Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease.
Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease.
复制标题
小檗碱对非酒精性脂肪肝患者的疗效
DOI：
10.1371/journal.pone.0134172
复制
发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
Gao X
中科院分区：
文献类型：
--
作者：
Yan HM;Xia MF;Wang Y;Chang XX;Yao XZ;Rao SX;Zeng MS;Tu YF;Feng R;Jia WP;Liu J;Deng W;Jiang JD;Gao X
目的通过随机、平行对照、开放性临床试验，评价植物药小檗碱（BBR）治疗非酒精性脂肪肝（NAFLD）的疗效。方法采用随机、平行对照、开放性临床试验（NIH注册号：NCT 00633282）。共有184例符合条件的NAFLD患者入选，并分别随机接受（i）生活方式干预（LSI），（ii）LSI+吡格列酮（PGZ）15 mg qd，（iii）LSI + BBR 0.5 g tid，共16周。观察治疗前后肝脏脂肪含量（HFC）、血糖和血脂、肝酶、血和尿BBR浓度。我们还分析了用BBR治疗的NAFLD动物模型中肝脏BBR含量和与葡萄糖和脂质代谢相关的基因表达。结果与LSI组相比，BBR + LSI组HFC显著降低（52.7%vs36.4%，p = 0.008），体重、HOMA-IR和血脂水平改善更明显（均p<0.05）。BBR在降低体重和改善血脂方面优于PGZ 15 mg qd。BBR相关不良事件较轻，主要发生在消化系统。在BBR治疗的受试者中，血清和尿液BBR浓度分别为6.99ng/ml和79.2ng/ml。动物实验表明，BBR有利地定位于肝脏，并改变肝脏代谢相关基因的表达。结论BBR可改善NAFLD及相关代谢紊乱。BBR对NAFLD的治疗作用可能与直接调节肝脏脂质代谢有关。试用注册ClinicalTrials.gov NCT 00633282
Objectives A randomized, parallel controlled, open-label clinical trial was conducted to evaluate the effect of a botanic compound berberine (BBR) on NAFLD. Methods A randomized, parallel controlled, open-label clinical trial was conducted in three medical centers (NIH Registration number: NCT00633282). A total of 184 eligible patients with NAFLD were enrolled and randomly received (i) lifestyle intervention (LSI), (ii) LSI plus pioglitazone (PGZ) 15mg qd, and (iii) LSI plus BBR 0.5g tid, respectively, for 16 weeks. Hepatic fat content (HFC), serum glucose and lipid profiles, liver enzymes and serum and urine BBR concentrations were assessed before and after treatment. We also analyzed hepatic BBR content and expression of genes related to glucose and lipid metabolism in an animal model of NAFLD treated with BBR. Results As compared with LSI, BBR treatment plus LSI resulted in a significant reduction of HFC (52.7% vs 36.4%, p = 0.008), paralleled with better improvement in body weight, HOMA-IR, and serum lipid profiles (all p<0.05). BBR was more effective than PGZ 15mg qd in reducing body weight and improving lipid profile. BBR-related adverse events were mild and mainly occurred in digestive system. Serum and urine BBR concentrations were 6.99ng/ml and 79.2ng/ml, respectively, in the BBR-treated subjects. Animal experiments showed that BBR located favorably in the liver and altered hepatic metabolism-related gene expression. Conclusion BBR ameliorates NAFLD and related metabolic disorders. The therapeutic effect of BBR on NAFLD may involve a direct regulation of hepatic lipid metabolism. Trial Registration ClinicalTrials.gov NCT00633282