Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid
Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid
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DOI：
10.1111/j.1365-2036.2010.04512.x
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发表时间：
2011-01-15
影响因子：
7.6
通讯作者：
Lindor, K.
中科院分区：
文献类型：
--
作者：
Levy, C.;Peter, J. A.;Lindor, K.
研究背景熊去氧胆酸（UDCA）治疗效果不佳的原发性胆汁性肝硬化患者需要新的治疗方法.非诺贝特是一种纤维酸，具有调节免疫应答和细胞增殖的作用，目的评价非诺贝特治疗UDCA不完全应答的原发性胆汁性肝硬化患者的疗效和安全性。方法我们对20例血清碱性磷酸酶（ALP）>= 2 × ULN的原发性胆汁性肝硬化患者进行了初步研究。非参数统计检验和斯皮尔曼相关性检验被用来作为appropriate.ResultsTwenty患者接受非诺贝特（160毫克/天），除了UDCA为48周。与基线值相比，48周时的中位血清ALP显著降低[基线时为351（214-779）U/L，48周时为177（60-384）U/L，P < 0.05]。停药后发生ALP反弹。血清天冬氨酸转氨酶和免疫球蛋白M也显著降低，而胆红素和白蛋白保持不变。中位IL-1从28.9（2.7-10 000）降至11.3（2.5-277.7）pg/mL（P = 0.049），中位IL-6从4.6（3.2-5205）降至3.5（3.2-73.4）pg/mL（P = 0.027）。烧心是最常见的不良事件，导致两个研究subjects.ConclusionsCombination治疗的非诺贝特和UDCA诱导原发性胆汁性肝硬化和UDCA反应不完全的患者的生化显着改善。需要进一步研究。
P>BackgroundNewer therapies are needed for patients with primary biliary cirrhosis and incomplete response to ursodeoxycholic acid (UDCA). Fenofibrate is a fibric acid postulated to regulate immune response and cell proliferation.AimTo evaluate the efficacy and safety of fenofibrate in patients with primary biliary cirrhosis and incomplete response to UDCA.MethodsWe undertook a pilot study involving 20 patients with primary biliary cirrhosis and serum alkaline phosphatase (ALP) >= 2x ULN. Nonparametric statistical tests and Spearman correlation test were used as appropriate.ResultsTwenty patients received fenofibrate (160 mg/day) in addition to UDCA for 48 weeks. Median serum ALP decreased significantly at 48 weeks compared with baseline values [351 (214-779) U/L at baseline vs. 177 (60-384) U/L at 48 weeks, P < 0.05]. A rebound in ALP occurred upon drug discontinuation. Serum aspartate aminotransferase and Immunoglobulin M also decreased significantly, while bilirubin and albumin remained unchanged. Median IL-1 decreased from 28.9 (2.7-10 000) to 11.3 (2.5-277.7) pg/mL (P = 0.049), and median IL-6 from 4.6 (3.2-5205) to 3.5 (3.2-73.4) pg/mL (P = 0.027). Heartburn was the most frequent adverse event, leading to discontinuation of two study subjects.ConclusionsCombination therapy of fenofibrate and UDCA induced significant biochemical improvement in patients with primary biliary cirrhosis and incomplete response to UDCA. Further studies are warranted.