益气散聚方治疗非酒精性脂肪性肝病随机对照临床试验

Effects of Yiqi Sanju Formula on non-alcoholic fatty liver disease:a randomized controlled trial

目的:观察中药益气散聚方对非酒精性脂肪性肝病(non-alcoholic fatty liver disease,NAFLD)患者的疗效。方法:将符合纳入标准的67例NAFLD患者,随机分为益气散聚方组39例和安慰剂对照组28例。分别予益气散聚方和安慰剂治疗3个月,观察治疗前后临床症状、肝脾CT比值、体质量指数(body mass index,BMI)、腰围、稳态模型胰岛素抵抗指数(homeostatic model assessment for insulin resistance,HOMA2-IR)、肝功能、肿瘤坏死因子α(tumor necrosis factor-α,TNF-α)、高敏C反应蛋白(high sensitivity C-reactive protein,hs-CRP)和血脂等方面的变化。结果:治疗后,益气散聚方组临床症状明显缓解,肝脾CT比值明显上升,BMI、HOMA2-IR水平下降,肝功能好转,TNF-α、hs-CRP和血脂水平明显下降,与安慰剂组相比,差异有统计学意义;益气散聚方组总有效率为94.87%。结论:中药益气散聚方治疗NAFLD疗效确切。

Objective：To observe the therapeutic effects of Yiqi Sanju Formula（YQSJF）,a compound traditional Chinese herbal medicine,in treatment of non-alcoholic fatty liver disease（NAFLD）.Methods：Sixty-seven patients diagnosed with NAFLD were randomly divided into two groups： YQSJF-treated group（39cases） and placebo group（28cases）.The NAFLD patients in the two groups were treated with YQSJF and placebo respectively for3months.Clinical symptoms,the CT ratio of liver-spleen,body mass index（BMI）,waist circumference,homeostatic model assessment for insulin resistance（HOMA2-IR） and the levels of alanine aminotransferase（ALT）,aspartate aminotransferase（AST）,tumor necrosis factorα-（TNFα-）,high sensitivity C-reactive protein（hs-CRP）,triglyceride（TG）,total cholesterol（TC）,high-density lipoprotein（HDL） and low-density lipoprotein（LDL） were evaluated before and after treatment.Results：After treatment,the clinical symptoms were improved and the levels of BMI,waist circumference,HOMA2-IR,ALT,AST,TG and TC were decreased significantly in the YQSJF-treated group（P〈0.05）.The CT ratio of liver-spleen in the YQSJF-treated group was increased significantly as compared with the placebo group（P〈0.01）.Conclusion：YQSJF has reliable and definite therapeutic effects on NAFLD.