沙丁胺醇霧化鎂劑治療難治性急性哮喘兒童不能降低住院風險
作者：
小柯機器人發布時間：2020/11/26 10:55:49
加拿大卡爾加裡大學Stephen B. Freedman團隊聯合多倫多大學Suzanne Schuh團隊比較了沙丁胺醇霧化鎂與安慰劑對急診室難治性急性哮喘患兒住院治療的影響。2020年11月24日，該研究發表在《美國醫學會雜誌》上。
儘管靜脈注射鎂劑可減少難治性小兒急性哮喘的住院率，但由於侵入性和安全性問題，鎂劑的使用方法有所不同。霧化鎂劑預防住院的益處尚不清楚。
為了評估霧化鎂劑對初治後仍處於中重度呼吸窘迫的急性哮喘患兒的療效，2011年9月26日至2019年11月19日，研究組在加拿大的7個三級醫院兒科急診室進行了一項隨機、雙盲、平行組臨床試驗，招募了818例2-17歲的中重度哮喘兒童，在接受口服皮質類固醇治療1小時和吸入3次沙丁胺醇和異丙託品治療後，經小兒呼吸功能評估標準（PRAM）評定為5分或更高（12分制）。將患兒隨機分組，其中410例接受3次霧化沙丁胺醇聯合硫酸鎂治療，408例聯合生理鹽水安慰劑治療。主要結局為24小時內哮喘住院率。
818例患兒的中位年齡為5歲，男孩佔63%，共有816名完成了試驗。接受鎂劑治療的409名患兒中有178名（43.5％）住院，而接受安慰劑治療的407名患兒中有194名（47.7％），組間差異不顯著。兩組間從基線到240分鐘的PRAM評分、呼吸頻率、氧飽和度、收縮壓的變化，或平均額外使用沙丁胺醇治療的次數均無統計學差異。接受鎂劑治療的患兒中有17名發生了噁心/嘔吐或鼻咽痛（佔4％），接受安慰劑治療的患兒中有5名（佔1％）。
總之，對於急診科的難治性急性哮喘兒童，沙丁胺醇聯合霧化鎂劑與安慰劑相比，並不能降低24小時內因哮喘而住院的風險。
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