中国组织工程研究 ›› 2026, Vol. 30 ›› Issue (15): 3993-4009.doi: 10.12307/2026.738

• 骨与关节循证医学 evidence-based medicine of the bone and joint • 上一篇    下一篇

髓芯减压联合不同方法治疗早中期股骨头坏死的网状 Meta 分析

郭玉祺1,李嘉程2,卢博文1,张加豪1,李  刚2   

  1. 1山东中医药大学第一临床医学院,山东省济南市  250014;2山东中医药大学附属医院骨伤中心,山东省济南市  250014

  • 接受日期:2025-07-09 出版日期:2026-05-28 发布日期:2025-11-10
  • 通讯作者: 李刚,博士,教授,主任医师,博士生导师,山东中医药大学附属医院骨伤中心,山东省济南市 250014
  • 作者简介:郭玉祺,男,2000年生,山东省淄博市人,汉族,山东中医药大学在读硕士,主要从事骨与关节疾病研究。
  • 基金资助:
    泰山学者特聘专家(入选年度2025年—李刚)项目(tsxztpzj-02),项目负责人:李刚;山东省重点研发计划(重大科技创新工程)项目(2021CXGC010501),项目负责人:李刚;山东省自然科学基金项目(ZR2022LZY003),项目负责人:李嘉程

Network meta-analysis of core decompression combined with various therapies for early and mid-stage osteonecrosis of the femoral head

Guo Yuqi1, Li Jiacheng2, Lu Bowen1, Zhang Jiahao1, Li Gang2   

  1. 1First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China; 2Department of Orthopedics and Traumatology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • Accepted:2025-07-09 Online:2026-05-28 Published:2025-11-10
  • Contact: Li Gang, MD, Professor, Chief physician, Doctoral supervisor, Department of Orthopedics and Traumatology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • About author:Guo Yuqi, Master candidate, First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • Supported by:
    Taishan Scholar Distinguished Expert (Selected in the Year 2025-Li Gang) Project, No. tsxztpzj-02 (to LG); Shandong Provincial Key Research & Development Program (Major Scientific and Technological Innovation Project), No. 2021CXGC010501 (to LG); Shandong Provincial Natural Science Foundation, No. ZR2022LZY003 (to LJC)

摘要:

文题释义:

髓芯减压术:是治疗早中期股骨头坏死的常用保髋治疗方式。通过在股骨头内钻孔,清除部分坏死骨组织,以降低骨内髓腔压力,改善局部微循环和血流灌注,从而延缓坏死进程,促进骨再生与组织修复。髓芯减压术主要适用于尚未发生明显结构性塌陷的早期股骨头坏死患者,通常对应于Ficat、Steinberg或ARCO等分期系统中的Ⅰ-Ⅱ期,可在一定程度上延缓全髋关节置换的时间,为联合干预创造条件。
贝叶斯网状Meta分析:是一种用于同时比较多种干预措施的系统评价方法,基于贝叶斯统计推断原理,利用马尔科夫链蒙特卡洛算法模拟干预间效应值的后验分布。该方法可整合直接与间接比较证据,在处理稀疏数据和复杂网络结构方面具有优势,并可通过累积排序曲线实现干预效应的概率排序。相比传统频率学派方法,贝叶斯网状Meta分析在多干预疗效评价中具有更强的适应性与解释力,广泛应用于药物治疗、手术技术和临床路径优化等循证研究领域。

