中医药治疗非酒精性脂肪性肝病临床试验的相关问题探讨

季光

doi:10.3969/j.issn.1001-5256.2014.04.003

中医药治疗非酒精性脂肪性肝病临床试验的相关问题探讨

DOI: 10.3969/j.issn.1001-5256.2014.04.003

季光

上海中医药大学脾胃病研究所,上海中医药大学附属龙华医院消化内科

基金项目:

上海卫生三年行动计划重大项目资助(ZYSNXD-CC-ZDYJ042)；

详细信息

中图分类号: R575.5
计量
- 文章访问数: 3015
- HTML全文浏览量: 14
- PDF下载量: 608
- 被引次数: 0
出版历程
- 收稿日期: 2013-10-21
- 出版日期: 2014-04-20

Relevant issues concerning clinical trials of traditional Chinese medicine treatment of nonalcoholic fatty liver disease

Ji Guang

Institute of Digestive Diseases and Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Research funding:

摘要

摘要:
非酒精性脂肪性肝病的患病率呈逐年上升趋势,中医药作为非酒精性脂肪性肝病的主要治疗手段之一,其临床试验受到关注和重视。从现有已经报道的临床试验来看,须要在证候选择性、疾病评估标准、行为干预控制和疗效评价指标确立等关键问题上形成共识。结合国内外研究新进展,对上述问题进行全面述评,期望为提高中医药治疗非酒精性脂肪性肝病临床试验的质量提供对策和建议。
- 脂肪肝 /
- 中医疗法 /
- 临床试验 /
- 综述
Abstract:
Since the prevalence of nonalcoholic fatty liver disease (NAFLD) has been rising in recent years, more and more attention is being paid to clinical trials of traditional Chinese medicine (TCM) treatment, which is one of the main methods for treating NAFLD.According to the reported clinical trials, consensus needs to be reached on such key points as syndrome selectivity, diagnostic criteria for disease, control of behavior intervention, and establishment of outcome assessment indices.Considering the recent research progress in the world, these issues are reviewed, in order to provide better measures and suggestions for improving the quality of clinical trials of TCM treatment of NAFLD.
- fatty liver /
- TCM THERAPY /
- clinical trials /
- review

HTML全文

参考文献(23)

[1]SZCZEPANIAK LS, NURENBERG P, LEONARD D, et al.Magnetic resonance spectroscopy to measure hepatic triglyceride content:prevalence of hepatic steatosis in the general population[J].Am J Physiol Endocrinol Metab, 2005, 288 (2) :e462-e468.

[2]WEI HF, JI G, ZHENG PY.Study of standardizat ion of syndrome diagnosis:an analysis of current status[J].J Chin Integr Med, 2007, 5 (2) :115-121. (in Chinese) 魏华凤, 季光, 郑培永.证候诊断规范化研究的现状分析[J].中西医结合学报, 2007, 5 (2) :115-121.

[3]ZHANG BL, KANG LY, XIANG YZ.Several questions about efficacy evaluation of clinical research on new drugs of Chinese materia medica[J].Chin J New Clin Rem, 2007, 26 (11) :861-863. (in Chinese) 张伯礼, 康立源, 项耀祖.中药新药临床试验中有关疗效评价若干问题的思考[J].中国新药与临床杂志, 2007, 26 (11) :861-863.

[4]BEATON MD, CHAKRABARTI S, LEVSTIK M, et al.Phase II clinical trial of phlebotomy for non-alcoholic fatty liver disease[J].Aliment Pharmacol Ther, 2013, 37 (7) :720-729.

[5]ZHANG XD, PEI XZ, DA HY.Declaration of new Chinese medicine treatment of fatty liver and related issues discussed in recent years[J].Tradit Chin Drug Res Clin Pharmacol, 2009, 20 (2) :180-182. (in Chinese) 张晓东, 裴小静, 笪红远.近年治疗脂肪肝中药新药申报概况及相关问题探讨[J].中药新药与临床药理, 2009, 20 (2) :180-182.

[6]MEHTA SR.Advances in the treatment of nonalcoholic fatty liver disease[J].Ther Adv Endocrinol Metab, 2010, 1 (3) :101-115.

