Low-dose versus high-dose methylprednisolone for children with severe Mycoplasma pneumoniae pneumonia (MCMP): A randomized controlled trial.

Abstract

Importance: Although macrolides combined with glucocorticoid therapy have demonstrated efficacy in preventing long-term pulmonary lesions of severe Mycoplasma pneumoniae pneumonia (MPP), evidence regarding glucocorticoid dose is lacking.

Objective: To evaluate the effects of low- and high-dose methylprednisolone on the risk of long-term pulmonary lesions for children with severe MPP when combined with azithromycin.

Methods: This randomized, parallel-controlled, multicenter clinical trial was conducted in mainland China and enrolled pediatric patients hospitalized with severe MPP. A total of 424 enrolled patients were randomized (allocation ratio of 1:1) to azithromycin combined with either a low-dose [2 mg/(kg·d)] or a high-dose [10 mg/(kg·d)] methylprednisolone treatment for 3 d followed by tapering over 12 d. The primary outcome was the incidence of composite adverse outcomes, including atelectasis, bronchiectasis, or bronchiolitis obliterans 6 months after treatment.

Results: A total of 118 (27.8%) developed adverse pulmonary lesions at 6 months after treatment; 66 of 211 (31.3%) in the high-dose methylprednisolone group and 52 of 213 (24.4%) in the low-dose group, respectively. The risk ratio of long-term pulmonary lesions in a high-dose group to those in a low-dose group was 1.28 (95% confidence interval [95% CI]: 0.94-1.75). In addition, the risk of hypertension in the high-dose group (8.1%, 17 of 211) was higher than that in the low-dose group (1.4%, three of 213), with a risk ratio of 5.72 (95% CI: 1.70-19.23).

Interpretation: Azithromycin combined with low-dose methylprednisolone demonstrates non-inferior efficacy in reducing pulmonary lesions at 6-month follow-up compared to combined with high-dose methylprednisolone while exhibiting a more favorable safety profile.