Abstract：Objective：To observe the clinical effect of Jianpi Bushen Huoxue method for polycystic ovary syndrome(PCOS) with syndrome of the spleen- kidney deficiency and phlegm- stasis obstruction. Methods： A total of 80 cases of PCOS patients with syndrome of the spleen- kidney deficiency and phlegm- stasis obstruction were divided into the observation group and the control group according to the random number table method， 40 cases in each group. The control group was treated with ethinylestradiol and cyproterone acetate tablets，and the observation group was additionally treated with Jianpi Bushen Huoxue prescription based on the treatment of the control group. Both groups were treated for continuously three menstrual cycles， and the treatment was stopped during period. Before and after treatment， testosterone(T)， dihydrotestosterone(DHT)， luteinizing hormone(LH)， follicle stimulating hormone(FSH)， fasting blood glucose(FBG)，and fasting insulin(FINS) in serum were detected in the two groups，and insulin resistance index(HOMA-IR) was calculated. Ovarian volume，number of follicle，and recovery of ovulation were detected and recorded in the two groups. Acne severity and hirsutism score before and after treatment were recorded，and the rate of return to normal menstruation was recorded. Waist circumference，hip circumference，weight and height were measured before and after treatment，and waist to hip ratio(WHR) and body mass index(BMI) were calculated. Results： After treatment， the clinical effect in the observation group was better than that in the control group(Z=2.014，P＜0.05). After treatment，levels of T，DHT，LH and FSH in the two groups were decreased when compared with those before treatment(P＜0.05)， and the four levels in the observation group were lower than those in the control group(P＜0.05). After treatment， number of follicle and ovarian volume in the two groups were decreased when compared with those before treatment(P＜0.05)，and the number and the volume in the observation group were smaller than those in the control group(P＜0.05). After treatment，the rate of return to normal menstruation was 75.00% in the observation group，higher than that of 52.50% in the control group，the difference being significant(P＜0.05). After treatment，the rate of ovulation recovery was 57.50% in the observation group，higher than that of 35.00% in the control group，the difference being significant(P＜0.05). After treatment，levels of FBG，HOMA-IR， BMI and WHR in the two groups were decreased when compared with those before treatment(P＜0.05)，and the four levels in the observation group were lower than those in the control group(P＜0.05). After treatment，scores of acne and hirsutism in the two groups were decreased when compared with those before treatment(P＜0.05)， and the two scores in the observation group were lower than those in the control group(P＜0.05). Conclusion：In the treatment of PCOS patients with syndrome of the spleen-kidney deficiency and phlegm-stasis obstruction，the therapy of Jianpi Bushen Huoxue method can improve high androgen and insulin resistance， regulate levels of endocrine hormones， reduce ovarian volume and follicle number，promote the recovery of menstruation and ovulation，improve hirsutism，acne，obesity and other symptoms，and enhance the clinical effect.