Objective To observe the therapeutic effect of Xiaoluo Mixture Ⅰ for cervical lymphadenopathy（ CL）. Methods Sixty cases of CL were randomized into the treatment group and control group

with 30 in each.The control group was given routine western medicine. The treatment group was added with Xiaoluo Mixture Ⅰ one dose daily. The treatment lasted for 4 months. The efficacy was observed. The TCM symptom scores were evaluated before and after treatment. The levels of interferon-γ（ IFN-γ） and tumor necrosis factor-α（ TNF-α） were detected.The adverse reactions were compared. Results The total effective rate of the treatment group and control group was86. 4% and 66. 7% respectively

with a significant difference between groups（ P < 0. 05）. The symptoms such as depression

poor appetite

fever and fatigue were significantly relieved in the treatment group after treatment（ P <0. 05）. Comparing with the control group

poor appetite and fatigue were significantly relieved in the treatment group after treatment（ P < 0. 05）. The IFN-γ level was significantly increased but the TNF-α level was significantly decreased in the treatment group after treatment（ P < 0. 05）. There was no significant difference between groups in the TNF-α level after treatment（ P > 0. 05）. Conclusion Xiaoluo Mixture Ⅰ could improve the immune capacity and symptoms in the treatment of CL.