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阿莫西林(克拉莫西林‘比彻姆’)颗粒剂在儿科的临床研究(作者译)

[Clinical investigation of amoxicillin (clamoxyl 'Beecham') granules in pediatrics (author's transl)].

作者信息

Nakazawa S, Sato H, Fujii S, Kohima S, Hirama Y

出版信息

Jpn J Antibiot. 1976 Jul;29(7):695-700.

PMID:1048199
Abstract

Amoxicillin granule (100 mg AMPC potency per 1.0 g granule) was administered to pediatric patients with the following results. 1) AAMPC serum concentration and the urinary recovery of two preparations (Clamoxyl 'Beecham' and Sawacillin 'Fujisawa') granule were compared in a cross over trial in 5 healthy adult volunteers. No significant difference in the results was observed between the two granules. 2) The peak serum concentration after oral administration of 10 mg/kg AMPC to 5 children gave an average of 5.06 mug/ml 1 hour after administration. The 6-hour urinary excretion was distributed 51.4 approximatley 78.9%. 3) AMPC was administered at a dose of about 20 mg/kg/day to 35 children with acute pediatric infections that is scarlet fever, acute tonsillitis, tonsillitis lacunalis, acute bronchitis, bronchial asthma +bronchitis and infectious impetigo. An effective therapeutic result was obtained in all cases. 4) The granule was well accepted by young children, and at a dose level of about 20 mg/kg/day for a week no disorder on hepatorenal function was observed in any og the patients.

摘要

对儿科患者施用阿莫西林颗粒(每1.0克颗粒含100毫克阿莫西林效价),结果如下。1)在5名健康成年志愿者中进行交叉试验,比较了两种制剂(“比彻姆”克拉霉素和“藤泽”沙维西林)颗粒的阿莫西林血清浓度和尿回收率。两种颗粒的结果未观察到显著差异。2)对5名儿童口服10毫克/千克阿莫西林后,给药1小时后的血清峰值浓度平均为5.06微克/毫升。6小时的尿排泄量分布在约51.4%至78.9%之间。3)对35名患有急性儿科感染(即猩红热、急性扁桃体炎、陷窝性扁桃体炎、急性支气管炎、支气管哮喘+支气管炎和传染性脓疱病)的儿童,以约20毫克/千克/天的剂量施用阿莫西林。所有病例均获得了有效的治疗效果。4)该颗粒很受幼儿接受,在约20毫克/千克/天的剂量水平下服用一周,任何患者均未观察到肝肾功能紊乱。

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