Evans M, Bhat R, Vidyasagar D, Patel M, Hastreiter A
Pediatr Pharmacol (New York). 1981;1(3):251-8.
Plasma concentrations of indomethacin were studied in 18 premature infants exhibiting significant patent ductus arteriosus (sPDA) after either intravenous or oral drug administration. Oral absorption of indomethacin was prolonged and bioavailability, based on area under the curve (AUC), was less than 20%. The mean volume of distribution for indomethacin was 0.36 l/kg and showed only a small variation between subjects. The drug elimination half-life ranged from 10-25 hours and demonstrated a significant correlation with gestational age. There was no evidence to support dose-dependent clearance or enterohepatic circulation in this study. Side effects of indomethacin were limited in one infant. No significant changes were observed in hematocrit, platelet count, and serum creatinine. The results from this study support the continued use of intravenous sodium indomethacin trihydrate at doses of 0.2 mg/kg and intervals of 18-24 hours for pharmacological treatment of sPDA.
在18例患有显著动脉导管未闭（sPDA）的早产儿中，研究了静脉或口服给药后吲哚美辛的血浆浓度。吲哚美辛的口服吸收延长，基于曲线下面积（AUC）的生物利用度低于20%。吲哚美辛的平均分布容积为0.36 l/kg，受试者之间仅有微小差异。药物消除半衰期为10 - 25小时，与胎龄呈显著相关。本研究没有证据支持剂量依赖性清除或肝肠循环。1例婴儿中吲哚美辛的副作用有限。血细胞比容、血小板计数和血清肌酐未观察到显著变化。本研究结果支持继续以0.2 mg/kg的剂量、18 - 24小时的间隔静脉注射三水合吲哚美辛钠用于sPDA的药物治疗。
