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对乙酰氨基酚口服与直肠给药治疗早产儿动脉导管未闭的疗效及安全性比较:临床随机试验

Comparison of Therapeutic Effect and Safety of Oral and Rectal Use of Acetaminophen on Patent Ductus Arteriosus in Preterm Infants: Clinical Randomized Trial.

作者信息

Vakiliamini Mazyar, Daryoushi Hooman, Babai Homa, Chegene Lorestani Roya, Rostamian Mosayeb, Akya Alisha, Habibi Reza, Ghadiri Keyghobad

机构信息

Department of Pediatrics, Clinical Research Development Center, Imam Khomaini and Mohammad Kermanshahi Hospitals, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Department of Pediatrics, Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.

出版信息

Glob Pediatr Health. 2023 Jan 29;10:2333794X231152116. doi: 10.1177/2333794X231152116. eCollection 2023.

DOI:10.1177/2333794X231152116
PMID:36733954
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9887655/
Abstract

The prevalence of patent ductus arteriosus (PDA) in preterm infants is high. There is little information about the therapeutic effect and safety of rectal acetaminophen in the treatment of PDA. We aimed to compare the therapeutic effect and safety of oral and rectal acetaminophen on PDA in preterm infants. This study was a single-blind randomized clinical trial using 40 preterm infants. The cases were hospitalized in the neonatal intensive care unit of Mohammad Kermanshahi and Imam Reza hospitals of Kermanshah. Subjects were randomly divided into 2 groups, the first group was treated with oral acetaminophen and the second group was treated with rectal acetaminophen. The presence of PDA and response to treatment was assessed based on pre- and post-treatment echocardiographic criteria. The likelihood of complications or prohibition of acetaminophen use was assessed with paraclinical tests before and after treatment. The neonates were in the age range of 30 to 35 weeks. Twenty-one cases (52.5%) were boys and 19 cases (47.5%) were girls. Two cases in the oral-acetaminophen group and 1 case in the rectal-acetaminophen group needed the second round of treatment. There was no difference between the success of treatment and the type of treatment. The study showed that there was no difference between PDA treatment of preterm infants with oral and rectal acetaminophen. Also, no side effects were observed in treatment with any of the treatments. Therefore, it could be suggested that in infants who are intolerant to oral acetaminophen, the rectal form can be used.

摘要

早产儿动脉导管未闭(PDA)的患病率很高。关于直肠用对乙酰氨基酚治疗PDA的疗效和安全性的信息很少。我们旨在比较口服和直肠用对乙酰氨基酚治疗早产儿PDA的疗效和安全性。本研究是一项单盲随机临床试验,纳入了40例早产儿。这些病例在克尔曼沙阿的穆罕默德·克尔曼沙希医院和伊玛目·礼萨医院的新生儿重症监护病房住院。研究对象被随机分为两组,第一组接受口服对乙酰氨基酚治疗,第二组接受直肠用对乙酰氨基酚治疗。根据治疗前后的超声心动图标准评估PDA的存在情况和治疗反应。通过治疗前后的辅助检查评估使用对乙酰氨基酚出现并发症或禁忌的可能性。这些新生儿的年龄在30至35周之间。21例(52.5%)为男孩,19例(47.5%)为女孩。口服对乙酰氨基酚组有2例和直肠用对乙酰氨基酚组有1例需要第二轮治疗。治疗成功率和治疗类型之间没有差异。研究表明,口服和直肠用对乙酰氨基酚治疗早产儿PDA没有差异。此外,任何一种治疗方法均未观察到副作用。因此,可以建议,对于不耐受口服对乙酰氨基酚的婴儿,可以使用直肠剂型。

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Comparison of Therapeutic Effect and Safety of Oral and Rectal Use of Acetaminophen on Patent Ductus Arteriosus in Preterm Infants: Clinical Randomized Trial.对乙酰氨基酚口服与直肠给药治疗早产儿动脉导管未闭的疗效及安全性比较:临床随机试验
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本文引用的文献

1
Oral paracetamol vs. oral ibuprofen in the treatment of symptomatic patent ductus arteriosus in premature infants: A randomized controlled trial.口服对乙酰氨基酚与口服布洛芬治疗早产儿有症状动脉导管未闭的随机对照试验
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Pharmacological Closure of Patent Ductus Arteriosus: Selecting the Agent and Route of Administration.动脉导管未闭的药物封堵:药物及给药途径的选择
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Clinical pharmacology of paracetamol in neonates: a review.对乙酰氨基酚在新生儿中的临床药理学:综述
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Efficacy of paracetamol for the treatment of patent ductus arteriosus in preterm neonates.对乙酰氨基酚治疗早产儿动脉导管未闭的疗效。
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Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial.口服对乙酰氨基酚与口服布洛芬治疗早产儿动脉导管未闭的随机对照试验。
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Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial.口服对乙酰氨基酚与布洛芬治疗早产儿动脉导管未闭的比较:一项随机对照试验。
PLoS One. 2013 Nov 4;8(11):e77888. doi: 10.1371/journal.pone.0077888. eCollection 2013.
7
Paracetamol therapy for patent ductus arteriosus in premature infants: a chance before surgical ligation.对早产儿动脉导管未闭采用对乙酰氨基酚治疗:手术结扎前的一次机会。
Pediatr Cardiol. 2014 Feb;35(2):276-9. doi: 10.1007/s00246-013-0770-9. Epub 2013 Aug 13.
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A different first-choice drug in the medical management of patent ductus arteriosus: oral paracetamol.动脉导管未闭药物治疗中的一种不同的首选药物:口服对乙酰氨基酚。
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Patent ductus arteriosus: an overview.动脉导管未闭:概述
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10
Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment.对乙酰氨基酚关闭动脉导管:治疗动脉导管未闭的新方法。
Pediatrics. 2011 Dec;128(6):e1618-21. doi: 10.1542/peds.2011-0359. Epub 2011 Nov 7.