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用于早产儿视网膜病变眼部检查的磁性无创耳针疗法:一项多中心随机对照试验

Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial.

作者信息

Gan Kimberly M L, Oei Ju-Lee, Quah-Smith Im, Kamar Azanna A, Lordudass Alexis A D, Liem Kian D, Lindrea Kwee Bee, Daly Mary, Gaunker Nilima, Mangat Avneet K, Yaskina Maryna, Schmölzer Georg M

机构信息

Faculty of Medicine, University of New South Wales, Kensington, NSW, Australia.

School of Women's and Children's Health, University of New South Wales, Kensington, NSW, Australia.

出版信息

Front Pediatr. 2020 Dec 23;8:615008. doi: 10.3389/fped.2020.615008. eCollection 2020.


DOI:10.3389/fped.2020.615008
PMID:33425820
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7786201/
Abstract

Eye exam for Retinopathy of prematurity (ROP) is a painful procedure and pharmacological analgesia might be ineffective. We hypothesized that magnetic auricular acupuncture (MAA) compared to placebo will decrease pain during ROP exam in preterm infants. Multicentre randomized controlled trial conducted in three hospitals (Australia, Canada, and Malaysia). Eligibility: >32 weeks, ROP exam, not sedated, and parental consent. A total of 100 infants were randomized (1:1) to MAA ( = 50) or placebo ( = 50). MAA stickers or placebo were placed on both ears by an unblinded investigator. Pain was assessed using the Premature Infant Pain Profile. Primary analyses were by intention-to-treat. ClinicalTrials.gov:NCT03650621. The mean (standard deviation, SD) gestation, birthweight, and postnatal age were (MAA 28(3) vs. placebo 28(2) weeks; MAA 1,057(455) vs. placebo 952(273) g; MAA 7(3) vs. placebo 7(3) weeks. Placebo infants had significantly higher PIPP scores during [mean difference 1.6 points (95%CI 0.1-3.1)] and 1 h mean difference 1.5 points (95%CI 0.7-2.2) after the procedure ( < 0.03). Heart rate was lower (173(22) vs. 184(18)/min) and oxygen saturations were higher (93.8(6.2) vs. 91.7(6.1)%, = 0.05) in MAA infants. No adverse effects. MAA may reduce physiological pain responses during and after ROP exam in preterm infants. Assessment of long-term effects are warranted. : www.ClinicalTrials.gov, identifier: NCT03650621.

摘要

早产儿视网膜病变(ROP)的眼部检查是一个痛苦的过程,药物镇痛可能无效。我们假设,与安慰剂相比,磁耳针(MAA)将减轻早产儿ROP检查期间的疼痛。在三家医院(澳大利亚、加拿大和马来西亚)进行的多中心随机对照试验。入选标准:孕周>32周、ROP检查、未镇静且获得家长同意。总共100名婴儿被随机分组(1:1)至MAA组(n = 50)或安慰剂组(n = 50)。由未设盲的研究者在双耳放置MAA贴纸或安慰剂。使用早产儿疼痛量表评估疼痛。主要分析采用意向性分析。ClinicalTrials.gov标识符:NCT03650621。平均(标准差,SD)孕周、出生体重和出生后年龄分别为(MAA组28(3)周 vs. 安慰剂组28(2)周;MAA组1057(455)g vs. 安慰剂组952(273)g;MAA组7(3)周 vs. 安慰剂组7(3)周。安慰剂组婴儿在检查期间[平均差异1.6分(95%CI 0.1 - 3.1)]及检查后1小时[平均差异1.5分(95%CI 0.7 - 2.2)]的早产儿疼痛量表得分显著更高(P<0.03)。MAA组婴儿心率较低(173(22)次/分钟 vs. 184(18)次/分钟),血氧饱和度较高(93.8(6.2)% vs. 91.7(6.1)%,P = 0.05)。无不良反应。MAA可能减轻早产儿ROP检查期间及检查后的生理疼痛反应。有必要评估其长期影响。网址:www.ClinicalTrials.gov,标识符:NCT03650621。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e613/7786201/a7d85367ba9f/fped-08-615008-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e613/7786201/05ed5f70c28c/fped-08-615008-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e613/7786201/a7d85367ba9f/fped-08-615008-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e613/7786201/05ed5f70c28c/fped-08-615008-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e613/7786201/a7d85367ba9f/fped-08-615008-g0002.jpg

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引用本文的文献

[1]
The grass is always greener: a critical look at the lessons and challenges of acupuncture education in America.

Front Med (Lausanne). 2025-4-22

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本文引用的文献

[1]
A Scoping Review of Acupuncture as a Potential Intervention for Neonatal Abstinence Syndrome.

Med Acupunct. 2019-4-1

[2]
Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.

Lancet. 2018-11-30

[3]
Infant Analgesia With a Combination of Breast Milk, Glucose, or Maternal Holding.

Pediatrics. 2018-9

[4]
Anatomo-Physiologic Basis for Auricular Stimulation.

Med Acupunct. 2018-6-1

[5]
Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis.

Pediatrics. 2018-6-1

[6]
Magnetic noninvasive acupuncture for infant comfort (MAGNIFIC) - a single-blinded randomised controlled pilot trial.

Acta Paediatr. 2017-8-29

[7]
Acupuncture in the neonatal intensive care unit-using ancient medicine to help today's babies: a review.

J Perinatol. 2017-7

[8]
Evidence for Neurotoxicity Due to Morphine or Hydromorphone Use in Renal Impairment: A Systematic Review.

J Palliat Med. 2016-11

[9]
The strange case of the ear and the heart: The auricular vagus nerve and its influence on cardiac control.

Auton Neurosci. 2016-8

[10]
The burden of venipuncture pain in neonatal intensive care units: EPIPPAIN 2, a prospective observational study.

Int J Nurs Stud. 2016-5

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