摘要:目的:观察恩替卡韦治疗丙氨酸转氨酶( ALT)<2×正常值上限( ULN),但肝穿刺病理检查炎症活动度≥G2和(或)纤维化分期≥S2的慢性乙型肝炎病毒( HBV)感染者的抗病毒疗效。方法连续收集2008年1月至2011年10月浙江省丽水市人民医院感染科患者中HBsAg阳性,且治疗前HBV DNA均>1.0×104 U/mL的乙型肝炎患者的资料。其中,血清ALT<2×ULN,但肝组织病理检查炎症活动度≥G2和(或)纤维化分期≥S2为观察组,共75例;临床诊断CHB,治疗前ALT(2~5)×ULN的患者为对照1组,共38例;临床诊断CHB,ALT>5×ULN的患者为对照2组,共42例。所有患者均给予恩替卡韦(0.5 mg,1次/d,口服)治疗,观察并比较治疗第12、24、48、96和144周时三组患者的ALT复常率、HBV DNA转阴率、HBeAg转阴率和血清学转换率等。计量资料采用方差分析,计数资料采用χ2检验。结果观察组治疗第12、24、48、96和144周时的ALT 复常率分别为86.7%、90.7%、90.7%、92.0%和96.0%,高于对照1组(χ2=2.04、2.15、2.78、2.69和2.47, P <0.01),但与对照2组比较差异无统计学意义(χ2=2.53、2.42、2.09、2.24和2.32,P>0.05)。观察组治疗第12、24和48周时的HBV NDA转阴率分别为70.7%、78.7%和82.7%,高于对照1组(χ2=4.56、4.23和4.28,P<0.05),但与对照2组比较差异均无统计学意义(χ2=2.75、2.62和2.98,P>0.05)。观察组在治疗第48、96和144周时的HBeAg转阴率分别为6.6%、21.3%和25.3%,均高于对照1组(χ2=4.68、4.78和5.01,P<0.05),但与对照2组比较差异均无统计学意义(χ2=2.24、2.57和2.13,P>0.05)。观察组治疗第24周时HBeAg血清学转换率为4.0%,高于对照1组(χ2=2.87, P<0.05);与对照2组比较,观察组第96和144周时的血清学转换率较低(χ2=2.92和3.14,P<0.05)。结论 ALT<2×ULN但肝组织病理炎症活动度≥G2和(或)纤维化分期≥S2的慢性HBV感染者采用恩替卡韦抗病毒治疗可获得较好的疗效。%Objective To evaluate the efficacy of entecavir treatment in chronic hepatitis B virus ( HBV ) infected patients with mild hepatic dysfunction and marked pathological injury.Methods One hundred and fifty five chronic hepatitis B ( CHB) patients with HBV DNA>1.0 ×104 U/mL admitted in Lishui People’ s Hospital during January 2008 to October 2011 were enrolled in the study.Patients were divided into three groups: those with serum ALT <2 ×ULN and liver inflammation injury ≥G2 and/or fibrosis stage≥S2 were in observation group ( n=75 ); patients with ALT ( 2-5 ) ×ULN were in control group 1 (n=38);patients with ALT>5 ×ULN were in control group 2 (n=42).All patients were given entecavir (0.5 mg, 1/d, p.o) treatment.ALT normalization rates, HBV DNA negative rates, HBeAg negative conversion rates and seroconversion rates at 12-, 24-,48-, 96-and 144-week were observed and compared among groups.Variance analysis andχ2 test were performed for measurement data and numeration data, respectively.Results ALT normalization rates in observation group were 86.7%, 90.7%, 90.7%, 92.0%and 96.0%at 12-, 24-, 48-, 96-and 144-week, which were higher than those in control group 1 (χ2 =2.04, 2.15, 2.78, 2.69 and 2.47, P <0.01), but no statistically significant difference was observed between observation group and control group 2 (χ2 =2.53,2.42,2.09,2.24 and 2.32,P>0.05) . HBV DNA negative rates in observation group were 70.7%, 78.7%and 82.7%at 12-, 24-and 48-week, which were higher than those in control group 1 (χ2 =4.56, 4.23 and 4.28, P<0.05), but no statistically significant difference was observed between observation group and control group 2 (χ2 =2.75, 2.62 and 2.98, P>0.05).HBeAg negative conversion rates in observation group were 6.6%, 21.3%and 25.3%at 48-, 96-, and 144-week, which were higher than those in control group 1 (χ2 =4.68, 4.78 and 5.01, P<0.05), but no statistically significant difference was observed between observation group and control group 2 (χ2 =2.24, 2.57 and 2.13, P>0.05).HBeAg seroconversion rate in observation group was 4.0%at 24-week, which were higher than that in control group 1 (χ2 =2.87, P <0.05), but the seroconversion rates at 96-and 144-week were lower than those in control group 2 (χ2 =2.92 and 3.14, P<0.05).Conclusion The efficacy of entecavir treatment for HBV infected patients with mild hepatic dysfunction and marked pathological injury is satisfactory.