视神经脊髓炎

定义 英文原文（暂无中文）

A rare inflammatory disease of the central nervous system characterized mainly by attacks of uni- or bilateral optic neuritis (ON) and acute myelitis.

别名

Devic病

基本事实

遗传方式

多基因/多因素

发病年龄

青少年期、成年期、儿童期、老年期

患病率

1-9 / 1 000 000（Martinique）

临床表型 17

近两年的全球研究 2,144L2

2024/10 起在 Europe PMC 检索所得，按发表时间倒序显示最近 20 篇。标题未译成中文——自动翻译需要接入 LLM 服务，尚未引入。

• 2026-10综述开放获取
  Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases
  Signal transduction and targeted therapy · DOI · Europe PMC
• 2026-10开放获取
  Targeting the HPGDS-PGD<sub>2</sub> axis to treat Th17 cell-mediated autoimmunity in multiple sclerosis
  Signal transduction and targeted therapy · DOI · Europe PMC
• 2026-10开放获取
  Serum GFAP and Age Accurately Distinguish AQP4-IgG Positive and Double Seronegative NMOSD From MOGAD After a Recent Attack
  European journal of neurology · DOI · Europe PMC
• 2026-10
  Evolution of Therapeutic Plasma Exchange Use and Outcomes in Children Across American Society for Apheresis Categories: A Single-Center Cohort Study
  Journal of clinical apheresis · DOI · Europe PMC
• 2026-10开放获取
  The Association of Apparent Myelin Water Fraction With Diffusional Kurtosis and Biophysical Modeling Parameters
  NMR in biomedicine · DOI · Europe PMC
• 2026-09综述
  Eculizumab and Ravulizumab During Pregnancy in Neuromyelitis Optica Spectrum Disorder and Myasthenia Gravis: Balancing Maternal Disease Control and Fetal Safety
  CNS drugs · DOI · Europe PMC
• 2026-09开放获取
  Real‑world pharmacovigilance of rituximab‑associated adverse reactions in children and adolescents: Disproportionality signal detection and time‑to‑onset pattern characterization using the FAERS database
  Human vaccines & immunotherapeutics · DOI · Europe PMC
• 2026-09综述开放获取
  The Immune Checkpoint Inhibitors Journey: From Early Promise to Lasting Impact
  Journal of immunotherapy and precision oncology · DOI · Europe PMC
• 2026-09综述
  Use of MRI in neuromyelitis optica spectrum disorder and myelin oligodendrocyte glycoprotein antibody-associated disease - MAGNIMS consensus recommendations
  Nature reviews. Neurology · DOI · Europe PMC
• 2026-09
  MRI Characteristics of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease: A Review
  JAMA neurology · DOI · Europe PMC
• 2026-09综述
  Metabolic reprogramming in neuromyelitis optica spectrum disorder: From astrocyte dysfunction to immune-mediated neuroinflammation
  Multiple sclerosis and related disorders · DOI · Europe PMC
• 2026-09
  Diagnostic delay and poor functional outcomes in late-onset NMOSD: A Thai cohort study
  Multiple sclerosis and related disorders · DOI · Europe PMC
• 2026-09综述
  Stem Cell-Based Therapies for Central Nervous System Demyelinating Diseases: Clinical Evidence, Therapeutic Niches, and Translational Boundaries
  Medical science monitor : international medical journal of experimenta · DOI · Europe PMC
• 2026-09开放获取
  Human Autoantibodies Against MOG Isoforms: α3 Antibodies Suggest Relapsing Disease Course in Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
  Neurology(R) neuroimmunology & neuroinflammation · DOI · Europe PMC
• 2026-09开放获取
  Spatial organization of AQP4 water channel expression in the human brain
  Science advances · DOI · Europe PMC
• 2026-09开放获取
  Diagnostic Utility of Novel and Established Spinal MRI Signs in AQP4-IgG-Seropositive NMOSD Myelitis
  Neurology · DOI · Europe PMC
• 2026-09
  From Lesion Length to Lesion Pattern in Neuromyelitis Optica Spectrum Disorder Myelitis: Implications for Diagnostic Criteria
  Neurology · DOI · Europe PMC
• 2026-09综述
  Optimizing the management of AQP4 antibody-positive NMOSD: A Canadian consensus
  Multiple sclerosis and related disorders · DOI · Europe PMC
• 2026-09综述开放获取
  Epstein-Barr Virus: More than Just an Infection
  Viruses · DOI · Europe PMC
• 2026-09
  Meningococcal infection in patients receiving eculizumab or ravulizumab for generalized myasthenia gravis or neuromyelitis optica spectrum disorder: A real-world study of US clinical practice
  Journal of the neurological sciences · DOI · Europe PMC

