中药复方调肝降脂颗粒干预非酒精性脂肪肝病的随机对照临床研究

目的：观察非酒精性脂肪肝（Non-alcoholic fatty liver disease,NAFLD）患者临床表现,探讨中药复方调肝降脂颗粒的临床疗效。方法：采用前瞻性、随机、双盲、平行对照设计,选择100例符合诊断标准、纳入标准的NAFLD患者,按1∶1随机分为治疗组、对照组。治疗组予调肝降脂颗粒剂,对照组予易善复胶囊,连续治疗3个月。应用CT检查肝脏变化,全自动生化分析仪检测ALT变化,综合症状、体征、CT、ALT变化评价临床疗效。结果：调肝降脂颗粒总有效率为86%,易善复总有效率为64%,经Ridit分析,治疗组疗效明显优于对照组（P〈0.01）。调肝降脂颗粒同时能降低血清ALT,而易善复无此效应（P〈0.01）。结论：中药复方调肝降脂颗粒具有降低血清谷丙转氨酶,回缩肝脏,明确改善NAFLD的疗效,安全有效,值得临床推广应用。

A Randomized Control Trial about Regulating Liver to Lowering Lipid Granules Treating NAFLD

Objective：To discuss the clinical effect by observing the manifestation of NAFLD.Methods： It is a Randomized Control Trial.100 NAFLD cases conform to diagnostic criteria and inclusion criteria.All the patients were divided into two groups randomly.The intervention group was treated with regulating liver to lowering lipid granules whereas the control group was treated with Polygene Phosphate tidylcholine Capsules for three months.The total therapeutic effect evaluating was according to syndrome,signs,combined with the changes of CT and ALT.Results： The total effective rate in intervention group is 86% whereas that rate in control group is 64%.There is a significance difference in the two groups.Meanwhile,the regulating liver to lowering lipid granules can reduce the serum ALT.Comared to control group,the difference is obvious.Conclusions： The regulating liver to lowering lipid granules exerts an exact effect on reducing ALT and retracting liver.It is worthy to Popularization and Application.