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一项关于静脉注射镁剂治疗儿童镰状细胞疼痛危象的多中心随机对照试验。

A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children.

作者信息

Brousseau David C, Scott J Paul, Badaki-Makun Oluwakemi, Darbari Deepika S, Chumpitazi Corrie E, Airewele Gladstone E, Ellison Angela M, Smith-Whitley Kim, Mahajan Prashant, Sarnaik Sharada A, Casper T Charles, Cook Lawrence J, Dean J Michael, Leonard Julie, Hulbert Monica L, Powell Elizabeth C, Liem Robert I, Hickey Robert, Krishnamurti Lakshmanan, Hillery Cheryl A, Nimmer Mark, Panepinto Julie A

机构信息

Pediatric Emergency Medicine, Medical College of Wisconsin, and the Children's Research Institute, Milwaukee, WI;

Pediatric Hematology and Oncology/Blood Research Institute, Medical College of Wisconsin, and the Children's Research Institute, Milwaukee, WI;

出版信息

Blood. 2015 Oct 1;126(14):1651-7. doi: 10.1182/blood-2015-05-647107. Epub 2015 Jul 31.

DOI:10.1182/blood-2015-05-647107
PMID:26232172
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4591790/
Abstract

Magnesium, a vasodilator, anti-inflammatory, and pain reliever, could alter the pathophysiology of sickle cell pain crises. We hypothesized that intravenous magnesium would shorten length of stay, decrease opioid use, and improve health-related quality of life (HRQL) for pediatric patients hospitalized with sickle cell pain crises. The Magnesium for Children in Crisis (MAGiC) study was a randomized, double-blind, placebo-controlled trial of intravenous magnesium vs normal saline placebo conducted at 8 sites within the Pediatric Emergency Care Applied Research Network (PECARN). Children 4 to 21 years old with hemoglobin SS or Sβ(0) thalassemia requiring hospitalization for pain were eligible. Children received 40 mg/kg of magnesium or placebo every 8 hours for up to 6 doses plus standard therapy. The primary outcome was length of stay in hours from the time of first study drug infusion, compared using a Van Elteren test. Secondary outcomes included opioid use and HRQL. Of 208 children enrolled, 204 received the study drug (101 magnesium, 103 placebo). Between-group demographics and prerandomization treatment were similar. The median interquartile range (IQR) length of stay was 56.0 (27.0-109.0) hours for magnesium vs 47.0 (24.0-99.0) hours for placebo (P = .24). Magnesium patients received 1.46 mg/kg morphine equivalents vs 1.28 mg/kg for placebo (P = .12). Changes in HRQL before discharge and 1 week after discharge were similar (P > .05 for all comparisons). The addition of intravenous magnesium did not shorten length of stay, reduce opioid use, or improve quality of life in children hospitalized for sickle cell pain crisis. This trial was registered at www.clinicaltrials.gov as #NCT01197417.

摘要

镁是一种血管舒张剂、抗炎剂和止痛剂,可能会改变镰状细胞疼痛危象的病理生理学。我们假设,静脉注射镁可以缩短住院时间,减少阿片类药物的使用,并改善因镰状细胞疼痛危象住院的儿科患者的健康相关生活质量(HRQL)。“危机中儿童的镁”(MAGiC)研究是一项在儿科急诊应用研究网络(PECARN)内的8个地点进行的随机、双盲、安慰剂对照试验,比较静脉注射镁与生理盐水安慰剂。4至21岁的血红蛋白SS或Sβ(0)地中海贫血且因疼痛需要住院治疗的儿童符合条件。儿童每8小时接受40mg/kg的镁或安慰剂,最多6剂,外加标准治疗。主要结局是从首次研究药物输注时间起的住院小时数,使用范埃尔特伦检验进行比较。次要结局包括阿片类药物的使用和HRQL。在208名登记的儿童中,204名接受了研究药物(101名接受镁,103名接受安慰剂)。组间人口统计学和随机分组前的治疗情况相似。镁组的住院时间中位数四分位间距(IQR)为56.0(27.0 - 109.0)小时,而安慰剂组为47.0(24.0 - 99.0)小时(P = 0.24)。镁组患者接受1.46mg/kg吗啡当量,而安慰剂组为1.28mg/kg(P = (此处原文有误,应为P = 0.12))。出院前和出院后1周HRQL的变化相似(所有比较的P > 0.05)。对于因镰状细胞疼痛危象住院的儿童,添加静脉注射镁并没有缩短住院时间、减少阿片类药物的使用或改善生活质量。该试验在www.clinicaltrials.gov上注册,编号为#NCT01197417。

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本文引用的文献

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Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: methodological issues of a randomized controlled trial.静脉注射镁治疗小儿镰状细胞血管阻塞性危象:一项随机对照试验的方法学问题。
Pediatr Blood Cancer. 2014 Jun;61(6):1049-54. doi: 10.1002/pbc.24925. Epub 2014 Jan 17.
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Intravenous magnesium sulfate for vaso-occlusive episodes in sickle cell disease.静脉注射硫酸镁治疗镰状细胞病血管阻塞性发作。
Pediatrics. 2013 Dec;132(6):e1634-41. doi: 10.1542/peds.2013-2065. Epub 2013 Nov 25.
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PedsQL™ Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity.儿童生活质量问卷多维疲劳量表在镰状细胞病中的应用:可行性、信度和效度。
Pediatr Blood Cancer. 2014 Jan;61(1):171-7. doi: 10.1002/pbc.24776. Epub 2013 Sep 13.
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IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies.IMPROVE 试验:一项针对镰状细胞病疼痛发作的患者自控镇痛的随机对照试验:原理、设计挑战、初步经验以及对未来研究的建议。
Clin Trials. 2013 Apr;10(2):319-31. doi: 10.1177/1740774513475850.
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PedsQL™ sickle cell disease module: feasibility, reliability, and validity.《PedsQL™ 镰状细胞病模块:可行性、信度和效度》
Pediatr Blood Cancer. 2013 Aug;60(8):1338-44. doi: 10.1002/pbc.24491. Epub 2013 Feb 25.
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The effects of hydroxycarbamide and magnesium on haemoglobin SC disease: results of the multi-centre CHAMPS trial.羟基脲和镁对血红蛋白 SC 病的影响:多中心 CHAMPS 试验的结果。
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