补肾健脾方对HBeAg阳性乙肝病毒携带者的抗病毒疗效  

Antiviral therapeutic effects of Bushen Jianpi prescription on hepatitis B virus carriers with positive e antigen

作　　者：陈英杰[1] 童光东[1] 贺劲松[1] 邢宇锋[1] 高辉[1] 周小舟[1] 邱梅[1] 郑颖俊[1] 徐文军[1] 徐韶敏[1] 陈亮[1] 唐海鸿[1] 张来[1] 占伯林[1] 马文峰[1] 孙新锋[1] 李群[1] 张晓晖[1] 周大桥[1] 

机构地区：[1]广州中医药大学深圳附属医院肝病科,广东深圳518033

出　　处：《中西医结合肝病杂志》2012年第4期200-204,共5页Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases

基　　金：国家"十一五"科技重大专项(No.2008ZX10005-008)

摘　　要：目的:评价补肾健脾方对HBeAg阳性HBV携带者的抗病毒疗效及安全性。方法:采用多中心、随机、双盲、安慰剂对照的临床研究方法。300例e-抗原阳性乙肝病毒携带者随机双盲分入两个试验组,其中治疗组200例,对照100例。52周的双盲治疗期间,治疗组患者给予补肾健脾方治疗,对照组患者给予安慰剂治疗,以上药物均为颗粒冲剂,用法均为1剂/d,分两次开水冲服。治疗过程中检测患者血清HBV DNA定量及乙肝两对半定量并观察不良反应的发生。结果:治疗52周时治疗组患者血清HBV DNA水平明显下降,与0周及安慰剂对照组比较,差异有显著性意义;其中治疗组下降>1 lg及>2 lg的比例为45.98%、21.84%,明显多于对照组的11.83%、5.38%。治疗过程中,治疗组患者HBeAg均值、HBsAg均值均呈持续下降趋势。52周时,治疗组患者HBeAg均值、HBsAg均值下降均显著优于安慰剂对照组,差异有显著性意义;而HBsAg下降>0.5 lg的百分率治疗组、对照组分别为22.99%、7.53%,差异有显著性意义。52周时,两组患者血清HBV DNA水平下降>3 lg及阴转比例,HBeAg阴转率以及HBeAg血清转换比例,HBsAg下降>1 lg、>2 lg及阴转比例相似,差异均无显著性意义。研究过程中,各组均未发生任何严重不良事件。结论:补肾健脾方有一定的抑制HBV的作用,作用呈时间依赖趋势。Objective：To evaluate the antiviral therapeutic effects and safety of Bushen Jianpi prescription to hepatitis B virus carriers with positive e antigen.Methods：With the multi-center,randomized,double-blinded and placebo-controlled methods,300 cases of hepatitis B virus carriers with positive e antigen were double-blinded randomized into 2 groups,with 200 cases in treated group and 100 cases in controlled group.During the 52-week treatments,Bushen Jianpi prescription was applied in treated group and Bushen Jianpi placebo prescription was adopted in controlled group.All the drugs above were granular formulation,one dose twice per day taken with water.During the treatments,the DNA quantitative of serum HBV and the two pairs of semi-hepatitis B quantitative were tested and the occurrence of adverse effects was observed.Results：At the 52nd week,the DNA levels of serum HBV in treated group were remarkably decreased,with significant difference compared with that at the 0 week respectively.The ratio of decreasing over 1 lg and over 2 lg was 45.98% and 21.84% in treated group,which were much more compared with that of 11.83% and 5.38% in controlled group.During the treatments,the average values of HBeAg and HBsAg in treated group were continuously decreasing.At the 52nd week,the average values of HBeAg in treated group were obviously decreased compared with that in the placebo controlled group,with significant difference.The ratio of HBsAg decreasing over 0.5 lg was 22.99% in treated group,which was superior to that of 7.53% in controlled group,with significant difference.At the 52nd week,in two groups,the decreasing of DNA level of serum HBV over 3 lg and negative-transmission ratio,the HBeAg negative-transmission ratio,the HBeAg seroconversion ratio and the HBsAg decreasing over 1 lg and over 2 lg and negative-transmission ratio were almost the same without significant difference.There was no case of serious adverse effects during the treatments.Conclusion：Bushen Jianpi prescription has the function of HBV inhibi

关 键 词：乙型肝炎病毒携带者 e-抗原阳性 补肾健脾 中医药疗法 临床研究 多中心 随机 双盲 对照 

分 类 号：R259[医药卫生—中西医结合]