恩替卡韦治疗慢性乙型肝炎病毒感染的疗效观察及其影响因素
Effect of entecavir in the treatment of chronic hepatitis B virus infection and its influencing factors
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摘要: 目的：探讨恩替卡韦（entecavir，ETV）治疗慢性乙型肝炎（chronic hepatitis B，CHB）病毒感染的疗效及其影响因素，为临床合理选择抗病毒药物提供依据。方法：选择符合乙型肝炎病毒（hepatitis B virus，HBV）感染的病人共79例，予以ETV口服0.5 mg/d，每3个月随访病人肝功能、HBV-DNA、乙肝两对半。结果：HBV感染病人在治疗12周、24周、48周时HBV-DNA低于检测下限率分别为45.6%、60.8%、81.0%，丙氨酸氨基转移酶复常率分别为67.24%、86.20%、96.55%，HBV-DNA低于检测下限率和丙氨酸氨基转移酶复常率均随着治疗时间的增加而升高（P<0.01）。治疗史、肝硬化、乙型肝炎E抗原（HBeAg）状态和HBV-DNA基线水平与HBV-DNA低于检测下限率有关（P<0.05~P<0.01）。在治疗12周时，初治组HBV-DNA低于检测下限率为52.3%，高于经治组的14.3%（P<0.01），24周和48周时，2组间检测下限率差异均无统计学意义（P>0.05）；无肝硬化和HBV-DNA基线水平≤ 7.00log10copies/mL组在治疗12周、24周、48周时HBV-DNA低于检测下限率均高于有肝硬化组和HBV-DNA基线水平≤ 7.00log10copies/mL组（P<0.05~P<0.01）；HBeAg（-）组在治疗12周和24周时HBV-DNA低于检测下限率均高于HBeAg（+）组（P<0.05和P<0.01），48周时2组低于检测下限率差异无统计学意义（P>0.05）。79例病人在随访期间未见明显不良反应，无病毒突破及反弹病例出现。结论：ETV治疗HBV感染疗效显著，不良反应少见，初治及HBeAg状态对ETV治疗HBV感染者早期疗效有影响，但对远期疗效无明显影响；无肝硬化、HBV-DNA ≤ 7.00log10copies/mL对ETV治疗HBV感染者远期疗效有影响，可为病人使用本药物提供预判依据。Abstract: Objective:To investigate the effects of entecavir(ETV) in the treatment of chronic hepatitis B(CHB) virus infection,and its influencing factors for providing the basis in rational selection of antiviral drugs.Methods:A total of 79 patients with CHB virus infection were treated with 0.5 mg/d ETV by oral from August 2014 to February 2015.The liver function,HBV-DNA and hepatitis B two and half test were detected every three months.Results:After 12,24 and 48 weeks of treatment,the HBV-DNA negative percentage(<500 copies/mL) in patients was 45.6%,60.8% and 81.0%,respectively,the alanine aminotransferase(ALT) normalization rate were 67.24%,86.20% and 96.55%,respectively,and the HBV-DNA negative percentage and ALT normalization rate increased with the time increasing(P<0.01).The treatment history,cirrhosis,HBeAg level and baseline level of HBV-DNA were related to the HBV-DNA negative percentage(P<0.05 to P<0.01).After 12 weeks of treatment,the HBV-DNA negative percentage at initial treatment group and treated group was 52.3% and 14.3%,respectively(P<0.05),and the differences of which in two groups at 24 weeks and 48 weeks of treatment were not statistically significant(P>0.05).At 12,24 and 48 weeks of treatment,the HBV-DNA negative percentage in noncirrhosis patients with HBV-DNA ≤ 7.00log10 copies/mL were higher than that in cirrhosis patients with HBV-DNA >7.00log10 copies/mL(P<0.05 to P<0.01).At 12 weeks and 24 weeks of treatment,the HBV-DNA negative percentage in patients with HBeAg(-) was higher than that in patients with HBeAg(+)(P<0.05 to P<0.01),and the difference of which in two groups at 48 weeks of treatment was not statistically significant(P>0.05).No obvious adverse reaction,viral breakthrough and rebound were found in 79 patients during the following up period.Conclusions:The effect of ETV in the treatment of CHB virus infection is significant and with rare adverse reactions.Initial treatment and HBeAg status have significant effect on the early efficacy of ETV in treating HBV infection,but which has not significant effect on the long-term outcome.Noncirrhosis and HBV-DNA ≤ 7.00log10 copies/mL have some effects on long-term therapy,which can provide the evidence of predicting prognosis.
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Key words:
- chronic hepatitis B /
- virus infection /
- entecavir
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