摘要
目的 研究阿德福韦酯对拉米夫定耐药慢性乙型肝炎（CHB）患者的疗效和安全性。方法采用多中心、随机、双盲双模拟、拉米夫定对照的临床实验，选择拉米夫定耐药的CHB患者247例，按1：1比例随机分为实验组（123例）和对照组（124例）。所有患者完成12周治疗后均进入阿德福韦酯开放治疗期。完成12周和48周治疗时，检测血清HBVDNA及A坍水平并进行安全性评估。结果治疗12周时实验组ALT均值下降35．9U／L，血清HBVDNA平均下降3．01log10拷贝／mL，其中61．8％（76／123）的受试者血清HBVDNA下降≥2log10拷贝／mL；对照组A坍均值增加2．8U／L，血清HBVDNA平均下降0．78log10拷贝／mL，其中血清HBVDNA下降〉／2log10拷贝／mL的受试者比率仅为17．7％（22／124）。治疗48周时，实验组ALT均值下降59．7U／L，血清HBVDNA平均下降4．70log10拷贝／mL，87．0％（107／123）的受试者血清HBVDNA下降≥2log10拷贝／mL；对照组ALT均值下降56．6U／L，血清HBVDNA平均下降4．43log10拷贝／mL，85．5％（106／124）的受试者血清HBVDNA下降≥2log10拷贝／mL。2组均未发生与研究药物相关的严重不良反应。结论阿德福韦酯治疗拉米夫定耐药CHB患者可在病毒学及生化学方面取得较好疗效，且安全性良好。
Objective To investigate the efficacy and safety of adefovir dipivoxil （ADV） for chronic hepatitis B （CHB） patients with lamivudine （LMD） resistance. Methods A total of 247 LMD- resistant CHB patients were included in this multi-center, randomized （ 1 ： 1 ）, double-blinded and LMD- controlled clinical trial. All subjects were swithed to open-labelled ADV treatment after 12-week doubleblinded stage. Serum HBV DNA and ALT levels were monitored and safety assessments were conducted at 12th and 48th week during the treatment. Results At 12th week, mean reduction of ALT in trial group was 35.9 U/L, and the reduction of HBV DNA was 3.01 log10 copies/mL. The reductions of HBV DNA in 61.8% （76/123） subjects were more than 2 log10 copies/mL. While in the control group, ALT raised 2.8 U/L in average, and the reduction of HBV DNA was 0.78 log10 copies/mL. The reductions of HBV DNA in 17.7% （22/124） subjects were more than 2 log10 copies/mL. At 48th week, mean reduction of ALT in trial group was 59.7 U/L, and the reduction of HBV DNA was 4.70 log10 copies/mL. The reductions of HBV DNA in 87.0% （107/123） subjects were more than 2 log10 copies/mL. While in the control group, mean reduction of ALT was 56.6 U/L, and the reduction of HBV DNA was 4.43 log10 copies/mL. The reductions of HBV DNA in 85.5% （106/124） subjects were more than 2 log10 copies/mL. No severe adverse effect related to the investigational product was observed in both groups. Conclusion ADV is safe and effective in the treatment of LMD-resistant CHB patients with virological and biochemical improvements.
出处
《中华临床感染病杂志》
CAS
2009年第1期9-12,共4页
Chinese Journal of Clinical Infectious Diseases
基金
国家重点基础研究发展计划资助项目（2007CB512900）
关键词
肝炎
乙型
慢性
阿德福韦酯
拉米夫定
抗药性
临床研究
Chronic hepatitis B
Adefovir dipivoxil
Lamivudine
Drug resistance
Clinicalstudy
