镜检查和活检评估的食管炎改善以及食管酸超敏反应降低方面,雷尼替丁优于安慰剂。然而,超过一半的病例对雷尼替丁的症状反应并不理想。将服用雷尼替丁(R)的有症状反应者与无反应者(NR)进行比较时,在8周治疗前后,食管炎的严重程度或酸灌注试验阳性频率方面没有差异。无反应者更年轻,且更常出现贲门功能不全和胃脱垂的内镜征象。雷尼替丁是反流性疾病患者的一种有效药物。不能期望裂孔区域的机械问题会受到雷尼替丁的影响,这可能就是一半患者没有反应的原因。

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