非诺贝特治疗难治型原发性胆汁性胆管炎的有效性和安全性

Efficacy and safety of fenofibrate in primary biliary cholangitis patients with incomplete response to ursodeoxycholic acid

目的评价非诺贝特用于治疗难治型原发性胆汁性胆管炎/肝硬化(primary biliary cholangitis/cirrhosis,PBC)患者的有效性和安全性。方法入组19例熊去氧胆酸(UDCA)应答不良的患者,在维持原有熊去氧胆酸治疗基础上予非诺贝特200 mg/d,在开始非诺贝特前、使用非诺贝特3、6、12个月等不同时间点监测患者血生化等指标变化,评价其安全性和有效性。结果使用非诺贝特治疗的难治型PBC患者,1例血清胆红素上升,其他无严重不良反应;使用非诺贝特治疗后患者的ALP、GGT及AST较用药前下降,其中ALP由(210. 2±113. 2) U/L降为(110. 1±75. 8) U/L,GGT由(258. 5±201. 2) U/L降为(128. 2±103. 4) U/L,AST由(58. 3±30. 6) U/L降为(39. 2±16. 0) U/L,差异有统计学意义(P<0. 05)。结论对熊去氧胆酸应答不良的难治型PBC患者,加用非诺贝特有助于血ALP、GGT和AST水平的下降,且相对安全,不良反应较少。

Objective To assess the efficacy and safety of fenofibrate treatment in primary biliary cholangitis/cirrhosis(PBC)patients with incomplete response to ursodeoxycholic acid(UDCA).Methods19 PBC patients with incomplete response to UDCA were enrolled and were given 200 mg/d of fenofibrate,while their original UDCA treatment continued.The serum levels of ALP,AST,GGT,ALT,CHO,and TBil of these patients were monitored and recorded at baseline,3 months,6 months,and 12 months after the trial started.Results(1)No severe adverse effect was reported other than a patient with elevated serum TBil level.(2)Serum ALP,GGT and AST levels of the patients decreased significantly as compared with baseline,with ALP decreasing from(210.2±113.2)U/L to(110.1±75.8)U/L,GGT decreasing from(258.5±201.2)U/L to(128.2±103.4)U/L,AST decreasing from(58.3±30.6)U/L to(39.2±16.0)U/L(P<0.05).Conclusions Fenofibrate can help to reduce ALP,GGT and AST in PBC patients with incomplete response to UDCA without causing severe adverse effects.