益气散聚方治疗非酒精性脂肪性肝病随机对照临床试验

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。

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

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 (39 cases) and placebo group (28 cases). The NAFLD patients in the two groups were treated with YQSJF and placebo respectively for 3 months. 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 factor-alpha (TNF-alpha), 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).