Department of Pharmacy, Primary Children's Hospital, Salt Lake City, UT.
Am J Health Syst Pharm. 2019 May 17;76(11):815-819. doi: 10.1093/ajhp/zxz055.
The study analyzes the effectiveness and safety of a higher than standard enoxaparin dosing protocol implemented for pediatric patients requiring initiation of therapeutic anticoagulation.
A retrospective review of 2 enoxaparin dosing and monitoring protocols was performed. The standard protocol used 1.5 mg/kg/dose (in patients <3 months of age) and 1 mg/kg/dose (in patients ≥3 months of age) with anti-Xa monitoring following the first dose. The high-dose protocol was implemented at 1.7 mg/kg/dose (in patients <3 months of age), 1.5 mg/kg/dose (in patients 3 through 11 months of age), 1.2 mg/kg/dose (in patients 1 through 4 years of age), and 1.1 mg/kg/dose (in patients 5 through 17 years of age), with anti-Xa monitoring after the second dose. Primary outcomes were number of dosing changes prior to and time to first target anti-Xa level. Secondary outcomes included percentage of patients with anti-Xa levels above target level.
The median number of dose changes required to achieve a target anti-Xa level was 1 (interquartile range [IQR], 0-1.5) and 0 (IQR, 0-1) for the standard-dose (n = 87) and high-dose groups (n = 132) (p = 0.17), respectively. The median number of dose adjustments to achieve target anti-Xa levels in the 3 through 11 months of age subgroup declined from 2 (IQR, 1-3.25) to 0 (IQR, 0-1) in the standard- versus high-dose groups, respectively (p < 0.01). No difference was seen in other age subgroups. Patients with above-target levels did not differ statistically between groups.
Initiating enoxaparin at higher doses in pediatric patients may result in fewer dosing changes than standard dosing. Benefit was demonstrated for the 3-11 months of age high-dose subgroup. Across all groups, the high-dose strategy was safe and did not result in a statistically significant increase in above-target levels.
本研究分析了为需要开始治疗性抗凝的儿科患者实施高于标准依诺肝素给药方案的有效性和安全性。
对两种依诺肝素给药和监测方案进行了回顾性分析。标准方案在<3 个月龄的患者中使用 1.5mg/kg/剂量，在≥3 个月龄的患者中使用 1mg/kg/剂量，并在首剂后进行抗 Xa 监测。高剂量方案在<3 个月龄的患者中使用 1.7mg/kg/剂量，在 3 至 11 个月龄的患者中使用 1.5mg/kg/剂量，在 1 至 4 岁的患者中使用 1.2mg/kg/剂量，在 5 至 17 岁的患者中使用 1.1mg/kg/剂量，并在第二剂后进行抗 Xa 监测。主要结局为达到首个目标抗 Xa 水平前的剂量调整次数和达到首个目标抗 Xa 水平的时间。次要结局包括抗 Xa 水平高于目标水平的患者百分比。
标准剂量组（n=87）和高剂量组（n=132）达到目标抗 Xa 水平所需的剂量调整中位数分别为 1（四分位距 [IQR]，0-1.5）和 0（IQR，0-1）（p=0.17）。在 3 至 11 个月龄亚组中，标准剂量组到高剂量组的目标抗 Xa 水平的剂量调整中位数从 2（IQR，1-3.25）下降到 0（IQR，0-1）（p<0.01）。在其他年龄亚组中没有差异。各组之间靶标水平以上的患者没有统计学差异。
在儿科患者中起始依诺肝素高剂量可能比标准剂量需要更少的剂量调整。在 3 至 11 个月龄高剂量亚组中观察到了益处。在所有组中，高剂量策略是安全的，不会导致靶标水平以上的比例统计学显著增加。
