恩替卡韦单用和拉米夫定联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎的临床研究  

Efficacy of Entecavir Mono-Therapy or Lamivudine Plus Adefovir Dipivoxil Combination Therapy in Patients with Chronic HBeAg-Positive Hepatitis B

作　　者：李耀才[1] 陈春[1] 李女[1] 伍思国[1] 杨智娟[1] 江敏毓 梁培红[1] 

机构地区：[1]茂名市人民医院感染科,广东茂名525000

出　　处：《今日药学》2015年第8期578-580,584,共4页Pharmacy Today

基　　金：广东省药学会肝炎用药研究基金(2012G17)

摘　　要：目的评估恩替卡韦单用和拉米夫定联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎临床疗效。方法将HBeAg阳性慢性乙型肝炎患者60例随机分为治疗组30例和对照组30例,治疗组用恩替卡韦0.5 mg/d,疗程为2年,对照组用拉米夫定100mg/d、阿德福韦酯10 mg/d,疗程2年,2组治疗前3个月均加用甘草酸二胺肠溶胶囊150 mg tid。结果治疗组HBV DNA定量下降至检测下限在前3个月治疗组明显高于对照组(P=0.039),治疗6个月以后2组则无显著性差异(P>0.05),治疗组ALT复常率、HBeAg转阴率、HBeAg转换率2组比较则差异无统计学意义(P>0.05),2组肝组织学SSG计分及SSS计分治疗后均较治疗前明显下降(均P<0.005),治疗后肝组织学SSG计分、SSS计分好转率及下降幅度2组比较则差异无统计学意义(P>0.05),治疗组未发现肾功能损害,对照组有2例出现肾功能损害,治疗组未发生耐药,对照组2例发生耐药(1例rt L180M,1例rt L180M+rt M204V)。结论恩替卡韦比拉米夫定联合阿德福韦酯能更快降低病毒水平、降低耐药发生率,有更好的成本效益及安全性。OBJECTIVE To compare the clinical effects of entecavir mono-therapy or lamivudine plus adefovir dipivoxil combination therapy in patients with chronic HBeAg-positive hepatitis B. METHODS A total of 60 patients with chronic HBeAg-positive hepatitis B were randomly divided into 2 groups. 30 patients in treated group were treated with entecavir 0.5 mg / d for 2 years and diammonium Glycyrrizinate enteric-coated capsules for the first 3 months. 30 patients in control group were treated with lamivudine100 mg / d and adefovir dipivoxil 10 mg / d for 2 years and diammonium glycyrrizinate enteric-coated capsules for the first 3 months.RESULTS The undetectable-rate of HBV DNA in the treated group was significantly higher than in the control group after the first 3months（ P = 0.039）. After 6 months to 2 years therapy,ALT normalization-rate,the undetectable-rate of HBV DNA,the negative-rate of serum HBe Ag,the transition-rate of serum HBeAg / Anti-HBe,the improve-rate of hepatic histological activity and hepatic fibrosis in needle liver biopsy specimens had no significant difference between the treated group and the control group（ P〉0.05）. 2 patients were leaded to renal injury in the control group. 2 patients were leaded to drug resistance（ 1 rt L180 M,1 grt L180M＋rt M204V） in the control group. None patients were leaded to renal injury and drug resistance in the treated group.CONCLUSION Entecavir mono-therapy is superior to lamivudine plus adefovir dipivoxil combination therapy in decreasing serum HBV DNA and lesser resistant mutants in patients with chronic HBeAg-positive hepatitis B. Entecavir mono-therapy has better cost-effectiveness and safety than lamivudine plus adefovir dipivoxil combination therapy in patients with chronic HBeAg-positive hepatitis B.

关 键 词：恩替卡韦 拉米夫定 阿德福韦酯 HBEAG阳性 慢性乙型肝炎 

分 类 号：R97[医药卫生—药品]