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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。
Objective To evaluate the safety and efficacy of domestic adefovir dipivoxil tablets in the treatment of HBeAg-positive chronic hepatitis B patients. Methods 238 patients with HBeAg-positive chronic hepatitis B were treated with oral adefovir dipivoxil 10 mg / d by multicentre, double-blind and randomized controlled trial. After 48 weeks of treatment and after treatment, serum HBV DNA negative conversion rate , ALT normalization rate, HBeAg negative conversion rate, anti - HBe positive conversion rate and adverse reactions. Results In the first 12 weeks of double-blind controlled trials, the serum HBV DNA negative rate, ALT normalization rate, HBeAg negative rate and anti-HBe positive rate in the experimental group were all higher than those in the placebo control group, 50.0% 5.1%; 35.0% vs 8.5%; 12.5% vs 2.5%; 5.8% vs 0 (x ~ 2 values were 59.89.24.52, P <0.05; At the end of the 36-week open trial period after oral administration of adefovir dipivoxil tablets in both the experimental and placebo groups, they were 87.5% vs. 78.0%, 78.3% vs. 72.7%, 29.6% vs. 24.5%, 15.6% 10.9% (x ~ 2 values were 3.78,0.83,0.72,1.09, P> 0.05). Conclusion The safety and efficacy of domestic adefovir dipivoxil tablets in the treatment of HBeAg-positive chronic hepatitis B are similar to that of other drugs approved by the public in the foreign countries.