国产恩替卡韦分散片对慢性乙型肝炎初次抗病毒的疗效分析

Analysis of the efficacy of initially antiviral therapy for chronic hepatitis B

目的比较国产恩替卡韦分散片与进口恩替卡韦及拉米夫定对慢性乙型肝炎初次抗病毒的疗效。方法168例未接受过抗病毒治疗的慢性乙型肝炎患者完全随机分为3组：国产恩替卡韦组（54例），进口恩替卡韦组（56例），拉米夫定组（58例），治疗1年。观察3组患者治疗第12、24、48周的ALT复常率、HbeAg和HBVDNA的阴转率，平均血清HBVDNA基线水平。结果治疗第12、24、48周国产恩替卡韦组的ALT复常率、HbeAg和HBVDNA的阴转率均明显高于拉米夫定组[第12周分别为74．1％（4JD例）比51．7％（30例）、24．1％（13例）比8．6％（5例）、77．8％（42例）比55．2％（32例），第24周分别为85．2％（46例）比63．8％（37例）、27．8％（15例）比10．3％（6例）、81．5％（44例）比60．3％（35例），第48周分别为88．9％（48例）比69．0％（40例）、33．3％（18例）比13．8％（8例）、96．3％（52例）比67．2％（39例），均P〈0．05]，与进口恩替卡韦组比较，差异均无统计学意义（均P〉0．05）。结论慢性乙型肝炎初次抗病毒治疗国产恩替卡韦分散片疗效明显高于拉米夫定，而与进口恩替卡韦片的疗效差异无统计学意义。

Objective To compare the efficacy of initially antiviral therapy for chronic hepatitis B with home- made Entecavir dispersible tablets and imported enteeavir tablets and lamivudine. Methods Totally 168 HBeAg - positive patients without receiving any antiviral therapy were selected. Patients were randomly divided into 3 groups： lamivudine group （58 cases）, imported entecavir tablets （56 cases） and home-made entecavir dispersible tablets（54 cases） ,respectively, for 1 year. Results The serum ALT normalization rate, HBeAg negative rate and the HBV DNA negative rate of home-made Entecavir dispersible tablets group in the 12th, 24th and 48th week were significantly higher than those of lamivudine group. In the 12th, 24th and 48th week ALT normalization, HBeAg and HBV DNA negative conversion rate of home-made entecavir was significantly higher than those of the lamivudine group. There was no significant difference between imported entecavir group and home-made entecavir group. Conclusion Home-made entecavir for the treatment of chronic hepatitis initial antiviral efficacy is significantly higher than lamivudine group but there is no significant difference with imt）orted enteeavir.