Mao Qiang, Wang Weidong, Xu Taotao, Zhang Shanxing, Xiao Luwei, Chen Di, Jin Hongting, Tong Peijian
Department of Orthopaedic Surgery, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China; Zhejiang Chinese Medical University, Hangzhou, China.
J Bone Miner Res. 2015 Apr;30(4):647-56. doi: 10.1002/jbmr.2390.
The objective of this study was to determine the benefits of combination treatment with mechanical support and targeted intra-arterial infusion of peripheral blood stem cells (PBSCs) mobilized by granulocyte-colony stimulating factor (G-CSF) via the medial circumflex femoral artery on the progression of osteonecrosis of the femoral head (ONFH). Fifty-five patients (89 hips) with early and intermediate stage ONFH were recruited and randomly assigned to combination treatment or mechanical support treatment (control group). All hips received mechanical support treatment (porous tantalum rod implantation). Then, hips in the combination treatment group were performed targeted intra-arterial infusion of PBSCs. At each follow-up, Harris hip score (HHS) and Association Research Circulation Osseous (ARCO) classification were used to evaluate the symptoms and progression of osteonecrosis. Total hip arthroplasty (THA) was assessed as an endpoint at each follow-up. At 36 months, 9 of the 41 hips (21.95%) in the control group progressed to clinical failure and underwent THA whereas only 3 of the 48 hips (6.25%) in the combination treatment group required THA (p = 0.031). Kaplan-Meier survival analysis showed a significant difference in the survival time between the two groups (log-rank test; p = 0.025). Compared to the control group, combination treatment significantly improved the HHS at 36 months (p = 0.003). At the final follow-up examination, radiological progression was noted in 13 of 41 hips (31.71%) for the control group, but in only 4 of 48 hips (8.33%) for the combination treatment group (p = 0.005). The overall collapse rates were 15.15% (5/33 hips) and 8.11% (3/37 hips) in the control and combination treatment groups, respectively. Targeted intra-arterial infusion of PBSCs is capable of enhancing the efficacy of biomechanical support in the treatment of ONFH. This clinical trial confirmed that the combination treatment might be a safe and feasible choice for the treatment of early or intermediate stages of ONFH.
本研究的目的是确定通过股内侧旋动脉对经粒细胞集落刺激因子（G-CSF）动员的外周血干细胞（PBSCs）进行机械支持与靶向动脉内输注的联合治疗对股骨头坏死（ONFH）进展的益处。招募了55例（89髋）早、中期ONFH患者，并随机分配至联合治疗组或机械支持治疗组（对照组）。所有髋关节均接受机械支持治疗（多孔钽棒植入）。然后，联合治疗组的髋关节进行PBSCs的靶向动脉内输注。每次随访时，采用Harris髋关节评分（HHS）和骨循环研究协会（ARCO）分类来评估坏死的症状和进展情况。每次随访时，将全髋关节置换术（THA）作为评估终点。36个月时，对照组41髋中有9髋（21.95%）进展至临床失败并接受THA，而联合治疗组48髋中只有3髋（6.25%）需要进行THA（p = 0.031）。Kaplan-Meier生存分析显示两组生存时间存在显著差异（对数秩检验；p = 0.025）。与对照组相比，联合治疗在36个月时显著改善了HHS（p = 0.003）。在最后一次随访检查时，对照组41髋中有13髋（31.71%）出现影像学进展，而联合治疗组48髋中只有4髋（8.33%）出现影像学进展（p = 0.005）。对照组和联合治疗组的总体塌陷率分别为15.15%（5/33髋）和8.11%（3/37髋）。PBSCs的靶向动脉内输注能够增强生物力学支持在ONFH治疗中的疗效。该临床试验证实，联合治疗可能是治疗早、中期ONFH的一种安全可行的选择。
