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苦乐清汤治疗非酒精性脂肪性肝炎临床疗效观察研究

The Clinical Research of Treatment of Kuleqing Tang in Nonalcoholic Steatohepatitis

【作者】 徐兴龙

【导师】 孙丽霞;

【作者基本信息】 南京中医药大学 , 中医学, 2011, 硕士

【摘要】 研究背景:非酒精性脂肪性肝炎(NASH),是西方国家最常见的肝脏疾病之一,随着国人生活水平的提高,糖尿病、高脂血症、高血压、冠心病等“富贵病”的发病率不断上升,NASH成为肝源性转氨酶升高的主要原因之一。也是隐源性肝硬化的重要病因之一,目前尚缺乏理想的治疗药物。苦乐清汤是我们根据国医大师一周仲瑛教授多年临证经验,从“肝肾不足,痰瘀湿阻”基本理论出发,综合国内外多家研究成果,提炼整理出来的治疗NASH方药。经临床初步观察发现该方具有保肝降酶、调节血脂和血糖、降低肝内脂肪含量,逆转肝纤维化及早期肝硬化等多重作用。研究目的:通过临床试验,进一步观察苦乐清汤治疗NASH的临床疗效,评价其治疗NASH I临床疗效,观察其安全性,为临床治疗NASH提供有效药物。方法:选择40例符合入选病例标准的患者,随机分为治疗组和对照组,治疗组予苦乐清汤,对照组予易善复(多烯磷脂酰胆碱)。3个月为1疗程,观察ALT、AST、GGT、AKP等肝脏酶学指标、肝脏脂肪浸润程度及相关安全性指标,采用SPSS10.0进行统计学处理分析,客观评价苦乐清汤的安全性及有效性。结果:苦乐清汤具有明显的改善NASH患者乏力、消化不良、肝区隐痛等临床症状及体征作用,对ALT、AST、GGT、AKP等肝脏酶学指标改善作用显著,可降低肝脏脂肪浸润的程度及体重指数,对血常规、尿常规、肾功能等安全性指标无显著性影响。结论:苦乐清汤确是有效治疗NASH的方药,值得进一步深入研究。

【Abstract】 Background:Non-alcoholic steatohepatitis(NASH) is one of the most commonly seen hepatopathy in western countries. While in China,with the improvement of living standard and the increasing in morbidity of the rich people’s diseases like diabetes、hyperlipidemia、hypertension、coronary heart disease, NASH is becoming one of the primary causes to the rise of hepatogenic aminotransferase lacking of certain effective medicine currently and to cryptogenic cirrhosis. Kuleqing,based upon the experience of professor Zhou Zhongying a famous expert devoting his whole life to Chinese medicine,proceeding from the basic pathogenesis of deficiency of liver and kidney as well as phlegm accumulating with stagnation’,combining the domestic and overseas research achievements,is expected to be an effective patent herbal medicine for NASH. After the preliminary observation, we find its multiple roles in protecting liver-cell and reducing aminotransferase、adjusting the lipidemia and blood glucose、lowering down the lipid content in the liver、reversing liver fibrosis and early cirrhosis.Objective:to further test and verify the clinical effect of Kuleqing on NASH and to observe its safety,and all in all,to provide an effective medicine for the treatment of NASH.Method:we select 40 qualified cases and divide into treatment group(with Kuleqing) and control group(with Essentiale) randomly.we set 3 months as a therapeutic course and monitor the biological indicator as ALT、AST、TBIL、GGT、AKP and also the infiltrating degree of lipid in the liver as well as relevant safety indicator.Then, we do the statistic analysis by SPSS 10.0 and objectively evaluate its efficiency and safety.Result:Kuleqing can not only improve the clinical manifestations and signs like fatigue、indigestion、dull pain in the liver area、hepatosplenomegaly but also the biological indicator markedly、lower down the level of lipid infiltration and BMI.we haven’t found any adverse effect from the blood routine test、urine routine test and renal function.Conclusion:it is true a effective medicine for NASH and deserve further researches.

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