Objective To observe the clinical curative effect and the safety of Qishen Huogu Formula（ 芪参活骨方） in treating osteonecrosis of the femeral head with spleen and kidney deficiency

and blood stasis obstructing the collaterals syndrome. Methods Sixty patients with femoral head necrosis（ 97 hips in total

54 hips of ARCO Ⅱstage

43 hips of ARCO Ⅲ stage） treated with Shenqi huogu Formula for over 6 months were collected. Harris hip scores and radiographic results were set as the evaluation index

and the changes after the treatment were compared.The clinical curative effect

imaging findings

as well as the safety were evaluated. Results In 97 hips of 60 patients with femoral head necrosis

6 hips（ 6. 19%） were cured

36 hips（ 37. 11%） markedly effective

45 hips（ 46. 39%） effective

and 10 hips（ 10. 31%） invalid. The total effective rate was 89. 69%. Imaging evaluation of 97 hips showed that 67 hips（ 69. 07%） were stable

and 30 hips（ 30. 93%） aggravating; in patients of ARCO Ⅱstage

39 hips（ 72. 22%） stable

15 hips（ 27. 78%） aggravating. In patients of ARCO Ⅲ stage

29 hips（ 67. 44%） were stable

and 14 hips（ 32. 56%） aggravating. After treatment

Harris hip joint function total scores and the degree of pain

joint function

joint deformity and joint activity scores in 97 hips of 60 patients with femoral head necrosis were significantly improved compared with that before treatment（ P < 0. 01）. Harris scores of patients of the Ⅱ and Ⅲ stage after treatment were both significantly improved compared with that before treatment（ P <0. 01）. Conclusion Qishen Huogu Formula has a certain effect in treating femoral head necrosis of spleen and kidney deficiency and blood stasis obstructing the collaterals syndrome. It could improve hip pain

joint activity

walking and living ability of patients preferably and has the same curative effect on ARCO stage Ⅱ and Ⅲ.