摘要
目的:评价补肾清透方对e-抗原阳性乙肝病毒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2个试验组,其中治疗组200例,对照100例。52周的治疗期间,治疗组给予补肾清透方治疗,对照组给予安慰剂治疗,以上药物均为颗粒冲剂,用法均为每日1剂,分两次开水冲服。治疗过程中检测血清乙型肝炎病毒(HBV)DNA定量及乙肝二对半定量并观察不良反应的发生。结果:治疗52周时治疗组血清HBV DNA水平明显下降,与0周及安慰剂对照组比较,差异有统计学意义(P<0.01);其中治疗组下降>1 lg及>2 lg的比例为41.36%,19.37%,多于对照组的15.96%,4.26%。治疗过程中,治疗组的HBeAg均值、HBsAg均值均呈持续下降趋势。52周时,治疗组的HBeAg均值下降显著优于安慰剂对照组,而HBeAg均值下降未能优于安慰剂对照组(P>0.05);其中HBsAg下降>0.5 lg比例治疗组、对照组分别为27.23%,8.51%,差异有统计学意义(P<0.01)。52周时,两组的血清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,差异均无统计学意义。研究过程中,各组均未发生任何严重不良事件。结论:补肾清透方有一定的抑制HBV的作用,作用呈时间依赖趋势。
Objective： To evaluate the antiviral therapeutic effects and safety of Bushen Qingtou prescription to hepatitis B virus （HBV） carriers with positive e antigen. Method： With the multi-center, randomized, double-blinded and placebo-controlled methods, 300 cases of HBV 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 Qingtou prescription was applied in treated group and Bushen Qingtou 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. Result： 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 41.36% and 19.37% in treated group, which were more compared with that of 15.96% and 4.26% in Controlled Group. During the treatments, the average values of HBeAg 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, while the average values of HBsAg in treated group were not better. The ratio of HBsAg decreasing over 0.5lg was 27.23% in treated group, which was superior to that of 8.51% 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 Qingtou prescription has the function of HBV inhibition, which have the tendency of time-dependence.
出处
《中国实验方剂学杂志》
CAS
北大核心
2013年第7期283-288,共6页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家科技部"十一五"重大专项课题(2008ZX10005-008)
关键词
乙型肝炎病毒携带者
e-抗原阳性
补肾清透
随机对照
Hepatitis B virus carriers
positive e antigen
Bushen Qingtou prescription
randomized controlled trial
