California Pacific Medical Center Department of Pharmacy, San Francisco, CA 94120, USA.
J Clin Pharm Ther. 2010 Oct;35(5):589-92. doi: 10.1111/j.1365-2710.2009.01142.x.
Indomethacin, a non-selective inhibitor of prostaglandin synthesis, is the gold standard treatment for patent ductus arteriosus (PDA). Indomethacin has been shown to permanently close the ductus and when given prophylactically, it reduces the incidence of PDA (1, 2).
This study compares PDA closure and surgical ligation rates between patients using two different indomethacin administration protocols.
This is a retrospective comparison analysis of 72 neonates, who received one of two indomethacin administration protocols. Our previous protocol suggested an initial dose of 0·2 mg/kg followed by two 0·1 mg/kg, with doses infused over 4 h and a 24-h dosing interval. A new potentially more useful protocol using the same mg/kg dose regimen but with doses infused over 30 min and a 12-h dosing interval, was evaluated. Each neonate was allowed three courses of treatment before surgical ligation was performed for persistent PDA.
There were no statistically significant differences between the two protocol groups when comparing percentages of neonates with gestational age≤28 weeks, birth weight≤1000 g, male gender or receiving indomethacin for the indication of PDA prophylaxis vs. treatment. There was a trend towards a higher PDA closure rate and subsequently a lower PDA ligation rate in the new protocol when compared with the previous protocol.
In this small population of premature neonates, there was a trend, but no significant difference, towards increasing PDA closure and lower surgical ligation rates in neonates given indomethacin with more frequent dosing and shorter infusion time. A well-powered randomized controlled trial is now needed.
非选择性前列腺素合成抑制剂吲哚美辛是动脉导管未闭（PDA）的金标准治疗药物。吲哚美辛已被证明可永久性关闭动脉导管，预防性使用时可降低 PDA 的发生率（1，2）。
本研究比较了使用两种不同吲哚美辛给药方案的患者中 PDA 闭合和手术结扎率。
这是对 72 名接受两种不同吲哚美辛给药方案之一的新生儿进行的回顾性比较分析。我们之前的方案建议初始剂量为 0.2mg/kg，随后两次 0.1mg/kg，剂量输注 4 小时，间隔 24 小时。评估了一种新的、可能更有用的方案，该方案使用相同的 mg/kg 剂量方案，但剂量输注 30 分钟，间隔 12 小时。每个新生儿允许接受三个疗程的治疗，然后再对持续 PDA 进行手术结扎。
当比较胎龄≤28 周、出生体重≤1000g、男性或因 PDA 预防与治疗而接受吲哚美辛的新生儿比例时，两组方案之间没有统计学上的显著差异。与旧方案相比，新方案中 PDA 闭合率较高，随后 PDA 结扎率较低，这一趋势明显。
在这一小部分早产儿中，与使用旧方案相比，接受更频繁给药和更短输注时间的吲哚美辛治疗的新生儿，PDA 闭合率升高，手术结扎率降低，但差异无统计学意义。现在需要一项精心设计的随机对照试验。
