中文English
ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R

留言板

尊敬的读者、作者、审稿人, 关于本刊的投稿、审稿、编辑和出版的任何问题, 您可以本页添加留言。我们将尽快给您答复。谢谢您的支持!

姓名
邮箱
手机号码
标题
留言内容
验证码

跟踪非酒精性脂肪性肝病的临床试验-无创指标评价

瞿欢佳 施军平

引用本文:
Citation:

跟踪非酒精性脂肪性肝病的临床试验-无创指标评价

DOI: 10.3969/j.issn.1001-5256.2018.12.003
详细信息
  • 中图分类号: R575

Clinical trials tracking nonalcoholic fatty liver disease: Noninvasive measures

  • 摘要: 非酒精性脂肪性肝病(NAFLD)已成为当前肝病领域的研究热点之一,但迄今为止,美国食品药品监督管理局尚未批准用于非酒精性脂肪性肝炎的治疗药物,NAFLD的临床治疗试验仍面临诸多机遇与挑战。肝脏组织学目前被认为是追踪NAFLD进展的可靠替代终点,但由于其有创性也制约了NAFLD治疗药物的开发。近年来,一些非侵入测量方法已被应用于当前临床试验的次要或探索性终点。

     

  • [1] MCPHERSON S, HARDY T, HENDERSON E, et al. Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies:Implications for prognosis and clinical management[J]. J Hepatol, 2015, 62 (5) :1148-1155.
    [2] GOH GB, Mc CULLOUGH AJ. Natural history of nonalcoholic fatty liver disease[J]. Dig Dis Sci, 2016, 61 (5) :1226-1233.
    [3] SANYAL AJ, BRUNT EM, KLEINER DE, et al. Endpoints and clinical trial design for non-alcoholic steatohepatitis[J]. Hepatology, 2011, 54 (1) :344-353.
    [4] HANNAH WN Jr, TORRES DM, HARRISON SA. Nonalcoholic steatohepatitis and endpoints in clinical trials[J]. Gastroenterol Hepatol (NY) , 2016, 12 (12) :756-763.
    [5] VERMA S, JENSEN D, HART J, et al. Predictive value of ALT levels for non-alcoholic steatohepatitis (NASH) and advanced fibrosis in non-alcoholic fatty liver disease (NAFLD) [J]. Liver Int, 2013, 33 (9) :1398-1405.
    [6] JANCZYK W, LEBENSZTEJN D, WIERZBICKA-RUCIN'SKA A, et al. Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease:A randomized controlled trial[J]. J Pediatr, 2015, 166 (6) :1358-1363.
    [7] LAVINE JE, SCHWIMMER JB, VAN NATTA ML, et al. Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents:The TONIC randomized controlled trial[J].JAMA, 2011, 305 (16) :1659-1668.
    [8] SANYAL AJ, CHALASANI N, KOWDLEY KV, et al. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis[J]. N Engl J Med, 2010, 362 (18) :1675-1685.
    [9] CHEN J, ZHU Y, ZHENG Q, et al. Serum cytokeratin-18 in the diagnosis of non-alcoholic steatohepatitis:A meta-analysis[J].Hepatol Res, 2014, 44 (8) :854-862.
    [10] FELDSTEIN AE, ALKHOURI N, De VITO R, et al. Serum cytokeratin-18 fragment levels are useful biomarkers for nonalcoholic steatohepatitis in children[J]. Am J Gastroenterol, 2013, 108 (9) :1526-1531.
    [11] HE L, DENG L, ZHANG Q, et al. Diagnostic value of CK-18, FGF-21, and related biomarker panel in nonalcoholic fatty liver disease:A systematic review and meta-analysis[J]. Biomed Res Int, 2017, 2017:9729107.
    [12] RATZIU V, SHEIKH MY, SANYAL AJ, et al. A phase 2, randomized, double-blind, placebo-controlled study of GS-9450in subjects with nonalcoholic steatohepatitis[J]. Hepatology, 2012, 55 (2) :419-428.
    [13] FRIEDMAN SL, RATZIU V, HARRISON SA, et al. A randomized, placebo-controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis[J]. Hepatology, 2018, 67 (5) :1754-1767.
    [14] BEDOGNI G, BELLENTANI S, MIGLIOLI L, et al. The fatty liver index:A simple and accurate predictor of hepatic steatosis in the general population[J]. BMC Gastroenterol, 2006, 6:33.
    [15] LEE JH, KIM D, KIM HJ, et al. Hepatic steatosis index:A simple screening tool reflecting nonalcoholic fatty liver disease[J]. Dig Liver Dis, 2010, 42 (7) :503-508.
