冷凝集素病

定义 英文原文（暂无中文）

Cold agglutinin disease is a type of autoimmune hemolytic anemia defined by the presence of cold autoantibodies (autoantibodies which are active at temperatures below 30°C).

别名

慢性冷凝集素病

基本事实

遗传方式

多基因/多因素

发病年龄

成年期

患病率

1-9 / 1 000 000（Europe）

临床表型 14

近两年的全球研究 329L2

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
  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
• 2026-09病例报告开放获取
  Case Report: Severe mixed autoimmune hemolytic anemia associated with acute cytomegalovirus infection in an immunocompetent adult
  Frontiers in immunology · DOI · Europe PMC
• 2026-09病例报告开放获取
  Complement inhibition by sutimlimab in cold agglutinin disease promotes red blood cell agglutination and may lead to circulatory complications, eryptosis and hemolysis
  Frontiers in immunology · DOI · Europe PMC
• 2026-09综述开放获取
  Cold agglutinin disease: pathophysiology, diagnosis, and the evolving therapeutic landscape
  Blood research · DOI · Europe PMC
• 2026-09开放获取
  The impact of chemoimmunotherapy on primary cold agglutinin disease and Waldenström macroglobulinemia-associated cold agglutinin syndrome
  Frontiers in medicine · DOI · Europe PMC
• 2026-09
  Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach From the Writing Committee of the American Society for Apheresis: The Tenth Special Issue
  Journal of clinical apheresis · DOI · Europe PMC
• 2026-09综述开放获取
  Complement Activation by Post-Translationally Modified Proteins: Links to Chronic Inflammation and Autoimmunity
  Immunological reviews · DOI · Europe PMC
• 2026-09综述开放获取
  Anti-CD38 monoclonal antibodies in multiple myeloma and beyond: immunotherapeutic mechanisms, evidence maturity, and clinical positioning
  Frontiers in immunology · DOI · Europe PMC
• 2026-08开放获取
  Therapeutic Plasma Exchange Using Membrane Plasma Separation Across a Broad Spectrum of Indications: An Eight-Year Single-Center Retrospective Cohort Study
  International journal of general medicine · DOI · Europe PMC
• 2026-08开放获取
  Complement-Dominant Relapse of Mixed Autoimmune Hemolytic Anemia After Rituximab Response
  EJHaem · DOI · Europe PMC
• 2026-08
  Interpretive Challenges in Electrophoretic and Mass Spectrometric Methods for Monoclonal Gammopathy Detection in Patients with Cold Agglutinin Disease
  Clinical chemistry · DOI · Europe PMC
• 2026-08综述开放获取
  Targeting CD38 Across Autoimmune and Plasma Cell-Driven Immune-Mediated Diseases: Rationale, Clinical Evidence, and Emerging Therapeutic Landscape
  BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene th · DOI · Europe PMC
• 2026-08病例报告开放获取
  Combination therapy of sutimlimab and rituximab can lead to stable remission in autoimmune hemolytic anemia: a case series
  Annals of hematology · DOI · Europe PMC
• 2026-08综述开放获取
  Innate immunity: current understandings and future perspectives
  Signal transduction and targeted therapy · DOI · Europe PMC
• 2026-08开放获取
  Effectiveness of the DigniCap® Scalp Cooling System for the Prevention of Chemotherapy-Induced Alopecia: An Observational Study in a Uruguayan Cohort
  Cureus · DOI · Europe PMC
• 2026-08病例报告开放获取
  Probable Cold Agglutinin Disease Presenting With Profound Anemia and Cardiopulmonary Decompensation in a 93-Year-Old Woman: A Case Report
  Cureus · DOI · Europe PMC
• 2026-08病例报告开放获取
  A blended phenotype of primary immunodeficiency and Temtamy syndrome: Dual homozygosity for <i>STK4</i> and <i>C12orf57</i> gene variants in a Tunisian infant
  Molecular genetics and metabolism reports · DOI · Europe PMC
• 2026-08病例报告开放获取
  DAT-negative autoimmune hemolytic anemia following acute hepatitis a in a pediatric patient with elevated IgA: a rare case report and literature review
  Annals of medicine and surgery (2012) · DOI · Europe PMC
• 2026-08综述开放获取
  Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non-Japanese Individuals
  Journal of clinical pharmacology · DOI · Europe PMC
• 2026-08综述病例报告开放获取
  Temperature Safeguards and Peri-Procedural Strategies for Stem Cell Collection in Cold Agglutinin Disease: A Case Report and Literature Review
  Journal of clinical apheresis · DOI · Europe PMC

境外已获批用于本病的药物 1L2

欧盟 1 项、美国 0 项。同一药物在两地各批一次的，会分别列出。

• Enjaymo欧盟2022-11-15
  sutimlimab
  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 2L2

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 2

• 招募中NCT07019038
  National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
  观察性 · 2001/01/01Institute of Hematology & Blood Diseases Hospital, China
  中国研究中心 1 个：Tianjin
• 尚未开始招募NCT06847607
  A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)
  不适用 · 干预性 · 2025/03/01Bing Han
  中国研究中心 1 个：Beijing

中国境外的在招试验 6L2

CT.gov 报告命中 6 项，此处取回并展示最近的 4 项。

• 尚未开始招募NCT07091370
  Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy
  I 期 · 干预性 · 2025/12/27Juventas Cell Therapy Ltd.
• 招募中NCT07083960
  OM336 in Autoimmune Cytopenias
  I 期 · 干预性 · 2025/08/01Lakefront Biotherapeutics West LLC
  澳大利亚、美国
• 招募中NCT05318534
  Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
  I 期 · 干预性 · 2022/04/08Gliknik Inc.
  英国
• 招募中NCT05931718
  Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
  观察性 · 2019/06/01Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  意大利

外部标识与链接