A Phase II/III, Multicenter, Safety, Efficacy, and Pharmacokinetic Study of Dexmedetomidine in Preterm and Term Neonates
A Phase II/III, Multicenter, Safety, Efficacy, and Pharmacokinetic Study of Dexmedetomidine in Preterm and Term Neonates
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DOI：
10.1016/j.jpeds.2013.10.002
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发表时间：
2014-02-01
影响因子：
5.1
通讯作者：
Gramlich, Lisa
中科院分区：
文献类型：
--
作者：
Chrysostomou, Constantinos;Schulman, Scott R.;Gramlich, Lisa
目的探讨右美托咪定在早产儿和足月新生儿（>= 28 ~ 28 ~ < 36周）和II组（n = 24）（>= 36 ~ 3）伴有躁动/疼痛的安全性、有效性和药代动力学特征，其中4例（10%）患者需要更多镇静，17例（40%）患者需要更多镇痛。尽管药代动力学变量存在显著差异，但I组的体重调整血浆清除率较低（0.3 vs 0.9 l h(-1)）。kg(-1))和增加的消除半衰期（7.6 vs 3.2小时）与II组相比。26例患者（62%）报告56例不良事件（ae）；仅有3例ae（5%）与右美托咪定相关。没有严重的不良反应，没有不良反应或血流动力学改变需要右美托咪定停用。结论右美托咪定对早产儿和足月新生儿具有良好的镇静作用，且耐受性良好，无明显不良反应。早产儿血浆清除率降低，消除半衰期延长。
Objective To investigate the safety, efficacy, and pharmacokinetic profile of dexmedetomidine in preterm and full-term neonates >= 28 to = 28 to < 36 weeks, and group II (n = 24), >= 36 to 3, indicating agitation/pain, with 4 patients (10%) requiring more sedation and 17 (40%) requiring more analgesia. Though there was significant variability in pharmacokinetic variables, group I appeared to have lower weight-adjusted plasma clearance (0.3 vs 0.9 L.h(-1).kg(-1)) and increased elimination half-life (7.6 vs 3.2 hours) compared with group II. Fifty-six adverse events (AEs) were reported in 26 patients (62%); only 3 AEs (5%) were related to dexmedetomidine. There were no serious AEs and no AEs or hemodynamic changes requiring dexmedetomidine discontinuation.Conclusion Dexmedetomidine is effective for sedating preterm and full-term neonates and is well-tolerated without significant AEs. Preterm neonates had decreased plasma clearance and longer elimination half-life.