急诊科使用雾化镁vs安慰剂加沙丁胺醇对难治性急性哮喘患儿住院情况的影响：一项随机临床试验
2021/10/20
摘要
重要性：尽管静脉注射镁可降低难治性小儿急性哮喘的住院率，但由于其侵袭性和安全性的考虑，镁剂的使用有所不同。雾化镁预防住院的益处尚不清楚。
目的：评估雾化镁对初始治疗后仍处于中重度呼吸窘迫的急性哮喘患儿的疗效。
试验设计、设置和参与者：2011年9月26日至2019年11月19日，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。参加者为2-17岁的健康儿童，患有中度至重度哮喘，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吸入治疗后，经小儿呼吸功能评估标准（PRAM）评定为5分或更高（12分制）。在5846例被筛查的患者中，因纳入标准排除了4332例，273例拒绝参加，还有423例因其他原因被排除。最终对818例进行随机分组，其中816例纳入了分析。
干预：参与者在3次雾化沙丁胺醇治疗的基础上，被随机分配接受硫酸镁（n=410）或5.5%生理盐水安慰剂（n=408）治疗。
主要结局和测量：主要结局是在24小时内因哮喘进行住院治疗。次要结局包括PRAM评分，呼吸频率，60、120、180和240分钟时的氧饱和度，20、40、60、120、180和240分钟时的血压以及240分钟内接受沙丁胺醇治疗的次数。
结果：在818名随机分组的患者（中位年龄为5岁；男性为63%）中，有816名完成了试验（409名接受了镁剂治疗，407名接受了安慰剂治疗）。在409名接受镁剂治疗的儿童中，有178名（43.5%）住院，而407名接受安慰剂的儿童中，有194名（47.7%）住院（差异为-4.2%；绝对风险差异95%CI为-11%至2.8%；P=0.26）。以下结局均没有显著的组间差异：PRAM评分从基线到240分钟的变化（变化的差异为0.14分，95%CI为-0.23至0.50；P=0.46）、呼吸频率（0.17次/分钟，95%CI位-1.32至1.67；P=0.82）、氧饱和度（-0.04%，95%CI为-0.53%至0.46%，P=0.88）、收缩压（-0.78mmHg，95%CI，-1.48至3.03，P=0.50）、平均额外沙丁胺醇的治疗次数（镁剂：1.49；安慰剂1.59；风险比，0.94，95%CI为0.79至1.11；P=0.47）。在接受镁剂治疗的409名儿童中，有17名发生了恶心、呕吐或鼻咽痛（4%），在接受安慰剂的407名患儿中有5名（占1%）。
结论和相关性：在急诊科的难治性急性哮喘患儿中，沙丁胺醇联合雾化镁与安慰剂对比，并未显著降低24小时内因哮喘而住院的比率。该发现不支持在难治性急性哮喘儿童中使用雾化镁联合沙丁胺醇。
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
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
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.
重要性：尽管静脉注射镁可降低难治性小儿急性哮喘的住院率，但由于其侵袭性和安全性的考虑，镁剂的使用有所不同。雾化镁预防住院的益处尚不清楚。
目的：评估雾化镁对初始治疗后仍处于中重度呼吸窘迫的急性哮喘患儿的疗效。
试验设计、设置和参与者：2011年9月26日至2019年11月19日，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。参加者为2-17岁的健康儿童，患有中度至重度哮喘，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吸入治疗后，经小儿呼吸功能评估标准（PRAM）评定为5分或更高（12分制）。在5846例被筛查的患者中，因纳入标准排除了4332例，273例拒绝参加，还有423例因其他原因被排除。最终对818例进行随机分组，其中816例纳入了分析。
干预：参与者在3次雾化沙丁胺醇治疗的基础上，被随机分配接受硫酸镁（n=410）或5.5%生理盐水安慰剂（n=408）治疗。
主要结局和测量：主要结局是在24小时内因哮喘进行住院治疗。次要结局包括PRAM评分，呼吸频率，60、120、180和240分钟时的氧饱和度，20、40、60、120、180和240分钟时的血压以及240分钟内接受沙丁胺醇治疗的次数。
结果：在818名随机分组的患者（中位年龄为5岁；男性为63%）中，有816名完成了试验（409名接受了镁剂治疗，407名接受了安慰剂治疗）。在409名接受镁剂治疗的儿童中，有178名（43.5%）住院，而407名接受安慰剂的儿童中，有194名（47.7%）住院（差异为-4.2%；绝对风险差异95%CI为-11%至2.8%；P=0.26）。以下结局均没有显著的组间差异：PRAM评分从基线到240分钟的变化（变化的差异为0.14分，95%CI为-0.23至0.50；P=0.46）、呼吸频率（0.17次/分钟，95%CI位-1.32至1.67；P=0.82）、氧饱和度（-0.04%，95%CI为-0.53%至0.46%，P=0.88）、收缩压（-0.78mmHg，95%CI，-1.48至3.03，P=0.50）、平均额外沙丁胺醇的治疗次数（镁剂：1.49；安慰剂1.59；风险比，0.94，95%CI为0.79至1.11；P=0.47）。在接受镁剂治疗的409名儿童中，有17名发生了恶心、呕吐或鼻咽痛（4%），在接受安慰剂的407名患儿中有5名（占1%）。
结论和相关性：在急诊科的难治性急性哮喘患儿中，沙丁胺醇联合雾化镁与安慰剂对比，并未显著降低24小时内因哮喘而住院的比率。该发现不支持在难治性急性哮喘儿童中使用雾化镁联合沙丁胺醇。
(中日友好医院呼吸与危重症医学科 张清 摘译 林江涛 审校)
(JAMA. 2020 Nov 24;324(20):2038-2047. doi: 10.1001/jama.2020.19839.)
(JAMA. 2020 Nov 24;324(20):2038-2047. doi: 10.1001/jama.2020.19839.)
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
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
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.
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