CAJ | 학술논문

目的：观察恩替卡韦（ETV）联合阿德福韦酯（ADV）治疗耐拉米夫定（LAM）慢性乙型肝炎的疗效。方法选取 LAM 耐药患者66例，随机分成两组，治疗组36例应用 ETV 联合 ADV 挽救治疗，对照组30例应用 LAM 联合 ADV 挽救治疗，观察两组治疗前及治疗后12周、48周谷丙转氨酶（ALT）、谷草转氨酶（AST）、总胆红素（TBIL）、乙型肝炎病毒 DNA（HBV-DNA）、乙型肝炎 e 抗原（HBeAg）含量变化以及治疗48周时非 rtM204I 位点变异发生率。结果治疗组挽救治疗后12周 ALT 和 AST 分别降至（36．5±13．23）U／L 和（50．2±11．66）U／L，显著低于同期对照组 ALT[（60．3±12．28）U／L，P ＜0．01]及 AST [（69．7±13．56）U／L，P ＜0．01]含量；治疗后48周治疗组 ALT 和 AST 降至（27．9±10．58）U／L 和（26．7±10．95）U／L，低于同期对照组 ALT[（50．4±11．53）U／L，P ＜0．01]及 AST[（44．9±15．33），P ＜0．05]含量。治疗12周及48周，治疗组 HBV-DNA 转阴率分别为85．5％及91．7％，显著高于同期对照组转阴率（53．3％和73．3％，P 均＜0．05）。治疗组48周后出现1例新的非 rtM204I 位点变异，而对照组非 rtM204I位点变异情况为6例，两组相比差异有统计学意义（χ2＝5．12，P ＝0．024）。结论ETV 联合 ADV 用于既往 LAM 耐药的慢性乙型肝炎患者的挽救治疗疗效明显，值得临床推广。
목적：관찰은체잡위（ETV）연합아덕복위지（ADV）치료내랍미부정（LAM）만성을형간염적료효。방법선취 LAM 내약환자66례，수궤분성량조，치료조36례응용 ETV 연합 ADV 만구치료，대조조30례응용 LAM 연합 ADV 만구치료，관찰량조치료전급치료후12주、48주곡병전안매（ALT）、곡초전안매（AST）、총담홍소（TBIL）、을형간염병독 DNA（HBV-DNA）、을형간염 e 항원（HBeAg）함량변화이급치료48주시비 rtM204I 위점변이발생솔。결과치료조만구치료후12주 ALT 화 AST 분별강지（36．5±13．23）U／L 화（50．2±11．66）U／L，현저저우동기대조조 ALT[（60．3±12．28）U／L，P ＜0．01]급 AST [（69．7±13．56）U／L，P ＜0．01]함량；치료후48주치료조 ALT 화 AST 강지（27．9±10．58）U／L 화（26．7±10．95）U／L，저우동기대조조 ALT[（50．4±11．53）U／L，P ＜0．01]급 AST[（44．9±15．33），P ＜0．05]함량。치료12주급48주，치료조 HBV-DNA 전음솔분별위85．5％급91．7％，현저고우동기대조조전음솔（53．3％화73．3％，P 균＜0．05）。치료조48주후출현1례신적비 rtM204I 위점변이，이대조조비 rtM204I위점변이정황위6례，량조상비차이유통계학의의（χ2＝5．12，P ＝0．024）。결론ETV 연합 ADV 용우기왕 LAM 내약적만성을형간염환자적만구치료료효명현，치득림상추엄。
Objective This paper evaluated the efficacy of the combined therapy with entecavir (ETV)and adefovir (ADV) in patients with chronic hepatitis B who experienced lamivudine (LAM)-resistance.Methods Sixty-six LAM-resistance patients were randomly divided into two groups.Thiry-six patients who were diagnosed with LAM-resistance chronic hepatitis B(CHB)were assigned as the treatment group and received the combined therapy with ETV plus ADV.Thirty CHB patients receiving the combined therapy with LAM plus ADV were assigned as the control group.The changes of levels of ALT,AST, TBIL,HBV-DNA,HBV serum markers and mutation status before and after 12 and 48 weeks of treatment,as well as the rate of mutations other than that at rtM204I after 48 weeks of treatment,were measured in both groups.Results The levels of ALT and AST in the treatment group [(36.5±13.23)U/L,(50.2 ±11 .66)U/L]were significantly lower than that in the control group [(60.3±12.28)U/L,(69.7±13.56)U/L]in 12 weeks (P <0.01).Similarly,the values of ALT and AST in the treatment group [(27.9 ±10.58)U/L,(26.7 ±10.95 )U/L]were also lower than that in the control group [(50.4 ± 11 .53)U/L,(44.9±15.33)]in 48 weeks (P <0.05).The rate of undetected serum HBV DNA in two check points (12 and 48 weeks)in the treatment group (85.5% and 91 .7%)was statistically higher than that in the control group (53.3% and 73.3%,both P <0.05 ).However,there was no significant difference in the HBeAg seroconversion rate among HBeAg-positive patients between the two groups.One case of new mutation other than rtM204I was found in the treatment group, while 6 new mutations were detected in the control group (χ2 =5.12,P =0.024).Conclusion The combined therapy with ETV and ADV has critical therapeutic effect in treating LAM-resistant CHB patients,and the present clinical application is highly recommended.