软坚散结丸治疗乙肝肝硬化代偿期瘀血阻络证的临床观察  

Clinical Observation on Ruanjian Sanjie Pills in the Treatment of Hepatitis B-Related Compensated Cirrhosis with Blood Stasis Blocking Collaterals Syndrome

作　　者：刘思晨 胡敬宝 鲁艳平[1,2] 姚晓莹 孙姮辉 朱琴艳 LIU Sichen;HU Jingbao;LU Yanping;YAO Xiaoying;SUN Henghui;ZHU Qinyan(The Seventh Clinical Medical School of Guangzhou University of Chinese Medicine,Shenzhen 518100 Guangdong,China;Bao'an Hospital of Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine,Shenzhen 518100 Guangdong,China)

机构地区：[1]广州中医药大学第七临床医学院,广东深圳518100 [2]广州中医药大学附属宝安中医院,广东深圳518100

出　　处：《广州中医药大学学报》2025年第3期600-605,共6页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：广东省中医药局科研项目(编号:20201303);深圳市“医疗卫生三名工程”资助项目(编号:SZZYSM202311014)。

摘　　要：【目的】观察软坚散结丸治疗乙型肝炎(简称乙肝)肝硬化代偿期瘀血阻络证患者的临床疗效。【方法】将2023年1月至2024年4月就诊于广州中医药大学附属宝安中医院的80例乙肝肝硬化代偿期瘀血阻络证患者随机分为试验组和对照组,每组各40例。对照组给予口服恩替卡韦抗乙肝病毒(HBV)治疗,试验组在对照组的基础上加用软坚散结丸治疗,疗程为1年。观察2组患者治疗前后血常规[白细胞计数(WBC)、血小板计数(PLT)]、肝功能[白蛋白(ALB)、总胆红素(TBIL)、谷丙转氨酶(ALT)、谷草转氨酶(AST)]、凝血酶原时间(PT)、肝硬度值(LSM)和中医证候积分的变化情况,并评价2组患者的临床疗效和用药安全性。【结果】(1)脱落情况方面,对照组脱落3例,试验组脱落4例,最终对照组37例、试验组36例纳入疗效统计。(2)疗效方面,治疗1年后,试验组的总有效率为91.67%(33/36),对照组为67.57%(25/37),组间比较(χ^(2)检验),试验组的疗效明显优于对照组(P<0.05)。(3)血常规方面,治疗后,试验组的WBC、PLT均较治疗前升高(P<0.05),而对照组的WBC、PLT均无明显变化(P>0.05);治疗后组间比较,试验组的WBC、PLT均较对照组明显升高(P<0.05)。(4)肝功能和凝血功能方面,治疗后,2组患者的ALB均较治疗前升高(P<0.05),2组患者的PT值和试验组的ALT较治疗前降低(P<0.05),而2组患者的TBIL、AST及对照组的ALT治疗前后比较,差异均无统计学意义(P>0.05);组间比较,试验组对PT值的降低程度明显优于对照组(P<0.05),而2组患者的ALT、AST、TBIL、ALB比较,差异均无统计学意义(P>0.05)。(5)肝脏硬度值方面,治疗后,2组患者的LSM均较治疗前降低(P<0.05),且试验组的降低程度明显优于对照组(P<0.05)。(6)中医证候积分方面,治疗后,2组患者的中医证候积分均较治疗前降低(P<0.05),且试验组的降低程度明显优于对照组(P<0.05)。(7)安全性方面,治疗过程中,2组患者均无明Objective To observe the clinical efficacy of Ruanjian Sanjie Pills in the treatment of patients with hepatitis B-related cirrhosis in compensatory stage differentiated as blood stasis blocking collaterals syndrome.Methods A total of 80 cases of patients with hepatitis B-related cirrhosis in compensatory stage admitted to Bao'an Hospital of Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine from January 2023 to April 2024 were randomly divided into the trial group and the control group,40 cases in each group.The control group was treated with oral administration of Entecavir for hepatitis B virus(HBV),and the trial group was treated with Ruanjian Sanjie Pills on the basis of treatment for the control group,the course of treatment covering one year.Before and after treatment,the two groups were observed in the changes of routine blood test indicators of white blood cell count(WBC)and platelet count(PLT),liver function indicators[albumin(ALB),total bilirubin(TBIL),alanine transaminase(ALT)and aspartate transaminase(AST)],prothrombin time(PT),liver stiffness measurement(LSM),and traditional Chinese medicine(TCM)syndrome scores.After treatment,the clinical efficacy and safety were evaluated.Results(1)There were three cases in the control group and four cases in the trial group fell off,and eventually 37 cases in the control group and 36 cases in the trial group were enrolled in the efficacy statistics.(2)After one year of treatment,the total effective rate of the trial group was 91.67%(33/36)and that of the control group was 67.57%(25/37),and the intergroup comparison(tested by chi-square test)showed that the therapeutic efficacy of the trial group was significantly superior to that of the control group(P<0.05).(3)After treatment,the routine blood test indicators of WBC and PLT in the trial group were increased compared with those before treatment(P<0.05),while the WBC and PLT in the control group did not change significantly(P>0.05).The post-treatment WBC and PLT in the trial group were signific

关 键 词：软坚散结丸 乙型肝炎 肝硬化 代偿期 瘀血阻络证 肝功能 肝脏硬度 

分 类 号：R259.752[医药卫生—中西医结合]