Fenofibrate in primary biliary cirrhosis: a pilot study.
Fenofibrate in primary biliary cirrhosis: a pilot study.
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DOI：
10.2174/1874192401004010120
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发表时间：
2010-04-28
期刊：
影响因子：
--
通讯作者：
Tsianos E
中科院分区：
文献类型：
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作者：
Liberopoulos EN;Florentin M;Elisaf MS;Mikhailidis DP;Tsianos E
大多数原发性胆汁性肝硬化（PBC）患者接受熊去氧胆酸（UDCA）治疗;然而，有些患者没有完全反应。PBC也与血脂异常有关，但与血管风险的联系尚未得到证实。在这项研究中，我们比较了UDCA单药治疗与非诺贝特+UDCA治疗对UDCA单药治疗不完全生化应答≥ 8个月的PBC患者。10例接受UDCA（600 mg/天）治疗后肝酶持续升高的PBC患者（57.2±13.3岁）随机接受UDCA（4例患者）或微粉化非诺贝特（200 mg/天）+UDCA（6例患者）治疗8周。在联合治疗组中观察到总胆固醇、甘油三酯和非高密度脂蛋白胆固醇显著降低。与基线相比，该组中碱性磷酸酶、γ-谷氨酰转肽酶和丙氨酸氨基转移酶的血清活性也降低（分别为-32.6%; p=0.012，-44%; p=0.031和-16.9%; p=0.029）。相比之下，在继续UDCA单药治疗的患者中未观察到肝酶或脂质谱的显著变化。两组间脂质和酶变量的变化差异显著（p<0.03）。非诺贝特耐受性良好。对于UDCA单药治疗无效的PBC患者，非诺贝特联合UDCA给药似乎是安全的，并可改善血脂和肝脏指数。血脂谱的改善是否转化为血管事件风险的降低仍有待确定。
Most patients with primary biliary cirrhosis (PBC) are treated with ursodeoxycholic acid (UDCA); however, some do not respond fully. PBC is also associated with dyslipidemia, but a link with vascular risk has not been confirmed. In this study we compared UDCA monotherapy with fenofibrate plus UDCA in PBC patients with incomplete biochemical response to UDCA monotherapy for ≥ 8 months. Ten patients (57.2±13.3 years old) with PBC and persistent elevations of liver enzymes after treatment with UDCA (600 mg/day) were randomized to continue UDCA (4 patients) or to receive micronized fenofibrate (200 mg/day) plus UDCA (6 patients) for 8 weeks. Significant reductions in total cholesterol, triglycerides and non-high density lipoprotein cholesterol were observed in the combination treatment group. The serum activities of alkaline phosphatase, gamma-glutamyl transpeptidase and alanine aminotranferase also decreased in this group compared with baseline (-32.6%; p=0.012, -44%; p=0.031 and -16.9%; p=0.029, respectively). In contrast, no significant alterations in liver enzymes or lipid profile were observed in patients who continued UDCA monotherapy. The changes in the lipid and enzyme variables differed significantly (p<0.03) between the 2 groups. Fenofibrate was well tolerated. The administration of fenofibrate plus UDCA seems to be safe and may improve lipid and liver indices in patients with PBC who do not respond fully to UDCA monotherapy. Whether the improved lipid profile translates into a decreased risk of vascular events remains to be established.