Objective:To explore the therapeutic effect of Shenbitang combined with diclofenac sodium for early-to-middle stage osteonecrosis of the femoral head caused by kidney deficiency and blood stasis. Method:A total of 106 cases eligible patients were randomly divided into the control group (53 cases) and the observation group (53 cases). The patients in control group were treated with Xianling Gubao capsules combined with diclofenac sodium release tablets; Shenbitang combined with diclofenac sodium release tablets was adopted in the observation group

with a treatment course of 6 months and a follow-up of 12 months in both groups.The Harris scale

SF-36

the traditional Chinese medicine(TCM) syndromes scale and imaging scores were observed before and after treatment. The changes of plasma viscosity (PV)

electrophoresis (EPT)

erythrocyte sedimentation rate (ESR)

erythrocyte deposition (HCT) were detected. The effective rates

recurrence rates and safety indexes were compared between two groups. Result:The 2 cases in control group and 4 cases in observation group withdrew from the study. The total effective rate was 97.9% in observation group

higher than 82.4% in control group (P<0.05). The recurrence rate was 8.1% in observation group

lower than 35.5% in control group in follow-up for 12 months (P<0.05). As compared with the control group after treatment

the Harris scores

the SF-36 scores

and hip imaging scores were significantly higher in observation group (P<0.05)

and the TCM syndrome scores

PV

EPT

ESR

and HCT indexes were significantly lower (P<0.05). The incidence of adverse reactions was 12.2% in observation group

lower than 35.5% in control group (P<0.05). The incidence rate of abnormal indexes in routine blood test and urine test was 15.9% and 9.8% respectively in observation group

lower than 30.6% and 18.4% in control group (P<0.05). Conclusion:Shenbitang combined with diclofenac sodium release tablets could significantly improve the clinical symptoms and PV

EPT

ESR and HCT indexes

and reduce the recurrence rate and incidence of adverse reactions in the treatment of early-to-middle stage osteonecrosis of the femoral head caused by kidney deficiency and blood stasis.