恩替卡韦分散片治疗慢性乙型肝炎临床研究

Entecavir dispersible tablet for the treatment of chronic hepatitis B

目的评价恩替卡韦分散片治疗慢性乙型肝炎(chronic hepatitisB,CHB)的抗病毒疗效及安全性。方法采用随机、双盲、双模拟、阳性药物恩替卡韦片(博路定)平行对照试验方法。120例CHB患者按2:1的比例随机双盲分成2组,其中试验组80例,对照组40例。24周的双盲治疗期间,试验组口服恩替卡韦分散片0.5mg/d及不含恩替卡韦片的模拟剂1片/d,对照组口服恩替卡韦片0.5mg/d及不含恩替卡韦分散片的模拟剂1片/d;接着2组均接受24周的开放治疗,口服恩替卡韦分散片0.5mg/d。结果治疗12周时试验组和对照组血清HBVDNA水平分别下降4.98、4.73log10,治疗24周时分别下降5.45、5.00log10,治疗48周时分别下降5.19、5.01log10,2组比较差异均无统计学意义。治疗12周时试验组与对照组血清HBVDNA水平完全抑制(<1×102U/ml)率分别为41.33%和51.43%,治疗24周时分别为83.10%和74.19%,治疗48周时分别为76.47%和67.74%,2组比较差异均无统计学意义。治疗12周和24周时试验组和对照组血清HBVDNA水平较基线水平下降≥21og10的比例均为100.00%,治疗48周时分别为95.59%和100.00%,2组比较差异均无统计学意义。治疗12周时试验组和对照组的ALT复常率分别为92.00%和82.86%,治疗24周时分别为97.18%和93.55%,治疗48周时分别为83.82%和90.32%,2组比较差异均无统计学意义。试验组和对照组均未发生任何严重不良事件。结论恩替卡韦分散片在治疗CHB方面具有显著的抗病毒作用,疗效与恩替卡韦片相当,是一种安全有效的抗乙肝病毒药物。

Objective To evaluate the efficacy and safety of entecavir dispersible tablet for the treatment of chronic hepatitis B （CHB）. Methods A randomized, double-blind, double-dummy and active drug-controlled trial was performed. Totally 120 CHB patients were randomly divided into a test group （n=80） and a control group （n=40）. During the first 24 weeks, the patients in the test group were administered with 0.5 mg of entecavir dispersible tablet and one tablet of dummy entecavir （Baraclude） once daily and those in the control group with 0.5 mg of entecavir and one tablet of dummy entecavir dispersible tablet once daily. Then all the pa- tients received open-labeled entecavir dispersible tablet （0.5 mg/d） for another 24 weeks. Results Serum HBV DNA levels of the test group and the control group decreased by 4.98 and 4.73 log10 at week 12, by 5.45 and 5.00 log10 at week 24,and by 5.19 and 5.01 logl0 at week 48, respectively, and the differences were not significant between the two groups. The rates of serum HBV DNA suppression （less than 1×10^2U/ml） of the test group and the control group were 41.33% and 51.43% at week 12, 83.10% and 74.19% at week 24 and 76.47% and 67.74% at week 48, respectively, and the differences were not significant between the two groups. Compared with the baseline levels, all the patients in both groups had a decrease （t〉2 logl0） in serum HBV DNA levels at week 12 and 24, and 95.59% of the patients in the test group and all the patients in the control group had that decrease at week 48. The differences were not significant between the two groups. The rates of ALT normalization in the test group and the control group were 92.00% and 82.86% at week 12, 97.18% and 93.55% at week 24, and 83.82% and 90.32% at week 48, respectively, and the differences were not significant between the two groups. No patients in the two groups had any severe adverse events. Conclusions Enteeavir dispersible tablet has antiviral efficacy on CHB patients, with the same therapeutic efficacy as entecavir. It is an effective and safe agent for the treatment of CHB patients.