克来夫定与阿德福韦酯随机对照治疗慢性乙型肝炎患者48周临床分析

Forty-eight weeks treatment with clevudine and adefovir for chronic hepatitis B infection：a double-blind randomized study

摘要:

目的：评价克来夫定胶囊治疗慢性乙型肝炎患者的有效性和安全性。方法：将2010年04月至2010年05月重庆医科大学附属第一医院感染科收治的18例慢性乙型肝炎患者，随机分为试验组（9例）和对照组（9例），试验组给予克来夫定胶囊30 mg，1次/d口服；对照组给予阿德福韦酯片10 mg，1次/d口服。所有患者治疗不少于48周。分别于治疗前、治疗4、8、12、24、36周及48周检测所有患者肝功能、肾功能，血清乙型肝炎病毒（hepatitis B virus，HBV）DNA水平、HBV血清学标志物，并观察药物不良反应。结果：治疗48周时，受试者中试验组和对照组HBV DNA对数值分别为2.081±0.228和3.017±1.578（P=0.115）。治疗48周时，所有受试者中试验组和对照组HBV DNA完全病毒学应答率分别为77.78%和66.67%（P=1.000），两组部分病毒学应答率相同，均为88.89%（P=1.000），丙氨酸氨基转移酶复常率分别为66.67%和77.78%（P=1.000）；另外，试验组和对照组血清HBeAg血清学转换率分别为33.33%和0.00%（P >0.05）。治疗过程中试验组有1例于随访第47周因发生rtL180M、rtM204I突变而退出试验，其余病例未发现与治疗药物相关的严重不良反应及并发症。结论：克来夫定胶囊能显著降低慢性乙型肝炎患者血清HBV DNA，安全性与阿德福韦酯相当。

Abstract:

Objective：To compare the efficacy and safety of clevudine（CLV） and adefovir（ADV） treatment for chronic hepatitis B patients（CHB）. Methods：Totally 18 CHB patients enrolled from our hospital between April and May 2010 were treated with daily dose of CLV 30 mg（n=9，experiment group） or ADV 10 mg（n=9，control group） randomly for at least 48 weeks. Liver and renal functions were tested；serum HBV DNA and HBV markers were detected for all patients before treatment at the 4th，8th，12th，24th，36th and the 48th week during treatment，respectively. Adverse drug reactions were observed. Results：At the 48th week during treatment，me－dian log10 HBV DNA in two groups were 2.081±0.228 and 3.017±1.578，respectively（P=0.115）. Partial virological response rates were similar（88.89%） in the two groups（P=1.000）. Complete virological response rates were 77.78 and 66.67% in experimental and con－trol groups（P=1.000）. Normalization rates of alanine aminotransferase were 66.67 and 77.78% in experimental and control groups（P=1.000）. HBeAg seroconversion rates were 33.33% and 0.00% in experimental and control groups（P >0.05）. One patient in experi－ment group showed virologic breakthrough with rtL180M and rtM204I mutation at the 47th week during follow-up. Conclusions：CLV showed potent antiviral activity for CHB patients；its safety is similar to ADV.