复方牛胎肝提取物治疗非酒精性脂肪性肝病的多中心临床研究

目的观察复方牛胎肝提取物片治疗非酒精性脂肪性肝病（NAFLD）的近期效果及其安全性。方法多中心、开放、非随机临床试验,在综合治疗的基础上,应用复方牛胎肝提取物片（3片/次,2次/日,口服,共3个月）治疗240例NAFLD,其中男195例,女45例,平均年龄为（42.2±11.3）岁,基础疾病为超重和/或中心性肥胖。结果有240例被纳入本研究,临床症状改善率85.9%（164/191）,其中以肝区不适感改善效果最为显著;ALT复常率62.5%（115/184）,从治疗前的（79.59±43.63）U/L下降至（43.99±14.83）U/L,P〈0.01,同时AST、GGT和TG、TC和LDL-C也明显下降,P〈0.01;而HDL-C以及空腹血糖、HOMA-IR无明显改变,P〉0.05。35.4%（85/240）的患者B超脂肪肝程度下降1个或1个以上等级;74例患者肝/脾CT值从治疗前的0.78±0.18升高到治疗后的0.93±0.16,P〈0.001。未进行饮食控制和增加运动的患者BMI、腰/臀围以及ALT、AST、GGT、TG、TC较治疗前均明显下降,P〈0.001,但饮食控制和增加运动的患者下降更快,P〈0.001。全组病例不良反应发生率为4.58%（11/240）,主要表现为消化道症状。结论复方牛胎肝提取物片对NAFLD有一定治疗效果,且不良反应轻微。

Therapeutic efficacy of anfate in patients with non-alcoholic fatty liver disease

Objective To evaluate the therapeutic efficacy and safety of Anfate（Compound Embryonic Bovine Liver Extract Tablets）in patients with non-alcoholic fatty liver disease（NAFLD）.Methods A multicenter,open,non-randomized clinical trial was performed on 240 NAFLD patients with overweight and/or central obesity（male：95,female：45,average age：（42.2±11.3） years）and the patients were treated with Anfate（240 mg p.o bid for 12 weeks）on the base of combined therapy.Results The improvement rate of clinical symptoms was 85.9%（164/191）.Malaise in hepatic region improved most.The ALT was significantly improved in 68.5%（126/184）of the patients,from（79.59±43.63）U/L before treatment down to（43.99±14.83）U/L after treatment（P0.01）.AST,GGT,TG,TC and LDL-C also had a significant improvement.HDL-C,FBG and HOMA-IR did not show a significant change（P0.05）.Fatty liver levels decreased one or more than one degree by B-ultrasound in 35.4%（85/240）patients.The liver spleen ratio significantly increased from 0.78±0.18 before treatment to 0.93±0.16 after treatment by CT in 74 patients（P0.001）.Patients with Anfate treatment group were divided into two as diet control group and increased exercise group.BMI,waist hip ratio（WHR）,ALT,AST,GGT,TG,TC in both groups were all significantly decreased（P0.001）and more quickly in the former group.Adverse reaction rate was 4.58%（11/240）and most of them showed digestive tract symptom.Conclusion Anfate has a good clinical effect on NAFLD and has no marked toxic or other side effect.