Objective： To observe the effect of Zhu’s Bushen Huoxue Formula on pregnancy outcome and serum interleukin（IL）-2 ， IL-4 and IL-10 levels in recurrent spontaneous abortion （RSA） patients with kidney deficiency and blood stasis.,Methods,2,Twenty patients with RSA and 20 patients with normal termination of pregnancy were selected， and the serum levels of IL-2， IL-4 and IL-10 in the two groups were detected by ELISA. Sixty-four patients with kidney deficiency and blood stasis RSA were randomly divided into two groups， 32 cases in the treatment group and 32 cases in the control group. The control group was given dydrogesterone orally for routine fetal protection， while the treatment group was given traditional Chinese medicine（TCM） Bushen Huoxue Formula orally on the basis of the control group. The changes of TCM syndrome scores， serum levels of IL-2， IL-4， IL-10 and pregnancy outcomes were compared between the two groups before and after treatment.,Results,2,①The levels of IL-2 and IL-4 in peripheral blood of RSA patients were significantly higher than those of normal group， and IL-10 was significantly lower than that of normal group （,P,<,0.01）. ②After treatment， TCM syndrome score and serum IL-2 and IL-4 levels decreased in both groups， while serum IL-10 level increased. The results in the treatment group were more obvious than those in the control group， and the live birth rate in the treatment group was higher than that in the control group （,P,<,0.01）.,Conclusion,2,The serum levels of IL-2， IL-4 and IL-10 in patients with RSA were significantly higher than those in the normal group， while the level of IL-10 were significantly lower than those in the normal group（,P,<,0.01）， suggesting that inflammatory factors IL-2， IL-4 and IL-10 may be involved in the pathogenesis of RSA. Zhu's Bushen Huoxue Formula may improve the live birth rate and pregnancy outcome of RSA patients by reducing the levels of IL-2， IL-4 and increasing the level of IL-10 in peripheral blood.