活血消脂胶囊治疗非酒精性脂肪肝临床研究

Clinical study of Huoxue-Xiaozhi capsule on non-alcoholic fatty liver disease

目的 评价活血消脂胶囊对非酒精性脂肪肝(non-alcoholic fatty liver disease,NAFLD)的疗效.方法 将符合入选标准的100例NAFLD患者采用随机数字表法分为2组,每组50例.治疗组口服活血消脂胶囊,对照组口服复方蛋氨酸胆碱片,2组均治疗8周.采用全自动生化分析仪检测ALT、AST、γ-谷氨酰转肽酶(glutamyl transpeptidase-γ,γ-GT)、ALP,采用ELISA法检测血清超敏-C反应蛋白(hypersensitive C-reactive protein,hs-CRP)、同型半胱氨酸(homocysteine,Hcy)、IL-18,分别于治疗前后行肝脏影像学检测,并进行症状、体征评分,评价临床疗效.结果 治疗组总有效率为90.0%(45/50)、对照组为74.0%(37/50),2组比较差异有统计学意义(Z=-2.328,P=0.020).治疗后,治疗组血清hs-CRP[(2.4±2.9)mg/L比(3.6±2.8)mg/L,t=2.105]、Hcy[(11.2±5.5)μmol/L比(13.9±6.4)μmol/L,t=2.262]、IL-18[(690.6±61.3)ng/L比(775.4±60.5)ng/L,t=6.962]水平低于对照组(P<0.05或P<0.01).治疗后,治疗组胁下痞块、面色萎黄、面色晦暗、肝区叩痛或胁肋隐痛的改善情况均优于对照组(Z值分别为-2.563、-2.788、-2.780、-2.220,P<0.05);血清ALT、AST、γ-GT、ALP水平均低于对照组(t值分别为18.820、19.811、10.221、3.248,P值均<0.001).结论 活血消脂胶囊可改善NAFLD患者的肝功能,降低血清hs-CRP、Hcy、IL-18水平,疗效优于口服复方蛋氨酸胆碱片治疗.

Objective To evaluate the curative effect of Huoxue-Xiaozhi capsule on non-alcoholic fatty liver disease (NAFLD). Methods A total of 100 patients with NAFLD who met the inclusion criteria were divided into 2 groups with 50 patients in each group by random number table method. The treatment group was treated with Huoxue-Xiaozhi capsule, while the control group was treated with Compound Methionine Choline Tablets. Both groups were treated for 8 weeks. The ALT, AST, γ-GT (γ- glutamyltranspeptidase ), ALP (alkaline phosphatase, alkaline phosphate) were detected by automatic blood biochemical analyzer. The serum high sensitivity-C reactive protein (hs-CRP) and Homocysteine (Hcy) were detected by supplementary detection method. The serum IL-18 was detected by ELISA method, and liver imaging was performed before and after treatment. The symptoms and signs were evaluated, and clinical efficacy was evaluated. Results The total effective rate was 90.0% (45/50) in the treatment group and 74.0% (37/50) in the control group. The difference between the two groups was statistically significant (Z=-2.328, P=0.020 ). After treatment, the serum hs-CRP (2.4 ± 2.9 mg/L vs. 3.6 ± 2.8 mg/L, t=2.105), Hcy (11.2 ± 5.5 μmol/L vs. 13.9 ± 6.4 μmol/L, t=2.262), IL-18 (690.6 ± 61.3 ng/L vs. 775.4 ± 60.5 ng/L, t=6.962) in the treatment group were significantly lower than those in the control group (P<0.05 or P<0.01). After treatment, the improvement of hypochondriac lump, sallow complexion, dark complexion and hypochondriac dull pain in the treatment group were superior to those in the control group (Z values were -2.563, -2.788, -2.780, -2.220 respectively, all Ps<0.05 ). The Serum ALT, AST,γ-GT and ALP levels were significantly lower than those of the control group (t values were 18.820, 19.811, 10.221 and 3.248 respectively, all Ps<0.001 ). Conclusions The Huoxue-Xiaozhi capsule can improve the liver function and reduce the levels of serum hs-CRP, HCY and IL-18, and its curative effect of NAFLD.