Pediatric Emergency and Critical Care, PGIMER and Dr. RML Hospital, New Delhi, India.
Division of Pediatric Cardiology, Department of Pediatrics, PGIMER, Delhi, India.
Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012965. doi: 10.1002/14651858.CD012965.pub2.
Acute bronchiolitis is a significant burden on children, their families and healthcare facilities. It mostly affects children younger than two years of age. Treatment involves adequate hydration, humidified oxygen supplementation, and nebulisation of medications, such as salbutamol, epinephrine, and hypertonic saline. The effectiveness of magnesium sulphate for acute bronchiolitis is unclear.
To assess the effects of magnesium sulphate in acute bronchiolitis in children up to two years of age.
We searched CENTRAL, MEDLINE, Embase, LILACS, CINAHL, and two trials registries to 30 April 2020. We contacted trial authors to identify additional studies. We searched conference proceedings and reference lists of retrieved articles. Unpublished and published studies were eligible for inclusion.
Randomised controlled trials (RCTs) and quasi-RCTs, comparing magnesium sulphate, alone or with another treatment, with placebo or another treatment, in children up to two years old with acute bronchiolitis. Primary outcomes were time to recovery, mortality, and adverse events. Secondary outcomes were duration of hospital stay, clinical severity score at 0 to 24 hours and 25 to 48 hours after treatment, pulmonary function test, hospital readmission within 30 days, duration of mechanical ventilation, and duration of intensive care unit stay.
We used standard methodological procedures expected by Cochrane. We used GRADE methods to assess the certainty of the evidence.
We included four RCTs (564 children). One study received funding from a hospital and one from a university; two studies did not report funding sources. Comparator interventions differed among all four trials. Studies were conducted in Qatar, Turkey, Iran, and India. We assessed two studies to be at an overall low risk of bias, and two to be at unclear risk of bias, overall. The certainty of the evidence for all outcomes and comparisons was very low except for one: hospital re-admission rate within 30 days of discharge for magnesium sulphate versus placebo. None of the studies measured time to recovery, duration of mechanical ventilation, duration of intensive care unit stay, or pulmonary function. There were no events of mortality or adverse effects for magnesium sulphate compared with placebo (1 RCT, 160 children). The effects of magnesium sulphate on clinical severity are uncertain (at 0 to 24 hours: mean difference (MD) on the Wang score 0.13, 95% confidence interval (CI) -0.28 to 0.54; and at 25 to 48 hours: MD on the Wang score -0.42, 95% CI -0.84 to -0.00). Magnesium sulphate may increase hospital re-admission rate within 30 days of discharge (risk ratio (RR) 3.16, 95% CI 1.20 to 8.27; 158 children; low-certainty evidence). None of our primary outcomes were measured for magnesium sulphate compared with hypertonic saline (1 RCT, 220 children). Effects were uncertain on the duration of hospital stay in days (MD 0.00, 95% CI -0.28 to 0.28), and on clinical severity on the Respiratory Distress Assessment Instrument (RDAI) score at 25 to 48 hours (MD 0.10, 95% CI -0.39 to 0.59). There were no events of mortality or adverse effects for magnesium sulphate, with or without salbutamol, compared with salbutamol (1 RCT, 57 children). Effects on the duration of hospital stay were uncertain (magnesium sulphate: 24 hours (95% CI 25.8 to 47.4), magnesium sulphate + salbutamol: 20 hours (95% CI 15.3 to 39.0), and salbutamol: 24 hours (95% CI 23.4 to 76.9)). None of our primary outcomes were measured for magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine (1 RCT,120 children). Effects were uncertain for the duration of hospital stay in hours (MD -0.40, 95% CI -3.94 to 3.14), and for RDAI scores (0 to 24 hours: MD -0.20, 95% CI -1.06 to 0.66; and 25 to 48 hours: MD -0.90, 95% CI -1.75 to -0.05).
AUTHORS' CONCLUSIONS: There is insufficient evidence to establish the efficacy and safety of magnesium sulphate for treating children up to two years of age with acute bronchiolitis. No evidence was available for time to recovery, duration of mechanical ventilation and intensive care unit stay, or pulmonary function. There was no information about adverse events for some comparisons. Well-designed RCTs to assess the effects of magnesium sulphate for children with acute bronchiolitis are needed. Important outcomes, such as time to recovery and adverse events should be measured.