[7]PARKER HM, JOHNSON NA, BURDON CA, et al.Omega-3supplementation and non-alcoholic fatty liver disease:a systematic review and meta-analysis[J].J Hepatol, 2012, 56 (4) :944-951.

[8]CUSSONS AJ, WATTS GF, MORI TA, et al.Omega-3 fatty acid supplementation decreases liver fat content in polycystic ovary syndrome:a randomized controlled trial employing proton magnetic resonance spectroscopy[J].J Clin Endocrinol Metab, 2009, 94 (10) :3842-3848.

[9]BASARANOGLU M, ACBAY O, SONSUZ A.A controlled trial of gemfibrozil in the treatment of patients with nonalcoholic steatohepatitis[J].J Hepatol, 1999, 31 (2) :384.

[10]LEUSCHNER UF, LINDENTHAL B, HERRMANN G, et al;NASH Study Group.High-dose ursodeoxycholic acid therapy for nonalcoholic steatohepatitis:a double-blind, randomized, placebo-controlled trial[J].Hepatology, 2010, 52 (2) :472-479.

[11]RATZIU V, de LEDINGHEN V, OBERTI F, et al.A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis[J].J Hepatol, 2011, 54 (5) :1011-1019.

[12]PAMUK GE, SONSUZ A.N-acetylcysteine in the treatment of nonalcoholic steatohepatitis[J].J Gastroenterol Hepatol, 2003, 18 (10) :1220-1221.

[13]BUGIANESI E, GENTILCORE E, MANINI R, et al.A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease[J].Am J Gastroenterol, 2005, 100 (5) :1082-1090.

[14]RATZIU V, GIRAL P, JACQUEMINET S, et al.Rosiglitazone for nonalcoholic steatohepatitis:one-year results of the randomized placebo-controlled Fatty Liver Improvement with Rosiglitazone Therapy (FLIRT) trial[J].Gastroenterology, 2008, 135 (1) :100-110.

[15]KELLOW NJ, SAVIGE GS.Dietary advanced glycation end-product restriction for the attenuation of insulin resistance, oxidative stress and endothelial dysfunction:a systematic review[J].Eur J Clin Nutr, 2013, 67 (3) :239-248.

[16]AITHAL GP, THOMAS JA, KAYE PV, et al.Randomized, placebo-controlled trial of pioglitazone in nondiabetic subjects with nonalcoholic steatohepatitis[J].Gastroenterology, 2008, 135 (4) :1176-1184.

[17]OMER Z, CETINKALP S, AKYILDIZ M, et al.Efficacy of insulin-sensitizing agents in nonalcoholic fatty liver disease[J].Eur J Gastroenterol Hepatol, 2010, 22 (1) :18-23.

[18]JI G.Pay attention to insulin resistance in chronic liver diseases[J].J Chin Integr Med, 2010, 8 (1) :1-6. (in Chinese) 季光.重视慢性肝病中的胰岛素抵抗[J].中西医结合学报, 2010, 8 (1) :1-6.

[19]YU L.Action mechanism of traditional Chinese medicines for reducing insulin resistance in patients with type 2 diabetes[J].J Changchun Univ Tradit Chin Med, 2012, 28 (2) :79-81. (in Chinese) 俞露.中医药改善Ⅱ型糖尿病胰岛素抵抗机制研究[J].长春中医药大学学报, 2012, 28 (2) :79-81.

[20]PROMRAT K, KLEINER DE, NIEMEIER HM, et al.Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis[J].Hepatology, 2010, 51 (1) :121-129.

[21]DUFOUR JF, ONETA CM, GONVERS JJ, et al.Randomized placebo-controlled trial of ursodeoxycholic acid with vitamin e in nonalcoholic steatohepatitis[J].Clin Gastroenterol Hepatol, 2006, 4 (12) :1537-1543.

[22]WONG VW, VERGNIOL J, WONG GL, et al.Diagnosis of fibrosis and cirrhosis using liver stiffness measurement in nonalcoholic fatty liver disease[J].Hepatology, 2010, 51 (2) :454-462.

[23]HARRISON SA, OLIVER D, ARNOLD HL, et al.Development and validation of a simple NAFLD clinical scoring system for identifying patients without advanced disease[J].Gut, 2008, 57 (10) :1441-1447.

施引文献

资源附件(0)

访问统计