国家医保药品目录中点名本病的药品 2L2

出自《国家基本医疗保险、生育保险和工伤保险药品目录（2025年）》（医保发〔2025〕33号，2026-01-01 起执行）。下列药品在药品名称或限定支付范围里出现了本病的名称。

• 伊奈利珠单抗注射液乙类谈判药品
  限抗水通道蛋白4(AQP4)抗体阳性的视神经脊髓炎谱系疾病(NMOSD)成人患者。
• 萨特利珠单抗注射液乙类谈判药品
  限≥12岁青少年及成人患者水通道蛋白4(AQP4)抗体阳性的视神经脊髓炎谱系疾病(NMOSD)。

境外已获批用于本病的药物 6L2

欧盟 2 项、美国 4 项。同一药物在两地各批一次的，会分别列出。

• Enspryng欧盟2021-06-24
  satralizumab
  官方记录
• Uplizna欧盟2022-04-25
  inebilizumab
  官方记录
• Soliris美国2019-06-27
  eculizumab
  官方记录
• Uplizna美国2020-06-11
  inebilizumab
  官方记录
• Enspryng美国2020-08-14
  satralizumab-mwge
  官方记录
• Ultomiris美国2024-03-22
  ravulizumab-cwvz
  官方记录

数据来自欧洲药品管理局（EMA）的药品与罕见病用药资格公开导出表，以及美国 FDA 的罕见病用药资格数据库（Orphan Drug Product Designation Database）。两边口径不同：欧盟一侧取的是当前状态仍为「已授权」的药品；美国一侧记录的是「曾获批准」这一事实，FDA 的公开表不追踪药物此后是否退市（例如 Relyvrio 于 2024 年撤市，表中仍记为已获批）。请以官方记录页为准。

在中国开展的临床试验 75L2

按病名在 ClinicalTrials.gov 检索、并校验研究中心含中国大陆而来。登记状态不等于现在真的能入组——务必按 NCT 号到原站核实，并与主治医生商量。

登记为可入组 35

• 招募中NCT04106830
  Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)
  观察性 · 2019/01/01Beijing Tiantan Hospital
  中国研究中心 1 个：Beijing
• 招募中NCT04561557
  Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
  早期 I 期 · 干预性 · 2020/09/22Tongji Hospital
  中国研究中心 1 个：Wuhan
• 招募中NCT05154370
  China National Registry of Neuro-Inflammatory Diseases
  观察性 · 2021/12/15Beijing Tiantan Hospital
  中国研究中心 1 个：Beijing
• 招募中NCT05145361
  Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
  早期 I 期 · 干预性 · 2022/04/07Shanghai Pharmaceuticals Holding Co., Ltd
  中国研究中心 4 个：Beijing、Taiyuan、Tianjin、Xi’an
• 招募中NCT05504694
  Ofatumumab in AQP4-IgG Seropositive NMOSD
  I 期、II 期 · 干预性 · 2022/06/28Tang-Du Hospital
  中国研究中心 1 个：Xi'an
• 招募中NCT06697535
  A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
  II 期 · 干预性 · 2023/05/24Guangzhou JOYO Pharma Co., Ltd
  中国研究中心 1 个：Changsha
• 仅邀请入组NCT06643858
  Normal Chinese Lifespan Brain Charts Initiative (NCLBCI)
  观察性 · 2023/12/01Beijing Tiantan Hospital
  中国研究中心 1 个：Beijing
• 招募中NCT06541626
  Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases
  观察性 · 2024/01/01Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  中国研究中心 1 个：Guangzhou
• 招募中NCT05966467
  Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
  观察性 · 2024/02/01Alexion Pharmaceuticals, Inc.
  中国研究中心 6 个：Beijing、Guangzhou、Henan、Shanghai、Sichuan、Wuhan
• 招募中NCT06249438
  A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
  I 期 · 干预性 · 2024/03/20RenJi Hospital
  中国研究中心 1 个：Shanghai
• 招募中NCT07653984
  Cohort Study on Neuroimmune Diseases in the Reproductive Age
  观察性 · 2024/04/21Third Affiliated Hospital, Sun Yat-Sen University
  中国研究中心 1 个：Guangzhou
• 招募中NCT06413654
  A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
  II 期、III 期 · 干预性 · 2024/07/17Shanghai Jiaolian Drug Research and Development Co., Ltd
  中国研究中心 51 个：Beijing、Cangzhou、Changsha、Chengdu、Fuzhou、Guangzhou 等 33 地
• 招募中NCT06502015
  Biomarkers in Autoimmune Disease of Nervous System
  观察性 · 2024/07/31Tongji Hospital
  中国研究中心 1 个：Wuhan
• 招募中NCT06474520
  Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)
  不适用 · 干预性 · 2024/08/08Tongji Hospital
  中国研究中心 1 个：Wuhan
• 尚未开始招募NCT06485232
  Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.
  早期 I 期 · 干预性 · 2025/02/28Xuanwu Hospital, Beijing
  中国研究中心 1 个：Beijing
• 招募中NCT06620809
  The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
  I 期 · 干预性 · 2025/03/28Tongji Hospital
  中国研究中心 1 个：Wuhan
• 招募中NCT06829524
  HANDLE-a Real World Study on Satralizumab in NMOSD
  观察性 · 2025/03/31Huashan Hospital
  中国研究中心 1 个：Shanghai
• 招募中NCT07022197
  Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
  I 期、II 期 · 干预性 · 2025/04/10Tianjin Medical University General Hospital
  中国研究中心 1 个：Tianjin
• 招募中NCT06763848
  Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder
  不适用 · 干预性 · 2025/04/25Third Affiliated Hospital, Sun Yat-Sen University
  中国研究中心 1 个：Guangzhou
• 招募中NCT06939166
  Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases
  早期 I 期 · 干预性 · 2025/06/17Tianjin Huanhu Hospital
  中国研究中心 1 个：Tianjin
• 招募中NCT06885957
  Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
  观察性 · 2025/07/01Tongji Hospital
  中国研究中心 1 个：Wuhan
• 尚未开始招募NCT07266051
  Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)
  观察性 · 2025/12Xiamen Hospital of Traditional Chinese Medicine
  中国研究中心 5 个：Xiamen
• 招募中NCT07377305
  Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
  不适用 · 干预性 · 2025/12/08Tang-Du Hospital
  中国研究中心 1 个：Xi'an
• 招募中NCT07420296
  Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder
  III 期 · 干预性 · 2026/01/01Tianjin Medical University General Hospital
  中国研究中心 1 个：Tianjin
• 招募中NCT07410039
  Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
  IV 期 · 干预性 · 2026/02/01Chinese PLA General Hospital
  中国研究中心 1 个：Beijing

