Alansari Khalid, Ahmed Wessam, Davidson Bruce L, Alamri Mohamed, Zakaria Ibrahim, Alrifaai Mahomud
Department of Pediatrics, Division of Pediatric Emergency Medicine, Sidra Medical and Research Centre, Doha, Qatar.
Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.
Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.
Intravenous magnesium sulfate, a rescue therapy added to bronchodilator and systemic steroid therapy for moderate and severe asthma, is uncommonly administered. We hypothesized that nebulized magnesium would confer benefit without undue risk.
Patients aged 2 to 14 y with moderate and severe asthma (PRAM severity score ≥ 4) admitted to infirmary/observation unit care were randomized double-blind on admission to receive 800 mg nebulized magnesium or normal saline placebo after all received intensive therapy with combined nebulized albuterol-ipratropium and intravenous methylprednisolone. Time to medical readiness for discharge was the primary outcome; sample size was chosen to detect a 15% absolute improvement. Improvement over time in PRAM severity score and other secondary outcomes were compared for the overall group and severe asthma subset.
One hundred and ninety-one magnesium sulfates and 174 placebo patients met criteria for analysis. The groups were similar with mean baseline PRAM scores >7. Blinded active therapy significantly increased blood magnesium level 2 hr post-treatment completion compared to placebo, 0.85 vs 0.82 mmol/L, P = 0.001. There were no important adverse effects. Accelerated failure time analysis showed a non-significantly shortened time to medical readiness for discharge of 14% favoring the magnesium sulfate group, OR = 1.14, 95% CI 0.93 to 1.40, P = 0.20. Mean times until readiness for discharge were 14.7 hr [SD 9.7] versus 15.6 hr [SD 11.3] for the investigational and placebo groups, respectively, P = 0.41.
Adding nebulized magnesium to combined nebulized bronchodilator and systemic steroid therapy failed to significantly shorten time to discharge of pediatric patients with moderate or severe asthma.
静脉注射硫酸镁作为一种在中度和重度哮喘治疗中添加到支气管扩张剂和全身类固醇治疗中的抢救疗法，使用并不普遍。我们推测雾化吸入镁剂可能有益且风险不大。
年龄在2至14岁、患有中度和重度哮喘（PRAM严重程度评分≥4）且入住医务室/观察病房的患者，在入院后接受雾化沙丁胺醇-异丙托溴铵和静脉注射甲泼尼龙的强化治疗后，被随机双盲分组，分别接受800毫克雾化镁剂或生理盐水安慰剂治疗。达到出院医疗准备状态的时间为主要结局指标；样本量的选择旨在检测出15%的绝对改善。比较了总体组和重度哮喘亚组中PRAM严重程度评分及其他次要结局指标随时间的改善情况。
191例接受硫酸镁治疗和174例接受安慰剂治疗的患者符合分析标准。两组的平均基线PRAM评分均>7，情况相似。与安慰剂相比，接受盲法活性治疗的患者在治疗结束后2小时血镁水平显著升高，分别为0.85 mmol/L和0.82 mmol/L，P = 0.001。未出现重要不良反应。加速失效时间分析显示，硫酸镁组达到出院医疗准备状态的时间非显著缩短了14%，优势比为1.14，95%置信区间为0.93至1.40，P = 0.20。研究组和安慰剂组达到出院准备状态的平均时间分别为14.7小时[标准差9.7]和15.6小时[标准差11.3]，P = 0.41。
在雾化支气管扩张剂和全身类固醇联合治疗中添加雾化镁剂未能显著缩短中度或重度哮喘儿科患者的出院时间。
