切换至 "中华医学电子期刊资源库"

中华关节外科杂志(电子版) ›› 2026, Vol. 20 ›› Issue (02) : 141 -150. doi: 10.3877/cma.j.issn.1674-134X.2026.02.002

专家共识

自体骨组织库建设专家共识
中华医学会骨科学分会关节外科学组   
  • 收稿日期:2026-01-16 出版日期:2026-04-01

Expert consensus on the construction of autologous bone tissue banks

Joint Surgery Group of the Orthopedic Society of the Chinese Medical Association   

  • Received:2026-01-16 Published:2026-04-01
引用本文:

中华医学会骨科学分会关节外科学组. 自体骨组织库建设专家共识[J/OL]. 中华关节外科杂志(电子版), 2026, 20(02): 141-150.

Joint Surgery Group of the Orthopedic Society of the Chinese Medical Association. Expert consensus on the construction of autologous bone tissue banks[J/OL]. Chinese Journal of Joint Surgery(Electronic Edition), 2026, 20(02): 141-150.

自体骨组织储存与再利用是骨缺损修复和重建治疗的重要策略。随着关节置换、创伤修复及骨肿瘤重建等手术量的增加,自体骨组织的获取机会不断增加,应用场景持续拓展。对于未来可能需接受分期重建、翻修手术或骨移植治疗的患者,术中保存自体骨组织可减少二次取骨损伤,并提高骨源利用效率。然而,在知情同意、伦理审查和法律法规框架下,如何规范自体骨组织获取、处理、检测、储存、运输及临床应用流程,尚缺乏统一标准。本专家共识基于国内外相关文献、组织库建设规范及现行技术标准,参考AATB、YY/T 0513.1-2019、GB/T 36988-2018和《自体骨组织库团体标准》(T/FDSA 0079-2025)等文件,结合我国骨科临床实践需求,经多学科专家反复讨论与论证后形成。本共识提出,自体骨组织储存应纳入覆盖术前评估、知情同意、术中获取、标识登记、冷链转运、分级储存、出库复核和临床使用的全过程管理体系,而非单一低温保存技术。在实施层面,建议建立手术室与骨库之间规范化交接及冷链管理流程;储存环节宜采用深低温(−196 ℃)条件,并配套完善质量管理体系与风险应急预案;临床应用应区分自体使用、亲属间使用及社会捐献等不同情形,明确适应证、禁忌证、筛查标准及伦理要求;伦理与法律层面,应明确组织所有权、知情同意、隐私保护及储存终止后的处置路径。本共识主要涵盖:(1)临床操作流程与骨库规范化管理;(2)储存与运输中的质量控制与风险管理;(3)深低温长期储存的安全性与稳定性;(4)跨区域冷链运输管理;(5)自体骨组织储存的适应证与禁忌证;(6)自体骨组织的临床应用原则;(7)自体骨组织的所有权与法律属性;(8)患者权益与隐私保护;(9)放弃储存情况下的合规处置。本共识旨在为医疗机构开展自体骨组织获取、储存与临床应用提供统一、可执行且可追溯的参考依据,以推动相关工作的安全、规范及依法合规开展,并促进标准化发展。

