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中华移植杂志(电子版) ›› 2025, Vol. 19 ›› Issue (02) : 76 -85. doi: 10.3877/cma.j.issn.1674-3903.2025.02.002

标准与指南

中国自身免疫性肝病肝移植受者免疫抑制方案应用指南
中华医学会器官移植学分会肝移植学组, 中国医师协会器官移植医师分会   
  1. 1. 国家肝脏移植技术医疗质量控制中心，310000　杭州
    2. 青岛大学附属医院器官移植中心，26600　青岛
    3. 北京清华长庚医院肝胆胰中心，100089　北京
    4. 树兰（杭州）医院肝胆胰外科，310022　杭州
  • 收稿日期:2025-03-24 出版日期:2025-04-25
  • 基金资助:
    国家重点研发计划(2021YFA1100500); 杭州医学院领军创新团队-器官移植临床研究(CXLJ202401); 浙江省"尖兵""领雁"研发攻关计划(2022C03108)

Chinese guidelines for the application of immunosuppressive regimens in liver transplant recipients with autoimmune liver diseases

Liver Transplantation Group, Branch of Organ Transplantation of Chinese Medical Association, Branch of Organ Transplant Physicians of Chinese Medical Doctor Association   

  1. 1. National Center for Healthcare Quality Management in Liver Transplant, Hangzhou 310000, China
    2. Organ Transplantation Center, Affiliated Hospital of Qingdao University, 266003 Qingdao, China
    3. Hepatobiliary and Pancreatic Center, Beijing Tsinghua Changgung Hospital, 100089 Beijing, China
    4. Department of Hepatobiliary and Pancreatic Surgery, Shulan (Hangzhou) Hospital, 310022 Hangzhou, China
  • Received:2025-03-24 Published:2025-04-25
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中华医学会器官移植学分会肝移植学组, 中国医师协会器官移植医师分会. 中国自身免疫性肝病肝移植受者免疫抑制方案应用指南[J/OL]. 中华移植杂志(电子版), 2025, 19(02): 76-85.

Liver Transplantation Group, Branch of Organ Transplantation of Chinese Medical Association, Branch of Organ Transplant Physicians of Chinese Medical Doctor Association. Chinese guidelines for the application of immunosuppressive regimens in liver transplant recipients with autoimmune liver diseases[J/OL]. Chinese Journal of Transplantation(Electronic Edition), 2025, 19(02): 76-85.

自身免疫性肝病是一组因机体免疫功能紊乱导致的特殊类型慢性肝病，包括自身免疫性肝炎、原发性胆汁性胆管炎、原发性硬化性胆管炎及重叠综合征。一旦疾病进展至终末期，肝移植是有效的治疗手段。然而，此类肝移植受者易发生排斥反应和疾病复发。因此，自身免疫性肝病肝移植受者术后免疫抑制方案的合理应用对其预后尤为重要。为规范和优化我国自身免疫性肝病肝移植受者术后免疫方案的应用，改善此类受者预后，中华医学会器官移植学分会肝移植学组和中国医师协会器官移植医师分会组织专家研讨，结合近年来循证医学依据和我国临床实践经验，并充分借鉴相关国内外指南和文献，制订了《中国自身免疫性肝病肝移植受者免疫抑制方案应用指南》。本指南重点阐述自身免疫性肝病肝移植的适应证、预后以及术后免疫抑制方案等内容，并科学规范地提出系列推荐意见，旨在优化我国自身免疫性肝病肝移植受者的综合管理。

关键词: 肝移植, 自身免疫性肝病, 免疫抑制剂

Autoimmune liver diseases (AILD) constitute a group of special chronic liver disorders caused by immune system dysfunction, including autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, and overlap syndromes. When the disease progresses to the end stage, liver transplantation becomes an effective treatment. However, these transplant recipients are prone to rejection and disease recurrence. Therefore, the rational application of post-transplant immunosuppressive regimens is particularly crucial for their prognosis. To standardize and optimize the use of immunosuppressive regimens for AILD liver transplant recipients in China and improve their outcomes, the Liver Transplantation Group, Branch of Organ Transplantation of Chinese Medical Association and the Branch of Organ Transplant Physicians of Chinese Medical Doctor Association have organized experts to systematically review and analyze domestic and international evidence-based medicine, combined with clinical practice experience in China, and thereby developed the "Chinese Guidelines for the Application of Immunosuppressive Regimens in Liver Transplant Recipients with Autoimmune Liver Diseases" . These guidelines focus on the indications, prognosis, and immunosuppressive regimens of liver transplantation in AILD and put forward a series of recommendations in a scientific and standardized way, aiming at optimizing the comprehensive management of liver transplant recipients with AILD in China.

