Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression

Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestatic liver disease characterized by progressive, non-suppurative, destructive cholangitis, potentially leading to fibrosis, cirrhosis, and liver failure. It predominantly affects middle-aged and elderly women, with highly variable progression rates: some patients remain stable long-term, while others rapidly develop portal hypertension and decompensation. Early risk factor identification and accurate risk stratification are essential for improving prognosis. Large-scale, multi-dimensional (clinical-pathological-laboratory) studies on PBC progression risk factors in the Chinese population remain scarce. The associations of histological stage, autoantibody profiles, and biochemical response with prognosis require further clarification. This retrospective observational study will enroll PBC patients with histologically confirmed diagnosis via liver biopsy at Beijing Ditan Hospital, Capital Medical University, from January 2015 to June 2026. We will systematically analyze clinical, laboratory, autoantibody, and pathological features. Univariate and multivariate logistic/Cox regression will be used to identify independent risk factors, aiming to establish a progression risk prediction model tailored to Chinese PBC patients. This model will support early identification of high-risk individuals and guide personalized treatment and follow-up strategies in clinical practice.

Inclusion Criteria: 1. Met the diagnostic criteria for PBC according to the Guidelines for the Diagnosis and Treatment of Primary Biliary Cholangitis (2021) and the Guidelines for the Diagnosis and Treatment of Primary Biliary Cholangitis (2025 Edition), satisfying at least two of the following three criteria: ① biochemical evidence of cholestasis (elevated ALP and/or GGT) with imaging excluding extrahepatic or intrahepatic large bile duct obstruction; ② positive AMAs/AMA-M2 or positivity for other PBC-specific autoantibodies (anti-gp210 or anti-sp100); ③ histologic evidence of non-suppurative destructive cholangitis and small bile duct destruction. (2) Underwent liver biopsy with a complete pathological report. (3) Had complete clinical data with missing values for key variables not exceeding 20%. Exclusion Criteria: 1. Concomitant other liver diseases, such as chronic hepatitis B, hepatitis C, hepatitis D, hepatitis E, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced liver injury, autoimmune hepatitis, primary hemochromatosis, or Wilson's disease. (2) Concurrent non-hepatotropic viral infections causing liver injury, including Epstein-Barr virus, cytomegalovirus, and human immunodeficiency virus. (3) Concurrent liver malignancy. (4) Age \< 18 years. (5) Severely incomplete clinical data with missing values for key variables exceeding 20%.