Autologous bone storage and reuse represent an important strategy for the repair and reconstruction of bone defects. With the increasing number of procedures such as joint arthroplasty, trauma repair, and bone tumor reconstruction, opportunities for harvesting autologous bone and its potential applications continue to expand. For patients who may require staged reconstruction, revision surgery, or bone grafting in the future, intraoperative preservation of autologous bone can reduce the need for secondary bone harvesting and improve the efficiency of bone resource utilization. However, under the frameworks of informed consent, ethical review, and regulatory requirements, standardized protocols for the procurement, processing, testing, storage, transportation, and clinical application of autologous bone remain lacking. This expert consensus was developed based on a comprehensive review of the literature, existing tissue bank regulations, and current technical standards, with reference to the American Association of Tissue Banks (AATB), YY/T 0513.1-2019, GB/T 36988-2018, and the Group Standard for Autologous Bone Tissue Banks (T/FDSA 0079-2025). It was formulated through iterative discussions and deliberations among multidisciplinary experts, taking into account the practical needs of orthopedic clinical practice in China. This consensus proposes that autologous bone storage should be integrated into a comprehensive management system covering the entire process, including preoperative evaluation, informed consent, intraoperative procurement, labeling and registration, cold-chain transportation, stratified storage, release verification, and clinical application, rather than being regarded as a single low-temperature preservation technique. At the implementation level, standardized handover procedures and cold-chain management between operating rooms and bone banks are recommended. Storage should preferably be performed under deep cryogenic conditions (−196 ℃), supported by a robust quality management system and risk contingency plans. Clinical application should differentiate among autologous use and legally compliant familial use or donation scenarios, with clearly defined indications, contraindications, screening criteria, and ethical requirements. From ethical and legal perspectives, issues including tissue ownership, informed consent, privacy protection, and disposal pathways following termination of storage should be explicitly addressed. This consensus mainly covers: (1) clinical workflows and standardized bone bank management; (2) quality control and risk management in storage and transportation; (3) safety and stability of long-term deep cryogenic storage; (4) cross-regional cold-chain transportation; (5) indications and contraindications for autologous bone storage; (6) principles of clinical application; (7) ownership and legal attributes of autologous bone tissue; (8) patient rights and privacy protection; and (9) compliant disposal following abandonment of storage. This consensus aims to provide standardized, practical, and traceable guidance for medical institutions in the procurement, storage, and clinical application of autologous bone tissue, thereby promoting safe, regulated, and legally compliant practices and advancing standardization in this field.

