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产后氨苄西林水平是否真的与分娩前产时抗生素预防性应用的持续时间有关?一项针对120名新生儿的药代动力学研究。

Are postnatal ampicillin levels actually related to the duration of intrapartum antibiotic prophylaxis prior to delivery? A pharmacokinetic study in 120 neonates.

作者信息

Berardi Alberto, Pietrangiolillo Zaira, Bacchi Reggiani Maria Letizia, Bianco Valentina, Gallesi Daniela, Rossi Katia, Facchinetti Fabio, Ferrari Fabrizio

机构信息

Unit Operativa di Terapia Intensiva Neonatale, Dipartimento Integrato Materno Infantile, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.

Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria S.Orsola-Malpighi, Bologna, Italy.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2018 Mar;103(2):F152-F156. doi: 10.1136/archdischild-2016-312546. Epub 2017 Jun 29.

DOI:10.1136/archdischild-2016-312546
PMID:28663282
Abstract

OBJECTIVE

To assess ampicillin levels according to the duration of intrapartum antibiotic prophylaxis (IAP).

DESIGN

Prospective cohort single-centre study.

SETTING

Tertiary care centre (Modena, Italy).

PATIENTS

120 neonates≥35 weeks' gestation exposed to IAP.

INTERVENTIONS

Neonates were divided into four groups, according to the duration of IAP prior to delivery: group 1 (n=30; <1 hour), group 2 (n=30; ≥1 and <2 hours), group 3 (n=30; ≥2 and <4 hours) and group 4 (n=30; ≥2 doses, ≥4 hours).

MAIN OUTCOME MEASURES

Blood samples were collected at delivery (from the umbilical cord) and at age 4 hours (from a peripheral vessel).

RESULTS

Median duration of IAP was 121 min (range 7-2045 min). Median ampicillin levels in umbilical cord blood were 10.4 µg/mL (IQR 6.4-14.9) and in peripheral blood were 4.7 µg/mL (IQR 2.8-6.4µg/mL). Umbilical cord blood levels reached a peak approximately 30 min after IAP and then declined significantly (p<0.001). Peripheral blood levels did not differ among study groups. Neonates exposed to a full loading dose (n=115) had peripheral blood levels 2.5-70 times higher than the minimal inhibitory concentration for group B streptococcus. There was no relationship between neonatal ampicillin concentrations and the duration of IAP prior to delivery (β=-0.0003, 95% CI -0.02 to 0.001, p=0.680).

CONCLUSIONS

Ampicillin levels reach a peak in the umbilical cord blood within 30 min of intrapartum administration. After a full loading dose, bactericidal levels persist for at least 4 hours after birth and seem independent of the duration of IAP prior to delivery.

摘要

目的

根据产时抗生素预防性应用(IAP)的持续时间评估氨苄西林水平。

设计

前瞻性队列单中心研究。

地点

三级医疗中心(意大利摩德纳)。

患者

120例孕周≥35周且接受IAP的新生儿。

干预措施

根据分娩前IAP的持续时间将新生儿分为四组:第1组(n = 30;<1小时),第2组(n = 30;≥1且<2小时),第3组(n = 30;≥2且<4小时)和第4组(n = 30;≥2剂,≥4小时)。

主要观察指标

在分娩时(从脐带采集)和出生4小时时(从外周血管采集)采集血样。

结果

IAP的中位持续时间为121分钟(范围7 - 2045分钟)。脐带血中氨苄西林的中位水平为10.4μg/mL(四分位间距6.4 - 14.9),外周血中为4.7μg/mL(四分位间距2.8 - 6.4μg/mL)。脐带血水平在IAP后约30分钟达到峰值,然后显著下降(p<0.001)。各研究组之间外周血水平无差异。接受足量负荷剂量的新生儿(n = 115)外周血水平比B族链球菌的最低抑菌浓度高2.5 - 70倍。新生儿氨苄西林浓度与分娩前IAP的持续时间之间无相关性(β = -0.0003,95%可信区间 -0.02至0.001,p = 0.680)。

结论

产时给予氨苄西林后30分钟内脐带血中氨苄西林水平达到峰值。给予足量负荷剂量后,杀菌水平在出生后至少持续4小时,且似乎与分娩前IAP的持续时间无关。

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