Abstract: OBJECTIVE To observe the efficacy and safety of modified Fucong decoction in treating children secretory otitis media (SOM) with obstructive sleep apnea and hypopnea syndrome (OSAHS). METHODS 120 patients were randomly divided into the control group and the observation group， each including 60 cases respectively. The control group was treated with Cefprozil + Olongma + Montelukast Sodium + Mometasone Furoate Nasal Spray. The observation group was treated with modified Fucong decoction on the basis of the treatment in the control group. Both of them have a 60-day-course. The contents of glutathione peroxidase (GSH-Px)， human epidermal growth factor (hEGF)， calcitonin gene-related peptide (CGRP) and endothelin-1 (ET-1) in serum were detected by radioimmunoassay. The project also resorted to cytometric bead array to detect the levels of tumor necrosis factor-α (TNF-α)， interleukin-1β (IL-1β)， interleukin-6 (IL-6) and interleukin-10 (IL-10) in serum. The apnea hyponea index (AHI) and 18 indexes of obstructive sleep apnea (OSA-18) were monitored for 7 consecutive hours. The project observed TCM syndrome grades of spleen-deficiency phlegm-dampness syndrome， as well as the effective rate and adverse reaction rates of the two groups. RESULTS There were 4 cases of abscission. The total effective rate in the observation group was 89.8%， higher than that in the control group， 75.4% (P<0.05). AHI， OSA-18 and TCM syndromes in the observation group improved much more significantly than those in the control group (P<0.05). The serum levels of GSH-Px， hEGF， CGRP and ET-1 of the observation group improved much more significantly than those in the control group (P<0.05). The incidence of adverse reactions was 1.7% in the observation group， lower than 15.8% in the control group (P<0.05). CONCLUSION Modified Fucong decoction can significantly improve the clinical symptoms of SOM with OSAHS and the incidence of adverse reactions is low， which is worthy of clinical application.