CAJ | 학술논문

目的：观察恩替卡韦单药序贯与拉米夫定联合阿德福韦酯治疗阿德福韦酯初治失败的慢性乙型肝炎患者的临床疗效及安全性。方法选择阿德福韦酯初治失败的慢性乙型肝炎患者213例，随机分为A组104例、B组109例；A组患者改用恩替卡韦单药治疗，B组患者予以拉米夫定联合阿德福韦酯治疗；至48周时分别观察、比较其血清HBV DNA水平中位数下降幅度、血清HBV DNA阴转率、HBeAg转阴率、生化学应答率。血清HBV DNA阴转患者继续原方案治疗至96周，并观察其维持血清HBV DNA阴转率、HBeAg转阴率、HBV基因耐药变异率及不良反应。结果治疗48周，两组患者血清HBV DNA水平中位数下降幅度、血清HBV DNA阴转率、HBeAg转阴率及生化学应答率，差异均无统计学意义（P均＞0.05）。血清HBV DNA阴转患者继续原方案治疗至96周，两组患者维持血清HBV DNA阴转率、HBeAg转阴率及HBV基因耐药变异率，差异均无统计学意义（P均＞0.05）。两组患者均无严重不良事件。结论阿德福韦酯初治失败的慢性乙型肝炎患者予以拉米夫定联合阿德福韦酯治疗或改用恩替卡韦单药治疗，均能取得较好的临床疗效；两种优化方案维持血清HBV DNA阴转率、HBeAg转阴率率及HBV耐药变异率均无明显差异，安全性良好均适用于患者临床治疗。
목적：관찰은체잡위단약서관여랍미부정연합아덕복위지치료아덕복위지초치실패적만성을형간염환자적림상료효급안전성。방법선택아덕복위지초치실패적만성을형간염환자213례，수궤분위A조104례、B조109례；A조환자개용은체잡위단약치료，B조환자여이랍미부정연합아덕복위지치료；지48주시분별관찰、비교기혈청HBV DNA수평중위수하강폭도、혈청HBV DNA음전솔、HBeAg전음솔、생화학응답솔。혈청HBV DNA음전환자계속원방안치료지96주，병관찰기유지혈청HBV DNA음전솔、HBeAg전음솔、HBV기인내약변이솔급불량반응。결과치료48주，량조환자혈청HBV DNA수평중위수하강폭도、혈청HBV DNA음전솔、HBeAg전음솔급생화학응답솔，차이균무통계학의의（P균＞0.05）。혈청HBV DNA음전환자계속원방안치료지96주，량조환자유지혈청HBV DNA음전솔、HBeAg전음솔급HBV기인내약변이솔，차이균무통계학의의（P균＞0.05）。량조환자균무엄중불량사건。결론아덕복위지초치실패적만성을형간염환자여이랍미부정연합아덕복위지치료혹개용은체잡위단약치료，균능취득교호적림상료효；량충우화방안유지혈청HBV DNA음전솔、HBeAg전음솔솔급HBV내약변이솔균무명현차이，안전성량호균괄용우환자림상치료。
Objective To observe differences of clinical curative effect and safety between entecavir monotherapy sequential treatment and lamivudine combined therapy with adefovir dipivoxil treatment after adefovir dipivoxil treated first failure in patients with chronic hepatitis B. Methods To choose 213 cases of patients with chronic hepatitis B who have been treated with adefovir dipivoxil first and failed at last,104 cases were randomly divided into group A and group B 109 cases; group A patients with en-tecavir monotherapy sequential therapy,patients in B group to Lamivudine combined therapy with adefovir dipivoxil;To 48 weeks respectively to observe and compare the levels decreased of serum HBV DNA median,serum complete virology response rates, serological response rates and biochemical response rates. Complete virological response in patients with serum continue their orig-inal solution treatment up to 96 weeks,and observed its maintained virological response rates,serological response rates,HBV gene drug resistance mutation rate and adverse reactions. Results After 48 weeks,group A and group B,median levels declined of serum HBV-DNA,serum virology response rates,Serological response rate and biochemical response rates,the difference was no statistically significant (P>0.05). The patients having complete virological response with serum continued their original solution treatment up to 96 weeks,group A and group B maintained virological response rates, serological response rate and serum HBV drug resistance gene mutation rates,the difference was no statistically significant (P>0.05). There were no serious adverse events of two groups of patients. Conclusion The patients of chronic hepatitis B failed in adefovir dipivoxil treated first should be treated with lamivudine combined therapy with adefovir dipivoxi or switch to entecavir monotherapy ,all can obtain good clinical curative effect;its maintained virological response rate,serological response rate and prevention of HBV serum drug resistance gene muta-tions rate were no significant differences,security is good. Two optimization schemes are suitable for clinical treatment of chronic hepatitis B patients.