Abstract： Objective： To observe the clinical effect of the therapy of Kouyanqing Granules combined with Kangbingdu Oral Liquid on children with herpetic stomatitis. Methods： A total of 80 children with herpetic stomatitis were randomly divided into the control group and the study group，with 40 cases in each group. The control group was treated with Kangbingdu Oral Liquid based on symptomatic western medicine，and the study group was additionally treated with Kouyanqing Granules based on the treatment of control group. One week after treatment， the clinical effects and incidence of adverse drug reactions (ADR) in the two groups were evaluated. The traditional Chinese medicine (TCM) syndrome scores，serum inflammatory factors，including tumor necrosis factor- α (TNF- α)，interleukin- 2 (IL- 2) and interleukin- 6 (IL- 6)，and immune indexes，including CD4 +/CD8 + and serum immunoglobulin A (IgA)，were compared before and after treatment. Results： After treatment， the total effective rate was 95.00% in the study group and 80.00% in the control group， the difference being significant (P＜0.05). After treatment， the scores of primary and secondary symptoms and other scores of TCM syndromes in the two groups were decreased when compared with those before treatment (P＜0.05)， and the scores of primary and secondary symptoms in the study group were lower than those in the control group (P＜0.05). After treatment，the levels of serum TNF-α，IL-2 and IL-6 in the two groups were decreased when compared with those before treatment (P＜0.05)，and the above three levels in the study group were lower than those in the control group (P＜0.05). After treatment，the levels of CD4+/CD8+ and serum IgA in the two groups were increased when compared with those before treatment (P＜0.05)， and the above two levels in the study group were higher than those in the control group (P＜0.05). The incidence of ADR was 10.00% in the study group and 5.00% in the control group，there being no significant difference between the two groups (P＞0.05). Conclusion： The therapy of Kouyanqing Granules combined with Kangbingdu Oral Liquid has a definite effect on the treatment of herpetic stomatitis in children， which can obviously improve the TCM syndromes，effectively inhibit the inflammatory responses of the body and enhance the immune function.