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在一项针对健康志愿者的双盲、随机、安慰剂对照、三交叉研究中,瑞尼液与胃仙-U液对胃内pH值的影响。

Effect of Rennie Liquid versus Maalox Liquid on intragastric pH in a double-blind, randomized, placebo-controlled, triple cross-over study in healthy volunteers.

作者信息

Hürlimann S, Michel K, Inauen W, Halter F

机构信息

Department of Medicine, Inselspital, Bern, Switzerland.

出版信息

Am J Gastroenterol. 1996 Jun;91(6):1173-80.

PMID:8651166
Abstract

OBJECTIVES

Despite years of successful use of calcium-containing antacids in acid-related disease, allegations of gastric rebound following their intake has brought these agents into disrepute. By assessing intragastric acidity over the 24-h period, we evaluated whether antacids induce a clinically relevant acid rebound.

METHODS

Twelve healthy volunteers were assigned to a double-blind, placebo-controlled, triple cross-over comparison of placebo, Maalox Liquid, and a calcium-containing antacid, Rennie Liquid. The two antacids had identical neutralizing capacity. Each drug was administered at standard doses q.i.d 1 h after the main meals (at 1000, 1400, and 1900 h) and at bedtime (2300 h). Intragastric acidity was monitored by continuous ambulatory 24-h pH-metry on 3 separate days with a wash-out period of 1 wk. Special attention was given to the acidity of pre-determined postantacid time intervals during the day and night.

RESULTS

Both antacids led to a significant increase of the median 24-h pH and the median pH of the first postantacid hour, compared with placebo. Neither Rennie Liquid nor Maalox Liquid led to a drop of intragastric pH during the putative acid rebound time (2nd and 3rd postantacid hr and at night). A marginal increase in serum calcium and gastrin concentration with Rennie Liquid, and magnesium concentration with Maalox Liquid, were observed.

CONCLUSIONS

No gastric acid rebound was detected with the calcium carbonate-containing antacid, Rennie Liquid, or with Maalox Liquid at standard doses. An identical increase of intragastric pH was achieved with Rennie Liquid and Maalox Liquid during the first postantacid hour and the entire 24-h period.

摘要

目的

尽管含钙抗酸剂在酸相关性疾病中已成功使用多年,但服用后出现胃反弹的说法已使这些药物声名狼藉。通过评估24小时内的胃内酸度,我们评估了抗酸剂是否会引起具有临床意义的酸反弹。

方法

12名健康志愿者被分配到一项双盲、安慰剂对照、三联交叉比较试验中,比较安慰剂、胃仙-U液和一种含钙抗酸剂雷尼液。两种抗酸剂具有相同的中和能力。每种药物均在主餐后1小时(10:00、14:00和19:00)及睡前(23:00)按标准剂量每日四次给药。在3个不同的日子里,通过连续动态24小时pH值监测法监测胃内酸度,洗脱期为1周。特别关注白天和夜间预先确定的抗酸剂后时间段的酸度。

结果

与安慰剂相比,两种抗酸剂均导致24小时pH值中位数和抗酸剂后第一小时的pH值中位数显著升高。在假定的酸反弹时间(抗酸剂后第2小时和第3小时以及夜间),雷尼液和胃仙-U液均未导致胃内pH值下降。观察到雷尼液使血清钙和胃泌素浓度略有升高,胃仙-U液使镁浓度略有升高。

结论

在标准剂量下,含碳酸钙的抗酸剂雷尼液或胃仙-U液均未检测到胃酸反弹。雷尼液和胃仙-U液在抗酸剂后第一小时和整个24小时期间使胃内pH值升高的幅度相同。

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