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两种抗酸制剂对胃内酸度影响的比较——一项双中心开放随机交叉安慰剂对照试验

Comparison of two antacid preparations on intragastric acidity--a two-centre open randomised cross-over placebo-controlled trial.

作者信息

Sulz M C, Manz M, Grob P, Meier R, Drewe J, Beglinger C

机构信息

Division of Internal Medicine, Department of Gastroenterology and Hepatology, University Hospital Basel, Basel, Switzerland.

出版信息

Digestion. 2007;75(2-3):69-73. doi: 10.1159/000102627. Epub 2007 May 11.

Abstract

BACKGROUND

Rennie and Riopan Gel are 2 of the most well-known and popular over-the-counter antacids; for heartburn symptoms, pain relief is fast with both preparations. A direct comparison with respect to intragastric acidity has not been done yet. The aim of our study was therefore to compare the effects of both preparations on intragastric acidity of fasting volunteers.

METHODS

The study was conducted as an open, randomised, placebo-controlled, 2-centre cross-over study. On different days, 24 healthy adult volunteers (11 males and 13 females) received equimolar acid-neutralising amounts of either Riopan Gel (800 mg magaldrate) or 2 tablets of Rennie (680 mg calcium carbonate and 80 mg magnesium carbonate) or no drug (control) with a wash-out period of at least 4 days between applications. The intragastric pH was measured for 3 h by intragastric pH-metry. The primary endpoint was the median time lag before intragastric pH >3.0 was reached for 10 consecutive min after drug administration.

RESULTS

For both antacids, the median pH during the first 30 min after drug administration was statistically significantly different from placebo (p < 0.05), but there was a statistically significant increase in pH during the first 5 min for Riopan Gel only.

CONCLUSION

Compared to placebo, both antacids (Rennie and Riopan Gel) have short-lasting effects on intragastric acidity. There is no statistically significant difference between the 2 preparations, except in the first 5 min, indicating a faster onset of action for Riopan Gel. We conclude that the antacid formulation (tablet or liquid) has little influence on intragastric acidity.

摘要

背景

雷尼(Rennie)和乐得胃凝胶(Riopan Gel)是两种最知名且最受欢迎的非处方抗酸剂;对于烧心症状,两种制剂都能快速缓解疼痛。尚未对两者的胃内酸度进行直接比较。因此,我们研究的目的是比较这两种制剂对空腹志愿者胃内酸度的影响。

方法

该研究作为一项开放、随机、安慰剂对照、双中心交叉研究进行。在不同日期,24名健康成年志愿者(11名男性和13名女性)接受等摩尔酸中和量的乐得胃凝胶(800毫克氢氧化铝镁)或2片雷尼(680毫克碳酸钙和80毫克碳酸镁)或不服用药物(对照),两次用药之间的洗脱期至少为4天。通过胃内pH测量法测量胃内pH值3小时。主要终点是给药后胃内pH值连续10分钟>3.0之前的中位时间间隔。

结果

对于两种抗酸剂,给药后前30分钟的中位pH值与安慰剂相比有统计学显著差异(p<0.05),但仅乐得胃凝胶在给药后前5分钟pH值有统计学显著升高。

结论

与安慰剂相比,两种抗酸剂(雷尼和乐得胃凝胶)对胃内酸度的作用持续时间较短。两种制剂之间除了在最初5分钟外没有统计学显著差异,表明乐得胃凝胶起效更快。我们得出结论,抗酸剂剂型(片剂或液体)对胃内酸度影响不大。

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