苦参素缓释片治疗HBeAg阳性慢性乙型肝炎随机双盲对照研究

目的:探讨应用苦参素缓释片治疗HBeAg阳性慢性乙型肝炎(CHB)患者的临床疗效及安全性。方法:40例HBeAg阳性CHB患者被随机分为对照组20例和治疗组20例。对照组给予苦参素胶囊治疗,治疗组予以苦参素缓释片治疗24周。两组患者同时口服拉米夫定治疗48周。观察治疗4周、8周、24周时两组患者ALT、HBV DNA水平。结果:36例患者完成24周的治疗观察。苦参素缓释片治疗组和苦参素胶囊治疗对照组的HBV DNA转阴率分别为38.89%和33.33%,ALT复常率分别为66.67%和72.22%。两组患者在HBV DNA转阴率和ALT复常率等方面比较差异无统计学意义(P>0.05)。两组患者治疗期间无严重不良事件发生。结论:苦参素缓释片治疗HBeAg阳性CHB安全有效,其疗效与临床常用药苦参素胶囊相似。

A randomized,double-blind,controlled study of effect of oxymatrine sustained-release tablets in treatment for patients with HBeAg-positive chronic hepatitis B

Objective： To investigate the clinical efficacy and safety of oxymatrine sustained-release tablets in treatment for patients with HBeAg-positive chronic hepatitis B. Methods： Forty patients with HBeAg-positive chronic hepatitis B were enrolled. The patients in control group and treatment group received oxymatrine capsules and sustained-release tablets, respectively, for 24 weeks, along with lamivudine therapy for 48 weeks. The levels of serum alanine aminotransferase （ALT） and HBV DNA were quantified at week 4, 8, and 24. Results： Thirty-six patients accomplished the 24 weeks of treatment and observation. At week 24, serum HBV DNA were all decreased, and to the levels below the limit of detection in 38.89% and 33.33% of patients in treatment and control group, respectively. Sixty-six point sixty-seven percent and 72. 22% patients in treatment group and control group, respectively, got normal serum ALT. There were no significant differences in the rates of serum HBV DNA negative and ALT normalization between the two groups （P 〉 0. 05 ） . No sever adverse events occurred in neither group. Conclusion： Similar to oxymatrine capsules, oxymatrine sustained-release tablets are effective and safe in treatment for patients with HBeAg-positive chronic hepatitis B.