李耀才,陈春,李女,伍思国,杨智娟,江敏毓,梁培红
LI Yaocai,CHEN Chuen,LI Nv,WU Siguo,YANG Zhijuan,JIANG Minshu,LIANG Peihong

• 1:茂名市人民医院感染科

摘要(Abstract)：

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(KeyWords)： 恩替卡韦;拉米夫定;阿德福韦酯;HBeAg阳性;慢性乙型肝炎
entecavir;lamivudine;adefovir dipivoxil;HBeAg-positive;chronic hepatitis B

Abstract:

Keywords:

基金项目(Foundation): 广东省药学会肝炎用药研究基金(2012G17)

作者(Author): 李耀才,陈春,李女,伍思国,杨智娟,江敏毓,梁培红
LI Yaocai,CHEN Chuen,LI Nv,WU Siguo,YANG Zhijuan,JIANG Minshu,LIANG Peihong

参考文献(References)：

• [1]中华医学会肝病学分会,中华医学会感染病学分会.慢性乙型肝炎防治指南[J].中华肝脏病杂志,2005,13(12):881-891.
• [2]中华肝脏病学会肝纤维化学组.肝纤维化诊断及疗效评估共识[J].中华肝脏杂志,2002,10:327-328.
• [3]林书瀚,张力图,邓伟,等.广西肝癌高发区人群血清HBV标志物与HBV-DNA水平的对比研究[J].应用预防医学,2012,18(3):142-143.
• [4]裴彦祯,韩涛,马晓艳,等.HBs Ag及HBVDNA定量水平在慢性乙型肝炎、肝硬化和肝癌患者中的变化[J].中华肝脏病杂志,2011,10:743-746.
• [5]梁丽,范恒,唐庆,等.慢性乙型病毒性肝炎病毒微笑制与肝癌的相关性研究[J].中西医结合研究,2011,3(2):57-61.
• [6]杨静.拉米夫定联合阿德福韦酯与恩替卡韦单药治疗慢性乙肝的疗效比较[J].皖南医学院学报,2015,34(1):56-58.
• [7]黄睿,郝迎迎,张俊,等.拉米夫定联合阿德福韦酯与恩替卡韦单药对慢性乙型肝炎初治患者疗效比较的Meta分析[J].重庆医学,2014,43(1):9-15.
• [8]张淑娥.拉米夫定联合阿德福韦酯与恩替卡韦单药治疗HBe Ag阳性慢性乙型肝炎疗效观察[J].实用肝脏病杂志,2014,17(5):527-528.
• [9]Kim du H,Sung DH,Min YK.Hypophosphatemic ostemalacia induced by low-dose adefovir therapy:focus on manifestations in the skeletal system and literature review[J].J Bone Miner Metab,2013,31(2):240-246.
• [10]Wu C,Zhang H,Qian Y,et al.Hypophosphatemic ostemalacia and renal Fanconi syndrome induced by low-dose adefovir dipivoxil:a case report and literature review suggesting ethnic predisposition[J].J Clin Pharm Ther,2013,38(4):321-326.
• [11]Wong T,Girgis CM,Ngu MC,et al.Hypophosphatemic ostemalacia after low-dose adefovir dipivoxil therapy for hepatitis B[J].J Clin Endocrinol Metab,2010,95(2):479-480.