Therapeutic efficacy of anfate in patients with non-alcoholic fatty liver disease
摘要: 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<...Abstract: 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 (P<0.01) .AST, GGT, TG, TC and LDL-C also had a significant improvement.HDL-C, FBG and HOMA-IR did not show a significant change (P>0.05) .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 (P<0.001) .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 (P<0.001) 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.
- fatty liver /
- liver extracts
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