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雷尼替丁和法莫替丁对健康受试者胃内pH值分布的影响。雷尼替丁泡腾片(300毫克)与法莫替丁薄膜片(40毫克)的随机交叉试验

[The effect of ranitidine and famotidine on the intragastric pH profile of healthy subjects. Randomized cross-over trial with ranitidine effervescent tablets (300 mg) versus famotidine film tablets (40 mg) ].

作者信息

Löser C, Burlage M, Fölsch U R

机构信息

Klinikum der Christian-Albrechts-Universität, I. Medizinische Klinik, Kiel.

出版信息

Arzneimittelforschung. 1994 May;44(5):626-9.

PMID:8024636
Abstract

Influence of Ranitidine and Famotidine on the Intragastric pH-profile in Healthy Volunteers/Randomised cross-over study of ranitidine effervescent tablets (300 mg) versus famotidine film coated tablets (40 mg). A controlled cross-over trial was carried out to compare the duration of time until the onset of action and its intensity following administration of ranitidine (R, Sostril, CAS 76824-35-6) effervescent tablets (300 mg) and famotidine (F, CAS 76824-35-6) film coated tablets (40 mg). Twelve volunteers (4 female, 8 male) participated in the study. The efficacy of the test medications was assessed by pH-metry during 12 h. The evaluation of the measurements showed that a pH-value 3.5 was reached 100 s after administration of R and 3,392 s (56.5 min) after F (p < 0.01). The median pH-values were significantly higher after R during the first 2 h. The AUC-values (area under the curve; pH-time) for 1, 2 and 4 h were calculated by the trapezoid rule. The intake of R resulted in significantly higher areas than that of F. After reaching the pH-value of 3.5 this value remained stable during the complete period of measurement (R = 12 h, F = 11 h). The faster onset of pH-value elevation could correspond clinically with a faster onset of pain relief.

摘要

雷尼替丁和法莫替丁对健康志愿者胃内pH值曲线的影响/雷尼替丁泡腾片(300毫克)与法莫替丁薄膜包衣片(40毫克)的随机交叉研究。进行了一项对照交叉试验,以比较服用雷尼替丁(R,索斯特里尔,CAS 76824-35-6)泡腾片(300毫克)和法莫替丁(F,CAS 76824-35-6)薄膜包衣片(40毫克)后起效时间及其强度的持续时间。12名志愿者(4名女性,8名男性)参与了该研究。通过pH测定法在12小时内评估受试药物的疗效。测量结果评估显示,服用R后100秒达到pH值3.5,服用F后3392秒(56.5分钟)达到(p<0.01)。在前2小时内,R后的pH中值显著更高。通过梯形法则计算1、2和4小时的AUC值(曲线下面积;pH-时间)。服用R后的面积显著高于F。达到pH值3.5后,该值在整个测量期间保持稳定(R=12小时,F=11小时)。pH值升高的更快起效在临床上可能与疼痛缓解的更快起效相对应。

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