另有 10 项未列出。

中国境外的在招试验 73L2

CT.gov 报告命中 73 项，此处取回并展示最近的 15 项。

• 尚未开始招募NCT07595965
  Evaluate the Safety and Tolerability of CE211NS21 in Patients With AQP4-IgG-positive NMOSD Relapse
  I 期 · 干预性 · 2026/12/01Corestemchemon, Inc.
• 尚未开始招募NCT07818356
  Comparative Study of Two Vaccination Schedules for the Subunit Herpes Zoster Vaccine in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disease Patients Treated With Anti-CD20 Therapy: an Open-label Randomised Controlled Trial
  IV 期 · 干预性 · 2026/10/20University Hospital, Toulouse
  法国
• 招募中NCT05909761
  Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
  观察性 · 2026/10/15Amgen
  美国
• 尚未开始招募NCT07804004
  A Safety and Efficacy Study Evaluating CTX112 in Subjects With Refractory Neurologic Autoimmune Disease
  I 期、II 期 · 干预性 · 2026/09/15CRISPR Therapeutics
• 尚未开始招募NCT07704294
  Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool
  观察性 · 2026/09/01King's College London
  英国
• 尚未开始招募NCT07573332
  A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients
  I 期 · 干预性 · 2026/09/01University of Texas Southwestern Medical Center
  美国
• 尚未开始招募NCT07738952
  Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder
  I 期、II 期 · 干预性 · 2026/08/17Kyushu University
• 尚未开始招募NCT07010302
  Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD
  IV 期 · 干预性 · 2026/08/01Massachusetts General Hospital
  德国、美国
• 尚未开始招募NCT07685678
  Riptylimab for the Treatment of Optic Neuritis and Myelitis Spectrum Diseases
  I 期、II 期 · 干预性 · 2026/07/15Zhongming Qiu
• 尚未开始招募NCT07526298
  Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Apparently Stable Patients
  观察性 · 2026/04/01IRCCS San Raffaele
  意大利
• 尚未开始招募NCT07341828
  A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy
  I 期 · 干预性 · 2026/02Huashan Hospital
• 尚未开始招募NCT07273292
  Autonomic Dysfunction in Neuromyelitis Optica Spectrum Disorder and Multiple Sclerosis : A Comparative Study
  观察性 · 2026/01/20Mohamed Moshref abd alsattar
• 尚未开始招募NCT07304960
  Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder
  观察性 · 2026/01/01Assiut University
• 尚未开始招募NCT06561009
  Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
  I 期、II 期 · 干预性 · 2025/12/01Tianjin Medical University General Hospital
• 尚未开始招募NCT07182409
  Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder
  观察性 · 2025/10/01First Affiliated Hospital of Chongqing Medical University

外部标识与链接