Increased indomethacin dosing for persistent patent ductus arteriosus in preterm infants: a multicenter, randomized, controlled trial.
Increased indomethacin dosing for persistent patent ductus arteriosus in preterm infants: a multicenter, randomized, controlled trial.
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增加吲哚美辛剂量治疗早产儿持续性动脉导管未闭：一项多中心、随机、对照试验。
DOI：
10.1016/j.jpeds.2008.01.031
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发表时间：
2008
期刊：
影响因子：
--
通讯作者：
Clyman,Ronald
中科院分区：
文献类型：
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作者：
Jegatheesan,Priya;Ianus,Vlad;Buchh,Basharat;Yoon,Grace;Chorne,Nancy;Ewig,Audrey;Lin,Emil;Fields,Scott;Moon-Grady,Anita;Tacy,Terri;Milstein,Jay;Schreiber,Michael;Padbury,James;Clyman,Ronald
目的：我们进行了一项多中心、随机、对照试验，以确定较高剂量的吲哚美辛是否会提高动脉导管未闭(PDA)的闭合率。研究设计：接受常规预防性3剂量吲哚美辛疗程的婴儿(孕28周)，如果在第三次预防性服用吲哚美辛之前的超声心动图上有持续性导管通畅的持续证据，则符合条件。将105名婴儿随机分为低剂量(0.1 mg/kg/d)或高剂量(0.2或0.5 mg/kg/d)吲哚美辛，疗程延长3天。结果高剂量组血清吲哚美辛浓度增加2.9倍，但持续性PDA发生率未见明显下降(低剂量组为52%，高剂量组为45%，P=.50)。中重度早产儿视网膜病变(ROP)发生率显著高于高剂量组(低=15%，高=36%，P<；.025)。中度和重度ROP的发生率与研究后吲哚美辛浓度直接相关(优势比=1.75，可信区间：1.15~2.68，P<；01)。结论在常规给药方案的基础上，增加吲哚美辛浓度对PDA闭合率影响不大，但与中/重度ROP和肾损害的发生率增加有关。
OBJECTIVEWe conducted a multicenter, randomized, controlled trial to determine whether higher doses of indomethacin would improve the rate of patent ductus arteriosus (PDA) closure.STUDY DESIGNInfants (<28 weeks gestation) who received a conventional, prophylactic 3-dose course of indomethacin were eligible if they had continued evidence of persistent ductus patency on an echocardiogram obtained before the third prophylactic indomethacin dose. Infants (n = 105) were randomized to receive an extended 3-day course of either low-dose (0.1 mg/kg/d) or higher-dose (0.2 or 0.5 mg/kg/d) indomethacin. An echocardiogram was obtained 24 hours after the last dose of study drug.RESULTSDespite increasing serum indomethacin concentrations by 2.9-fold in the higher-dose group, we failed to detect a significant decrease in the rate of persistent PDA (low = 52%; higher = 45%, P = .50). The higher-dose group had a significantly higher occurrence of serum creatinine >2 mg/100 mL (low = 6%, higher = 19%, P < .05) and moderate/severe retinopathy of prematurity (ROP) (low = 15%, higher = 36%, P < .025). The incidence of moderate/severe ROP was directly related to the poststudy indomethacin concentrations (odds ratio = 1.75, confidence interval: 1.15-2.68, P < .01).CONCLUSIONIncreasing indomethacin concentrations above the levels achieved with a conventional dosing regimen had little effect on the rate of PDA closure but was associated with higher rates of moderate/severe ROP and renal compromise.