优化方案治疗阿德福韦酯初治失败的慢性乙型肝炎患者的疗效分析

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。

Analysis of curative effect about treatment optimization scheme after Adefovir dipivoxil first treatment failure in patients with chronic hepatitis B

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 dipivoxi[ 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 original 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.