加拿大卡尔加里大学Stephen B. Freedman团队联合多伦多大学Suzanne Schuh团队比较了沙丁胺醇雾化镁与安慰剂对急诊室难治性急性哮喘患儿住院治疗的影响。2020年11月24日，该研究发表在《美国医学会杂志》上。

尽管静脉注射镁剂可减少难治性小儿急性哮喘的住院率，但由于侵入性和安全性问题，镁剂的使用方法有所不同。雾化镁剂预防住院的益处尚不清楚。

为了评估雾化镁剂对初治后仍处于中重度呼吸窘迫的急性哮喘患儿的疗效，2011年9月26日至2019年11月19日，研究组在加拿大的7个三级医院儿科急诊室进行了一项随机、双盲、平行组临床试验，招募了818例2-17岁的中重度哮喘儿童，在接受口服皮质类固醇治疗1小时和吸入3次沙丁胺醇和异丙托品治疗后，经小儿呼吸功能评估标准（PRAM）评定为5分或更高（12分制）。将患儿随机分组，其中410例接受3次雾化沙丁胺醇联合硫酸镁治疗，408例联合生理盐水安慰剂治疗。主要结局为24小时内哮喘住院率。

818例患儿的中位年龄为5岁，男孩占63%，共有816名完成了试验。接受镁剂治疗的409名患儿中有178名（43.5％）住院，而接受安慰剂治疗的407名患儿中有194名（47.7％），组间差异不显著。两组间从基线到240分钟的PRAM评分、呼吸频率、氧饱和度、收缩压的变化，或平均额外使用沙丁胺醇治疗的次数均无统计学差异。接受镁剂治疗的患儿中有17名发生了恶心/呕吐或鼻咽痛（占4％），接受安慰剂治疗的患儿中有5名（占1％）。

总之，对于急诊科的难治性急性哮喘儿童，沙丁胺醇联合雾化镁剂与安慰剂相比，并不能降低24小时内因哮喘而住院的风险。

附：英文原文

Title: Effect of Nebulized Magnesium vs Placebo Added to Albuterol on Hospitalization Among Children With Refractory Acute Asthma Treated in the Emergency Department: A Randomized Clinical Trial

Author: Suzanne Schuh, Judy Sweeney, Maggie Rumantir, Allan L. Coates, Andrew R. Willan, Derek Stephens, Eshetu G. Atenafu, Yaron Finkelstein, Graham Thompson, Roger Zemek, Amy C. Plint, Jocelyn Gravel, Francine M. Ducharme, David W. Johnson, Karen Black, Sarah Curtis, Darcy Beer, Terry P. Klassen, Darcy Nicksy, Stephen B. Freedman, Pediatric Emergency Research Canada (PERC) Network

Issue&Volume: 2020/11/24

Abstract:

Importance  While intravenous magnesium decreases hospitalizations in refractory pediatric acute asthma, it is variably used because of invasiveness and safety concerns. The benefit of nebulized magnesium to prevent hospitalization is unknown.

Objective  To evaluate the effectiveness of nebulized magnesium in children with acute asthma remaining in moderate or severe respiratory distress after initial therapy.

Design, Setting, and Participants  A randomized double-blind parallel-group clinical trial from September 26, 2011, to November 19, 2019, in 7 tertiary-care pediatric emergency departments in Canada. The participants were otherwise healthy children aged 2 to 17 years with moderate to severe asthma defined by a Pediatric Respiratory Assessment Measure (PRAM) score of 5 or greater (on a 12-point scale) after a 1-hour treatment with an oral corticosteroid and 3 inhaled albuterol and ipratropium treatments. Of 5846 screened patients, 4332 were excluded for criteria, 273 declined participation, 423 otherwise excluded, 818 randomized, and 816 analyzed.

Interventions  Participants were randomized to 3 nebulized albuterol treatments with either magnesium sulfate (n=410) or 5.5% saline placebo (n=408).

Main Outcomes and Measures  The primary outcome was hospitalization for asthma within 24 hours. Secondary outcomes included PRAM score; respiratory rate; oxygen saturation at 60, 120, 180, and 240 minutes; blood pressure at 20, 40, 60, 120, 180, and 240 minutes; and albuterol treatments within 240 minutes.

Results  Among 818 randomized patients (median age, 5 years; 63% males), 816 completed the trial (409 received magnesium; 407, placebo). A total of 178 of the 409 children who received magnesium (43.5%) were hospitalized vs 194 of the 407 who received placebo (47.7%) (difference, 4.2%; absolute risk difference 95% [exact] CI, 11% to 2.8%]; P=.26). There were no significant between-group differences in changes from baseline to 240 minutes in PRAM score (difference of changes, 0.14 points [95% CI, 0.23 to 0.50]; P=.46); respiratory rate (0.17 breaths/min [95% CI, 1.32 to 1.67]; P=.82); oxygen saturation (0.04% [95% CI, 0.53% to 0.46%]; P=.88); systolic blood pressure (0.78 mm Hg [95% CI, 1.48 to 3.03]; P=.50); or mean number of additional albuterol treatments (magnesium: 1.49, placebo: 1.59; risk ratio, 0.94 [95% CI, 0.79 to 1.11]; P=.47). Nausea/vomiting or sore throat/nose occurred in 17 of the 409 children who received magnesium (4%) and 5 of the 407 who received placebo (1%).

Conclusions and Relevance  Among children with refractory acute asthma in the emergency department, nebulized magnesium with albuterol, compared with placebo with albuterol, did not significantly decrease the hospitalization rate for asthma within 24 hours. The findings do not support use of nebulized magnesium with albuterol among children with refractory acute asthma.

DOI: 10.1001/jama.2020.19839

Source: https://jamanetwork.com/journals/jama/article-abstract/2773271