Key words: Liver transplantation, Autoimmune liver diseases, Immunosuppressants
表1 牛津循证医学中心2009版证据等级与推荐意见强度分级标准
推荐强度 证据等级 描述
A 1a RCTs的系统评价
  1b 结果可信区间小的RCT
  1c 显示"全或无效应"的任何证据
B 2a 队列研究的系统评价
  2b 单个的队列研究(包括低质量RCT，如失访率>20%者)
  2c 基于患者结局的研究
  3a 病例对照研究的系统评价
  3b 单个病例对照研究
C 4 病例报道、低质量队列研究和低质量病例对照研究
D 5 专家意见(即无临床研究支持的仅依据基础研究或临床经验的推测)
表2 AILD肝移植术后原发疾病复发的危险因素
复发因素 AIH PBC PSC
受者因素 年轻、伴随肝外自身免疫性疾病、黑色人种、高IgG、转氨酶高、移植前AIH炎症严重(转氨酶高或组织学检查提示中-重度炎症) 年轻、高IgM 年轻、男性、复发性胆管炎、高MELD评分、炎症性肠病(尤其是溃疡性结肠炎)、受者HLA-DR8、胆管癌
移植因素 供体/受体性别不匹配
HLA位点不匹配		 供体/受体性别不匹配
HLA位点不匹配、高龄供肝		 供体/受体性别不匹配、高龄供肝、边缘供肝、供体/受体巨细胞病毒血清学状态不匹配
移植后因素 MMF等抗代谢药物
停用糖皮质激素		 移植后早期胆汁淤积增加、他克莫司、环孢素(降低风险)、硫唑嘌呤(降低风险)、熊去氧胆酸(降低风险)、抗逆转录病毒治疗(降低风险) 炎症性肠病活动、全结肠切除术(降低风险)、胆道并发症、巨细胞病毒感染、T细胞介导的排斥反应(任意、多次、糖皮质激素抵抗)、抗胸腺细胞球蛋白
表3 AILD肝移植术后免疫抑制方案
类型 AIH PBC PSC
诱导治疗(移植后第1周) 巴利昔单抗(术后当天和术后4 d各注射20 mg)或甲泼尼龙(依各中心经验，术后当天注射500~1000 mg并逐日递减)
主要治疗 他克莫司口服，2次/d或1次/d(缓释剂)；目标谷浓度一般为：移植后0~3个月10~12 ng/mL，4 ~6个月6~8 ng/mL，7~12个月5~7 ng/mL，12个月以后5~7 ng/mL，特殊情况下遵医嘱调整
用药无时间限制
辅助 建议移植后12个月内进行三联治疗，长期进行二联治疗
MMF口服，2次/d，移植后12个月内1 000~2 000 mg/d，12个月后250~500 mg/d
硫唑嘌呤口服，移植后12个月内1.0~1.5 mg·kg－1·d－1，12个月后50~75 mg/d
泼尼松口服，30 mg/d，移植后12个月内逐渐减量，长期5~10 mg/d		 不建议长期使用泼尼松
MMF口服，2次/d，1 000~2 000 mg/d，移植后7~12个月停用
硫唑嘌呤口服，1.0~1.5 mg·kg－1·d－1，移植后7~12个月停用
泼尼松口服，30 m/d，逐渐减量，移植后4~6个月停用		 不建议长期使用泼尼松
合并炎症性肠病的受者：硫唑嘌呤口服，1.0~1.5 mg·kg－1·d－1，移植后7~12个月停用，如果炎症性肠病活动，考虑长期使用
无炎症性肠病的受者：MMF口服，2次/d, 1 000~2 000 mg/d，移植后7~12个月停用
泼尼松口服，30 mg/d，逐渐减量，移植后4~6个月停用
单药治疗 否 是 是
表4 降低AILD肝移植术后原发疾病复发风险的策略
  AIH PBC PSC
移植术前预防策略 等待期间维持免疫抑制治疗
控制病情：
治疗活动性肝硬化
积极治疗使AST/IgG于术前恢复正常水平
免疫抑制最小化，以降低围手术期感染风险		 等待期间维持UDCA治疗(13~15 mg·kg－1·d－1) 术前适当控制炎症性肠病
术前积极预防复发性胆管炎
移植术后预防措施 长期二联免疫抑制治疗
他克莫司联合：
甲泼尼龙(4~8 mg/d)
或MMF(250~500 mg，2次/d)
或硫唑嘌呤(50~75 mg/d)		 长期维持使用UDCA(13~15 mg·kg－1·d－1)
移植后早期他克莫司转换为环孢素		 积极预防排斥反应
治疗炎症性肠病，如无法控制，应考虑全结肠切除术
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