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Mycoplasma pneumoniae pneumonia (MPP) has high morbidity with an increased global burden. Xiaoer Feire Kechuan (XEFRKC) oral liquid comprises multiple herbal medicines and possesses numerous broad-spectrum antibacterial activities for MPP. Therefore, treatment options with XEFRKC to provide new clinical evidence for children with MPP needs to be explored.This study aimed to evaluate the clinical efficacy and safety of combined treatment of XEFRKC with azithromycin (XEFRKC + azithromycin) for treating the MPP in children.We conducted a comprehensive search in 7 databases to find the randomized controlled trials (RCTs) of XEFRKC + azithromycin treatment. Two researchers independently review the retrieval, extraction, and quality assessment of the dataset. In addition, we conducted the effect model to analyze the data and performed the meta-regression with sensitivity analysis to assess the heterogeneity and stability.A total of 30 RCTs with 2997 participants were included in this review. The results of primary outcomes showed that the XEFRKC + azithromycin therapy was significantly different with the azithromycin in response rate (RR = 1.18, 95% CI: 1.13 to 1.22), fever disappearance time (MD = -1.01, 95% CI: -1.18 to -0.84), cough disappearance time (MD = -2.18, 95% CI: -2.69 to -1.67), and pulmonary rales disappearance time (MD = -1.3, 95% CI: -1.71 to -0.88). For secondary outcomes and safety as well, XEFRKC + azithromycin had a significant difference compared with azithromycin. Meta-regression results showed that multiple covariables were not the source of heterogeneity. Moreover, sensitivity analysis showed that the stability of the meta-analysis results remained robust.For MPP in children, the XEFRKC + azithromycin therapy may be the better option compared with azithromycin alone. However, the accuracy of safety needs to be confirmed and verified with more high-quality RCTs.