    [16] ALLER R, IZAOLA O, GMEZ S, et al. Effect of silymarin plus vitamin E in patients with non-alcoholic fatty liver disease. A randomized clinical pilot study[J]. Eur Rev Med Pharmacol Sci, 2015, 19 (16) :3118-3124.
    [17] POLYZOS SA, KOUNTOURAS J, MANTZOROS CS, et al. Effects of combined low-dose spironolactone plus vitamin E vs vitamin E monotherapy on insulin resistance, non-invasive indices of steatosis and fibrosis, and adipokine levels in non-alcoholic fatty liver disease:A randomized controlled trial[J]. Diabetes Obes Metab, 2017, 19 (12) :1805-1809.
    [18] ESLAMPARAST T, POUSTCHI H, ZAMANI F, et al. Synbiotic supplementation in nonalcoholic fatty liver disease:A randomized, double-blind, placebo-controlled pilot study[J]. Am J Clin Nutr, 2014, 99 (3) :535-542.
    [19] JOY TR, MCKENZIE CA, TIRONA RG, et al. Sitagliptin in patients with non-alcoholic steatohepatitis:A randomized, placebocontrolled trial[J]. World J Gastroenterol, 2017, 23 (1) :141-150.
    [20] ZHRER E, ALISI A, JAHNEL J, et al. Efficacy of docosahexaenoic acid-choline-vitamin E (DHA-CHO-VE) in paediatric NASH:A randomized controlled clinical trial[J]. Appl Physiol Nutr Metab, 2017, 42 (9) :948-954.
    [21] HARRISON SA, MARRI SR, CHALASANI N, et al. Randomised clinical study:GR-MD-02, a galectin-3 inhibitor, vs. placebo in patients having non-alcoholic steatohepatitis with advanced fibrosis[J]. Aliment Pharmacol Ther, 2016, 44 (11-12) :1183-1198.
    [22] HARRISON SA, DENNIS A, FIORE MM, et al. Utility and variability of three non-invasive liver fibrosis imaging modalities to evaluate efficacy of GR-MD-02 in subjects with NASH and bridging fibrosis during a phase-2 randomized clinical trial[J]. PLo S One, 2018, 13 (9) :e0203054.
    [23] BAE JC, LEE WY, YOON KH, et al. Improvement of nonalcoholic fatty liver disease with carnitine-orotate complex in type 2 diabetes (CORONA) :A randomized controlled trial[J]. Diabetes Care, 2015, 38 (7) :1245-1252.
    [24] CUI J, PHILO L, NGUYEN P, et al. Sitagliptin vs. placebo for non-alcoholic fatty liver disease:A randomized controlled trial[J]. J Hepatol, 2016, 65 (2) :369-376.
    [25] JEONG JY, SOHN JH, BAEK YH, et al. New botanical drug, HL tablet, reduces hepatic fat as measured by magnetic resonance spectroscopy in patients with nonalcoholic fatty liver disease:A placebo-controlled, randomized, phase II trial[J]. World J Gastroenterol, 2017, 23 (32) :5977-5985.
    [26] OH B, CHOI WS, PARK SB, et al. Efficacy and safety of ursodeoxycholic acid composite on fatigued patients with elevated liverfunction and/or fatty liver:A multi-centre, randomised, doubleblinded, placebo-controlled trial[J]. Int J Clin Pract, 2016, 70 (4) :302-311.
    [27] JAYAKUMAR S, MIDDLETON MS, LAWITZ EJ, et al. Longitudinal correlations between MRE, MRI-PDFF, and liver histology in patients with non-alcoholic steatohepatitis:Analysis of data from a phase II trial of selonsertib[J]. J Hepatol, 2018.[Epub ahead of print]
  • 加载中
计量
  • 文章访问数:  1560
  • HTML全文浏览量:  15
  • PDF下载量:  386
  • 被引次数: 0
出版历程
  • 出版日期:  2018-12-20
  • 分享
  • 用微信扫码二维码

    分享至好友和朋友圈

目录

    /

    返回文章
    返回