Abstract：Objective：To observe the clinical effect of Biyuanruan capsules combined with ofloxacin for acute suppurative otitis media. Methods：A total of 172 patients with acute suppurative otitis media were divided into the observation group and the control group according to the random number table method，86 cases in each group. The control group was treated with ofloxacin otic solution， and the observation group was additionally treated with the oral administration of Biyuanruan capsules based on the treatment of the control group. The clinical effect， the clearance rate of pathogen， levels of inflammatory factors，immune-related indexes，the recovery progress of hearing were compared between the two groups. Results：The total effective rate was 95.35% in the observation group，higher than that of 80.23% in the control group(P＜ 0.05). Before treatment，when compared scores of tinnitus，ear pain，and ear pus between the two groups，there was no significance in the difference(P＞0.05). After treatment， scores of tinnitus， ear pain， and ear pus in the two groups were significantly decreased when compared with those before treatment(P＜0.05)，and each symptom score in the observation group was lower than that in the control group(P＜0.05). Before treatment，the detection rate of pathogen was 100% in the two groups. After treatment， the clearance rate of pathogen was 91.86% in the observation group， higher than that of 79.07% in the control group，the difference being significant(P＜0.05). Before treatment，when compared levels of tumor necrosis factor-α(TNF-α)，interleukin-6(IL-6)，interleukin-8(IL-8)，immunoglobulin A(IgA)，immunoglobulin G(IgG)，and immunoglobulin M(IgM) between the two groups， there was no significance in the difference(P＞0.05). After treatment， levels of TNF- α， IL- 6， IL- 8， IgA， IgG， and IgM in the two groups were significantly decreased when compared with those before treatment(P＜0.05)， and the six levels above in the observation group were lower than those in the control group(P＜0.05). Threshold of hearing at different frequencies in the observation group was significantly higher than that in the control group(P＜0.05). Conclusion： The therapy of Biyuanruan capsules combined with ofloxacin has a significant curative effect on acute suppurative otitis media， which can effectively clear pathogen， alleviate inflammatory responses， and improve immune function and hearing.