Nanri S, Sunakawa K, Yamashita N, Akita H, Hotta M, Jozaki K, Iwata S, Iwasaki Y, Kanemitsu T, Tojo M
Department of Pediatrics, School of Medicine, Keio University.
Jpn J Antibiot. 1987 Jun;40(6):1135-45.
A pharmacokinetic study was conducted in neonates (mature, premature) to which amikacin (AMK) was administered through intravenous drip infusion. The results of the study are summarized below. 1. Changes in blood concentrations of AMK obtained after intravenous drip infusion over a period of 30 or 60 minutes were comparable to those after intramuscular injection. 2. When AMK was administered to neonates (mature, premature) at a single intravenous (30 or 60 minutes) dose of 6 mg/kg, peak levels of 15.5 to 26.3 micrograms/ml were attained. These values were within the range of 15 to 30 micrograms/ml which are considered to be safe and effective peak levels. 3. In 0 day-neonates, half-lives of blood AMK levels rather long and widely varied (3 to 8 hours) but, in about 7 day-neonates, half-lives were 3 to 4 hours. 4. It is considered from the above results that the safe and effective blood concentrations of AMK in 0 to 7 day-old neonates can be obtained from intravenous administrations at each dose of 6 mg/kg repeated with intervals of 12 or 24 hours and, in 8 days or older neonates, from intravenous drip infusions over 30 or 60 minutes at each dose of 6 mg/kg repeated with intervals of 12 hours. 5. For neonates with very low birth weights, individual doses and intervals should be separately investigated.
对新生儿（足月儿、早产儿）进行了一项药代动力学研究，通过静脉滴注给予阿米卡星（AMK）。研究结果总结如下。1. 静脉滴注30或60分钟后获得的AMK血药浓度变化与肌肉注射后的变化相当。2. 当以6mg/kg的单次静脉注射剂量（30或60分钟）给新生儿（足月儿、早产儿）使用AMK时，峰值水平达到15.5至26.3微克/毫升。这些值在被认为是安全有效的峰值水平的15至30微克/毫升范围内。3. 在出生0天的新生儿中，AMK血药水平的半衰期较长且差异很大（3至8小时），但在约出生7天的新生儿中，半衰期为3至4小时。4. 从上述结果可以认为，0至7日龄新生儿中AMK的安全有效血药浓度可通过每12或24小时重复一次6mg/kg的静脉给药获得，而在8日龄及以上的新生儿中，可通过每12小时重复一次6mg/kg、持续30或60分钟的静脉滴注获得。5. 对于极低出生体重的新生儿，应分别研究个体剂量和给药间隔。
