中国组织工程研究

中国组织工程研究 ›› 2026, Vol. 30 ›› Issue (30): 8032-8039.doi: 10.12307/2026.969

• 组织构建学术探讨 tissue construction academic discussion • 上一篇    下一篇

骨再生技术在成人股骨头坏死保髋治疗中的临床应用指南

任文杰1，郭全义2，周广东3，常廷民4，李记天5，胡懿郃6，邢更彦7，关振鹏8，等
  

  1. 1河南省组织器官重塑与智能制造重点实验室，河南省新乡市   453003；2解放军总医院第四医学中心骨科医学部，北京市   100048；3上海交通大学医学院附属第九人民医院整复外科，上海市   200011；4河南医药大学第一临床学院，河南省新乡市   453003；5河南医药大学第一附属医院骨科，河南省新乡市   453100；6浙江大学医学院附属第一医院骨科，浙江省杭州市   310003；7中国人民解放军总医院第三医学中心骨科，北京市   100039；8北京大学首钢医院骨科，北京市   100144；
  • 收稿日期:2026-07-31 修回日期:2026-08-31 出版日期:2026-10-28 发布日期:2026-09-15
  • 通讯作者: 通讯作者：任文杰，博士生导师，河南医药大学组织工程与再生临床医学中心，河南省新乡市 453003 通讯作者：郭全义，博士生导师，解放军总医院第四医学中心骨科医学部，北京市 100048 通讯作者：李记天，博士生导师，河南医药大学组织工程与再生临床医学中心，河南省新乡市 453100
  • 基金资助:
    国家自然科学基金面上项目(82471191)；国家重点研发计划项目(2024YFA1107804)；河南省产业联合基金重大项目(235101610001)

Clinical guidelines for the use of bone regeneration techniques in the preservation of the hip in adults with osteonecrosis of the femoral head

Ren Wenjie1, Guo Quanyi2, Zhou Guangdong3, Chang Tingmin4, Li Jitian5, Hu Yihe6, Xing Gengyan7, Guan Zhenpeng8, et al.   

  1. 1Henan Provincial Key Laboratory of Organ Remodeling and Intelligent Manufacturing, Xinxiang 453003, Henan Province, China; 2Department of Orthopedics, The Fourth Medical Center of PLA General Hospital, Beijing 100048, China; 3Department of Plastic and Reconstructive Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 4The First Clinical College, Henan University of Medicine, Xinxiang 453003, Henan Province, China; 5Department of Orthopedics, The First Affiliated Hospital of Henan University of Medicine, Xinxiang 453100, Henan Province, China; 6Department of Orthopedics, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China; 7Department of Orthopedics, The Third Medical Center of PLA General Hospital, Beijing 100039, China; 8Department of Orthopedics, Peking University Shougang Hospital, Beijing 100144, China; 
  • Received:2026-07-31 Revised:2026-08-31 Online:2026-10-28 Published:2026-09-15
  • Contact: Ren Wenjie, Doctoral supervisor, Henan Provincial Key Laboratory of Organ Remodeling and Intelligent Manufacturing, Xinxiang 453003, Henan Province, China Co-corresponding author: Guo Quanyi, Doctoral supervisor, Department of Orthopedics, The Fourth Medical Center of PLA General Hospital, Beijing 100048, China Co-corresponding author: Li Jitian, Doctoral supervisor, Department of Orthopedics, The First Affiliated Hospital of Henan University of Medicine, Xinxiang 453100, Henan Province, China
  • About author:Ren Wenjie, Doctoral supervisor, Henan Provincial Key Laboratory of Organ Remodeling and Intelligent Manufacturing, Xinxiang 453003, Henan Province, China
  • Supported by:
    The National Natural Science Foundation of China (General Program), No. 82471191; the National Key Research and Development Program of China, No. 2024YFA1107804; the Major Project of Henan Provincial Industrial Joint Fund, No. 235101610001

