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头孢他啶在新生儿和早产儿中的基础与临床评估

[Fundamental and clinical evaluations of ceftazidime in neonates and premature infants].

作者信息

Motohiro T, Tanaka K, Koga T, Shimada Y, Tomita S, Sakata Y, Fujimoto T, Kuda N, Ishimoto K, Tominaga K

出版信息

Jpn J Antibiot. 1986 Aug;39(8):2171-92.

PMID:3540349
Abstract

Ceftazidime (CAZ) was administered to 24 neonates and premature infants aged 0-31 days in a dose of 10 mg/kg or 20 mg/kg by an intravenous bolus injection, and plasma concentration, urinary concentration and urinary recovery rate during the first 6 hours after the administration were determined. The CAZ was also administered to a total of 43 patients consisting of neonates, premature infants and infants at ages ranging from 0 day to 1 year 9 months (21 suffering or suspectedly suffering with various bacterial infections, and 22 treated for prophylaxis of infections), by intravenous bolus injections in a mean daily dose of 59.6 mg/kg in 2 to 4 divided doses for 9 days on the average. The clinical efficacy, prophylactic effects and bacteriological response were evaluated. Adverse effects of the drug were examined in 65 cases including 22 drop-out cases, and in some of them, abnormal laboratory findings were also examined. The results obtained are summarized as follows: Patients given 10 mg/kg of CAZ were divided into 5 groups on the basis of age: 0-3 days, 4-7 days, 8-14 days, 15-21 days, and 29 days and older, and mean peak plasma concentrations of CAZ were 40.7, 43.1, 37.1, 38.0 and 35.6 micrograms/ml, respectively, at 5 minutes after administration, with no significant difference. Mean AUC values were higher in younger-age groups, i.e. 189.9, 170.8, 159.1, 135.3 and 134.4 micrograms X hr/ml for the 5 different day-age groups, respectively, and mean half-lives of CAZ in plasma tended to be longer in younger-age groups, i.e. 3.16, 3.05, 2.84, 2.44 and 2.43 hours for the 5 groups, respectively. Patients given 20 mg/kg of CAZ were divided into 4 groups also on the basis of age: 0-3 days, 4-7 days, 8-14 days, and 15-21 days, and mean peak plasma concentrations for the 4 day-age groups were 72.9, 73.3, 70.0 and 78.4 micrograms/ml, respectively, at 5 minutes after administration, without any difference among these groups. Mean AUC values were 429.9, 327.3, 279.3 and 302.1 micrograms X hr/ml for the 4 groups, respectively, with the highest AUC in the youngest-age group. Dose response was observed in mean peak plasma concentrations and mean AUCs when 10 mg/kg and 20 mg/kg dose groups were compared for similar day-age patients. Mean half-lives of CAZ in plasma were 4.01, 3.51, 3.00 and 3.07 hours, the longest being in the youngest-age group.(ABSTRACT TRUNCATED AT 400 WORDS)

摘要

将头孢他啶(CAZ)以10mg/kg或20mg/kg的剂量通过静脉推注给予24例年龄在0至31天的新生儿和早产儿,并测定给药后前6小时的血浆浓度、尿浓度和尿回收率。头孢他啶还以平均每日剂量59.6mg/kg、分2至4次静脉推注,平均给药9天,给予总共43例患者,包括0天至1岁9个月的新生儿、早产儿和婴儿(21例患有或疑似患有各种细菌感染,22例用于预防感染)。评估了临床疗效、预防效果和细菌学反应。在65例患者(包括22例退出病例)中检查了该药物的不良反应,其中部分患者还检查了实验室异常结果。所得结果总结如下:给予10mg/kg头孢他啶的患者根据年龄分为5组:0至3天、4至7天、8至14天、15至21天以及29天及以上,给药后5分钟时头孢他啶的平均血浆峰浓度分别为40.7、43.1、37.1、38.0和35.6μg/ml,无显著差异。较年轻年龄组的平均AUC值更高,即5个不同日龄组分别为189.9、170.8、159.1、135.3和134.4μg·hr/ml,头孢他啶在血浆中的平均半衰期在较年轻年龄组中往往更长,即5组分别为3.16、3.05、2.84、2.44和2.43小时。给予20mg/kg头孢他啶的患者也根据年龄分为4组:0至3天、4至7天、8至14天以及15至21天,给药后5分钟时4个日龄组的平均血浆峰浓度分别为72.9、73.3、70.0和78.4μg/ml,这些组之间无差异。4组的平均AUC值分别为429.9、327.3、279.3和302.1μg·hr/ml,最年轻年龄组的AUC最高。当比较10mg/kg和20mg/kg剂量组中相似日龄患者的平均血浆峰浓度和平均AUC时,观察到剂量反应。头孢他啶在血浆中的平均半衰期为4.01、3.51、3.00和3.07小时,最长的在最年轻年龄组。(摘要截断于400字)

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