Clinical observation of Yishen Huoxue decoction(YSHXD) for the treatment of non-traumatic osteonecrosis of femoral head at early and middle stage

Abstract

To observe clinical efficacy of Yishen Huoxue decoction(YSHXD) for the treatment of non-traumatic osteonecrosis of femoral head at early and middle stage. From January to June 2016, 69 patients (72 hips) with non-traumatic osteonecrosis of femoral head at early and middle stage were divided into treatment group and control group according to therapeutic methods. In treatment group, there were 35 patients 43 hips, including 15 males and 20 females, aged from 28 to 62 years old with an average of(41.80±11.03) years old, 6 hips were at the stage I, 27 hips were at the stageII, 10 hips were at the stage IIIa according to ARCO classification; and treated by using YSHXD, one dose a day for 12 months. In control group, there were 34 patients 39 hips, including 16 males and 18 females, aged from 31 to 61 years old with an average of (43.35±13.52) years old, 5 hips were at the stage I, 26 hips were at the stageII, 8 hips were at the stage IIIa according to ARCO classification; and treated by using alendronate sodium tablets 70 mg every week for 12 months. Preoperative and postoperative HSS score at 2 weeks were observed and compared, EQ-5D index was used to compare clinical effects. ARCO classification was applied to imaging evaluation, the stage of ARCO over IIIa was considered as end point of observation. The final following-up time and ARCO classification were recorded and performed Kaplan-Meier survival analysis. All patients were followed-up from 26 to 76 months with an average of(43.50±13.26) months. Postoperative Harris score at 2 years in treatment group (84.92±7.56) was higher than that of before treatment (73.58±10.02) (P<0.05), and higher than that of control group(79.61±10.92)(P<0.05), especially the scores of joint function and activity were higher than those of control group(P<0.05). EQ-5D index in treatment group 0.66±0.12 was higher than that of control group 0.59±0.12(P<0.05). Nine hips were collapsed in treatment group at final follow-up, and 10 hips were collapsed in control group, and had no statistical difference between two groups (P>0.05). There was no statistical difference in kaplan-meier survival analysis curves between two groups (P>0.05). There were statistical difference in survival rate between the early, middle ARCO stage and different Harris evaluation. YSHXD for the treatment of non-traumatic osteonecrosis of femoral head at early and middle stage has obviously clinical effects, could improve hip joint function, and quality of life, and delay the process of femoral head necrosis collapse.