五灵胶囊治疗肝郁脾虚兼血瘀型乙型肝炎肝纤维化的疗效  

Efficacy of Wuling Capsules on liver fibrosis with liver depression,spleen defiency and blood stasis type B hepatitis

作　　者：杨明博 杨璞叶 阚洪敏 郭雅玲 任艳叶 YANG Mingbo;YANG Puye;KAN Hongmin;GUO Yaling;REN Yanye(Department of Traditional Chinese Medicine Hepatology,Xi’an Eighth Hospital,Xi’an 710061,China)

机构地区：[1]西安市第八医院中医肝病科,西安710061

出　　处：《西北药学杂志》2024年第5期18-25,共8页Northwest Pharmaceutical Journal

基　　金：西安市“科技+”行动计划-(17)医学研究项目[编号:20YXYJ00012(5)];陕西省重点研发计划项目(编号:2021SF-412);陕西省卫健委健康科研基金项目(编号:2021D005)。

摘　　要：目的 探讨五灵胶囊治疗肝郁脾虚兼血瘀型乙型肝炎肝纤维化的疗效及安全性。方法 将2020年5月—2022年5月就诊于西安市第八医院且符合纳入标准及排除标准的90例患者作为研究对象。将患者随机分为3组。A组单用核苷酸类似物[恩替卡韦胶囊或(和)富马酸替诺福韦二吡呋酯片]治疗。B组单用五灵胶囊治疗。C组用五灵胶囊联合核苷酸类似物治疗。观察指标包括中医证候积分,肝硬度值(liver stiffness measurement,LSM),FIB-4指数(fibrosis 4 score,FIB-4)值,肝纤维化指标透明质酸(hyaluronic acid,HA),Ⅲ型前胶原(typeⅢprocollagen,PCⅢ),Ⅳ型胶原(CollagenⅣ,Ⅳ-C),层黏连蛋白(laminin,LN),肝功能指标[丙氨酸氨基转移酶(alanine transaminase,ALT),天冬氨酸氨基转移酶(aspartate transaminase,AST)、总胆红素(total bilirubin,TBiL)、碱性磷酸酶(alkaline phosphatase,ALP)、谷氨酰转肽酶(glutamyl transpeptidase,GGT)],HBV DNA,腹部B超,血、尿、粪常规,心电图等。比较各组患者治疗前后症状及相关指标的变化,并评价治疗的安全性。结果 治疗24周后,C组患者的中医证候积分由(19.25±6.12)分降至(7.12±2.32)分,LSM由(13.2±2.48) kPa降至(5.24±3.14) kPa,FIB-4值由(2.67±0.94)降至(1.72±0.84),显著优于A组和B组(P<0.05)。HA由(126.42±64.28) ng·mL^(-1)降至(66.72±21.26) ng·mL^(-1),PCⅢ由(25.42±10.67) ng·mL^(-1)降至(12.39±5.62) ng·mL^(-1),Ⅳ-C由(109.78±30.42) ng·mL^(-1)降至(65.70±16.26) ng·mL^(-1),LN由(118.72±30.34) ng·mL^(-1)降至(71.12±10.42) ng·mL^(-1),以上指标改善情况显著优于A组和B组(P<0.05);3组患者的肝功能均明显改善,C组患者的血清ALT由(86.13±16.72) U·L^(-1)降至(36.68±14.25) U·L^(-1),AST由(49.65±9.85) U·L^(-1)降至(31.34±8.45)U·L^(-1),ALP由(104.69±13.28) U·L^(-1)降至(62.53±9.56) U·L^(-1),改善情况显著优于A组和B组(P<0.05)。C组及A组患者的HBV DNA较治疗前均明显下降,2组间比较差异无统计学意义(P>0.05),�Objective To explore the efficacy and safety of Wuling Capsules in treating liver fibrosis of hepatitis B with liver depression,spleen deficiency,and blood stasis type.Methods The patients who were admitted to Xi’an Eighth Hospital during May 2020 and May 2022 and met the inclusion and exclusion criteria were screened,and they signed the informed consent form.90 patients were randomized into 3 groups with different intervention regimens.Group A was treated with nucleotide analogues alone,including Entecavir Capsules or/and Tenofovir Disoproxil Fumarate Tablets,taken as required.Group B was treated with Wuling Capsules,5 capsules at a time,3 times a day,half an hour after meals.Group C was treated with Wuling Capsules combined with nucleotide analogues.The indexes were compared among groups,including traditional Chinese medicine(TCM)syndrome score,liver stiffness measurement(LSM),fibrosis 4 score(FIB-4),hyaluronic acid(HA),typeⅢprocollagen(PCⅢ)and typeⅣCollagen(Ⅳ-C),liver function,alanine transaminase(ALT),aspartate transaminase bilirubin(TBiL),alkaline phosphatase(ALP),glutamyl transpeptidase(GGT),HBV DNA,and the images of ultrasound and electrocardiogram,etc..The changes of symptoms and related outcomes before and after treatment in each group were compared,and the safety was evaluated under the requirement of the Internal Ethics Committee of Xi’an Eighth Hospital.Results After 24 weeks of treatment,the TCM syndrome score of group C patients decreased from(19.25±6.12)points to(7.12±2.32)points,the LSM decreased from(13.2±2.48)kPa to(5.24±3.14)kPa,and the FIB-4 value decreased from(2.67±0.94)to(1.72±0.84),significantly better than group A and group B(P<0.05).The HA decreased from(126.42±64.28)ng·mL^(-1) to(66.72±21.26)ng·mL^(-1),PCⅢdecreased from(25.42±10.67)ng·mL^(-1) to(12.39±5.62)ng·mL^(-1),Ⅳ-C decreased from(109.78±30.4)ng·mL^(-1) to(65.70±16.26)ng·mL^(-1),LN decreased from(118.72±30.34)ng·mL^(-1) to(71.12±10.42)ng·mL^(-1),and the improvement was significantly better than

关 键 词：五灵胶囊 乙型病毒性肝炎 慢性 肝纤维化 肝功能 

分 类 号：R975[医药卫生—药品]