阿德福韦酯和恩替卡韦初始治疗不同病毒载量的HBeAg阴性慢性乙型肝炎患者的随机对照研究  

A comparison of treatment with Adefovir Dipivoxil and Entecavir for diffrent viral loads of patients with HBeAg-negative chronic hepatitis B :a randomized controlled study

作　　者：闵筱辉[1] 区正红[1] 刘婷[1] 张立伐[1] 

机构地区：[1]中山大学孙逸仙纪念医院感染科,广东广州510120

出　　处：《中国医药导报》2013年第31期85-88,共4页China Medical Herald

基　　金：广东省科技计划资助项目(编号2012B031800078)

摘　　要：目的根据患者基线病毒载量的不同进行分层,比较阿德福韦酯(ADV)和恩替卡韦(ETV)初始治疗HBeAg阴性慢性乙型肝炎患者2年的疗效。方法 98例HBeAg阴性慢性乙型肝炎患者随机分两组,分别给予ADV和ETV,两组再根据基线病毒载量各分层为高病毒组(HBV DNA≥1×106copies/mL)和低病毒组(HBV DNA<1×106copies/mL),观察2年不同时期两组的乙肝病毒水平、丙氨酸氨基转移酶(ALT)水平以及病毒学耐药性。结果在低病毒组,两种药物不同时间点在病毒下降水平、ALT水平等方面均无明显差异,ADV治疗96周的乙肝病毒检测不到率为92.9%,与ETV的100.0%相似(P=0.684),两组均未发现病毒耐药。而在高病毒组,ADV治疗4、12、24、48、72、96周的病毒下降水平均明显低于同期的ETV组(P<0.05),96周的乙肝病毒检测不到率仅为45.0%,也明显低于同期ETV组的84.2%(P<0.01);ADV治疗24、48、72、96周时ALT水平也均高于同期的ETV组(P<0.05),ALT复常率则呈相反的趋势(P<0.05)。ADV高病毒组治疗2年的病毒学耐药率为14.3%(3/21),而ETV组无耐药病例。结论 HBeAg阴性慢性乙型肝炎患者中,ADV治疗低病毒载量患者能够达到ETV相同的满意疗效,可以作为该类患者的一线药物;而当基线病毒载量≥1×106copies/mL,ADV的疗效明显低于ETV,耐药性也增加,不宜首选。Objective To compare the 2-year treatment efficacies of Adefovir Dipivoxil （ADV） and Entecavir （ETV） in different viral loads of patients with HBeAg-negative chronic hepatitis B. Methods 98 patients of HBeAg-negative chronic hepatitis B were assigned to randomly receive ADV or ETV once daily for 96 weeks. According to the basehne viral load, the patients of each group divided into high viral load group （HBV DNA ≥1×10^6 copies/mL） and low virus load group （HBV DNA〈 1×10^6 copies/mL） again. The changes in HBV DNA and alanine aminotransferase （ALT） levels and resistance of drugs were compared in different groups. Results In the low viral load group, the ALT levels and reducing virus levels between the two drugs were similar at the different time points. HBV DNA levels were less than 500 copies/mL in 92.9% of patients in ADV group at 96 week, which was similar to the ETV group （100.0%） in the low viral load group （P = 0.654）. The viral resistance was not found in ADV and ETV low viral load groups. However, in the high viral load group, the reducing virus levels in ADV group were significantly lower than that in ETV group at 4, 12, 24, 48,72 and 96 week （P 〈 0.05）. HBV DNA levels were less than 500 copies/mL in 45.0% of patients in ADV group at 96 week, which was also significantly lower than ETV group （84.2%） at the same time point （P 〈 0.01）. The ALT levels were also higher in ADV high viral load group than that in ETV low viral load group at 24, 48,72 and 96 week （P 〈 0.05）. The ALT normalization rate showed a reverse trend （P 〈 0.05）. At 96 week, the total virological resistance rate was 14.3% in ADV high viral load group, but there was no drug case in the ETV high viral load group. Conclusion For HBeAg-negative chronic hepatitis B, ADV therapy, same to ETV therapy, can obtain a satisfactory efficacy in patients with low viral load. ADV can be used as first-choice drug in these patients. However, if the baseline viral load of patients is more than 1×10

关 键 词：HBEAG阴性 慢性乙型肝炎 阿德福韦酯 恩替卡韦 分层 

分 类 号：R575[医药卫生—消化系统]