壳脂胶囊治疗非酒精性脂肪性肝病临床疗效观察

Clinical study on effect of Kezhi capsule in treating nonalcoholic fatty liver diseases

目的:观察壳脂胶囊治疗非酒精性脂肪性肝病(NAFLD)的临床疗效。方法:将确诊为NAFLD患者120例,采用随机数字表法分为两组,治疗组患者口服壳脂胶囊1.25g/次,3次/d;对照组患者口服多烯磷脂酰胆碱胶囊456mg/次,3次/d,疗程均为3个月。观察治疗前后患者中医证候改善情况,监测其肝功能、血脂、血糖及肝脏彩超结果变化。结果:治疗组患者乏力、肝区不适、头晕、口苦、胸闷改善情况优于对照组,差异有显著性意义(P<0.01或P<0.05)。治疗组中医证候疗效总有效率88.3%,对照组为70.0%,两组比较差异有显著性意义(P<0.05)。治疗组患者在总胆固醇(TCh)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)改善方面优于对照组(P<0.05);而在γ-谷氨酰转移酶(GGT)、丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、空腹血糖(FBG)及肝脏彩超结果变化方面比较,两组差异无显著性意义(P>0.05)。结论:壳脂胶囊能有效改善NAFLD患者肝功能及肝脏影像学表现,能有效降低血脂、血糖,并能明显改善中医证候,值得临床推广应用。

Objective：To observe the clinical effect of Kezhi capsules in treating nonalcoholic fatty liver diseases.Methods：One hundred and twenty patients with NAFLD were randomized into two groups.The patients in treatment group were treated by taking 1.25g Kezhi capsule one time,three times a day.And those in control group were treated by taking two Polyunsaturated phosphatidylcholine capsules,three times a day.All these patients were followed up 3 months to observe the changes in symptom ,liver function,blood-lipid ,FBG and USG.Results：The effective rate of the treatment group in alleviating symptoms such as Anergy、indisposition in hepatic region、swirl、bitterness in the mouth、dyspnea was superior to the control group （P0.05 or P0.01）.The total effective rate of TCM syndrome was 88.3% in treatment group,and 70% in the control group.And there were significant differences in the total effective rates of TCM syndrome between two groups（P0.05）.The treatment group was superior to the control group in the aspects of lowering the levels of TG、TCh、LDL（P0.05）.There was no difference between two groups in ameliorating ALT、AST、FBG and USG （P0.05）.Conclusion：Kezhi capsules can significantly ameliorate FBG、liver function and the USG,and exhibit more effect in ameliorating blood-lipid and alleviating symptoms in treating NAFLD than polyunsaturated phosphatidylcholine capsules.