恩替卡韦与阿德福韦酯单药治疗HBeAg阳性慢性乙型肝炎的效果及安全性比较

Comparison of efficacy and safety between entecavir versus adefovir dipivoxil in the treatment of HBeAg positive chronic hepatitis B

目的 比较恩替卡韦和阿德福韦酯治疗乙型肝炎病毒E抗原（HBeAg）阳性的慢性乙型肝炎（chronic hepatitis B，CHB）的效果和安全性。方法 96例HBeAg阳性CHB患者根据用药不同，分为恩替卡韦组和阿德福韦酯组，每组48例。两组患者在常规治疗基础上，恩替卡韦组给予恩替卡韦0.5 mg/日，阿德福韦酯组给予阿德福韦酯10 mg/日。比较两组患者治疗24、48、96周乙型肝炎病毒DNA（HBV DNA）转阴率，丙氨酸氨基转移酶（ALT）复常率和HBeAg转阴率以及不良反应情况和96周肝功能恢复情况。结果 恩替卡韦组第24周，48周以及96周的HBV DNA转阴率均显著高于阿德福韦酯组[24周：64.6%（31/48）与41.7%（20/48）；48周：83.3%（40/48）与52.1%（25/48）；96周：97.9%（47/48）与62.5%（30/48），χ2值分别为5.06、10.72、18.96，P均〈0.05]。恩替卡韦组第24周，48周的ALT复常率均显著高于阿德福韦酯组[24周：77.1%（37/48）与54.2%（26/48）；48周：85.4%（40/48）与62.5%（30/48），χ2值分别为5.59、6.54，P均〈0.05]，两组患者第96周ALT复常率之间无显著性差异（χ2＝0.71，P〉0.05）。两组患者不同时间点的血清HBeAg转阴率均不存在显著性差异（χ2值分别为0.07、0.22、0.44，P均〉0.05）。96周后，两组患者ALT均显著下降（t值分别为13.56、11.85，P均〈0.05），恩替卡韦组ALT显著低于阿德福韦酯组[（31.8±8.6）U/L与（38.5±7.5）U/L，t＝4.07，P〈0.05]；两组患者AST均显著下降（t值分别为41.27、33.68，P均〈0.05），恩替卡韦组AST显著低于阿德福韦酯组[（30.3±6.5）U/L与（37.6±7.1）U/L，t＝5.25，P〈0.05]；两组患者TBIL均显著下降（t值分别为28.92、22.23，P均〈0.05），恩替卡韦组TBIL显著低于阿德福韦酯组[（13.5±3.3） μmol/L与（18.7±3.9） μmol/L，t＝7.05，P〈0.05]；两组患者谷氨酰转肽酶（GGT）均显著下降（t值分别为16.99、13.97，P均〈0.05），恩替卡韦组GGT显著低于阿德福韦酯组[（35.6±10.4）U/L与（59.7±12.5）U/L，t＝10.27，P〈0.05]。结论 恩替卡韦治疗HBeAg阳性的CHB具有更高的HBV DNA转阴率，ALT复常率和HBeAg转阴率，是理想的抗病毒药物。

Objective To compare the efficacy and safety of entecavir versus adefovir dipivoxil in the treatment of HBeAg positive chronic hepatitis B （CHB）.Methods Ninety-six cases with HBeAg positive CHB were divided into ETV group and ADV group according to different medication.In addition to conventional treatment, ETV group received entecavir 0.5 mg/d, ADV group received adefovir dipivoxil 10 mg/d.HBV DNA negative conversion rate, alanine aminotransferase （ALT） recurrence rate and HBeAg negative conversion rate in 24 weeks, 48 weeks and 96 weeks were compared as well as the adverse reactions and liver function in 96 weeks.Results HBV DNA negative conversion rates in ETV group were significantly higher than those in ADV group in 24 weeks, 48 weeks and 96 weeks （24 weeks： 64.6%（31/48） vs.41.7%（20/48）; 48 weeks： 83.3%（40/48） vs.52.1%（25/48）; 96 weeks： 97.9%（47/48） vs.62.5%（30/48）, χ2=5.06, 10.72, 18.96, P〈0.05）. ALT recurrence rates in ETV group were significantly higher than those in ADV group at 24 weeks, 48 weeks （24weeks： 77.1%（37/48） vs.54.2%（26/48）; 48weeks： 85.4%（40/48） vs.62.5%（30/48）, χ2=5.59, 6.54, P〈0.05）. There was no significant difference in ALT complication rate at 96 week（χ2=0.71, P〉0.05）. There was no significant difference in HBeAg negative conversion rate between the two groups through treatment（χ2=0.07, 0.22, 0.44, P〉0.05）. After 96 weeks, ALT in both groups decreased significantly（t=13.56, 11.85, P〈0.05）, while ALT in ETV group was significantly lower than that in ADV group （ （31.8±8.6） U/L vs.（38.5±7.5） U/L, t=4.07, P〈0.05）. AST in both groups decreased significantly（t=41.27, 33.68, P〈0.05）, while AST in ETV group was significantly lower than that in ADV group （ （30.3±6.5） U/L vs.（37.6±7.1）U/L, t=5.25, P〈0.05）. TBIL in both groups decreased significantly（t=28.92, 22.23, P〈0.05）, while TBIL in ETV group was significantly lower than that in ADV group （ （13.5±3.3） μmol/L vs.（18.7±3.9） μmol/L, t=7.05, P〈0.05）. GGT in both groups decreased significantly （t=16.99, 13.97, P〈0.05）, while GGT in ETV group was significantly lower than that in ADV group （ （35.6±10.4）U/L vs.（59.7±12.5）U/L, t=10.27, P〈0.05）. There was no significant difference in adverse reaction between the two groups （χ2=1.96, P〉0.05）.Conclusion Entecavir has a higher rate of HBV DNA negative conversion rate, ALT recurrence rate and HBeAg negative conversion rate in the treatment of HBeAg positive CHB.It is an ideal antiviral drug.