阿德福韦酯片治疗e抗原阳性慢性乙型肝炎临床观察

目的 评价国产阿德福韦酯片治疗乙型肝炎e抗原(HBeAg)阳性慢性乙型肝炎患者的安全性与效果.方法 125例HBeAg阳性慢性乙型肝炎患者随机分为治疗组65例,口服阿德福韦酯片治疗;对照组60例,用α干扰素-2b治疗.两组治疗开始后,每4个月检查肝功能、肾功能、乙型肝炎病毒(HBV)标志物、HBV DNA定量等指标.24个月治 疗期间和治疗后,比较两组血清HBV DNA阴转率、丙氨酸氨基转移酶(ALT)复常率、HBeAg阴转率、HBeAg/抗-HBe血清转换率和不良反应.结果 治疗组患者治疗后6、12、18、24个月,HBeAg阴转率分别为12.3％、23.1％、41.5％和60.0％:HBV DNA阴转率分别为0％、13.8％、27.7％和43.1％；HBeAg/抗-HBe血清转换率分别为9.2％、16.9％、23.3％和50.8％,HBeAg阴转率、HBV DNA阴转率、HBeAg/抗-HBe血清转换率均随治疗时间延长而升高,且与对照组不同时期各项指标(治疗6、12个月HBV DNA阴转率除外)比较,差异均有统计学意义(P＜0.05或P＜0.01).治疗组患者治疗24个月后ALT复常率为66.1％,治疗期间无不良反应发生.结论 国产阿德福韦酯片治疗慢性乙型肝炎安全性与有效性较好,疗程延长疗效好.

Clinical observation on effect of adefovir dipivoxil in treating chronic hepatitis B with e antigen-positive

Objective To evaluate the safety and efficacy of domestic adefovir dipivoxil in the treatment of chronic hepatitis B(CHB) with e antigen-positive.Methods 125 CHB patients with HBeAg-positive were randomly divided into the treatment group and the control group.The treatment group(65 cases) received oral adefovir dipivoxil.The control group was treated by α-interferon-2b.After the beginning of treatment,the liver function,renal function,HBV markers and quantitative HBV DNA were detected every 4 months.During 24-month treatment course and after treatment,the rates of serum HBV-DNA negative-conversion,alanine aminotransferase(ALT) renormalization rate,HBeAg negative-conversion rate,anti-HBe positive-conversion rate,Cr and adverse reactions were compared between the two groups.Results After 6,12,18,24 months of treatment,the rates of HBeAg negative-conversion,HBV-DNA negative-conversion and HBeAg/Anti-HBe seroconversion rate were 12.3%,0%,9.2%;23.1%,13.8%,16.9%;41.5%,27.7%,23.3% and 60.0%,43.1% and 50.8% respectively,showing statistical differences among various indexes.Conclusion Domestic adefovir dipivoxil for treating CHB is safe and effective with prolonged treatment course.