Kakizaki Y, Yokoyama M, Tsushima N
Department of Pediatrics, Hirosaki University School of Medicine.
Jpn J Antibiot. 1994 Jul;47(7):889-95.
Clinical and pharmacokinetic studies were performed on a new carbapenem antibiotic, biapenem (L-627), in children with acute infectious diseases and the results were as follows: 1) Clinical efficacies were evaluated on the intravenous-administration at daily doses of 17-37.5 mg/kg for 4-7 consecutive days in 12 children; 8 children with pneumonia, 2 with cervical lymphadenitis, 1 with pyelonephritis and 1 with suspected sepsis. The clinical efficacies were excellent in 6 patients, good in 5 and poor in 1, yielding an efficacy rate of 91.7%. No side effects or abnormalities of the clinical laboratory tests were observed in 16 children including 12 children evaluated for the efficacy. 2) L-627 was administered at a dose of 6 mg/kg or 12 mg/kg, using 30 minutes drip infusion, to 5 children. Maximum concentrations of L-627 in plasma were observed at the end of administration and the values varied from 21.0 to 38.4 micrograms/ml (mean: 31.7 +/- 9.3, n = 3) at 6 mg/kg and 39.0 and 58.8 micrograms/ml (mean: 48.9, n = 2) at 12 mg/kg. The half-lives in plasma (beta phase) were from 0.73 to 1.41 hours (0.98 +/- 0.38, n = 3) and 0.88 and 0.90 hours (0.89, n = 2), and the urinary recovery rates in the first 6 hours were between 61.5 and 69.9% (65.5 +/- 4.2, n = 3) and 64.7 and 81.1% (72.9, n = 2) at 6 mg/kg and 12 mg/kg, respectively. The results indicate that L-627 is effective and safe in children with acute infectious diseases and suggest the usefulness of L-627 in the pediatric field.
对一种新型碳青霉烯类抗生素比阿培南（L-627）在患有急性传染病的儿童中进行了临床和药代动力学研究，结果如下：1）对12名儿童连续4至7天静脉注射，日剂量为17 - 37.5mg/kg，评估临床疗效；其中8名儿童患有肺炎，2名患有颈部淋巴结炎，1名患有肾盂肾炎，1名疑似败血症。6例临床疗效优秀，5例良好，1例较差，有效率为91.7%。在包括评估疗效的12名儿童在内的16名儿童中未观察到副作用或临床实验室检查异常。2）对5名儿童以6mg/kg或12mg/kg的剂量，采用30分钟静脉滴注给药。给药结束时观察到血浆中L-627的最高浓度，6mg/kg时其值在21.0至38.4微克/毫升之间（平均值：31.7±9.3，n = 3），12mg/kg时为39.0至58.8微克/毫升（平均值：48.9，n = 2）。血浆半衰期（β相）分别为0.73至1.41小时（0.98±0.38，n = 3）和0.88和0.90小时（0.89，n = 2），6mg/kg和12mg/kg时前6小时的尿回收率分别在61.5%至69.9%（65.5±4.2，n = 3）和64.7%至81.1%（72.9，n = 2）之间。结果表明L-627对患有急性传染病的儿童有效且安全，并提示L-627在儿科领域的实用性。
