替诺福韦二吡呋酯和恩替卡韦初治慢性HBV感染者的效果比较

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富马酸替诺福韦二吡呋酯和恩替卡韦初治慢性HBV感染者的效果比较Clinical effect of tenofovir disoproxil fumarate versus entecavir in treatment of treatment-nave patients with chronic HBV infection文章发布日期：2018年01月05日　 来源：　 作者：张家伟，耿家宝，卢锋，等　 点击次数：120次　 下载次数：4次
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【摘要】：目的比较富马酸替诺福韦二吡呋酯（TDF）、恩替卡韦（ETV组）治疗初治慢性HBV感染者的抗病毒疗效。方法收集2014年7月-2015年7月周口市中心医院和南京中医药大学附属八一医院接受TDF或ETV抗病毒治疗且定期随诊的420例初治慢性HBV感染或肝硬化患者，其中接受TDF治疗者184例（TDF组），接受ETV治疗者236例（ETV组）。监测患者的基线值以及治疗后4、8、12、24、48周的实验室指标：肝肾功能指标、血钙、血磷、肌酸激酶、HBV DNA水平、肝炎标志物(HBsAg、HBeAg、抗-HBe等)，以及药物的不良反应。计量资料组间比较采用t检验，计数资料组间比较采用χ2检验或Fisher确切概率法。结果治疗48周时，TDF组与ETV组的HBeAg阳性患者、HBeAg阳性且HBV DNA＞6 lg IU/ml患者的HBeAg阴转率比较差异均无统计学意义（P值均＞0.05）；TDF组与ETV组的HBeAg阴性患者、HBeAg阳性患者、HBeAg阳性且HBV DNA＞6 lg IU/ml患者的ALT复常率比较差异均无统计学意义（P值均＞0.05）。给予抗病毒治疗后，2组患者HBV DNA水平逐渐下降。治疗48周时，TDF组与ETV组的HBeAg阳性患者中的HBV DNA水平低于检测值下限率分别为75.5%、60.8%，差异有统计学意义（χ2=5.857，P=0.016）；TDF组与ETV组HBeAg阳性且HBV DNA＞6 lg IU/ml患者中HBV DNA水平低于检测值下限率分别为75.7%、60.5%，差异有统计学意义（χ2=5.722，P=0.017）。96周时，不管是整体还是在亚组（HBeAg阳性、HBeAg阳性且HBV DNA＞6 lg IU/ml）间比较，TDF组HBV DNA低于检测值下限率均高于ETV组（93.5% vs 86.9%， χ2=4.921，P=0.027；89.1% vs 76.2%， χ2=6.781，P=0.009；88.3% vs 73.7%, χ2=7.456，P=0.006）。结论在HBeAg阳性慢性HBV感染者中，TDF抑制HBV DNA的能力明显优于ETV，尤其对HBV DNA＞6 lg IU/ml的患者。
【Abstract】：ObjectiveTo investigate the antiviral effect of tenofovir disoproxil fumarate (TDF) versus entecavir (ETV) in the treatment of treatment-nave patients with chronic HBV infection. MethodsA total of 420 treatment-nave patients with chronic HBV infection or liver cirrhosis who received antiviral therapy with TDF or ETV and were regularly followed up in Zhoukou Central Hospital or Bayi Hospital Affiliated to Nanjing University of Chinese Medicine from July 2014 to July 2015 were enrolled, and among these patients, 184 received TDF (TDF group) and 236 received ETV (ETV group). Laboratory markers were measured at baseline and at weeks 4, 8, 12, 24, and 48 of treatment, including liver and renal function parameters, blood calcium, serum phosphate, creatine kinase, HBV DNA level, hepatitis markers (HBsAg, HBeAg, and anti-HBe). Adverse drug reactions were also monitored. The t-test was used for comparison of continuous data between groups, and the chi-square test or Fisher′s exact test was used for comparison of categorical data between groups. ResultsAt week 48 of treatment, there were no significant differences between the two groups in HBeAg clearance rate among both HBeAg-positive patients and HBeAg-positive patients with HBV DNA ＞6 lg IU/ml (P＞0.05). There were also no significant differences between the two groups in alanine aminotransferase normalization rate among HBeAg-negative patients, HBeAg-positive patients, and HBeAg-positive patients with HBV DNA ＞6 lg IU/ml (P＞0.05). Both groups had a gradual reduction in HBV DNA level after the antiviral therapy. At week 48 of treatment, there were significant differences between the TDF group and the ETV group in the proportion of patients with a HBV DNA level below the lower limit of detection among HBeAg-positive patients (75.5% vs 60.8%, χ2=5.857, P=0.016) and HBeAg-positive patients with HBV DNA ＞6 lg IU/ml (75.7% vs 60.5%, χ2=5.722, P=0.017). At week 96 of treatment, the TDF group had a significantly higher rate of HBV DNA below the lower limit of detection than the ETV group among all patients (93.5% vs 86.9%, χ2=4.921, P=0.027), HBeAg-positive patients (89.1% vs 76.2%, χ2=6.781, P=0.009), and HBeAg-positive patients with HBV DNA ＞6 lg IU/ml (88.3% vs 73.7%, χ2=7.456, P=0.006). ConclusionIn HBeAg-positive patients with chronic HBV infection, TDF has a better inhibitory effect on HBV DNA than ETV, especially in those with HBV DNA ＞6 lg IU/ml.
【关键字】：肝炎, 乙型, 慢性； 富马酸替诺福韦二吡呋酯； 恩替卡韦；治疗结果
【Key words】：hepatitis B, chronic； tenofovir disoproxil fumarate； entecavir；        treatment outcome
【引证本文】：ZHANG JW, GENG JB, LU F, et al. Clinical effect of tenofovir disoproxil fumarate versus entecavir in treatment of treatment-nave patients with chronic HBV infection［J］. J Clin Hepatol, 2018, 34(2): 272-275. （in Chinese)
张家伟， 耿家宝， 卢锋， 等. 富马酸替诺福韦二吡呋酯和恩替卡韦初治慢性HBV感染者的效果比较［J］. 临床肝胆病杂志, 2018, 34(2): 272-275.

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结论在HBeAg阳性慢性HBV感染者中，TDF抑制HBV DNA的能力明显优于ETV，尤其对HBV DNA＞6 lg IU/ml的患者。

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