Department of Pediatrics, All India Institute of Medical Sciences, Jodhpur, Rajathan, India.
Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajathan, India.
Indian J Pediatr. 2021 Nov;88(11):1080-1085. doi: 10.1007/s12098-021-03695-8. Epub 2021 Mar 27.
To evaluate the efficacy and safety of nebulized magnesium sulphate as a bronchodilator in young children aged 1-24 mo with moderate to severe bronchiolitis in comparison to standard therapy.
This was an open labeled randomized controlled trial comprising 60 children with moderate to severe bronchiolitis which was randomly assigned to 2 groups. Intervention group received nebulization with 3 mL of 3.2% magnesium sulphate (MgSO) (iso-osmolar) every 4 hourly for 24 h in addition to standard care and the control group received standard care alone. The primary outcome measure was to compare the improvement of bronchiolitis severity score (BSS) and length of hospitalization. The secondary outcome was to measure the need for noninvasive ventilation, need for admission to intensive care unit (ICU) in the initial visit, to evaluate the safety of magnesium sulphate and need for clinic revisit, hospital readmission and ICU readmission within 2 wk after discharge in both the groups.
The mean age of children allocated in the control group was 7.4 ± 5.1 mo and 7.7 ± 4.5 mo in the intervention group. There was no significant difference with respect to improvement of BSS or reduced length of hospitalization in both the groups (p > 0.05). BSS monitored sequentially after enrollment at 1, 2, 4, 8, 12, 16, and 24 h did not show statistically significant differences between the groups. Mean length of hospital stay was 2.89 ± 2.25 d in treatment group and 2.96 ± 1.86 d in control group (p = 0.902). No adverse events were observed in both the groups.
Nebulized magnesium sulphate is not superior to standard therapy in children with moderate to severe bronchiolitis.
CTRI/2018/06/014400.
评估雾化硫酸镁作为支气管扩张剂在 1-24 月龄中重度毛细支气管炎患儿中的疗效和安全性,并与标准治疗进行比较。
这是一项开放标签、随机对照试验,纳入 60 例中重度毛细支气管炎患儿,随机分为 2 组。干预组在标准治疗的基础上,每 4 小时雾化吸入 3 ml 3.2%硫酸镁(等渗),共 24 小时;对照组仅接受标准治疗。主要结局指标是比较毛细支气管炎严重程度评分(BSS)和住院时间的改善情况。次要结局指标是测量两组患儿需要无创通气、初始就诊时需要入住重症监护病房(ICU)、评估硫酸镁的安全性、以及出院后 2 周内需要门诊复诊、再次住院和入住 ICU 的情况。
对照组患儿的平均年龄为 7.4±5.1 个月,干预组为 7.7±4.5 个月。两组患儿 BSS 改善或住院时间缩短均无显著差异(p>0.05)。两组患儿分别在纳入后 1、2、4、8、12、16 和 24 小时连续监测 BSS,但组间无统计学差异。治疗组患儿的平均住院时间为 2.89±2.25 天,对照组为 2.96±1.86 天(p=0.902)。两组患儿均未观察到不良反应。
雾化硫酸镁在中重度毛细支气管炎患儿中并不优于标准治疗。
CTRI/2018/06/014400。