Efficacy and safety of fenofibrate addition therapy in patients with cirrhotic primary biliary cholangitis with incomplete response to ursodeoxycholic acid.
Efficacy and safety of fenofibrate addition therapy in patients with cirrhotic primary biliary cholangitis with incomplete response to ursodeoxycholic acid.
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非诺贝特加用治疗熊去氧胆酸不完全反应的肝硬化原发性胆汁性胆管炎患者的疗效和安全性
DOI：
10.1002/hep4.2103
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发表时间：
2022-12
影响因子：
5.1
通讯作者：
中科院分区：
文献类型：
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非诺贝特（FF）在对熊去氧胆酸（UDCA）反应不完全的原发性胆汁性胆管炎（PBC）患者中显示出潜在获益。然而，FF在肝硬化患者中的疗效和安全性仍不清楚。为了评价额外FF治疗对UDCA不完全缓解的PBC相关肝硬化患者的疗效和安全性，我们进行了一项回顾性分析，比较了额外FF治疗和继续UDCA单药治疗的临床结果。共纳入59例患者; 27例接受UDCA单药治疗，32例接受UDCA联合FF治疗。FF组碱性磷酸酶（ALP）正常化与UDCA组相比存在显著差异（分别为37% vs. 11%; p = 0.020）。额外FF治疗是ALP正常化的独立风险因素（风险比，7.679; 95%置信区间，2.059-28.633; p = 0.003）。FF和UDCA组分别有40%和48%（p = 0.562）发生肝脏恶化，11%和37%（p = 0.111）发生肝脏相关死亡或肝移植。与UDCA单药治疗相比，额外FF治疗与英国（UK）-PBC风险评分和肝纤维化替代血清指数降低相关。FF添加治疗12个月后，中位ALP水平和UK-PBC风险评分较基线降低35%和52%（分别为p = 0.001和0.210）。在随访期间，FF治疗的肾小球疾病病例中，血清转氨酶、甘油三酯和胆固醇进行性降低，而总胆红素、血清肌酐、血尿素、估计肾小球滤过率、天冬氨酸转氨酶/血小板比值指数和纤维化-4指数保持稳定。在我们的队列中未观察到与额外FF治疗相关的显著不良反应。结论：额外FF治疗与UDCA不完全缓解的血小板减少性PBC患者的ALP正常化率较高和UK-PBC风险评分较低相关。此外，FF治疗在肝硬化患者中似乎安全且耐受性良好，不良反应发生率较低。
Fenofibrate (FF) has shown potential benefits in patients with primary biliary cholangitis (PBC) who have an incomplete response to ursodeoxycholic acid (UDCA). However, the efficacy and safety of FF in patients with cirrhosis remain unclear. To evaluate the efficacy and safety of additional FF therapy in patients with PBC‐related cirrhosis with an incomplete response to UDCA, we conducted a retrospective analysis comparing the clinical results of additional FF therapy and continued UDCA monotherapy. A total of 59 patients were included; 27 cases underwent UDCA monotherapy and 32 cases underwent UDCA combined with FF therapy. A significant difference in alkaline phosphatase (ALP) normalization was achieved in the FF group compared to the UDCA group (37% vs. 11%, respectively; p = 0.020). Additional FF therapy was an independent risk factor for ALP normalization (hazard ratio, 7.679; 95% confidence interval, 2.059–28.633; p = 0.003). Hepatic deterioration was experienced by 40% versus 48% (p = 0.562) while 11% vs. 37% (p = 0.111) experienced liver‐related mortality or liver transplantation in the FF and UDCA groups, respectively. Compared to UDCA monotherapy, additional FF therapy was associated with lower United Kingdom (UK)‐PBC risk score and surrogate serum indices of liver fibrosis. After 12 months of add‐on FF therapy, median ALP level and UK‐PBC risk score decreased 35% and 52% from baseline (p = 0.001 and 0.210, respectively). Serum aminotransferase, triglyceride, and cholesterol decreased progressively, while total bilirubin, serum creatinine, blood urea, estimated glomerular filtration rate, aspartate aminotransferase‐to‐platelet ratio index, and fibrosis‐4 index remained stable in FF‐treated cirrhotic cases during follow‐up. No significant adverse effects associated with additional FF therapy were observed in our cohort. Conclusion: Additional FF therapy was associated with higher ALP normalization rates and lower UK‐PBC risk scores in patients with cirrhotic PBC with an incomplete response to UDCA. In addition, FF therapy seemed safe and well tolerated with a low frequency of adverse effects in patients with cirrhosis.
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影响因子：
7.6
作者：
Levy, C.;Peter, J. A.;Lindor, K.
通讯作者：
Lindor, K.
影响因子：
29.4
作者：
Parés, A;Caballería, L;Rodés, J
通讯作者：
Rodés, J
DOI：
10.2174/1874192401004010120
发表时间：
2010-04-28
期刊：
The open cardiovascular medicine journal
影响因子：
--
作者：
Liberopoulos EN;Florentin M;Elisaf MS;Mikhailidis DP;Tsianos E
通讯作者：
Tsianos E
影响因子：
3.1
作者：
Hegade, Vinod S.;Khanna, Amardeep;Jones, David E. J.
通讯作者：
Jones, David E. J.
影响因子：
6.7
作者：
Carrion, Andres F.;Lindor, Keith D.;Levy, Cynthia
通讯作者：
Levy, Cynthia