阿德福韦酯片治疗慢性乙型肝炎的临床研究

目的:评价阿德福韦酯片对慢性乙型肝炎患者的临床疗效及安全性。方法:采用随机、双盲、安慰剂平行对照、多中心临床试验,试验分两个阶段,持续48周。将病人随机分为阿德福韦酯组(A组)和安慰剂组(B组),第一阶段A组服用阿德福韦酯片10mg,每日1次。B组服用安慰剂,每日1次,双盲治疗12周;第二阶段A组和B组都服用阿德福韦酯片10mg,每日1次,开放治疗36周。分别在治疗的4、8、12、24、36、48周末进行疗效和安全性评价。结果:两组治疗至12周,血清HBV-DNA水平(对数值)分别下降2.27、0.48,较基线水平相比两组差异有统计学意义(P<0.05),即阿德福韦酯与安慰剂相比,可显著降低HBV-DNA水平。治疗至48周时,两组可使血清HBV-DNA(对数值)的含量较基线时分别下降3.30和3.40,两组数值较基线数值差异有统计学意义(P<0.05);分别有73.89%和74.68%的患者血清HBV-DNA的含量较基线时下降≥21og10,两组数值较基线数值差异无统计学意义(P≥0.05)。结论:阿德福韦酯片抑制乙肝病毒复制安全有效,是可以治疗慢性乙型肝炎的药物。

Clinical study on adefovir dipivoxil in the treatment of chronic hepatitis B

Objective:To evaluate the efficacy and safety of adefovir dipivoxil(ADV) for chronic hepatitis B patients.Methods:Patients with chronic hepatitis B were randomly divided into A or B group.During the first trial period,patients in group A and B received 10 mg of ADV and a placebo once a day for 12 weeks respectively.During the second trial period,all patients in group A and group B received 10 mg of ADV successively for 36 weeks.After 4,8,12,24,36,48week,all trial indicators were measured and assessed.Results:At 12 week,the serum HBVDNA levels of two groups were reduced 2.27 and 0.48.Compared with group B,group A could significantly lower the HBVDNA level(P<0.05).At week 48,the serum HBVDNA levels of two groups were reduced 3.30 and 3.40 compared with basic level(P<0.05).In73.89% and 74.68% of two group patients,HBV-DNA level lowered over 21og10,There was no significance in two group(P=0.895>0.05).Conclusion:ADV is safe and effective to inhibit the copy of hepatitis B virus,which can be used to treat chronic hepatitis B.