[1]朱立国,许博,魏戌,等.退行性颈脊髓病标准化生物样本库的建立与管理中西医专家共识(2025年版)[J].中国中医骨伤科杂志,2026,34(01):4-12.[doi:10.20085/j.cnki.issn1005-0205.260102]
　ZHU Liguo,XU Bo,WEI Xu,et al.Expert Consensus on the Establishment and Management of a Standardized Biobank for Degenerative Cervical Myelopathy(2025 Edition)[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2026,34(01):4-12.[doi:10.20085/j.cnki.issn1005-0205.260102]
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退行性颈脊髓病标准化生物样本库的建立与管理中西医专家共识(2025年版)()

《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第34卷
期数:
2026年01期
页码:
4-12
栏目:
脊柱脊髓疾病
出版日期:
2026-01-15

文章信息/Info

Title:
Expert Consensus on the Establishment and Management of a Standardized Biobank for Degenerative Cervical Myelopathy(2025 Edition)
文章编号:
1005-0205(2026)01-0004-09
作者:
朱立国1; 2; 许博1; 2; 魏戌1; 2; 杨少锋3; 李晋玉4; 周非非5; 崔学军6; 袁普卫7; 徐西林8; 刘爱峰9; 冯敏山1; 2; 张西峰1; 2; 尹逊路1; 2; 马国梁1; 2; 王志壮1; 2; 银河1; 2△; 杨克新1; 2△
1中国中医科学院望京医院(北京,100102)
2数智中医防治骨与关节退行性疾病北京市重点实验室
3湖南中医药大学第一附属医院
4北京中医药大学东直门医院
5北京大学第三医院
6上海中医药大学附属龙华医院
7陕西中医药大学附属医院
8黑龙江中医药大学附属第三医院
9天津中医药大学第一附属医院
Author(s):
ZHU Liguo1; 2; XU Bo1; 2; WEI Xu1; 2; YANG Shaofeng3; LI Jinyu4; ZHOU Feifei5; CUI Xuejun6; YUAN Puwei7; XU Xilin8; LIU Aifeng9; FENG Minshan1; 2; ZHANG Xifeng1; 2; YIN Xunlu1; 2; MA Guoliang1; 2; WANG Zhizhuang1; 2; YIN He1; 2△; YANG Kexin1; 2△
关键词:
退行性颈脊髓病;  生物样本库;  中西医结合;  标准化;  数据管理
Keywords:
degenerative cervical myelopathy;  biobank;  integrated traditional Chinese and Western medicine;  standardization;  data management
分类号:
R681.5
DOI:
10.20085/j.cnki.issn1005-0205.260102
文献标志码:
A
摘要:
本共识旨在为退行性颈脊髓病(DCM)标准化生物样本库的建立与管理提供系统、规范的中西医结合指导。随着人口老龄化加剧,退行性颈脊髓病已成为严重影响中老年人生活质量的重要疾病。共识指出:建立高质量的退行性颈脊髓病专病生物样本库,整合临床资料、影像学数据、生物样本(如血液、尿液)及中医证候信息,对推动疾病机制研究、早期诊断、疗效评估及中医药精准治疗具有重要意义。共识内容涵盖生物样本库的全流程管理,包括科研立项与伦理审查、样本采集与处理(遵循国内外相关标准)、数据信息整合(涵盖临床、影像、功能量表及中医辨证)、质量控制、长期存储与随访体系等。特别强调了中西医结合的特色,将现代多组学技术与中医整体观念相结合,以探索退行性颈脊髓病的生物标志物及中医药干预的效应机制。本共识由多学科专家团队共同制定,适用于所有涉及退行性颈脊髓病生物样本与数据采集、存储、使用及处置的研究机构与医疗单位,以促进数据共享与科研合作,提升退行性颈脊髓病的整体诊疗水平。
Abstract:
This consensus aims to provide systematic and standardized integrated traditional Chinese and Western medicine guidance for the establishment and management of a standardized biobank for degenerative cervical myelopathy(DCM).With the intensification of population aging,DCM has become a significant disease that severely affects the quality of life of middle-aged and elderly individuals.The consensus states that establishing a high-quality,disease-specific DCM biobank,integrating clinical data,imaging data,biological samples(e.g.,blood,urine),and traditional Chinese medicine(TCM)syndrome information,is of great importance for advancing research into disease mechanisms,early diagnosis,efficacy evaluation,and precision treatment with TCM.The consensus content covers the entire process management of the biobank,including scientific research project initiation and ethical review,sample collection and processing(adhering to relevant domestic and international standards),data integration(encompassing clinical,imaging,functional scale,and TCM syndrome differentiation data),quality control,long-term storage,and follow-up systems.It particularly emphasizes the characteristics of integrated traditional Chinese and Western medicine by combining modern multi-omics technologies with the holistic concept of TCM to explore biomarkers for DCM and the mechanisms of TCM interventions.This consensus was jointly developed by a multidisciplinary expert team and is applicable to all research institutions and medical units involved in the collection,storage,use,and disposal of DCM biological samples and data,aiming to promote data sharing and scientific research collaboration and to enhance the overall diagnosis and treatment level of DCM.