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摘要：


文题释义：
股骨头坏死骨再生技术：指针对股骨头坏死区骨组织修复障碍，利用髓芯减压、骨髓浓缩物/间充质干细胞、富血小板血浆、组织工程骨、支架材料及血管化骨移植等手段，改善局部微循环、促进血管新生和成骨，并在必要时提供结构支撑，以延缓股骨头塌陷和推迟或避免全髋关节置换的一类治疗技术。
生物增强保髋技术：指在传统保髋术式，尤其是髓芯减压基础上，加入具有促血管生成、促成骨或免疫调节作用的细胞、生物制剂、生长因子或组织工程材料，以提高坏死区修复能力的治疗策略，其疗效受疾病分期、病灶大小与位置、细胞/制剂质量及植入方式等因素影响。

背景：股骨头坏死的骨再生/生物增强保髋技术种类多，适应证、结构支撑需求及中长期获益受塌陷阶段、坏死范围和外侧柱受累等因素影响，临床应用仍需统一的分层决策框架。
目的：形成股骨头坏死骨再生技术的循证推荐意见，为临床保髋治疗选择及后续研究设计提供依据。
方法：参照《中国制订/修订临床诊疗指南的指导原则(2022版)》，在系统评价证据基础上采用推荐分级的评估、制订与评价(GRADE)方法评价证据质量和推荐强度，并依据证据到决策框架综合考虑资源利用、患者偏好与价值观、公平性和可及性；围绕14个临床问题，经多轮专家论证形成推荐意见。
结果与结论：指南提出以ARCO塌陷阶段为主线、结合坏死范围和外侧柱受累的分层策略。塌陷前期优先考虑髓芯减压联合骨髓浓缩物等再生增强；早期塌陷仅限严格筛选病例；大病灶或外侧柱受累需增加结构性支撑；ARCO ⅢB-Ⅳ期单纯再生保髋获益有限。双膦酸盐、体外冲击波、高压氧及富血小板血浆的增量获益仍不确定；精准导航可改善手术定位质量；外泌体、基因治疗及新型支架应限于临床研究。现有证据以中低质量为主，仍需标准化、多中心和长期结局研究。
https://orcid.org/0000-0003-4711-2352 (任文杰)；https://orcid.org/0000-0002-3162-0662 (郭全义) ；https://orcid.org/0000-0001-5449-8084 (李记天)


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

关键词: 股骨头坏死, 骨再生, 保髋治疗, 髓芯减压, 骨髓浓缩物, 富血小板血浆, 组织工程骨, 临床实践指南, GRADE

Abstract: BACKGROUND: Bone regeneration and biologically augmented hip-preserving techniques for osteonecrosis of the femoral head vary substantially in indications, structural support requirements, and medium- to long-term benefits. Their effectiveness is influenced by collapse stage, lesion size, and lateral pillar involvement, underscoring the need for a unified stratified decision framework.
OBJECTIVE: To develop evidence-based recommendations for bone regeneration technologies in osteonecrosis of the femoral head and to support clinical selection of hip-preserving treatments and future research design.
METHODS: The recommendations were developed with reference to the Guiding Principles for Developing/Revising Clinical Practice Guidelines in China (2022). Evidence from systematic reviews was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. The Evidence-to-Decision framework was used to consider research evidence, resource use, patient values and preferences, equity, and accessibility. Fourteen clinical questions were addressed, and recommendations were formed after multiple rounds of expert deliberation.
RESULTS AND CONCLUSION: A stratified strategy centered on the Association Research Circulation Osseous (ARCO) collapse stage and supplemented by lesion size and lateral pillar involvement is proposed. Before collapse, core decompression combined with regenerative augmentation, particularly bone marrow aspirate concentrate, is preferred. Hip preservation after early collapse should be restricted to carefully selected patients, whereas large lesions or lateral pillar involvement require additional structural support. Regenerative hip preservation alone has limited benefit in ARCO stage IIIB-IV disease. The incremental benefits of bisphosphonates, extracorporeal shock wave therapy, hyperbaric oxygen therapy, and platelet-rich plasma remain uncertain. Precision navigation may improve procedural accuracy, whereas extracellular vesicles, gene therapy, and emerging scaffolds should currently be used within clinical research. Standardized, multicenter studies with long-term outcomes are still required.

Key words: osteonecrosis of the femoral head, bone regeneration, hip preservation, core decompression, bone marrow aspirate concentrate, platelet-rich plasma, tissue-engineered bone, clinical practice guideline, GRADE

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