Dettmar P W, Sykes J, Little S L, Bryan J
Reckitt Benckiser Healthcare, Dansom Lane, Hull, UK.
Int J Clin Pract. 2006 Mar;60(3):275-83. doi: 10.1111/j.1368-5031.2006.00800.x.
The objective of the open, randomised, four-period crossover study was to compare the time of onset of effect of sodium alginate (SA), omeprazole, ranitidine and control, based on oesophageal and intragastric pH and to determine any correlation between reflux symptoms and episodes in volunteers suffering from occasional gastro-oesophageal reflux. SA showed extensive prevention of acid exposure in the oesophagus compared with other treatments during the first hour. Overall, SA was more effective than control or omeprazole and comparable with ranitidine. There was little evidence of association between 'oesophageal' symptoms and reflux episodes, but associations between 'gastric' symptoms and acidity in the oesophagus, fundus and corpus were apparent. For an immediate reduction in gastro-oesophageal reflux into the oesophagus and gastric acidity during the first hour, SA was significantly superior to control, ranitidine and omeprazole. Ranitidine showed a superior effect from 2 h, consistent with its pharmacological mode of action.
这项开放性、随机、四阶段交叉研究的目的是,基于食管和胃内pH值,比较海藻酸钠(SA)、奥美拉唑、雷尼替丁及对照的起效时间,并确定偶尔患有胃食管反流的志愿者反流症状与发作之间的相关性。与其他治疗相比,SA在第一个小时内对食管酸暴露有广泛的预防作用。总体而言,SA比对照或奥美拉唑更有效,与雷尼替丁相当。几乎没有证据表明“食管”症状与反流发作之间存在关联,但“胃”症状与食管、胃底和胃体酸度之间的关联很明显。为了在第一个小时内立即减少胃食管反流至食管和胃酸度,SA明显优于对照、雷尼替丁和奥美拉唑。雷尼替丁从2小时起显示出更好的效果,与其药理作用模式一致。