CAJ | 학술논문

目的：观察恩替卡韦联合阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎（CHB）患者的疗效和安全性。方法选取昆山市人民医院2011年5月至2013年5月门诊和住院的拉米夫定耐药患者45例，随机分成两组，治疗组23例应用恩替卡韦联合阿德福韦酯挽救治疗，对照组22例应用拉米夫定联合阿德福韦酯挽救治疗，观察两组治疗前及治疗后4、12、24、48周 HBV DNA、ALT、AST、TBil、Alb、HBV 血清学标志物含量变化以及治疗48周时非 rtM204I 位点变异发生率。计量资料组间比较用 t 检验，计数资料的组间比较用四格表χ2检验。结果治疗组挽救治疗后4、12周 ALT、AST 下降较对照组相比差异有统计学意义（t 值为3．124、5.271、4.476、5.125，P 值均＜0．01），挽救治疗24、48周后较对照组相比差异有统计学意义（t 值为2．240、2．307、2．886、2.908，P值均＜0.05）。治疗4、12、24、48周后，治疗组 HBV DNA 转阴率分别为73．9％、86．8％、95．7％、100％，较对照组差异有统计学意义（χ2值为11．79、5．75、10.29、5．89，P 值均＜0．05）。HBeAg 阳性患者阴转率在治疗组及对照组间差异无统计学意义。治疗组48周后未出现新的非 rtM204I 位点变异，而对照组非 rtM204I 位点变异情况为4例，两组相比差异有统计学意义（χ2＝4．59，P ＜0.05）。结论恩替卡韦联合阿德福韦酯用于既往拉米夫定耐药的 CHB 患者的挽救治疗疗效明显，值得临床推广。
목적：관찰은체잡위연합아덕복위지치료랍미부정내약만성을형간염（CHB）환자적료효화안전성。방법선취곤산시인민의원2011년5월지2013년5월문진화주원적랍미부정내약환자45례，수궤분성량조，치료조23례응용은체잡위연합아덕복위지만구치료，대조조22례응용랍미부정연합아덕복위지만구치료，관찰량조치료전급치료후4、12、24、48주 HBV DNA、ALT、AST、TBil、Alb、HBV 혈청학표지물함량변화이급치료48주시비 rtM204I 위점변이발생솔。계량자료조간비교용 t 검험，계수자료적조간비교용사격표χ2검험。결과치료조만구치료후4、12주 ALT、AST 하강교대조조상비차이유통계학의의（t 치위3．124、5.271、4.476、5.125，P 치균＜0．01），만구치료24、48주후교대조조상비차이유통계학의의（t 치위2．240、2．307、2．886、2.908，P치균＜0.05）。치료4、12、24、48주후，치료조 HBV DNA 전음솔분별위73．9％、86．8％、95．7％、100％，교대조조차이유통계학의의（χ2치위11．79、5．75、10.29、5．89，P 치균＜0．05）。HBeAg 양성환자음전솔재치료조급대조조간차이무통계학의의。치료조48주후미출현신적비 rtM204I 위점변이，이대조조비 rtM204I 위점변이정황위4례，량조상비차이유통계학의의（χ2＝4．59，P ＜0.05）。결론은체잡위연합아덕복위지용우기왕랍미부정내약적 CHB 환자적만구치료료효명현，치득림상추엄。
Objective To evaluate the efficacy and safety of the combined therapy with entecavir (ETV)and adefovir dipivoxil (ADV)in patients with lamivudine (LAM)-resistant chronic hepatitis B (CHB).Methods A total of 45 patients who were diagnosed with LAM-resistant CHB and admitted to the Kunshan People's Hospital from May 2011 to May 2013 were recruited in this study and randomly divided to two groups.The treatment group included 23 CHB patients who received the combined therapy with ETV and ADV.The control group in-cluded 22 CHB patients who received the combined therapy with LAMand ADV.The changes in levels of HBV DNA,alanine aminotrans-ferase (ALT),aspartate aminotransferase (AST),total bilirubin (TBil),albumin (Alb),and HBV serum markers before and after 4,12, 24,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.Comparison of continuous data between groups was made by t test,and comparison of categorical data by fourfold table chi -square test.Results The levels of ALT and AST in the treatment group were significantly lower than those in the control group after 4 and 12 weeks of treatment (t =3.124,5.271,4.476,5.125,all P <0.01 ),as well as 24 and 48 weeks of treatment (t =2.240,2.307,2.886, 2.908,all P <0.05 ).The serum HBV DNA clearance rates in the treatment group after 4,12,24,and 48 weeks of treatment were 73.9%,86.8%,95.7%,and 100%,respectively,all of which were significantly higher than those in the control group (χ2 =11.79, 5.75,10.29,5.89,respectively,all P <0.05).However,there was no significant difference in the HBeAg seroconversion rate among HBeAg -positive patients between the two groups.No mutations other than that at rtM204I were found in the treatment group,while four new mutations were detected in the control group (χ2 =4.59,P <0.05).Conclusion The combined therapy with ETV and ADV has good therapeutic effect in treating LAM-resistant CHB patients,and the clinical application is highly recommended.