荷泽降脂口服液治疗肝郁脾虚型非酒精性脂肪肝的临床研究

The clinical study of Heze Lipid-lowering Oral Liquid in the management of nonalcoholic fatty liver due to liver-qi stagnation and spleen deficiency

目的观察荷泽降脂口服液(绞股蓝、炒白术、丹参、泽泻、制半夏、荷叶、玄明粉、陈皮、山楂)治疗肝郁脾虚型非酒精性脂肪肝的临床疗效。方法采用多中心、随机、平行对照研究。受试者共120例,随机分为荷泽降脂口服液治疗组(60例)和西药易善复胶囊对照组(60例),均以4月为一疗程。观察两组患者治疗前后的临床主症、体征以及B超、CT对照、理化检查的变化,采用积分法作疗效评价,等级资料比较用Mann-Whiteney U秩和检验。结果荷泽降脂口服液组治疗后体重指数(BMI)与中医证候积分明显下降(P<0.05),组间比较差异有统计学意义(P<0.05);B超治疗前后亦有改善(P<0.05),组间比较差异有统计学意义(P<0.05);肝/脾CT值治疗后上升(P<0.05);谷草转氨酶、血清总胆固醇、高密度脂蛋白胆固醇治疗后均有改善(P<0.05);综合疗效的比较符合方案分析群集(PPS集),治疗组优于对照组,差异有统计学意义(P<0.05)。结论荷泽降脂口服液治疗肝郁脾虚型非酒精性脂肪性肝病疗效确切,安全性高。

AIM To observe the clinical effects of Heze Lipid-lowering Oral Liquid （Gynostemmatis pen- taphylli Herba, Atractylodis macrocephalae Rhizoma, Salviae miltiorrhizae Radix et Rhizoma, Alismatis Rhizoma, Alismatis Rhizoma, Nelumbinis Folium, Natrii sulfas exsiccatus, Citri reticulatae Pericarpium, Crataegi Fructus ） in the management of nonalcoholic fatty liver due to liver-qi stagnation and spleen deficiency. METHODS One hundred and twenty patients for a four-month course of treatment were randomly divided into the trial group （n = 60） for use of Heze lipid-lowering Oral Liquid, and the control group （ n = 60） for Yishanfu Capsules. Observa- tions on the changes of clinical signs and symptoms, B-ultrasound, CT, and other physical and chemical indexes between the two groups before and after the medications were recorded, and an integral method for comprehensive curative effect comment and Mann-Whiteney U tests were applied in the efficacy evaluation. RESULTS In the trial group, the BMI index and TCM syndrome integral decreased significantly （ P 〈 0.05 ）, and difference be- tween the two groups was statistically significant （ P 〈 0. 05 ）. There was distinct improvement from B-ultrasound results before and after the treatment with the trial agent （ P 〈 0.05 ）, and a significant statistical difference be- tween the two groups was also noticed （P 〈 0. 05 ）. The exhibited better Liver/spleen CT value was statistically sig- nificant （P 〈 0.05）. AST, TC and HDL-C were found to be more satisfactory after treatment （P 〈 0. 05 ）. And the medicine in use for the control group was inferior to that of the trial group from an o^erall view with a statistical- ly significant difference （P 〈 0. 05）. CONCULSION Heze Lipid-lowering Oral Liquid protects the liver by de- creasing the serum lipid and thus is worthy of clinical application to nonalcoholic fatty liver disease.