Department of Paediatrics, The University of Melbourne, Parkville, Australia;
The Royal Children's Hospital Melbourne, Parkville, Australia.
Pediatrics. 2019 Feb;143(2). doi: 10.1542/peds.2018-2179.
In adults, continuous infusions of vancomycin (CIV) are associated with earlier attainment of target drug concentrations, require fewer blood samples for monitoring, and may reduce drug toxicity. We aimed to determine, in young infants, if CIV or intermittent infusions of vancomycin (IIV) better achieves target vancomycin concentrations at the first steady-state level and to compare the frequency of drug-related adverse effects.
In a multicenter randomized controlled trial in 2 tertiary neonatal units over a 40-month period, young infants aged 0 to 90 days requiring vancomycin therapy for at least 48 hours were randomly assigned to CIV and IIV.
Of 111 infants randomized, 104 were included in the intention-to-treat analysis. Baseline characteristics were similar for both groups. The proportion of infants achieving target concentrations at the first steady-state level was higher for CIV compared with IIV (45 in 53 [85%] vs 21 in 51 [41%]; < .001). Fewer dose adjustments were required in the CIV group (median 0; range 0-1) compared with the IIV group (median 1; range 0-3; < .001). The mean daily dose required to achieve target concentrations was lower with CIV compared with IIV (40.6 [SD 10.7] vs 60.6 [SD 53.0] mg/kg per day, respectively; = .01). No drug-related adverse effects occurred in either group.
In young infants, CIV is associated with earlier and improved attainment of target concentrations compared with IIV. Lower total daily doses are required to achieve target levels with CIV. There is no difference in the rate of drug-related adverse effects.
在成人中,万古霉素持续输注(CIV)与更早达到目标药物浓度、需要更少的监测血样以及可能降低药物毒性相关。我们旨在确定在小婴儿中,CIV 或万古霉素间歇性输注(IIV)是否能更好地在第一次稳态水平达到目标万古霉素浓度,并比较药物相关不良反应的发生频率。
在 2 个三级新生儿单位进行的 40 个月的多中心随机对照试验中,需要万古霉素治疗至少 48 小时的 0 至 90 天龄的小婴儿被随机分配至 CIV 和 IIV 组。
111 名随机分组的婴儿中,104 名纳入意向治疗分析。两组的基线特征相似。与 IIV 相比,CIV 组在第一次稳态水平达到目标浓度的婴儿比例更高(45/53 [85%] 与 21/51 [41%]; <.001)。CIV 组需要的剂量调整次数少于 IIV 组(中位数 0;范围 0-1)与 IIV 组(中位数 1;范围 0-3; <.001)。与 IIV 相比,CIV 达到目标浓度所需的平均日剂量更低(40.6 [10.7] 与 60.6 [53.0] mg/kg/天,分别; =.01)。两组均未发生与药物相关的不良反应。
在小婴儿中,与 IIV 相比,CIV 与更早和更好地达到目标浓度相关。CIV 达到目标水平所需的总日剂量较低。药物相关不良反应的发生率无差异。