[1]
Tuchman A, Brodke DS, Youssef JA, et al. Autograft versus allograft for cervical spinal fusion: a systematic review[J]. Glob Spine J, 2017, 7(1): 59-70.
[2]
Gillman CE, Jayasuriya AC. FDA-approved bone grafts and bone graft substitute devices in bone regeneration[J/OL]. Mater Sci Eng C, 2021, 130: 112466. DOI: 10.1016/j.msec.2021.112466.
[3]
Ebraheim NA, Kelley LH, Liu X, et al. Periprosthetic distal femur fracture after total knee arthroplasty: asystematic review[J]. Orthop Surg, 2015, 7(4): 297-305.
[4]
American Association of Tissue Banks(AATB). Standards for Tissue Banking. 14th ed[DB/OL]. Washington, DC: AATB, 2020(2025-08-11)[2026-01-16].
[5]
Hovanyecz P, Lorenti A, Lucero JMJ, et al. Living donor bone banking: processing and discarding—from procurement to therapeutic use[J]. Cell Tissue Bank, 2015, 16(4): 593-603.
[6]
Yamamoto N, Hayashi K, Tsuchiya H. Progress in biological reconstruction and enhanced bone revitalization for bone defects[J]. J Orthop Sci, 2019, 24(3): 387-392.
[7]
Tsuchiya H, Wan SL, Sakayama K, et al. Reconstruction using an autograft containing tumour treated by liquid nitrogen[J]. J Bone Jt Surg Br Vol, 2005, 87-B(2): 218-225.
[8]
孙世荃, 李宝兴. 同种异体骨移植引起的疾病传播[J]. 中国骨肿瘤骨病, 2003, 2(6): 333-335, 344.
[9]
Yang Harmony TC, Yusof N, Ramalingam S, et al. Deep-freezing temperatures during irradiation preserves the compressive strength of human cortical bone allografts: acadaver study[J]. Clin Orthop Relat Res, 2022, 480(2): 407-418.
[10]
桑宏勋, 李丹, 胡蕴玉, 等. 骨库移植骨污染及控制[J]. 中国矫形外科杂志, 2000, 7(2): 109-111.
[11]
孟庆海, 王沛涛, 孙鹏, 等. 深低温保存自体颅骨的实验及临床研究[J]. 中华神经外科杂志, 1998, 14(1): 49-50.
[12]
Taillebot V, Krieger T, Maurel-Pantel A, et al. Freezing does not influence the microarchitectural parameters of the microstructure of the freshly harvested femoral head bone[J]. Cell Tissue Bank, 2024, 25(3): 747-754.
[13]
Karlsson JOM, Toner M. Long-term storage of tissues by cryopreservation: critical issues[J]. Biomaterials, 1996, 17(3): 243-256.
[14]
Nather A, Thambyah A, Goh JCH. Biomechanical strength of deep-frozen versus lyophilized large cortical allografts[J]. Clin Biomech, 2004, 19(5): 526-533.
[15]
马晓飞, 姜歆. 浅谈医疗器械第三方物流冷链质量管理体系关键控制点[J]. 中国医疗器械信息, 2022, 28(13): 20-22.
[16]
赵琦. 医药冷链物流环境下的温控技术与风险管理研究[J]. 中国储运, 2024(12): 206-207.
[17]
中华医学会骨科学分会创伤骨科学组, 中华医学会骨科学分会外固定与肢体重建学组, 中国医师协会骨科医师分会创伤专家工作委员会, 等. 中国创伤骨科患者围手术期静脉血栓栓塞症预防指南(2021)[J]. 中华创伤骨科杂志, 2021, 23(3): 185-192.
[18]
Zhang J, Li S, He H, et al. Clinical guidelines for indications, techniques, and complications of autogenous bone grafting[J]. Chin Med J, 2024, 137(1): 5-7.
[19]
边宛初, 周小雯, 左玉迪. 对脐血库“双重身份”的法律探析[J]. 医学与法学, 2022, 14(2): 96-100.
[20]
喻昭蓉, 周琴, 张平西, 等. 我国脐带血造血干细胞库监管现状及对策[J]. 中国输血杂志, 2014, 27(7): 768-770.
