OBJECTIVE: To observe the clinical efficacy and safety of Azithromycin combined with Xiaoer xiaoji zhike oral solution in the treatment of mycoplasma pneumonia in children. METHODS: Data of 120 children with mycoplasma pneumonia were retrospectively analyzed and divided into observation group (63 cases) and control group (57 cases) by different treatment methods. All children received conventional treatment(reducing fever,relieving cough and resolving phlegm). Based on it,control group received Azithromycin 10 mg/kg, intravenous infusion, once a day, after continuous infusion of 3 d, it stopped 4 d. Observation group additionally received Xiaoer xiaoji zhike oral solution, 10 ml for children younger than 5 years old, 15 ml for children in 5 years old or over, 3 times a day. 1-week was regarded as 1 treatment course, and it lasted for 2-3 courses. Clinical efficacy in 2 group was observed, recovery time of clinical signs, reduction of the number of inflammatory cells before and after treatment were compared, and the incidence of adverse reactions during treatment was recorded. RESULTS: After treatment, the total effective rate in observation group was significantly higher than control group, fever clearance time, disappearance time of cough, rales and pulmonary lesions were significantly shorter than control group, with statistical significance (P<0.05). Before treatment, there was no significant difference in the number of eosinophils and serum C reactive protein (CRP) level (P>0.05). After 1 week treatment, the number of eosinophils and CRP level in 2 groups were significantly lower than before, and observation group was significantly lower than control group, with statistical significance (P<0.05). And there was no significant difference in the incidence of adverse reactions(P>0.05). CONCLUSIONS: Azithromycin combined with Xiaoer xiaoji zhike oral solution shows good efficacy in the treatment of mycoplasma pneumonia in children, it can shorten the duration of clinical symptoms, improve the level of inflammatory cells, and does not increase the incidence of adverse reactions.