Abstract：Objective：To observe the clinical effect of the therapy of Bushen Tongbitai granules combined with Shexiang Haima Zhuifeng plaster for knee osteoarthritis. Methods： A hundred cases with knee osteoarthritis were divided into two groups according to the random number table method，50 cases in each group. The control group was treated with Bushen Tongbitai granules； the observation group was additionally treated with external application of Shexiang Haima Zhuifeng plaster based on the treatment of the control group. Before and after treatment，the scores of Visual Analogue Scale on pain (VAS)，Lysholm Knee Scale(Lysholm) and Western Ontario and McMaster University Osteoarthritis Index(WOMAC)，and the levels of inflammatory factor of interleukin-1β(IL-1β)，nitric oxide(NO)，interleukin-1(IL-1)，interleukin-6(IL-6) and tumor necrosis factor- α(TNF- α) were compared between the two groups. Results： After treatment， the VAS scores in both groups were significantly decreased when compared with those before treatment(P＜0.05)，and the scores of Lysholm were significantly increased(P＜0.05)；the improvement of the above two scores was more significant in the observation group than in the control group(P＜0.05). After treatment，the scores of daily function，pain，stiffness and the total scores in the two groups were significantly decreased when compared with those before treatment(P＜0.05)，and the above scores in the observation group were lower than those in the control group(P＜0.05). After treatment，the level of IL-1β in serum in the observation group was significantly increased when compared with that before treatment(P＜0.05)，and the levels of NO， IL-1，IL-6 and TNF-α were significantly decreased when compared with those before treatment(P＜0.05)；the changes of the above indexes in the observation group were more significant than those in the control group(P＜0.05). Conclusion：The therapy of Bushen Tongbitai granules combined with Shexiang Haima Zhuifeng plaster for knee osteoarthritis，can relieve inflammatory reactions， improve joint function and relieve pain， whose curative effect is better than that of Tongbitai granules alone.