[21]
王沛涛, 邵翠华, 李强. 移植用同种异体组织库流程及质量管理[J]. 中国组织工程研究与临床康复, 2011, 15(18): 3381-3386.
[22]
Wang W, Yeung KWK. Bone grafts and biomaterials substitutes for bone defect repair: a review[J]. Bioact Mater, 2017, 2(4): 224-247.
[23]
Secko DM, Preto N, Niemeyer S, et al. Informed consent in biobank research: a deliberative approach to the debate[J]. Soc Sci Med, 2009, 68(4): 781-789.
[24]
Dove ES, Chen J. Should consent for data processing be privileged in health research? A comparative legal analysis[J]. Int Data Priv Law, 2020, 10(2): 117-131.
[25]
Verma PR, Anjankar A, Singh PV. Need, strategies and requirements in the medical system for bone banks: a review article[J/OL]. Cureus, 2022, 14(9): e28785. DOI: 10.7759/cureus.28785.
[26]
张胜田, 李梅, 李群, 等. 国内外医疗废物管理与处置现状分析及对策建议[J]. 生态与农村环境学报, 2020, 36(12): 1505-1513.
[1] 中国临床肿瘤学会乳腺癌专家委员会, 中国医师协会肿瘤多学科诊疗专业委员会, 广东省药学会. 乳腺癌内分泌治疗超说明书用药专家共识[J/OL]. 中华乳腺病杂志(电子版), 2026, 20(02): 69-81.
[2] 中华医学会超声医学分会, 中国研究型医院肿瘤介入治疗委员会, 中国妇幼保健协会乳腺保健专业委员会, 中华医学会肿瘤学分会乳腺癌专业委员会, 中国抗癌协会乳腺癌专业委员会, 中国人体健康科技促进会乳腺专业委员会. 无手术适应证乳腺癌消融治疗专家共识(2025版)[J/OL]. 中华乳腺病杂志(电子版), 2026, 20(01): 1-8.
[3] 中华医学会骨科学分会关节外科学组. 智能传感动态引导技术在骨科手术应用的专家共识(2026版)[J/OL]. 中华关节外科杂志(电子版), 2026, 20(02): 131-140.
[4] 中华医学会骨科学分会关节外科学组, 王坤正, 史占军, 曲铁兵. 中国膝骨关节炎关节腔注射治疗专家共识(2026版)[J/OL]. 中华关节外科杂志(电子版), 2026, 20(01): 1-14.
[5] 王宏达, 单兴宇, 张浩强, 田志敏, 李焕玺, 何淳诺, 庄凯鹏, 周胜虎, 甄平. 人工骨修复材料在股骨头坏死修复中的应用[J/OL]. 中华关节外科杂志(电子版), 2026, 20(01): 77-86.
[6] 泌尿功能障碍预防和治疗专家组. 尿液菌群移植在部分女性泌尿系统疾病中的应用规范专家共识[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2026, 20(02): 127-133.
[7] 上海东方肝胆外科医院静脉输液委员会. 肝胆恶性肿瘤患者中长期血管通路选择及使用专家共识[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(02): 137-145.
[8] 中国医师协会结直肠肿瘤专业委员会, 中国抗癌协会NOSES专业委员会, 中国NOSES联盟. 结肠镜辅助结肠肿瘤经自然腔道取标本手术专家共识及操作标准[J/OL]. 中华结直肠疾病电子杂志, 2026, 15(02): 104-114.
[9] 中国医师协会结直肠肿瘤专业委员会单孔腹腔镜学组. 单孔腹腔镜结直肠手术专家共识(2025版)[J/OL]. 中华结直肠疾病电子杂志, 2026, 15(02): 97-103.
[10] 中国医师协会结直肠肿瘤专业委员会, 中国医师协会结直肠肿瘤专业委员会微创解剖学组. 直肠癌微创精细解剖手术专家共识(2025版)[J/OL]. 中华结直肠疾病电子杂志, 2026, 15(01): 1-16.
[11] 脊髓电刺激治疗卒中后偏瘫中国专家共识编写组, 中华医学会神经外科学分会功能神经外科学组, 中国研究型医院学会神经外科学专业委员会, 世界华人神经外科协会功能神经外科专业委员会, 北京医学会神经外科学分会功能神经外科专业组, 北京医学会神经外科学分会周围神经外科专业组. 脊髓电刺激治疗卒中后偏瘫中国专家共识(2025年)[J/OL]. 中华脑科疾病与康复杂志(电子版), 2026, 16(01): 8-18.
[12] 陈秀梅, 谢曼英, 陈思涓, 钟旭辉, 潘巧, 温丽娟, 本共识编写小组. 晚期非小细胞肺癌患者免疫相关不良反应的护理专家共识[J/OL]. 中华临床医师杂志(电子版), 2026, 20(02): 77-89.
[13] 王影新, 胡新媛, 郭杰, 赵禹, 刘飞, 曹淼. 自身免疫性大疱病患者口腔黏膜管理相关指南及共识的质量评价和内容分析[J/OL]. 中华临床医师杂志(电子版), 2026, 20(01): 41-48.
[14] 中华医学会检验医学分会分子诊断学组, 中华医学会检验医学分会临床免疫学组, 中国民族卫生协会流式细胞技术临床应用推广组. 医疗机构临床流式细胞实验室建设专家共识[J/OL]. 中华临床实验室管理电子杂志, 2026, 14(02): 89-103.
[15] 中华医学会心电生理和起搏分会, 中国医学装备协会心律失常技术分会, 中国医师协会心律学专业委员会. 心血管植入型电子器械磁共振成像检查标准流程建议[J/OL]. 中华心脏与心律电子杂志, 2026, 14(01): 1-10.
阅读次数
全文


摘要


AI


AI小编
你好!我是《中华医学电子期刊资源库》AI小编,有什么可以帮您的吗?