Abstract
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.