参考文献/References:

[1] THEODORE N.Degenerative cervical spondylosis[J].The New England Journal of Medicine,2020,383(2):159-168.
[2] TETREAULT L A,KARADIMAS S,WILSON J R,et al.The natural history of degenerative cervical myelopathy and the rate of hospitalization following spinal cord injury:an updated systematic review[J].Global Spine Journal,2017,7(3 Suppl):28S-34S.
[3] NEUROLOGY T L.A focus on patient outcomes in cervical myelopathy[J].The Lancet:Neurology,2019,18(7):615.
[4] NIU S,ANASTASIO A T,MAIDMAN S D,et al.The frequency of various “myelopathic symptoms” in cervical myelopathy:evaluation in a large surgical cohort[J].Clinical Spine Surgery:A Spine Publication,2020,33(10):E448-E453.
[5] OH T,LAFAGE R,LAFAGE V,et al.Comparing quality of life in cervical spondylotic myelopathy with other chronic debilitating diseases using the short form survey 36-health survey[J].World Neurosurgery,2017,106:699-706.
[6] COPPOLA L,CIANFLONE A,GRIMALDI A M,et al.Biobanking in health care:evolution and future directions[J].Journal of Translational Medicine,2019,17(1):172.
[7] LOFT S,POULSEN H E.Cancer risk and oxidative DNA damage in man[J].Journal of Molecular Medicine,1996,74(6):297-312.
[8] ZHANG L X,WANG H B,LI Q Z,et al.Big data and medical research in China[J].BMJ,2018,360:j5910.
[9] 袁骏毅,汤钦华,马群圣.胸腺瘤结构化专病数据库构建研究[J].中国医疗设备,2019,34(2):113-115.
[10] KRUSE C S,GOSWAMY R,RAVAL Y,et al.Challenges and opportunities of big data in health care:a systematic review[J].JMIR Medical Informatics,2016,4(4):e38.
[11] 张雪,罗汉华.颈椎病中西医病因病机研究[J].吉林中医药,2011,31(12):1177-1179.
[12] 张丽美,师彬.颈椎病中医辨证分型及中药治疗研究进展[J].中成药,2013,35(7):1522-1525.
[13] 金涛,王建民.GB/T 39725-2020《信息安全技术健康医疗数据安全指南》[J].标准生活,2022(3):46-51.
[14] 复旦大学,生物芯片上海国家工程研究中心,上海芯超生物科技有限公司,等.人类生物样本保藏伦理要求[S].北京:国家标准化管理委员会,2020.
[15] KHOURY B,KOGAN C,DAOUK S.International classification of diseases 11th edition(ICD-11)[M]//Encyclopedia of Personality and Individual Differences.Cham:Springer,2017:1-6.
[16] FEHLINGS M G,TETREAULT L A,RIEW K D,et al.A clinical practice guideline for the management of patients with degenerative cervical myelopathy:recommendations for patients with mild,moderate,and severe disease and nonmyelopathic patients with evidence of cord compression[J].Global Spine Journal,2017,7(3 Suppl):70S-83S.
[17] 中国中西医结合学会,中华中医药学会,中华医学会,等.脊髓型颈椎病中西医结合诊疗指南(2023年版)[J].中医正骨,2024,36(8):1-8.
[18] DAVIES B M,KHAN D Z,MOWFORTH O D,et al.RE-CODE DCM(Research objectives and common data elements for degenerative cervical myelopathy):a consensus process to improve research efficiency in DCM,through establishment of a standardized dataset for clinical research and the definition of the research priorities[J].Global Spine Journal,2019,9(1 Suppl):65S-76S.
[19] 生物芯片上海国家工程研究中心,浙江省肿瘤医院,南京鼓楼医院,等.人类组织样本采集与处理 第1部分:手术切除组织[S].北京:国家标准化管理委员会,2021.
[20] 212 IT.Technical Committee ISO 20658:2023(E)Requirements for the collection and transport of samples for medical laboratory examinations[S].Geneva:ISO,2017.
[21] 生物芯片上海国家工程研究中心,深圳华大生命科学研究院,广州中医药大学第二附属医院,等.人类生物样本管理规范[S].北京:国家标准化管理委员会,2021.
[22] 生物芯片上海国家工程研究中心,广东省中医院,中国合格评定国家认可委员会,等.生物样本库质量和能力通用要求[S].北京:中国国家标准化管理委员会,2019.
[23] 中国医科大学第一临床学院.临床化学检验血液标本的收集与处理[S].北京:中华人民共和国卫生部,2002.
[24] 广州中医药大学第二附属医院,生物芯片上海国家工程研究中心,浙江省肿瘤医院,等.人类血液样本采集与处理[S].北京:国家标准化管理委员会,2020.
[25] 深圳华大生命科学研究院,生物芯片上海国家工程研究中心,北京师范大学,等.人类尿液样本采集与处理[S].北京:国家标准化管理委员会,2020.
[26] 生物芯片上海国家工程研究中心,广州中医药大学第二附属医院,上海芯超生物科技有限公司,等.人类生物样本库管理规范[S].北京:国家标准化管理委员会,2021.
[27] Biotechnology-Biobanking-General requirements for biob-anking:ISO 20387[S].Geneva:ISO,2018.
(收稿日期:2025-11-11)

备注/Memo

备注/Memo:
基金项目:国家重点研发计划专项(2024YFC3507401)
中国中医科学院望京医院自主选题专项(WJYY-ZZXT-2023-22)
△通信作者 E-mail:milkywaymoon@163.com(银河)
13611261137@163.com(杨克新)
更新日期/Last Update: 2026-01-15