补肾健脾解毒方治疗慢性乙型肝炎病毒携带者的临床研究  

A multicenter,randomized,double-blind clinical trial on a Chinese Herbal Formula(Bushen Jianpi Jiedu Prescription)in the Treatment of Chronic Hepatitis B Virus Carriers

作　　者：邢宇锋[1] 许林艺 冯楝 韩志毅[1] 彭得倜 江丹生 贺劲松[1] 童光东[1] 周大桥[1] XING Yu-feng;XU Lin-yi;FENG Lian;ZHOU Da-qiao(Shenzhen Hospital of Traditional Chinese Medicine,department of hepatology(Guangdong,Shenzhen,518033),China;不详)

机构地区：[1]深圳市中医院肝病科,广东深圳518033 [2]广州中医药大学第四临床医学院

出　　处：《中西医结合肝病杂志》2021年第7期586-589,605,共5页Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases

基　　金：深圳市医疗卫生“三名工程”引进高层次医学团队项目(No.SZSM201612074);国家“十二五”科技重大专项(No.2012ZX10005-006)。

摘　　要：目的:评估补肾健脾解毒方治疗慢性乙型肝炎病毒(HBV)携带者的疗效及安全性。方法:选取慢性HBV携带者400例,经随机双盲法分为治疗组和对照组各200例。治疗组患者采用补肾健脾解毒方治疗,对照组患者予以安慰剂治疗。结果:治疗48、96周后,治疗组患者HBV DNA定量值下降均优于对照组(P<0.05),治疗96周后HBV DNA定量值≤104IU/ml患者占20.8%;治疗48、96周后,治疗组患者血清HBsAg水平下降均优于对照组(P<0.05);治疗48、96周后,治疗组与对照组患者HBsAg阴转率组间差异均无统计学意义(P>0.05);治疗48、96周后,治疗组患者HBeAg血清转换/阴转率升高均优于对照组(P<0.05),治疗96周后HBeAg血清阴转率达16.50%。研究过程中,各组均未发生任何严重不良事件。结论:补肾健脾解毒方对慢性HBV携带者具有显著抗HBV疗效,且安全有效。Objective:To evaluate the efficacy and safety of Bushenjianpijiedu decoction on chronic hepatitis B virus(HBV)carriers.Methods:A total of 400 cases of chronic HBV carriers were randomly divided into treatment group and control group,200 cases in each group.The treatment group was treated with Bushen Jianpi Jiedu Prescription,and the control group was treated with placebo.Results:After 48 and 96 weeks of treatment,the decrease of HBV DNA quantitative value in the treatment group was better than that in the control group(P<0.05),and the number of patients with HBV DNA quantitative value≤104IU/ml,after 96 weeks of treatment,was 20.8%.After 48 and 96 weeks of treatment,the decrease of serum HBsAg level in the treatment group was better than that in the control group(P<0.05).After 48 and 96 weeks of treatment,there was no significant difference in HBsAg negative conversion rate between the treatment group and the control group(P>0.05).After 48 and 96 weeks of treatment,the increase of HBeAg serum conversion/negative conversion rate in the treatment group was better than that in the control group(P<0.05),and the HBeAg serum negative conversion rate reached 16.50% after 96 weeks of treatment.During the study,no serious adverse events occurred in each group.Conclusion:Bushen Jianpi Jiedu Prescription has a significant anti-HBV effect on chronic HBV carriers,and it is safe and effective.

关 键 词：慢性HBV携带者 补肾健脾解毒方 多中心 随机 双盲 

分 类 号：R575.1[医药卫生—消化系统]