Prednisone et acide ursodésoxycholique pour la cholangite biliaire primitive avec hépatite de l'interface

Date de début de l'étude : 30 octobre 2024

Inclusion Criteria: 1. Voluntarily joining the group, able to understand and sign an informed consent form; 2. 18 years old ≤ age ≤ 75 years old; 3. The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: AMA or gp210, sp100 positive; Elevated serum ALP levels; Pathological manifestations include non suppurative cholangitis and destruction of the interlobular bile duct; 4. Liver histology suggests moderate to severe interfacial hepatitis (moderate,\&lt;50% portal or fibrous septa destruction, severe,\&gt;50% portal or fibrous septa destruction) with serum ALT\&lt;5 \* ULN, serum IgG\&lt;2 \* ULN, and negative serum anti smooth muscle antibodies; 5. Not receiving UDCA, hormone or other immunosuppressive therapy before enrollment; 6. ALP\&gt;1.67 \* ULN. Exclusion Criteria: * History or presence of other concomitant liver diseases. * ALT or AST \&gt; 5×ULN, TBIL \&gt; 3×ULN. * If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. * Allergic to fenofibrate or ursodeoxycholic acid. * Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users. * Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites. * Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse). * Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min. * Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen). * Planned to receive an organ transplant or an organ transplant recipient. * Needing Liver transplantation within 1 year according to the Mayo Rick score. * Any other condition(s) that would compromise the safety of the subject or compromise