Hoshina H, Hirosawa H, Mikuni K, Ichihashi H
Jpn J Antibiot. 1985 Feb;38(2):309-18.
BRL 25000, granules preparation containing 2 parts of amoxicillin (AMPC) and 1 part of clavulanic acid (CVA, beta-lactamase inhibitor) as its potassium salt, has been investigated fundamentally and clinically. An in vitro study of the antibacterial activity of BRL 25000 against clinically isolated S. aureus (34 strains) showed higher activity than for AMPC alone and demonstrated that CVA potentiated the activity of AMPC, showing a synergistic effect against beta-lactamase producing organisms. A total of 27 pediatric patients aged between 6 months and 13 years 8 months (23 with respiratory infections and 4 with urinary tract infections) were treated with a daily dose ranging from 31.7 to 54.5 mg/kg, divided into 3 or 4 doses a day for periods of 4-18 days. The clinical effect was evaluated as excellent in 26 cases, poor in 1 case and the efficacy ratio was therefore 96.3% (26/27). The bacteriological effect against 12 organisms isolated from 9 patients was studied and all were eradicated (12/12). A drug-related side effect was observed in only 1 patient who developed diarrhea on the 4th day of treatment which continued during the treatment for 10 days. However, no severe side effect and no abnormality related to the drug in laboratory findings were observed. From these results it is concluded that BRL 25000 will be a clinically effective drug in the treatment of mild and moderate infections in the pediatric field.
BRL 25000是一种颗粒制剂，其成分为2份阿莫西林（AMPC）和1份克拉维酸（CVA，β-内酰胺酶抑制剂）的钾盐，已进行了基础和临床研究。一项关于BRL 25000对临床分离的金黄色葡萄球菌（34株）抗菌活性的体外研究表明，其活性高于单独使用AMPC，并证明CVA增强了AMPC的活性，对产β-内酰胺酶的微生物显示出协同作用。共有27例年龄在6个月至13岁8个月之间的儿科患者（23例患有呼吸道感染，4例患有尿路感染）接受治疗，日剂量为31.7至54.5mg/kg，分3或4次给药，疗程为4至18天。临床疗效评估为优26例，差1例，有效率为96.3%（26/27）。对9例患者分离出的12种微生物的细菌学效果进行了研究，所有微生物均被清除（12/12）。仅1例患者出现与药物相关的副作用，在治疗第4天出现腹泻，治疗期间持续10天。然而，未观察到严重副作用，实验室检查结果也未发现与药物相关的异常。从这些结果得出结论，BRL 25000将是治疗儿科领域轻中度感染的一种临床有效药物。
