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静脉注射硫酸镁治疗细支气管炎:一项随机试验。

IV Magnesium Sulfate for Bronchiolitis: A Randomized Trial.

作者信息

Alansari Khalid, Sayyed Rafah, Davidson Bruce L, Al Jawala Shahaza, Ghadier Mohamed

机构信息

Division of Pediatric Emergency Medicine, Department of Pediatrics, Hamad Medical Corporation, Doha, Qatar; Weill Cornell Medical College, Doha, Qatar; Division of Pediatric Emergency Medicine, Department of Pediatrics, Sidra Medical and Research Center, Doha, Qatar.

Division of Pediatric Emergency Medicine, Department of Pediatrics, Hamad Medical Corporation, Doha, Qatar.

出版信息

Chest. 2017 Jul;152(1):113-119. doi: 10.1016/j.chest.2017.03.002. Epub 2017 Mar 9.

Abstract

BACKGROUND

The goal of this study was to determine if IV magnesium, useful for severe pediatric asthma, reduces time to medical readiness for discharge in patients with bronchiolitis when added to supportive care.

METHODS

We compared a single dose of 100 mg/kg of IV magnesium sulfate vs placebo for acute bronchiolitis. Patients received bronchodilator therapy, nebulized hypertonic saline, and 5 days of dexamethasone if there was eczema and/or a family history of asthma. Time to medical readiness for discharge was the primary efficacy outcome. Bronchiolitis severity scores and need for infirmary or hospital admission and for clinic revisits within 2 weeks were secondary outcomes. Cardiorespiratory instability onset was the safety outcome.

RESULTS

A total of 162 previously healthy infants diagnosed with bronchiolitis aged 22 days to 17.6 months (median, 3.7 months) were enrolled. Approximately one-half of patients had eczema and/or a family history of asthma; 86.4% had positive findings on nasopharyngeal virus swabs. Geometric mean time until medical readiness for discharge was 24.1 h (95% CI, 20.0-29.1) for the 78 magnesium-treated patients and 25.3 h (95% CI, 20.3-31.5) for the 82 patients receiving placebo (ratio, 0.95 [95% CI, 0.52-1.80]; P = .91). Mean bronchiolitis severity scores over time were similar for the two groups. The frequency of clinic visits in the subsequent 2 weeks (33.8% and 27.2%, respectively) was also similar. Fifteen magnesium recipients (19.5%) vs five placebo recipients (6.2%) were readmitted to the infirmary or hospital within 2 weeks (P = .016). No acute cardiorespiratory side effects were reported.

CONCLUSIONS

IV magnesium did not provide benefit for patients with acute bronchiolitis and may be harmful.

TRIAL REGISTRY

ClinicalTrials.gov; No.: NCT02145520; URL: www.clinicaltrials.gov.

摘要

背景

本研究的目的是确定对重症小儿哮喘有效的静脉注射镁剂,在添加到支持性治疗中时,是否能缩短细支气管炎患者达到出院医疗准备状态的时间。

方法

我们比较了单剂量100mg/kg静脉注射硫酸镁与安慰剂治疗急性细支气管炎的效果。患者接受支气管扩张剂治疗、雾化高渗盐水治疗,若有湿疹和/或哮喘家族史,则接受5天的地塞米松治疗。达到出院医疗准备状态的时间是主要疗效指标。细支气管炎严重程度评分以及2周内需要医务室或医院收治及门诊复诊情况是次要指标。心肺功能不稳定的发生情况是安全性指标。

结果

共纳入162名年龄在22天至17.6个月(中位数3.7个月)、先前健康且被诊断为细支气管炎的婴儿。约一半患者有湿疹和/或哮喘家族史;86.4%的患者鼻咽病毒拭子检测呈阳性。78名接受镁剂治疗的患者达到出院医疗准备状态的几何平均时间为24.1小时(95%CI,20.0 - 29.1),82名接受安慰剂治疗的患者为25.3小时(95%CI,20.3 - 31.5)(比值,0.95 [95%CI,0.52 - 1.80];P = 0.91)。两组随时间的平均细支气管炎严重程度评分相似。随后2周内门诊复诊频率(分别为33.8%和27.2%)也相似。15名接受镁剂治疗的患者(19.5%)与5名接受安慰剂治疗的患者(6.2%)在2周内再次入住医务室或医院(P = 0.016)。未报告急性心肺副作用。

结论

静脉注射镁剂对急性细支气管炎患者无益处,且可能有害。

试验注册

ClinicalTrials.gov;编号:NCT02145520;网址:www.clinicaltrials.gov。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf94/7094486/2f53ebd69c66/gr1_lrg.jpg

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