期刊论文

A randomized,double-blind,double-dummy control study on Callicarpa capsules in treating chronic hepatitis B

中文

中西医结合肝病杂志

1005-0264

2011

21

4

203-206

10.3969/j.issn.1005-0264.2011.04.004

本校为第一机构

目的:评估紫珠胶囊治疗慢性乙型肝炎(CHB)的抗病毒疗效和安全性.方法:多中心、随机、双盲、双模拟的对照研究.413例CHB患者,随机分为治疗组(紫珠胶囊)310例和对照组(苦参素胶囊)103例,用药时间24周.于12、24周检测患者血清HBV DNA和HBV标志物,每隔4周随访,记录中医症状积分以评价中医证候疗效,记录不良事件和实验室异常的数据,以监测研究药物的安全性.结果:两组患者的基础人口学、临床和病毒学特征相似.经过24周的治疗,治疗组抗病毒综合应答率为42.58％,HBV DNA下降超过两个log对数级比率为54.84％,优于对照组(P＜0.05)；HBV DNA阴转率为33.23％、HBeAg阴转率为31.93％、e抗原血清转换率为13.08...

Objective：To assess the antiviral efficacy and safety of Callicarpa capsules on treating chronic hepatitis B（CHB）.Methods： Multi-center,randomized,double-blind,double-dummy control study.Four hundred and thirteen cases of CHB were randomly divided into treatment group（Callicarpa capsules） 310 cases and control group（Oxymatrine capsules） 103 cases,medication for 24 weeks.Their serum HBV DNA and HBV markers were detected by the central laboratory at 12th and 24th week,patients were followed up every 4 weeks recording symptom scores to eva...