摘要
目的:评价阿德福韦酯(ADV)和恩替卡韦(ETV)治疗慢性乙型肝炎YMDD变异患者2年的疗效和安全性.方法:2005-06/2007-06我院门诊和住院经拉米夫定治疗后出现YMDD变异的乙型肝炎患者120例,随机分为4组.A组单用ADV10mg/d,治疗96wk;B组采用ADV10mg/d、拉米夫定100mg/d,联合治疗12wk,后单用ADV10mg/d,治疗84wk;C组采用ADV10mg/d、拉米夫定100mg/d,联合治疗96wk;D组接受ETV1mg/d,治疗96wk.患者在治疗前和12、24、48、72、96wk检测肝功能、HBVDNA、HBV标志物、电解质(血磷)、肾功能,对HBVDNA阳性患者检测YMDD变异株,病毒学无应答或反弹的患者进行HBVP区测序.结果:治疗96wk时4组患者间ALT水平、HBeAg阳性患者血清转换率比较,差异均无统计学意义(P>0.05).C组患者ALT复常率、HBVDNA达到检测水平以下的百分率与A组患者比较,差异有统计学意义(χ2=7.500,6.648,P<0.05);4组患者96wk的基因型耐药率分别为16.7%(5/30)、13.3%(4/30)、0及13.3%(4/30).A组1例患者出现重型肝炎.结论:YMDD变异后采用ADV与拉米夫定联合治疗更安全有效.
AIM： To evaluate the eff icacy and safety of adefovir dipivoxil alone or in combination with lamivudine or entecavir in the treatment of chronic hepatitis B （CHB） patients harboring YMDD variants. METHODS： One hundred and twenty CHB patients with YMDD variants were randomly divided into four groups： patients receiving adefovir dipivoxil alone for 96 weeks （Group A）, those receiving adefovir dipivoxil in combination with lamivudine during the first 12 weeks and adefovir dipivoxil alone for the following 84 weeks （Group B）, those receiving adefovir dipivoxil in combination with lamivudine for 96 weeks （Group C）, and those receiving entecavir alone for 96 weeks （Group D）. Before treatment and at weeks 0, 4,12, 24, 48, 72 and 96 after treatment, liver function, hepatitis B virus （HBV）-DNA level, HBV serological markers, serum phosphorus and renal function were determined in all patients. HBV YMDD mutation was detected in HBV DNA-positive patients. Sequencing of HBV P gene was performed in patients with a non-virological response or virological breakthrough.
RESULTS： After 96 weeks of treatment, no significant differences were noted in serum alanine aminotransferase （ALT） level and hepatitis B e-antigen （HbeAg） seroconversion rate among the four groups （all P 〉 0.05）. However, significant differences were observed in ALT normalization rate and the percentage of patients with undetectable HBV DNA between the Group A and Group C （χ2=7.500 and 6.648, respectively; both P 〈 0.05）. The frequencies of drug resistant genotypes in the four groups were16.7% （5/30）, 13.3% （4/30）, 0 and 13.3% （4/30）, respectively. Severe hepatitis occurred in one patient in the Group A.
CONCLUSION： Adefovir dipivoxil in combination with LAM is safe and effective in the treatment of chronic hepatitis B patients with YMDD variants.
出处
《世界华人消化杂志》
CAS
北大核心
2009年第29期3034-3037,共4页
World Chinese Journal of Digestology
基金
江苏省无锡市卫生系统指令性科研基金资助项目
No.XM0704~~
