中药联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎的临床研究

Clinical study of adefovir dipivoxil combined with traditional Chinese medicine in treating patients with HBeAg-positive chronic hepatitis B

目的:评价中西医结合治疗HBeAg阳性慢性乙型肝炎的有效性。方法:采取随机、双盲对照试验设计,以阿德福韦酯为对照药物,对60例慢性乙型肝炎患者进行48周的临床研究,根据患者入组时情况和生化学及乙肝病毒标记物(HBV-M)动态变化进行药物转换,试验组患者使用中药联合阿德福韦酯,对照组患者使用中药安慰剂联合阿德福韦酯。观察两组患者0、12、24、36、48周访视点的生化学、HBV-M及HBV DNA。结果:治疗48周后试验组和对照组ALT复常率分别为86.7%和80%(P>0.05),HBeAg阴转率为46.7%和20%(P<0.05),HBV DNA阴转率为80%和53.3%(P<0.05)。结论:中药联合阿德福韦酯治疗慢性乙型肝炎较单纯使用阿德福韦酯具有一定优势,中药的免疫调节功能可能在慢性乙型肝炎治疗中起到一定作用。

Objective： To evaluate the efficacy of adefovir dipivoxil combined with traditional Chinese medicine in HBeAg- positive chronic hepatitis B patients. Methods： A randomized clinical trial was performed, and 60 patients with HBeAg positive chronic hepatitis B were randomly assigned to the experimental group and the control group. Patients in the experimental group were given adefovir dipivoxil and traditional Chinese medicine, while Chinese medicine placebo were given those in the control group. The treatment course was 48 weeks. And according to the dynamic changes of biochemical and hepatitis B virus markers （HBV-M）, drug conversion was performed. The virologic, biochemical were observed for 0, 12, 24, 36 and 48 weeks. Results： At 48 weeks＇treatment , the recovery rate of ALT, HBeAg negative conversion rate and HBV DNA negative response rate be- tween the treatment group and control group was 86. 7% vs 80% （P ~0. 05）, 46. 7% vs 20% （P 〈0. 05）, 80% vs 53.3% （ P 〈 0. 05） . Conclusion： It showed the better function to apply combination treatment of the traditional Chinese medicine ＆ adefovir dipivoxil than purely adeforvir dipivoxil. The immune adjustment provided by traditional medicine should be possible to work on chronic hepatitis B.