Abstract
BACKGROUND: The application of Xiaoer Feike Granules (XFG) in respiratory diseases has garnered significant attention. This study aims to quantitatively assess the efficacy and safety of XFG when combined with azithromycin for the treatment of Mycoplasma pneumoniae pneumonia (MPP). METHODS: A comprehensive search of 8 public databases was conducted for relevant clinical trials published before July 1, 2024. The meta-analysis and trial sequential analysis were performed on the included studies. RESULTS: Compared with azithromycin alone, the combination of XFG and azithromycin significantly improved the clinical effective rate (RR = 1.17, 95% CI = 1.13-1.22, P < .00001), and reduced the duration of fever (MD = -1.67, 95% CI = -1.83 to -1.50, P < .00001), cough (MD = -1.85, 95% CI = -2.28 to -1.43, P < .00001), wheezing (MD = -2.07, 95% CI = -2.51 to -1.64, P < .00001), and rales (MD = -2.34, 95% CI = -3.11 to -1.57, P < .00001). It also lowered inflammatory markers, including C-reactive protein (MD = -8.22, 95% CI = -11.27 to -5.17, P < .00001), procalcitonin (MD = -0.50, 95% CI = -0.57 to -0.43, P < .00001), and tumor necrosis factor α (MD = -0.61, 95% CI = -0.72 to -0.49, P < .00001), while No significant difference was found in interleukin-6 levels (P = .11). In terms of safety, the combination of XFG and azithromycin significantly reduced the incidence of total adverse events (RR = 0.40, 95% CI = 0.19-0.84, P = .02), nausea and vomiting (RR = 0.42, 95% CI = 0.19-0.94, P = .03), abdominal pain and diarrhea (RR = 0.31, 95% CI = 0.13-0.75, P = .009), and erythra (RR = 0.27, 95% CI = 0.09-0.79, P = .02), with no significant differences in dizziness and headache (P = .24). Egger test indicated no evidence of publication bias in these outcomes (P > .05). CONCLUSION: Compared with azithromycin alone, XFG combined with azithromycin offers faster symptom resolution, reduced inflammation, and fewer adverse events. This combination may represent a safe and effective therapeutic strategy for MPP.