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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for ureaplasma colonization and bronchopulmonary dysplasia.
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Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for ureaplasma colonization and bronchopulmonary dysplasia.

机译：阿奇霉素在极易早产儿有脲原体定植和支气管肺发育不良的风险中的药代动力学，安全性和生物学作用。

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摘要

Ureaplasma spp. respiratory tract colonization is a significant risk factor for bronchopulmonary dysplasia (BPD), a chronic lung disorder in preterm infants. As an initial step preparatory to future clinical trials to evaluate the clinical efficacy of azithromycin to prevent BPD, the authors characterized the pharmacokinetics, safety, and biological effects of a single intravenous dose of azithromycin (10 mg/kg) in preterm neonates (n = 12) 24 to 28 weeks gestation at risk for Ureaplasma infection and BPD. A 2-compartment structural model with the clearance and volume of peripheral compartment (V2) allometrically scaled on body weight (WT) best described the pharmacokinetics of azithromycin in preterm neonates. The estimated parameters were clearance [0.18 L/h x WT(kg)(0.75)], intercompartmental clearance [1.0 L/h], volume of distribution of central compartment [0.93 L], and V2 [14.2 L x WT(kg)]. There were no serious adverse events attributed to azithromycin. A single dose of azithromycin did not suppress inflammatory cytokines or myeloperoxidase activity in tracheal aspirates. These results demonstrated the safety of azithromycin and developed a pharmacokinetic model that is useful for future simulation-based clinical trials for eradicating Ureaplasma and preventing BPD in preterm neonates.
机译：脲原体呼吸道定植是支气管肺发育不良（BPD）（早产儿的慢性肺部疾病）的重要危险因素。作为评估未来阿奇霉素预防BPD临床疗效的临床试验的第一步，作者描述了单剂量静脉注射阿奇霉素（10 mg / kg）对早产儿的药代动力学，安全性和生物学作用（n = 12）妊娠24到28周有感染脲原体和BPD的风险。 2室结构模型，其外围室（V2）的清除率和体积与体重（WT）呈异速成比例关系，最能说明阿奇霉素在早产儿中的药代动力学。估计参数为间隙[0.18 L / hx WT（kg）（0.75）]，室间间隙[1.0 L / h]，中央室的分布体积[0.93 L]和V2 [14.2 L x WT（kg）]。 。没有阿奇霉素引起的严重不良事件。单剂量阿奇霉素不能抑制气管抽吸物中的炎性细胞因子或髓过氧化物酶活性。这些结果证明了阿奇霉素的安全性，并开发了一种药代动力学模型，该模型可用于未来基于模拟的临床试验，以消除早产儿的脲原体和预防BPD。

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