摘要
目的观察国产阿德福韦酯(代丁)治疗YM DD突变后慢性乙型肝炎(CHB)的疗效。方法78例YM DD突变的CHB分为A、B两组:A组32例服用美国G ilead Se ience公司阿德福韦酯(ADV)10m g每天1次,52周;B组46例服用国产阿德福韦酯(代丁)10m g每天1次,52周。服药后第4、8、12、24、52周,检测ALT、HBVDNA定量、HB eA g、血常规、肾功能以及观察副反应。结果两组HBV DNA第4周开始下降,第52周ALT复常,HBVDNA<1×102拷贝/m l,HB eA g阴转率分别为53.1%、78.1%、12.5%和52.4%、76.9%、10.8%。有少数病例出现轻微乏力、头晕、腹痛、腹泻、脱发、腓肠肌痛、尿酸升高、性功能障碍,但可耐受。A组1例肝硬化失代偿期采用贺普丁(LAM)联用ADV 12周后肾衰加重中断治疗,B组1例全身皮疹中断治疗。结论国产阿德福韦酯(代丁)治疗YM DD突变的CHB与进口阿德福韦酯疗效相仿、价廉、副反应轻、安全。远期疗效,耐药性,停药后有无反跳需要进一步观察。
Objective To observe efficacy and safety of domestic adefovir dipivoxil（daiding） treatment of chronic hepatitis B virus （CHB） YMDD mutation with Lamivudine （LAM）. Methods 78 cases of CHB YMDD mutation were divided into group A and B. Adefovir dipivoxil （ADV,Gilead Science） 10 mg daily orally were administered for 52w in the group A （32 cases）. Domestic adefovir dipivoxil （daiding made in China）10 mg dail orally were administered for 52w in group B（46 cases）. After the 4,8,12,24, 52w,HBVDNA levels were measured by quantitative PCR and liver function tests, HBV serology and safety assessments were also conducted. Results The HBVDNA began to reduce from abnormal values at week 4 in two group. Abnormal ALT values restored and HBVDNA levels at baseline （〈 1 × 10^2opies/ml）,serum clearance rate of HBeAg was 53.1 %,78.1%, 12.5 % in group A and 52.4 %, 76.9 %, 10.8 % in group B at week 52,respectively. There was no severe adverse event related to medication studied in two trial groups beside renal insuffcincy in one patient and drug rash in one patient. Conclusion The efficacy and safety of daiding for CHB YMDD mutation with LAM are similar to ADV and will resulting significant clinical benefit. It is necessary to observe longer duration of therapeutic resistant,rebound and relapse after stopping daiding.
出处
《东南国防医药》
2006年第5期330-331,共2页
Military Medical Journal of Southeast China
关键词
阿德福韦酯
慢性乙型肝炎
YMDD突变
拉米夫定
Domestic adefovir dipivoxil（daiding）
Chronic hepatitis B
YMDD mutation
Lamivdine