摘要
目的:探讨髓芯减压联合不同治疗策略对早中期股骨头坏死患者的疗效及安全性评价。
方法:系统检索PubMed、Web of Science、Cochrane Library、EMbase、中国知网、维普、万方和中国生物医学文献数据库,纳入截至2025-01-19发表的关于髓芯减压联合治疗早中期股骨头坏死的随机对照试验。采用Cochrane偏倚风险评估工具对文献质量进行评价,运用GRADE系统评价证据等级,基于贝叶斯框架构建网状Meta分析模型。采用标准化均数差进行效应估计,结果以累积排序概率曲线下面积进行干预优效性排序。敏感性分析采用逐项剔除法评估模型稳健性,并通过基线协变量评估传递性假设。
结果:最终纳入73项随机对照试验,共计5 148例患者、5 777个髋关节,涵盖15种联合治疗方法。结果显示:①在提高综合临床疗效方面,髓芯减压联合自体骨髓单核细胞浓缩注射、骨髓间充质干细胞移植、支撑性植骨及补肾活血类中药复方汤剂等均优于单纯髓芯减压,其中髓芯减压联合自体骨髓单核细胞浓缩注射显示出最优的干预效果(累积排序概率曲线下面积=96.23%);②在髋关节功能改善方面,髓芯减压联合中医药序贯治疗疗效最优(累积排序概率曲线下面积=93.85%);③在疼痛缓解方面,髓芯减压联合中成药(补肾活血+活血化瘀)与活血化瘀类中药复方汤剂效果突出;④在影像学改善方面,髓芯减压联合自体源性干细胞局部植入效果最佳(累积排序概率曲线下面积=82.56%);⑤在临床安全性方面,髓芯减压联合活血化瘀类中药复方汤剂在降低不良事件发生率方面具有相对优势(P <  0.05)。为评估结果稳健性,采用逐项剔除法进行敏感性分析,显示模型稳定,主要干预结果对单项研究不敏感,传递性假设成立。
结论:髓芯减压联合干细胞移植、中医药序贯治疗等多种治疗方案在改善早中期股骨头坏死临床疗效方面优于单纯髓芯减压,表现为关节功能保护、结构重建与疼痛控制等多重优势。考虑部分干预文献数量有限及研究质量差异,仍需高质量、多中心、大样本随机对照试验进一步验证。


中国组织工程研究杂志出版内容重点:人工关节;骨植入物;脊柱;骨折;内固定;数字化骨科;组织工程

关键词: 髓芯减压术, 股骨头坏死, 联合治疗, 网状Meta分析, 随机对照试验

Abstract: OBJECTIVE: To evaluate the efficacy and safety of core decompression combined with various therapeutic strategies in patients with early to mid-stage osteonecrosis of the femoral head.
METHODS: A systematic search was conducted in PubMed, Web of Science, Cochrane Library, EMbase, China National Knowledge Infrastructure, VIP, WanFang Data, and Chinese Biomedical Literature Service System for randomized controlled trials published up to January 19, 2025, on core decompression combined with different interventions for early to mid-stage osteonecrosis of the femoral head. The quality of the included studies was assessed using the Cochrane Risk of Bias Tool. The Grading of Recommendations Assessment, Development and Evaluation approach was applied to evaluate the quality of evidence. A Bayesian network meta-analysis model was constructed to synthesize the data. Effect sizes were estimated using standardized mean differences, and cumulative ranking probabilities were calculated to determine the relative effectiveness of each intervention. Sensitivity analyses were performed using the leave-one-out method, and the assumption of transitivity was examined based on baseline covariates.
RESULTS: A total of 73 randomized controlled trials involving 5 148 patients and 5 777 hips were included, covering 15 different combination therapies. The findings revealed that: (1) In terms of overall clinical efficacy, core decompression combined with bone marrow aspirate concentrate of mononuclear cells, bone marrow mesenchymal stem cell transplantation, structural bone grafting, or kidney-tonifying and blood-activating decoction was superior to core decompression alone, with the combination involving bone marrow aspirate concentrate of mononuclear cells demonstrating the best effect (the area under the cumulative ranking probability curve = 96.23%). (2) For hip function improvement, core decompression combined with staged Chinese medicine treatment showed the highest efficacy (the area under the cumulative ranking probability curve = 93.85%). (3) Regarding pain relief, combinations with compound proprietary medicine treatment (kidney-tonifying and blood-activating plus blood-activating and stasis-resolving) or blood-activating and stasis-resolving decoction exhibited prominent benefits. (4) For radiological improvements, core decompression combined with autologous stem cell implantation showed the best outcomes (the area under the cumulative ranking probability curve = 82.56%). (5) In terms of safety, core decompression combined with blood-activating and stasis-resolving decoction was associated with a relatively lower incidence of adverse events (P < 0.05). Sensitivity analysis using the leave-one-out method confirmed the robustness of the findings. The model remained stable across analyses, and the transitivity assumption was supported by baseline covariate assessment.
CONCLUSION: Core decompression combined with stem cell transplantation, Chinese medicine-based sequential therapies, and other combination strategies provides superior clinical outcomes compared with core decompression alone for patients with early to mid-stage osteonecrosis of the femoral head, particularly in terms of joint function preservation, structural restoration, and pain relief. Further high-quality, multicenter, large-sample randomized controlled trials are needed to confirm these findings due to limitations in sample size and methodological quality of some included studies.

Key words: core decompression, osteonecrosis of the femoral head, combination therapy, network meta-analysis, randomized controlled trial

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