Gilman J T, Gal P
Drug Intell Clin Pharm. 1986 Jun;20(6):481-4. doi: 10.1177/106002808602000609.
The efficacy of the FDA guidelines for theophylline dosing in newborns was evaluated retrospectively in 224 patients who had clearance data available. Mean projected post loading dose serum concentration was 4.1 +/- 1.0 mg/L in 160 patients. Mean projected steady-state concentration was 4.8 +/- 1.6 mg/L in 189 patients receiving intravenous aminophylline and 4.2 +/- 1.3 mg/L in 35 patients on oral therapy. Projected serum concentrations were subtherapeutic (less than 6.0 mg/L) in 181 of the 224 patients analyzed. There was a statistically significant difference in serum concentrations between asphyxiated and nonasphyxiated patients (p less than 0.001). There was no significant difference in mean projected serum concentrations between patients age 26-41 weeks (postconceptional age). This study suggests that the FDA dosing guidelines for theophylline in infants is inadequate and results in subtherapeutic (less than 6.0 mg/L) serum concentrations in the majority of newborns.
对224例有清除率数据的患者进行回顾性评估，以评价美国食品药品监督管理局（FDA）的新生儿茶碱给药指南的疗效。160例患者负荷剂量后预计的血清平均浓度为4.1±1.0mg/L。189例接受静脉注射氨茶碱治疗的患者预计稳态浓度为4.8±1.6mg/L，35例接受口服治疗的患者为4.2±1.3mg/L。在分析的224例患者中，有181例患者预计的血清浓度低于治疗水平（低于6.0mg/L）。窒息患者和非窒息患者的血清浓度存在统计学显著差异（p<0.001）。孕龄26 - 41周的患者预计血清平均浓度无显著差异。这项研究表明，FDA的婴儿茶碱给药指南并不充分，导致大多数新生儿的血清浓度低于治疗水平（低于6.0mg/L）。
