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

doi:10.3877/cma.j.issn.1674-3903.2025.02.002

Abstract

Abstract:

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

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]. Chinese Journal of Transplantation(Electronic Edition), 2025, 19(02): 76-85.

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References 86

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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)

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)

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

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

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

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