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ملخص

Objective: We hypothesized that nebulized magnesium sulfate added to combined bronchodilator and systemic steroid therapy would shorten time to discharge without undue risk. Study design: Patients aged 2 to 14 y with moderate and severe asthma (PRAM severity score >4) admitted to infirmary care were randomized double-blind to 800 mg nebulized isotonic magnesium sulfate or normal saline placebo via Aeroneb Pro and Idehaler, after intensive therapy with combined albuterol-ipratropium and intravenous methylprednisolone. Time to medical readiness for discharge was the primary outcome. Improvement over time in PRAM severity score and other secondary outcomes were compared for the overall group and severe asthma subset. Results: 191 magnesium sulfate and 174 placebo patients met criteria for analysis. The groups were similar with mean baseline PRAM scores>7. Blinded active therapy significantly increased blood magnesium level 2 h post-treatment 0.85 (SD 0.07) vs 0.82 (SD 0.06) mmol/L, p=0.001). There were no important adverse effects. Accelerated failure time analysis showed a non-significantly relatively shortened time to medical readiness for discharge of 14% favoring the magnesium sulfate group, OR=1.14, 95% CI 0.93 to 1.40, p=0.20, with an absolute prolonged time at 24 h of 2.1 h, p=0.5 . Mean times until readiness for discharge were 14.6 h [SD 9.7] vs 15.6 h [SD 11.3] for the investigational and placebo groups, respectively, p=0.9. Conclusions: Adding nebulized magnesium sulfate to combined nebulized bronchodilator and systemic steroid therapy is either very weakly or very rarely effective, or futile for benefitting pediatric patients with moderate or severe asthma.

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