摘要
目的观察恩替卡韦分散片抗病毒48周的疗效。方法 60例慢性乙型肝炎患者分为A、B两组,每组各30例,A组口服恩替卡韦片(进口)作为对照组,B组口服恩替卡韦分散片(国产)为试验组,均为0.5mg/d,疗程48周,分别采用速率法、荧光定量聚合酶链反应(PCR)法、电化学发光法及微粒子发光法检测基线和服药后12、24、48周血清丙氨酸转氨酶(ALT)、HBV DNA、乙型肝炎表面抗原(HBsAg)及乙型肝炎e抗原(HBeAg),乙型肝炎e抗体(抗-HBe)水平;数据符合参数分析条件的计量资料采用t检验,等级资料的组间比较采用秩和检验,计数组间比较采用卡方检验或Fisher确切概率法,重复测量资料采用重复测量的方差分析。结果抗病毒治疗48周ALT复常率分别为90.0%(27/30)和86.7%(26/30),(χ2=1.172,P>0.05);A、B两组患者血清HBV DNA水平同步快速下降,组间比较差异无统计学意义(F=5.833,P>0.05),不同时间点比较差异有统计学意义(F=43.561,P<0.05);治疗48周时,血清HBV DNA水平测不到率分别为60.0%(18/30)和56.7%(17/30),(χ2=0.044,P>0.05);26例HBeAg(+)患者A、B组各13例,两组分别有2例vs 1例HBeAg阴转,1例vs 1例产生抗-HBe,差异均无统计学意义;至48周时,两组HBeAg(+)患者HBsAg水平同步缓慢下降,组间相比无明显差异(F=55.786,P>0.05),不同时点间比较差异有统计学意义(F=32.241,P<0.05)。A、B两组均无不良反应发生。结论恩替卡韦分散片为快速、强效、安全、低耐药抗慢性乙型肝炎病毒药物,和进口恩替卡韦片疗效无明显差异。
Objective To observe the efficacy and safety of entecavir in patients with hepatitis B virus（HBV） for 48 weeks. Methods Sixty chronic hepatitis B（CHB） patients were divided into A group, B group（ n = 30,each group）, the patients were treated with domestic（group A）and imported（group B） entecavir for 48 weeks（0.5 mg/d）, the alanine aminotransferase（ALT） levels, HBV DNA levels and serological markers of HBV were measured at baseline and the treatment weeks 12,24, 48, the efficacy and safety of the two nucleoside analogues were assessed at different time. Results At the treatment 48 weeks ,there were no significant differences in the normalization of ALT levels between two groups, 90.0%（27/30）and 86.7%（26/30） ,（χ2=1. 172, P〉0.05） ;the mean HBV DNA levels in group A and group 13 were falling quickly in the same level, there were no significant differences between groups（ F =5. 833, P 〉0.05）,but it has statistically significant at different times（ F =43. 561, P d0.05）; after treatment 48 weeks, undetectable serum HBV DNA levels of two groups were 60.0% （18/30） and 56.7% （17/30）, （χ2=0. 044, P〉 0.05） there were B hepatitis B e antigen HBeAg-position CHB patients in either group, but only（1 vs 1）patient had HBeAg/anti-HBe seroconversion. No adverse reactions were found in both groups. Conclusion Domestic entecavir is a rapid, powerful and safe antiviral drug, there are no obvious difference between domestic and imported drugs.
出处
《临床荟萃》
CAS
2015年第8期899-902,共4页
Clinical Focus
