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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。
Objective: To investigate the clinical efficacy and safety of oxymatrine sustained-release tablets in patients with HBeAg-positive chronic hepatitis B (CHB). Methods: Forty patients with HBeAg positive CHB were randomly divided into control group (20 cases) and treatment group (20 cases). The control group was treated with oxymatrine capsules, the treatment group was treated with oxymatrine sustained-release tablets for 24 weeks. Two groups of patients treated with oral lamivudine for 48 weeks. The levels of ALT and HBV DNA in the two groups were observed at 4 weeks, 8 weeks and 24 weeks after treatment. Results: Thirty-six patients completed 24 weeks of treatment. The rates of HBV DNA negative conversion were 38.89% and 33.33% in the treatment group of oxymatrine and the control group of matrine capsule respectively, and the rates of ALT normalization were 66.67% and 72.22% respectively. There was no significant difference between the two groups in HBV DNA negative rate and ALT normalization rate (P> 0.05). Two groups of patients without serious adverse events occurred during treatment. Conclusion: The oxymatrine sustained-release tablets are safe and effective in the treatment of HBeAg-positive CHB. The curative effect is similar to that of the commonly used oxymatrine capsule.