Department of Orthopaedic Surgery, Orthopedic Research Institute, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, China.
J Healthc Eng. 2021 Sep 24;2021:9313201. doi: 10.1155/2021/9313201. eCollection 2021.
The treatment results of core decompression (CD) and biomechanical support are not always satisfactory in osteonecrosis of the femoral head (ONFH). Stem cell therapy has been incorporated into traditional treatment in order to promote bone regeneration. The efficacy and safety of stem cell therapy combined with CD or biomechanical support on advanced and long-term patients with ONFH were unknown. The aim of this study was to assess whether stem cell combination therapy is superior to single CD or porous tantalum rod implantation treatment in ONFH.
A systematic search of the literature was performed to evaluate all included randomized controlled trials (RCTs) on stem cell combination therapy for patients with ONFH in PubMed, Cochrane Library, Web of Science, and Embase sites. We assessed the quality and risk of bias for the included studies. And the outcomes of Harris hip score (HHS), visual analogue scale (VAS), and adverse events were statistically analyzed.
We included 10 randomized controlled trials, containing a total of 498 patients with 719 hips. Stem cell therapy combined with CD versus CD alone for HHS of ONFH was different (MD = 8.87, 95% CI = [5.53, 12.22], < 0.00001). The combination of stem cell therapy and CD can effectively improve HHS. Similarly, the VAS of the stem cell combination therapy group also differed compared with the control group (MD = -14.07, 95% CI = [-18.32, -9.82], < 0.00001). The result showed that stem cell combination therapy can relieve the pain of patients with ONFH. There was no significant difference in adverse response outcome events between the combination therapy group and the control group (RR = 1.57, 95% CI = [0.62, 3.97], = 0.34).
Stem cell therapy combined with core decompression is an effective and feasible method with few complications in the clinical treatment of early-stage ONFH. Even in the combination of porous tantalum rod implantation and peripheral blood stem cells, stem cell combination therapy is superior to single biomechanical support treatment. But high-quality, large-sample, multicenter, and long-term follow-up RCTs are still needed to corroborate the efficacy and safety of stem cell combination therapy in ONFH treatment.
在股骨头坏死（ONFH）的治疗中，核心减压（CD）和生物力学支撑的治疗效果并不总是令人满意。为了促进骨再生，已经将干细胞疗法纳入传统治疗中。干细胞疗法联合 CD 或生物力学支撑治疗晚期和长期 ONFH 患者的疗效和安全性尚不清楚。本研究旨在评估干细胞联合治疗是否优于单独 CD 或多孔钽棒植入治疗 ONFH。
系统检索 PubMed、Cochrane 图书馆、Web of Science 和 Embase 网站上所有关于干细胞联合治疗 ONFH 患者的随机对照试验（RCT），评估纳入研究的质量和偏倚风险。并对 Harris 髋关节评分（HHS）、视觉模拟评分（VAS）和不良事件的结果进行统计学分析。
我们纳入了 10 项 RCT，共包含 498 例患者，719 髋。干细胞治疗联合 CD 与单独 CD 治疗 ONFH 的 HHS 不同（MD=8.87，95%CI=[5.53，12.22]，<0.00001）。干细胞治疗联合 CD 可有效改善 HHS。同样，干细胞联合治疗组的 VAS 也与对照组有差异（MD=-14.07，95%CI=[-18.32，-9.82]，<0.00001）。结果表明，干细胞联合治疗可缓解 ONFH 患者的疼痛。联合治疗组与对照组在不良反应事件结局方面无显著差异（RR=1.57，95%CI=[0.62，3.97]，=0.34）。
干细胞治疗联合核心减压是一种有效可行的方法，在早期 ONFH 的临床治疗中并发症较少。即使在多孔钽棒植入和外周血干细胞联合治疗中，干细胞联合治疗也优于单一生物力学支撑治疗。但仍需要高质量、大样本、多中心、长期随访的 RCT 来证实干细胞联合治疗在 ONFH 治疗中的疗效和安全性。
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