文献类型：期刊文献

中文题名：国医大师周信有肝病1号方联合恩替卡韦治疗乙肝肝硬化代偿期(肝郁血瘀型)临床观察

英文题名：Clinical observation of traditional Chinese medicine master ZHOU Xinyou's hepatopathy No.1 formula combined with Entecavir in the treatment of hepatitis B cirrhosis in compensatory stage(liver depression and blood stasis pattern)

作者：贾了婵[1];张玉静[1];姜艳贞[1];李思思[1];高永泽[2];付兆媛[2]

第一作者：贾了婵

机构：[1]甘肃中医药大学,兰州730000;[2]甘肃中医药大学附属医院脾胃病科

第一机构：甘肃中医药大学

年份：2026

卷号：34

期号：1

起止页码：13

中文期刊名：中国中西医结合消化杂志

外文期刊名：Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基金：甘肃省科技计划项目(No:23YFFA0054)。

语种：中文

中文关键词：周信有肝病1号方;恩替卡韦;乙肝肝硬化代偿期;肝郁血瘀证

外文关键词：ZHOU Xinyou's hepatopathy No.1 formula;Entecavir;compensated hepatitis B liver cirrhosis;liver depression and blood stasis pattern

摘要：目的:观察国医大师周信有肝病1号方联合恩替卡韦治疗肝郁血瘀型乙肝肝硬化代偿期的临床疗效。方法:招募82例符合肝郁血瘀型乙肝肝硬化代偿期诊断的患者为研究对象,根据随机数字表法将患者分为试验组和对照组,每组各41例。所有受试者均接受恩替卡韦胶囊基础抗病毒治疗,其中试验组联合应用国医大师周信有肝病1号方。治疗3个月后比较两组患者的临床疗效、肝功能相关指标[谷丙转氨酶(alanine aminotransferase, ALT)、谷草转氨酶(aspartate aminotransferase, AST)、白蛋白(albumin, ALB)、总胆红素(total bilirubin, TBIL)]、肝纤维化四项[Ⅲ型前胶原蛋白(typeⅢprocollagen, PCⅢ)、Ⅳ型胶原(typeⅣcollagen,Ⅳ-C)、层黏连蛋白(laminin, LN)、透明质酸(hyaluronic acid, HA)]、凝血酶原时间(prothrombin time, PT)、影像学检测指标[脾脏厚度、门静脉内径(diameter of the portal vein, DPV)、脾静脉内径(diameter of the splenic vein, DSV)、门静脉血流速度(velocity of portal vein, VPV)、脾静脉血流速度(velocity of splenic vein, VSV)、肝脏硬度值(liver stiffness measurement, LSM)]及不良反应发生情况。结果:试验组的治疗有效率显著优于对照组,差异有统计学意义(P<0.05)。治疗后,试验组的TBIL、ALT、AST水平显著低于对照组,ALB值明显高于对照组(P<0.05);与对照组比较,试验组的PCⅢ、Ⅳ-C、LN和HA水平呈现出显著降低趋势,差异有统计学意义(P<0.05);试验组的PT值明显下降,差异有统计学意义(P<0.05);在影像学指标评估层面,试验组患者治疗后的脾脏厚度、DPV、DSV、LSM均有明显降低(P<0.05),但VPV、VSV均呈上升趋势,差异有统计学意义(P<0.05);对照组经治疗后DSV、LSM、脾脏厚度、DPV均呈下降趋势(P<0.05),VSV有所升高(P<0.05),但VPV与治疗前比较差异无统计学意义(P>0.05);治疗过程中,两组患者均无不良反应发生。结论:对于肝郁血瘀型乙肝肝硬化代偿期患者,国医大师周信有肝病1号方联用恩替卡韦治疗疗效显著,能有效改善患者的肝功能水平,减轻肝纤维化程度,且安全性良好。
Objective:A clinical study on the efficacy of integrated therapy with traditional Chinese medicine Master ZHOU Xinyou's hepatopathy No.1 formula and Entecavir for compensated hepatitis B liver cirrhosis presenting with the liver depression and blood stasis pattern.Methods:A total of 82 patients diagnosed with compensated HBV-induced cirrhosis presenting with the liver depression and blood stasis pattern were enrolled.According to a random number table,they were randomly assigned to either the treatment group or the control group,with 41 patients in each group.All participants received standard antiviral therapy with Entecavir capsules.Patients in the treatment group were additionally administered traditional Chinese medicine Master ZHOU Xinyou's hepatopathy No.1 formula.After 3 months of treatment,the following outcomes were compared between the two groups:clinical efficacy;liver function parameters(alanine aminotransferase[ALT],aspartate aminotransferase[AST],albumin[ALB],total bilirubin[TBIL]);four key hepatic fibrosis serological markers(typeⅢ procollagen[PCⅢ],type Ⅳ collagen[Ⅳ-C],laminin[LN],hyaluronic acid[HA]);prothrombin time(PT);imaging parameters(spleen thickness,diameter of the portal vein[DPV],diameter of the splenic vein[DSV],velocity of portal vein[VPV],velocity of splenic vein[VSV],liver stiffness measurement[LSM]);and the incidence of adverse reactions.Results:The treatment group demonstrated a significantly higher total response rate compared to the control group,with statistical significance(P<0.05).Following the treatment,the treatment group demonstrated significantly lower levels of TBIL,ALT,and AST,along with a significantly higher ALB value compared to the control group(P<0.O5).Compared with the control group,the levels of PCⅢ,Ⅳ-C,LN,and HA in the treatment group were significantly lower,with the differences being statistically significant(P<0.O5).The treatment group exhibited a statistically significant decrease in prothrombin time(P<0.O5).Regarding imaging parameters,patients in the treatment group showed significant reductions in spleen thickness,DPV,DSV,and LSM(P<0.05),while their VPV and VSV significantly increased(P<0.05).In the control group,significant post-treatment decreases were observed in DSV,LSM,spleen thickness,and DPV(P<0.05),and VSV also increased significantly(P<0.05).In contrast,no significant change was found in VPV(P>0.05).No adverse reactions occurred in either group during the treatment period.Conclusion:For patients with compensated HBV-induced cirrhosis presenting with the liver depression and blood stasis pattern,the combined therapy of Master ZHOU Xinyou's hepatopathy No.1 formula with Entecavir yields significant therapeutic benefits.This regimen effectively improves liver function,reduces the degree of hepatic fibrosis,and demonstrates a favorable safety profile.