Core decompression combined with autologous bone marrow mesenchymal stem cells for femoral head necrosis: a meta-analysis of safety and efficacy

doi:10.3969/j.issn.2095-4344.0507

Abstract

Abstract:

BACKGROUND: Femoral head necrosis is a multifactorial disease, and has the youth oriented tendency. It often results in femoral head collapse and leads to total hip arthroplasty. Thus, finding a secure and effective treatment is of clinical benefits to relieve patients’ suffering and to reduce social economic burden. Bone marrow mesenchymal stem cells (BMSCs) transplantation has been used in the clinical practice of femoral head necrosis. However, the conclusion remains controversial.
OBJECTIVE: To access the safety and efficacy of the core decompression combined with autologous BMSCs transplantation in patients with femoral head necrosis by using meta-analysis approach.
METHODS: Randomized clinical controlled trials (RCTs) which compared the therapeutic effects between core decompression combined with autologous BMSCs and core decompression were systematically retrieved from inception to June 20, 2017 in PubMed, The Cochrane Library (Issue 5, 2017), Embase, CNKI, CBM, VIP and WanFang databases. After extraction of the information and evaluation of the study quality, a meta-analysis was performed by RevMan software.
RESULTS AND CONCLUSION: Eight RCTs with 323 patients (395 hips), 193 hips in BMSCs group and 202 in conventional therapeutic group, were ultimately included. The revisit time was 12-60 months. The overall quality of the trials was considered moderate-high. The results of meta-analysis show that compared with core decompression alone, autologous BMSCs transplantation combined with core decompression could alleviate the pain [Visual Analogue Scale: mean difference (MD)=-0.39, 95% confidence interval (CI) (-0.76, -0.01)], enhance the joint function [Harris score: 12 months MD=7.16, 95%CI (3.88, 10.44) and 24 months MD=11.16, 95%CI (8.32, 14.00)], decrease the rate of disease progression in radiography [odds ratio=0.23, 95%CI (0.09, 0.55)]. Although there was no statistical significance between two groups, BMSCs transplantation had trend to reduce the rate of total hip arthroplasty [risk ratio=0.44, 95%CI (0.19, 1.03)]. No obvious complications were found in the course of BMSCs therapy. Given the above, autologous BMSCs transplantation combined with core decompression is a secure and effective therapeutic method for femoral head necrosis.

中国组织工程研究杂志出版内容重点：干细胞；骨髓干细胞；造血干细胞；脂肪干细胞；肿瘤干细胞；胚胎干细胞；脐带脐血干细胞；干细胞诱导；干细胞分化；组织工程

Key words: Bone Marrow, Mesenchymal Stem Cell Transplantation, Femur Head Necrosis, Decompression, Surgical, Meta-Analysis, Tissue Engineering

CLC Number:

R394.2

Wang Qian, Huang Guo-xin, Chen Lei, Li De-sheng, Ai Jin-wei, Pei Bin. Core decompression combined with autologous bone marrow mesenchymal stem cells for femoral head necrosis: a meta-analysis of safety and efficacy[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(17): 2733-2739.

Figures/Tables 4

2.3 Meta分析结果 2.3.1 髋关节疼痛 3个研究运用目测类比评分评价了髓芯减压联合自体骨髓间充质干细胞移植与单一髓芯减压对股骨头缺血性坏死髋关节疼痛的影响[11，15-16]。Meta分析结果显示髓芯减压联合自体骨髓间充质干细胞移植更能减轻患者髋关节疼痛，且差异有显著性意义[I2=0%，MD=-0.39，95%CI (-0.76，-0.01)，P=0.04]，见图3。因纳入研究数量较少，未按随访时间进行亚组分析。 2.3.2 髋关节功能评分 7个研究运用Harris髋关节评分比较了两组治疗后髋关节功能差异[11-12，14-18]。其中，7个研究报道了随访12个月时Harris髋关节评分[11-12，14-18]，4个研究报道了随访24个月时Harris髋关节评分[11-12，14，17]。Meta分析结果显示：两组治疗后Harris髋关节评分差异有显著性意义[随访12个月：I2=64%，MD=7.16，95%CI (3.88，10.44)，P < 0.01；随访24个月：I2=28%，MD=11.16，95%CI (8.32，14.00)，P < 0.01]，见图4；随访12个月时各研究间异质性较大，分析1个研究对异质性影响较明显[18]，给予排除进行敏感性分析，结果性质未发生明显变化[I2=0%，MD=6.00，95%CI (4.05，7.96)，P < 0.01]。说明自体骨髓间充质干细胞移植能促进髋关节功能恢复。 2.3.3 病情进展率 4个研究运用影像学检查根据ARCO/ Ficat分期评价两组患者股骨头坏死病情进展率[13-14，17-18]。Meta分析结果显示，在髓芯减压的基础上联合自体骨髓间充质干细胞移植能降低患者股骨头坏死影像学病情进展率 [I2=0%，OR=0.23，95%CI (0.09，0.55)，P < 0.01]，见图5。 2.3.4 全髋关节置换率 3个研究报道了随访过程中全髋关节置换人数[11，13，16]。Meta分析结果显示髓芯减压联合自体骨髓间充质干细胞移植与单一髓芯减压比较治疗股骨头缺血性坏死有降低全髋置换率趋势，但两者差异无显著性意义[I2=36%，RR=0.44，95%CI (0.19，1.03)，P=0.06]，见图6。说明自体骨髓间充质干细胞移植不能降低股骨头缺血性坏死全髋置换率。 2.3.5 并发症率 4个研究报道了治疗过程中并发症发生情况[11-13，15]，均显示自体骨髓间充质干细胞移植过程中及随访期间无明显并发症发生，说明对股骨头缺血性坏死患者在髓芯减压基础上运用自体骨髓间充质干细胞移植是安全的。"

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