肝爽颗粒对慢性乙型肝炎肝纤维化(S1和S2期)肝郁脾虚兼血瘀证的早期防治疗效  

Ganshuang Granule Alleviates Early Liver Fibrosis(S1 and S2)in Chronic Hepatitis B with Liver Depression Spleen Deficiency and Blood Stasis Syndrome

作　　者：刘莉[1] 杨静[1] 李宗云[1] 韩刚 张春宝[1] LIU Li;YANG Jing;LI Zong-yun;HAN Gang;ZHANG Chun-bao(Harrison International Peace Hospital,Hengshui 053000,China;School of Pharmacy,North China University of Science and Technology,Tangshan 063000,China)

机构地区：[1]哈励逊国际和平医院,河北衡水053000 [2]华北理工大学药学院,河北唐山063000

出　　处：《中国实验方剂学杂志》2022年第11期132-138,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河北省中医管理局科技计划项目(2018545)。

摘　　要：目的:探讨肝爽颗粒用于慢性乙型肝炎(CHB)肝纤维化(S1和S2期)肝郁脾虚兼血瘀证的防治效果。方法:将100例患者采用数字表法分为对照组(50例,脱失4例,剔除2例,最后完成44例)和观察组(50例,脱失5例,剔除2例,最后完成43例)。两组患者均给予口服恩替卡韦片,0.5 mg/次,1次/d,共12个月;并视情况口服谷胱甘肽片。对照组,口服肝爽颗粒模拟药,3 g/次,3次/d;观察组,口服肝爽颗粒,3 g/次,3次/d;共治疗12个月。进行肝穿刺病理检查,比较两组患者炎性活动度分级及纤维化程度分期情况;比较两组患者肝脏硬度值(LSM)、肝功能、乙型肝炎病毒(HBV)DNA、肝郁脾虚证评分、天冬氨酸氨基转移酶(AST)与血小板比值指数(APRI)和基于4因子的纤维化指数(FIB-4)。结果:治疗后,与对照组比较,观察组患者肝组织纤维化程度分期轻于对照组(P<0.05);观察组患者肝组织炎性活动程度轻于对照组(P<0.05);观察组患者炎性活动程度分级有效率为77.78%,高于对照组的45.83%(χ^(2)=5.546,P<0.05);观察组纤维化程度分期有效率为59.26%,高于对照组的16.67%(χ^(2)=9.669,P<0.01);观察组在治疗后6个月、12个月的LSM和肝郁脾虚证评分均低于对照组(P<0.05,P<0.01);观察组患者丙氨酸氨基转移酶(ALT)、AST、碱性磷酸酶(ALP)水平低于对照组(P<0.01);观察组APRI和FIB-4水平低于对照组(P<0.01)。结论:肝爽颗粒联合恩替卡韦用于CHB肝纤维化(S1和S2期)的防治,可减轻炎症活动情况和纤维化程度,能延缓而且具有逆转肝纤维化的作用,并具有保肝和改善中医证候的效果,值得临床使用与进一步的研究。Objective:To explore the effect of Ganshuang granule on liver fibrosis(S1 and S2)in chronic hepatitis B(CHB)with liver depression spleen deficiency and blood stasis syndrome.Method:A total of 100 patients were classified into the control group(50 in total with 4 lost and 2 rejected,44 finally included)and observation group(50 in total with 5 lost and 2 rejected,43 finally included)with the random number table method.Both groups were given oral entecavir tablets(0.5 mg/time,once a day,12 months),and oral glutathione tablets was applied depending on the conditions of patients.In addition,the control group took the analog drug of Ganshuang granule(3 g/time,3 times/day,12 months)and the observation group received Ganshuang granules(3 g/time,3 times/day,12 months),followed by histological examination of the liver by puncture biopsy.The two groups were compared in terms of inflammatory activity grade and fibrosis stage,as well as liver stiffness measure(LSM),liver function,hepatitis B virus(HBV)DNA,liver depression and spleen deficiency syndrome score,aspartate aminotransferase(AST)-to-platelet ratio index(APRI),and fibrosis index based on the four factors(FIB-4).Result:After treatment,liver fibrosis in the observation group was milder than that in the control group(P<0.05)and the inflammatory activity grade in the observation group was lower than that in the control group(P<0.05).The effective rate in down-regulating inflammatory activity grade in the observation group was 77.78%as compared with the 45.83%in the control group(χ^(2)=5.546,P<0.05).The effective rate in decreasing the fibrosis stage in the observation group was 59.26%,which was higher than that(16.67%)in the control group(χ^(2)=9.669,P<0.01).The LSM and score of the liver stagnation and spleen deficiency syndrome in the observation group were lower than those in the control group at the 6th months and 12th months of treatment(P<0.05,P<0.01).The levels of alanine aminotransferase(ALT),AST,and alkaline phosphatase(ALP)in the observation group were lower

关 键 词：慢性乙型肝炎 肝纤维化 肝郁脾虚证 肝爽颗粒 早期防治 纤维化程度 

分 类 号：R242[医药卫生—中医临床基础] R285.5[医药卫生—中医学]