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一项静脉注射对乙酰氨基酚与吲哚美辛治疗极低出生体重儿临床显著动脉导管未闭的随机试验。

A randomized trial of intravenous acetaminophen versus indomethacin for treatment of hemodynamically significant PDAs in VLBW infants.

机构信息

University of Tennessee Health Science Center, Memphis, TN, USA.

Regional One Health, Memphis, TN, USA.

出版信息

J Perinatol. 2021 Jan;41(1):93-99. doi: 10.1038/s41372-020-0694-1. Epub 2020 May 21.

DOI:10.1038/s41372-020-0694-1
PMID:32439957
Abstract

Objective was to compare the rate of successful treatment of hsPDA based on echocardiogram criteria after use of IV acetaminophen or IV indomethacin in very low-birthweight infants. The study was a multi-center, randomized controlled trial. Infants born prior to 32 weeks with birthweight ≤ 1500 g were included if PDA treatment was indicated within the 21 days after birth. hsPDA was defined by strict echocardiogram criteria. Eligible infants were randomized to treatment with either IV acetaminophen or IV indomethacin. Of 86 eligible infants, 17 infants were randomized to acetaminophen and 20 to indomethacin. One (5.9%) hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002). Eight (47%) in the acetaminophen group and 3 (15%) in the indomethacin group received transcatheter PDA closure (p = 0.07). IV indomethacin was more effective than IV acetaminophen for treatment of hsPDAs. More infants in the acetaminophen group received transcatheter closure.

摘要

目的是比较在极低出生体重儿中使用静脉注射对乙酰氨基酚或静脉注射吲哚美辛后,根据超声心动图标准治疗新生儿持续性肺动脉高压(hsPDA)的成功率。该研究是一项多中心、随机对照试验。如果出生后 21 天内需要治疗 PDA,则将出生体重≤1500g、胎龄<32 周的婴儿纳入研究。hsPDA 由严格的超声心动图标准定义。符合条件的婴儿被随机分为静脉注射对乙酰氨基酚或静脉注射吲哚美辛治疗组。在 86 名符合条件的婴儿中,17 名婴儿被随机分配到对乙酰氨基酚组,20 名婴儿被分配到吲哚美辛组。与吲哚美辛组 11 例(55%)相比,对乙酰氨基酚组有 1 例(5.9%)hsPDA 治疗成功(p=0.002)。对乙酰氨基酚组有 8 例(47%)和吲哚美辛组有 3 例(15%)接受了经导管 PDA 封堵(p=0.07)。与静脉注射对乙酰氨基酚相比,静脉注射吲哚美辛治疗 hsPDA 更有效。对乙酰氨基酚组中更多的婴儿接受了经导管封堵。

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Cochrane Database Syst Rev. 2020 Jan 27;1(1):CD010061. doi: 10.1002/14651858.CD010061.pub4.
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Practice variation in the management of patent ductus arteriosus in extremely low birth weight infants in the United States: Survey results among cardiologists and neonatologists.
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J Perinatol. 2025 Mar;45(3):319-325. doi: 10.1038/s41372-024-02199-5. Epub 2024 Dec 18.
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