Abstract: OBJECTIVE To observe the efficacy and safety of Zishen Jianpi Formula combined lymphocyte immunotherapy for recurrent abortion of deficiency of both the spleen and kidney syndrome. METHODS 120 patients with recurrent abortion of deficiency of both the spleen and kidney were randomly divided into control group and experimental group， 60 cases in each group. The control group was treated with lymphocyte immunotherapy， and the experimental group was given Zishen Jianpi Formula on the basis of the treatment of control group. The TCM syndrome scores， serum blocking antibodies (CD3⁺， CD4⁺， CD8⁺， CD4⁺/CD8⁺) and inflammatory factors (IFN-γ， TNF-α， IL-1β， IL-10) were observed. The effective rate and adverse reaction rate of the two groups were compared. RESULTS 3 patients in control group and 2 patients in experimental group were fell off during the study. The term birth rate of experimental group was 89.7%， which was higher than that of control group 71.9%(P<0.05). The total effective rate of experimental group was 94.8%， which was higher than that of control group 80.7% (P<0.05). The TCM symptom scores， serum blocking antibody and inflammatory factor levels in experimental group were higher than the control group (P<0.05). The incidence of adverse reaction in treatment group was 10.3% (6/58)， which was lower than that of control group 28.1% (16/57) (P<0.05). CONCLUSION Zishen Jianpi Formula combined with lymphocyte immunotherapy for recurrent abortion of deficiency of both the spleen and kidney syndrome can significantly improve the rate of full-term delivery. The mechanism may be related to improving blood coagulation function， regulating serum blocking antibody and inflammatory factor levels.