Abstract: Objective: To observe the clinical effect of the therapy of external application of SHI's Shangke Diaoshang ointment combined with Xiaozhong Jiedu tang on acute gouty arthritis(AGA). Methods:A total of 70 patients with AGA were divided into the treatment group and the control group according to the random number table method, with 35 cases in each group. Both groups were given lifestyle guidance. The treatment group was additionally given external application of SHI's Shangke Diaoshang ointment combined with self-made Xiaozhong Jiedu tang,and the control group was additionally given diclofenac sodium dual release enteric-coated capsules. Both groups were treated for seven days. The clinical effects in the two groups were observed. Before and after treatment,the scores of Visual Analogue Scale(VAS) for joint pain,scores of joint swelling and joint activity and changes of laboratory indexes,including blood uric acid(BUA),erythrocyte sedimentation rate(ESR) and C-reactive protein(CRP) in the two groups were compared. During treatment,the adverse reactions in the two groups were observed. Results:After treatment,the scores of joint swelling,joint activity and VAS in the two groups were decreased when compared with those before treatment(P<0.05),and the above three scores in the treatment group were lower than those in the control group,differences being significant(P<0.05). After treatment,the BUA,ESR and CRP in the two groups were decreased when compared with those before treatment(P<0.05), and the above three indexes in the treatment group were lower than those in the control group, and there was significant difference being found in the comparison of BUA between the two groups(P<0.05). The total effective rate was 91.43% in the treatment group,higher than that of 62.86% in the control group,the difference being significant(P<0.05). During follow- up,no obvious adverse reactions occurred among the 35 cases in the treatment group. A case of gastric pain occurred in the control group,and the symptom was relieved after stopping treatment. Conclusion:The external application of SHI's Shangke Diaoshang ointment combined with Xiaozhong Jiedu tang for AGA can effectively alleviate clinical symptoms,with high safety.