清肝活血方治疗酒精性肝硬化湿热瘀结证的随机对照临床试验

Randomized controlled trial of Qing Gan Huo Xue Prescription in the treatment of alcoholic liver cirrhosis

目的:观察清肝活血方(Qing Gan Huo Xue Prescription,QGHXP)用于酒精性肝硬化(alcoholic liver cirrhosis,ALC)湿热瘀结证患者治疗的临床疗效。方法:将符合ALC诊断的69例患者随机分为两组,中药组35例,予以中药清肝活血方;对照组34例,予以多烯磷脂酰胆碱胶囊456 mg tid po;疗程均为24周。观察指标:临床症状疗效;肝酶水平(血清AST、γ-GT、ALT和ALP);瞬时弹性成像技术(transient elastrography,TE)FibroTouch检测肝硬度测量值(liver stiffness measurement,LSM),APRI评分(AST to platelet ratio index,APRI)、FIB-4指数(fibrosis-4 index/indices,FIB-4 index/indices)和Maddrey判别函数评估肝功能。结果:中药组和对照组临床症状疗效总有效率分别为85.70%和61.80%,中药组优于对照组(P=0.024);肝酶水平:治疗后中药组AST、ALP、γ-GT、ALT较治疗前降低,且均低于对照组(P<0.05)。治疗后中药组LSM低于对照组(14.19±1.49)vs(15.06±1.24)(P<0.05),中药组APRI评分、FIB-4指数和Maddrey判别函数低于对照组(P<0.05)。结论:QGHXP用于治疗ALC湿热瘀结证患者可缓解患者临床症状、肝酶水平,并改善ALC肝功能和预后。

Objective:To evaluate the efficacy of Qing Gan Huo Xue Prescription(QGHXP)in the treatment of patients with alcoholic liver cirrhosis(ALC)of damp and heat stasis syndrome.Methods:A total of 69 patients with ALC were randomly divided into TCM group(n=35)and control group(n=34).The TCM group was given QGHXP 1 pack TID orally.Control group received polyene phosphatidylcholine capsule 456 mg TID for 24 weeks.The observation measurements are symptom efficacy rate,serum level of liver enzyme,and non-invasive liver cirrhosis evaluation,including liver stiffness measurement(LSM)examininged by FibroTouch,APRI score,FIB-4 index and Maddrey discriminant function.Results:The symptom efficacy rate of the experimental group and the control group was 85.70%and 61.80%(P=0.024).Liver enzyme levels(serum ALP,γ-GT,AST and ALT)of TCM group were lower than those of control group(P<0.05).LSM of TCM group was reduced after treatment,and was significant lower than control group(14.19±1.49)vs.(15.06±1.24)(P<0.05).The APRI scores,FIB-4 index and Maddrey discriminant functions of TCM group were lower than those of control group(P<0.05).Conclusion:QGHXP is an effective alternative for the treatment of damp and heat stasis syndrome of ALC in improving liver function and clinical symptoms.