【摘要】 目的评价国产阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎患者的安全性与效果。方法采用多中心、双盲、随机对照的方法,观察238例HBeAg阳性慢性乙型肝炎患者经口服阿德福韦酯片10 mg/d,48周治疗期间和治疗后,血清HBV DNA阴转率、ALT复常率、HBeAg阴转率、抗- HBe阳转率以及不良反应。结果在前12周的双盲对照试验中,试验组血清HBV DNA阴转率、ALT复常率、HBeAg阴转率和抗-HBe阳转率均高于安慰剂对照组,分别为50.0%比5.1%;35.0%比8.5%;12.5%比2.5%;5.8%比0(x~2值分别为59.89.24.52,P<0.05;四格表确切概率法检验,P<0.05)。在试验组和安慰剂对照组均口服阿德福韦酯片的后36周开放试验期结束后,则分别为87.5%比78.0%;78.3%比72.7%;29.6%比24.5%;15.6%比10.9%(x~2值分别为3.78,0.83,0.72,1.09,P>0.05)。结论国产阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎的安全性与有效性与国外同类批准上市使用的药物相似。更多还原

【Abstract】 Objective To evaluate the safety and efficacy of adefovir dipivoxil made in China for treating hepatitis B e antigen(HBeAg)-positive chronic hepatitis B patients.Methods This was a multicenter,double-blinded,randomized controlled trial.Two hundred and thirty-eight patients with HBeAg-positive chronic hepatitis B were assigned to receive either adefovir dipivoxil(10 mg/d,120 patients)or placebo(118 patients)for 12 weeks in 5 medical centers in China.Then,both groups of patients entered 36 weeks open-labeled adefovir dipivoxil treatment phase(10 mg/d),The rates of serum HBV DNA clearances,alanine aminotransferase levels(ALT)normalization,HBeAg loss and anti-HBe seroconversion were evaluated respectively during and post the 48-week treatment.Results After 12 weeks of treatment,the rates of serum HBV DNA clearance(real-time fluorescent quanti- tative polymerase chain reaction,the detection limit was 1×10~4 copy per milliliter),ALT normaliza- tion,HBeAg loss and anti-HBe seroconversion of adefovir dipivoxil group were all significantly higher than those of placebo group(50.0% vs 5.1%,35.0% vs 8.5%,12.5% vs 2.5% and 5.8% vs 0, respectively,x~2=59.89,24.52,P<0.05;exact probabilities in 2×2 table,P<0.05).At the end of 36 weeks open-labeled 10 mg adefovir dipivoxil treatment,these rates were not significantly differ- ent between adefovir dipivoxil group and placebo plus adefovir dipivoxil group(87.50% vs 78.0%, 78.3% vs72.7%,29.6% vs 24.5%,and 15.6% vs 10.9%,respectively.x~2 value were 3.78, 0.83,0.72,1.09.P>0.05).The safety profile of adefovir dipivoxil was similar to that of placebo. Conclusions The safety profile and efficacy of domestic adefovir dipivoxil for treating HBeAg-positive chronic hepatitis B patients are similar to its counterparts that have been licensed aboard.更多还原