接受单剂量奈韦拉平预防 HIV-1 母婴传播的早产儿的奈韦拉平血浆浓度。

Nevirapine plasma concentrations in premature infants exposed to single-dose nevirapine for prevention of mother-to-child transmission of HIV-1.

机构信息

School of Pharmacy, University of the Western Cape.

出版信息

S Afr Med J. 2011 Sep 5;101(9):655-8.

PMID:21920159

Abstract

BACKGROUND

No pharmacokinetic data exist for premature infants receiving single-dose nevirapine (sd NVP) for prevention of mother-to-child transmission (MTCT) of HIV.

AIM

To describe NVP decay pharmacokinetics in two groups of premature infants - those whose mothers either received or did not receive NVP during labour.

METHODS

Infants less than 37 weeks' gestation were prospectively enrolled. Mothers received sd NVP during labour. Infants received sd NVP and zidovudine. Blood was collected on specified days after birth and NVP concentrations were determined by liquid chromatography-mass spectrometry.

RESULTS

Data were obtained from 81 infants, 58 born to mothers who received sd NVP during labour (group I) and 23 to mothers who did not receive NVP (group II). Of the infants 29.6% were small for gestational age (SGA). Median (range) maximum concentration (Cmax), time to reach maximum concentration (Tmax), area under the plasma concentration-time curve (AUC) and half-life (T½) were 1 438 (350 - 3 832) ng/ml, 25h50 (9h40 - 83h45), 174 134 (22 308 - 546 408) ng/h/ml and 59.0 (15.4 - 532.6) hours for group I and 1 535 (635 - 4 218) ng/ml, 17h35 (7h40 - 29h), 168 576 (20 268 - 476 712) ng/h/ml and 69.0 (22.12 - 172.3) hours for group II. For group II, the median (range) volume of distribution (Vd) and body clearance (Cl) were 1 702.6 (623.7 - 6 189.8) ml and 34.9 (6.2 - 163.8) ml/h. The AUC was higher (p=0.006) and Cl lower (p<0.0001) in SGA infants. Plasma concentrations exceeding 100ng/ml were achieved over 8 days in 78% infants in group I and 70.0% in group II. The MTCT rate was 4.8%.

CONCLUSION

Women in preterm labour often deliver with little advance warning. Our study suggests that NVP dosing of preterm infants as soon as possible after birth without maternal intrapartum dosing may be as effective as combined maternal and infant dosing.

摘要

背景

目前尚无接受单剂量奈韦拉平（sdNVP）预防母婴传播（MTCT）的早产儿药代动力学数据。

目的

描述两组早产儿中 NVP 衰减的药代动力学特征，即母亲在分娩时接受或未接受 NVP 的早产儿。

方法

前瞻性纳入胎龄小于 37 周的婴儿。母亲在分娩时接受 sdNVP。婴儿接受 sdNVP 和齐多夫定。在出生后特定的日子采集血液，并通过液相色谱-质谱法测定 NVP 浓度。

结果

共 81 名婴儿的数据纳入研究，其中 58 名婴儿的母亲在分娩时接受 sdNVP（I 组），23 名婴儿的母亲未接受 NVP（II 组）。婴儿中 29.6%为小于胎龄儿（SGA）。I 组的最大浓度（Cmax）、达到最大浓度的时间（Tmax）、血浆浓度-时间曲线下面积（AUC）和半衰期（T½）中位数（范围）分别为 1438（350-3832）ng/ml、25h50（9h40-83h45）、174134（22308-546408）ng/h/ml 和 59.0（15.4-532.6）小时，II 组分别为 1535（635-4218）ng/ml、17h35（7h40-29h）、168576（20268-476712）ng/h/ml 和 69.0（22.12-172.3）小时。对于 II 组，体积分布（Vd）和体清除率（Cl）中位数（范围）分别为 1702.6（623.7-6189.8）ml 和 34.9（6.2-163.8）ml/h。SGA 婴儿的 AUC 更高（p=0.006），Cl 更低（p<0.0001）。I 组 78%的婴儿和 II 组 70.0%的婴儿在 8 天内达到超过 100ng/ml 的血浆浓度。MTCT 率为 4.8%。