复方生脉成骨胶囊治疗塌陷前期非创伤性股骨头坏死的临床研究

目的:评估复方生脉成骨胶囊辅助负重控制治疗塌陷前期非创伤性股骨头坏死的临床适应证及疗效。方法:采用复方生脉成骨胶囊辅助负重控制治疗塌陷前期非创伤性股骨头坏死患者54例(65髋),男41例,女13例,平均年龄38.39岁(22~69岁);ARCO分期:ⅠA8髋,ⅠB2髋,ⅡA9髋,ⅡB14髋,ⅡC32髋。疼痛分级:0级29髋;1级18髋;2级14髋;3级4髋。坏死指数:≤30%共33髋,30%~≤60%共19髋,60%共13髋。坏死部位:A型7髋,B型20髋,C1型27髋,C2型11髋。骨髓水肿:0级32髋,Ⅰ级14髋,Ⅱ级11髋,Ⅲ级8髋。结果:平均随访37月,65髋中11髋最终行髋关节手术,生存54髋,髋关节的总体生存率为83.08%。随访终期Harris评分平均为89分。对疼痛、ARCO分期、坏死指数、坏死部位、骨髓水肿进行分层,以手术为终点的Kaplan-Meier生存曲线分析显示,各组间比较差异均有统计学意义(P0.05)。结论:复方生脉成骨胶囊辅助负重控制治疗塌陷前期非创伤性股骨头坏死的临床结果显示可改善生存率。疼痛、ARCO分期、坏死部位、坏死指数、骨髓水肿是影响髋关节生存率的重要指标。

Clinical Study on Compound Shengmai Chenggu Capsule in the Treatment of Pre-collapse Nontraumatic Osteonecrosis of Femoral Head

Objective：To observe the indications and efficacy of compound Shengmai Chenggu Capsule（CSCC） in treating pre-collapse nontraumatic osteonecrosis of femoral head（NONFH）.Methods：Fifty-four patients（65 hips） with pre-collapse NONFH were treated with CSCC.There were 41 males and 13 females,with the average age of 38.39 years.According to the grading system of the Association Research Circulation Osseous（ARCO）,10 hips were classified as stage Ⅰ,8 hips in stage ⅠA and 2 hips in stageⅠ B;55 hips were classified as stage Ⅱ,9 hips in stageⅡ A and 14 hips in stageⅡ B and 32 hips in stageⅡ C.Based on grading scale of pain,29 hips were in grade 0,18 hips in grade 1,14 hips in grade 2 and 4 hips in grade 3.There were 33 hips with the necrotic extent less than 30%,19 hips between 30% and 60%,and 13 hips more than 60%.As for the necrotic position,7 hips fell into type A,20 hips into type B,27 hips into type C1,and 11 hips into type C2.According to distribution of bone marrow edema（BME） on T1-and T2-weighted MR images,and fat suppression images,hips were classified into four categories： 32 hips of grade 0,14 hips of grade distributing to femoral head（grade 1）,distributing to femoral neck（grade 2）,distributing to proximal femoral（grade 3）.32 hips in grade 0,14 hips in grade Ⅰ,11 hips in grade Ⅱ,and 8 hips in grade Ⅲ.Results：After the mean follow-up of thirty-seven months,11 hips received hip arthroplasty in the end,and 54 hips survived,with the total survival rate 83.08%.The mean Harris hip score for survival hips was 89.There were significant differences in pain,ARCO staging,necrotic extent,necrotic location and bone marrow edema between all the groups（P0.05）.Conclusion： The early clinical results of CSCC associated with weight-bearing are encouraging in treating pre-collapse NONFH.There are several important factors that will affect the hip survival,such as pain,ARCO stage,necrotic location,necrotic extent,bone marrow edema,etc.