Objective:To observe the clinical efficacy of modified Wubi Shanyao Pill in the treatment of chronic pyelonephritis with syndrome of deficiency of both spleen and kidney,as well as its effects on immune response function. Methods90 patients of chronic pyelonephritis with syndrome of deficiency of both spleen and kidney were randomly divided into the treatment group and control group,45 cases in each group. The control group was treated with conventional bacteriostasis therapy,and the treatment group was treated with modified Wubi Shanyao Pill based on the treatment for the control group,with a course of one month. The clinical efficacy and recurrence rate were observed. And the related indexes of humoral immunity and cellular immunity were compared,including serum immunoglobulin (IgA,IgG,IgM),complement C3,interleukin-6 (IL-6),tumor necrosis factor-α (TNF-α) and positive expression rate of Toll like receptor 4 (TLR4) in peripheral blood mononuclear cells.  Results: ①The clinical total effective rates were 93.3% in the treatment group and 77.8% in the control group. The clinical efficacy of the treatment group was significantly better than that of the control group (P<0.05). ②Compared with treatment before,the levels of IgA,IgG and complement C3 in the treatment group were significantly increased after treatment (P<0.05);while in the control group,there were no statistically significant differences on the levels of IgA,IgG,IgM and complement C3 between treatment before and after (P>0.05). After treatment,there were statistically significant differences on the levels of IgA,IgG and complement C3 between the two groups,and the levels in the treatment group were significantly higher than those in the control group (P<0.05). ③For the comparison between treatment before and after,there were statistically significant differences on the levels of IL-6 and TNF-α and positive expression rate of TLR4 in both groups (P<0.05). After treatment,there were statistically significant differences on the levels of IL-6 and TNF-α and positive expression rate of TLR4 between the two groups,and the levels of IL-6 and TNF-α and the positive expression rate of TLR4 in the treatment group were significantly lower than those in the control group (P<0.05). ④During the follow-up,there were 8 cases with recurrence in the treatment group(8/42) and 18 cases with recurrence in the control group (18/35). The total recurrence frequencies were 11 times in the treatment group and 25 times in the control group. The recurrence rate of the treatment group was significantly lower than that of the control group (P<0.05).  Conclusion:Modified Wubi Shanyao Pill combined with conventional bacteriostasis therapy of western medicine shows satisfactory efficacy in the treatment of chronic pyelonephritis,which can significantly decrease the recurrence rate,regulate the immune response function and inhibit the inflammatory state in patients.