急性细支气管炎给儿童、其家庭和医疗保健机构带来了巨大负担。它主要影响两岁以下的儿童。治疗包括充分的水化、湿化氧气补充和沙丁胺醇、肾上腺素和高渗盐水等药物的雾化吸入。硫酸镁治疗急性细支气管炎的效果尚不清楚。
评估硫酸镁在 2 岁以下儿童急性细支气管炎中的作用。
我们检索了 CENTRAL、MEDLINE、Embase、LILACS、CINAHL 和两个试验注册库,截至 2020 年 4 月 30 日。我们联系了试验作者以确定其他研究。我们检索了会议记录和检索到的文章的参考文献。未发表和已发表的研究都有资格纳入。
随机对照试验(RCT)和准随机对照试验,比较硫酸镁单独或与其他治疗与安慰剂或其他治疗在 2 岁以下急性细支气管炎儿童中的疗效。主要结局是恢复时间、死亡率和不良事件。次要结局是住院时间、治疗后 0 至 24 小时和 25 至 48 小时的临床严重程度评分、肺功能检查、30 天内再次住院、机械通气时间和重症监护病房住院时间。
我们使用了 Cochrane 预期的标准方法学程序。我们使用 GRADE 方法评估证据的确定性。
我们纳入了四项 RCT(564 名儿童)。其中一项研究得到了一家医院的资助,另一项研究得到了一所大学的资助;两项研究未报告资助来源。所有四项试验的对照干预措施均不同。这些研究分别在卡塔尔、土耳其、伊朗和印度进行。我们评估了两项研究的总体偏倚风险较低,两项研究的偏倚风险不确定,总体偏倚风险较低。除了一项研究(硫酸镁与安慰剂相比 30 天内再次住院的风险比)外,所有结局和比较的证据确定性均非常低。硫酸镁与安慰剂相比,没有一项研究测量恢复时间、机械通气时间、重症监护病房住院时间或肺功能。硫酸镁与安慰剂相比,没有死亡或不良事件(1 RCT,160 名儿童)。硫酸镁对临床严重程度的影响尚不确定(0 至 24 小时:Wang 评分差值 0.13,95%置信区间-0.28 至 0.54;25 至 48 小时:Wang 评分差值-0.42,95%置信区间-0.84 至-0.00)。硫酸镁可能会增加 30 天内再次住院的风险(风险比 3.16,95%置信区间 1.20 至 8.27;158 名儿童;低确定性证据)。硫酸镁与高渗盐水(1 RCT,220 名儿童)相比,我们没有测量任何主要结局的住院时间持续时间。住院时间持续天数的效应不确定(MD 0.00,95%置信区间-0.28 至 0.28),治疗后 25 至 48 小时的 RDAI 评分的临床严重程度效应不确定(MD 0.10,95%置信区间-0.39 至 0.59)。硫酸镁与沙丁胺醇(1 RCT,57 名儿童)或硫酸镁加沙丁胺醇(1 RCT,57 名儿童)相比,没有死亡或不良事件的报道。硫酸镁对住院时间的影响不确定(硫酸镁:24 小时(95%置信区间 25.8 至 47.4),硫酸镁加沙丁胺醇:20 小时(95%置信区间 15.3 至 39.0),沙丁胺醇:24 小时(95%置信区间 23.4 至 76.9))。硫酸镁加肾上腺素与不治疗或生理盐水加肾上腺素(1 RCT,120 名儿童)相比,我们没有测量任何主要结局的住院时间。住院时间持续时间的效应不确定(MD-0.40,95%置信区间-3.94 至 3.14),RDAI 评分的效应不确定(0 至 24 小时:MD-0.20,95%置信区间-1.06 至 0.66;25 至 48 小时:MD-0.90,95%置信区间-1.75 至-0.05)。
目前尚无足够的证据表明硫酸镁治疗 2 岁以下儿童急性细支气管炎的疗效和安全性。对于一些比较,没有恢复时间、机械通气时间和重症监护病房住院时间或肺功能的证据。一些比较没有关于不良事件的信息。需要设计良好的 RCT 来评估硫酸镁治疗急性细支气管炎儿童的疗效。应测量重要结局,如恢复时间和不良事件。