Low-dose versus high-dose methylprednisolone for children with severe Mycoplasma pneumoniae pneumonia (MCMP): A
Baoping Xu1, Ling Cao2, Yunxiao Shang3
1Department of Respiratory Disease Beijing Children's Hospital, Capital Medical University China National Clinical Research Center of Respiratory Diseases National Center for Children's Health Beijing China.
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.
Insights
Low-dose methylprednisolone with azithromycin is as effective as high-dose for preventing long-term pulmonary lesions in severe Mycoplasma pneumoniae pneumonia (MPP). The low-dose regimen offers a better safety profile, reducing risks like hypertension.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pulmonology
Background:
- Severe Mycoplasma pneumoniae pneumonia (MPP) can lead to long-term pulmonary complications.
- Macrolide and glucocorticoid therapy is effective in preventing these lesions, but optimal glucocorticoid dosage remains unclear.
Purpose of the Study:
- To compare the efficacy and safety of low-dose versus high-dose methylprednisolone combined with azithromycin in treating severe pediatric MPP.
- To assess the impact of different methylprednisolone doses on the risk of long-term pulmonary lesions.
Main Methods:
- A randomized, parallel-controlled, multicenter clinical trial involving 424 pediatric patients with severe MPP.
- Patients received azithromycin plus either low-dose (2 mg/kg/d) or high-dose (10 mg/kg/d) methylprednisolone for 3 days, followed by a 12-day taper.
- The primary outcome was the incidence of composite adverse pulmonary outcomes (atelectasis, bronchiectasis, bronchiolitis obliterans) at 6 months.
Main Results:
- The incidence of long-term pulmonary lesions was 24.4% in the low-dose group and 31.3% in the high-dose group (Risk Ratio: 1.28, 95% CI: 0.94-1.75).
- Hypertension occurred in 1.4% of the low-dose group versus 8.1% in the high-dose group (Risk Ratio: 5.72, 95% CI: 1.70-19.23).
Conclusions:
- Low-dose methylprednisolone combined with azithromycin is non-inferior to high-dose therapy for preventing pulmonary lesions in severe pediatric MPP.
- The low-dose regimen offers a superior safety profile, with significantly lower rates of hypertension.
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