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早产儿的庆大霉素治疗:两种给药方案的比较。

Gentamicin therapy in preterms: a comparison of two dosage regimens.

作者信息

Krishnan L, George S A

机构信息

Department of Pediatrics, Kasturba Medical College Hospital, Manipal.

出版信息

Indian Pediatr. 1997 Dec;34(12):1075-80.

PMID:9715552
Abstract

OBJECTIVE

To compare the pharmacokinetic profile of gentamicin given as a once daily dose as against the conventional twelve hourly dose in preterm neonates.

DESIGN

Randomized double blind study.

SETTING

Tertiary level Neonatal Intensive Care Unit.

SUBJECTS

Eighteen preterms admitted during the period January 1994 to May 1994.

METHODS

The babies were randomly assigned to receive either the once daily (plan O, 4 mg/kg Q 24 h) or the conventional (plan C, 2.5 mg/kg Q 12 h) gentamicin dosage regimen. Blood was collected for the first peak level one hour after the first dose of gentamicin. Trough and peak-2 levels were collected before and one hour after the dose due at 48 hours, respectively. Assays were done using fluorescence immunoassay and the pharmacokinetic estimations were calculated using the three measured levels on a simplified one-compartment open model. Serum concentration time curves were plotted using the computerized Bayesian forecasting. Student 't' and Mann-Whitney U tests were applied as required.

MAIN OUTCOME MEASURES

Initial peak levels and steady state trough and peak levels in both groups.

RESULTS

Optimum therapeutic peak level after the first dose was achieved only with the once daily gentamicin regimen (mean level 5.88 vs 3.88 micrograms/ml p = 0.000). Mean trough levels remained over 2 micrograms/ml in the conventional regimen (2.76 vs 1.96 micrograms/ml p = 0.019) group. Mean peak levels at the steady state were not significantly different in either regimen (6.65 vs 5.45 micrograms/ml in conventional p = 0.177). None of the neonates showed nephrotoxicity.

CONCLUSION

Once daily dose (4 mg/kg) of gentamicin has logistic and monetary benefits in addition to the obvious pharmacokinetic advantage.

摘要

目的

比较在早产儿中每日一次给予庆大霉素的药代动力学特征与传统每12小时给药一次的药代动力学特征。

设计

随机双盲研究。

地点

三级新生儿重症监护病房。

研究对象

1994年1月至1994年5月期间收治的18例早产儿。

方法

将婴儿随机分为接受每日一次(方案O,4mg/kg每24小时一次)或传统(方案C,2.5mg/kg每12小时一次)庆大霉素给药方案。在首次给予庆大霉素后1小时采集血液用于测定首次峰值水平。谷值和第二次峰值水平分别在48小时应给药剂量之前和之后1小时采集。使用荧光免疫测定法进行检测,并使用简化的单室开放模型上的三个测量水平计算药代动力学参数。使用计算机化贝叶斯预测绘制血清浓度-时间曲线。根据需要应用学生t检验和曼-惠特尼U检验。

主要观察指标

两组的初始峰值水平以及稳态谷值和峰值水平。

结果

仅每日一次庆大霉素给药方案在首次给药后达到了最佳治疗峰值水平(平均水平5.88对3.88微克/毫升,p = 0.000)。在传统给药方案组中,平均谷值水平保持在2微克/毫升以上(2.76对1.96微克/毫升,p = 0.019)。两种给药方案在稳态时的平均峰值水平无显著差异(传统方案中为6.65对5.45微克/毫升,p = 0.177)。没有新生儿表现出肾毒性。

结论

每日一次剂量(4mg/kg)的庆大霉素除了具有明显的药代动力学优势外,还有后勤和经济方面的益处。

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