新生儿丁胺卡那霉素的药动学研究  

Pharmacokinetics Study of Amikacin in Newborn Infants

作　　者：任鼎泰[1] 俞惠民[1] 孙伟[1] 

机构地区：[1]浙江医科大学附属儿童医院,杭州310003

出　　处：《中华围产医学杂志》1999年第2期108-110,共3页Chinese Journal of Perinatal Medicine

摘　　要：目的　探讨丁胺卡那霉素（ＡＭＫ）在新生儿中有效、安全的用药剂量和方法。　方法　２９ 例不同日龄的新生儿，予ＡＭＫ７．５ ｍｇ／ｋｇ １ 次静脉滴注，于滴毕后０．５ 、４ 、８ 和１２ 小时分别采取静脉血，以荧光偏振免疫法测定血药浓度，并计算药动学主要参数。然后按药动学参数特点确定以ＡＭＫ 剂量１０ ｍｇ／ｋｇ 每天１ 次３０ 分钟静脉滴注，应用于２０ 例不同日龄细菌感染新生儿，分别测定血药峰浓度和谷浓度。　结果　ＡＭＫ 的代谢符合一室模型。２９ 例新生儿予ＡＭＫ７ ．５ ｍｇ／ｋｇ １ 次静脉滴注后，血药浓度峰值平均为（１１．５６ ±３ ．７４）μｇ／ｍｌ；而１２ 小时后的平均血药浓度在２ ．５ μｇ／ｍｌ 以下。表观分布容积（Ｖｄ）、消除半衰期（ Ｔ１／２）、消除速率常数（Ｋｅ） 和清除率（Ｃｌ） 分别为（０．７１ ±０ ．２１）Ｌ／ｋｇ、（４ ．７±１ ．６）ｈ 、（０ ．１６ ±０．０５）ｈ－ １ 和（１ ．８４ ±０ ．５）ｍｌ／（ｍｉｎ·ｋｇ）。随日龄增长，消除半衰期（Ｔ１／２） 逐渐缩短，而消除速率常数（Ｋｅ） 逐渐延长，差异有非常显著和显著意义（ Ｐ分别＜ ０．０１ 、＜ ０ ．０５） ；Ｖｄ 随日龄增长逐渐减少，而Ｃｌ 随日龄增长逐渐增高。Objective To explore effective and safe dosage and administration method of amikacin in newborn infants. Methods A single dose amikacin of 7.5 mg/kg was administrated by intravenous drip infusion over 30 minutes to 29 newborn infants, serum drug levels were measured at 0.5,4,8 and 12 hours after administration respectively by fluorescence polarization immunoassay (FPIA). Pharmacokinetics parameters were calculated from the drug levels. The dose of AMK was then adjusted to 10 mg/kg intravenous drip infusion once daily over 30 minutes administrated in 20 bacterial infected newborn infants according to our pharmacokenetics study. The peak and the trough levels were determined respectively. Results Metabolism of amikacin was fitted to one compartment model. The mean peak level of amikacin in 29 newborn infants who received 7.5 mg/kg was 11.56±3.74 μg/ml; the mean level at 12 hrs after administration was less than 2.5 μg/ml. Vd, T1/2, Ke and Cl values were 0.71±0.21 L/kg,4.7±1.60 h,0.16±0.05 h -1 and 1.84± 0.50 ml/(min·kg) respectively. T1/2 and Ke increased with age, the differences were significant ( P <0.01 and <0.005 respectively); Vd decreased and Cl increased with age, but the differences were not significant. In 20 bacterial infected neonates who received 10 mg/kg amikacin, the mean peak level was 16.8±2.7 μg/ml; the trough level was 0.65±0.53 μg/ml. Conclusion Intravenous administration of amikacin of 7.5 mg/kg once a day for newborn infants is safe, but the peak level is below the effective concentration range. Considering both efficiency and safety, appropriate dose of amikacin is 10 mg/kg intravenously once a day for neonates; the duration of infusion should be 30 minutes for those less than 14 days of age and 45~60 minutes for those over 14 days of age.

关 键 词：丁胺卡那霉素 新生儿 剂量 血药浓度 药物动力学 

分 类 号：R978.12[医药卫生—药品] R722.05[医药卫生—药学]