替诺福韦与恩替卡韦治疗HBeAg阳性慢性乙型病毒性肝炎患者临床短期疗效
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摘要
目的:观察替诺福韦(TDF)与恩替卡韦(ETV)治疗HBeAg阳性慢性乙型肝炎患者的抗病毒治疗效果。方法:收集2016年6月-2018年6月于我科门诊及住院治疗的80例慢性乙型肝炎(CHB)患者,随机分为TDF组(n=40)和ETV组(n=40)。TDF组应用富马酸替诺福韦二吡呋酯片治疗,ETV组患者应用恩替卡韦分散片治疗,随访48周。分析治疗24和48周后血清丙氨酸氨基转移酶(ALT)复常率、HBV DNA转阴率、HBeAg血清学转换率。结果:在治疗24周后,ETV组及TDF组患者的血清ALT复常率分别是55%和50%、HBV-DNA转阴率分别是70%和57. 5%,HBeAg血清学转换率分别是2. 5%和5%,差异无统计学意义(P分别为0. 654、0. 245和0. 556);在治疗48周后,ETV组及TDF组患者的血清ALT复常率分别是82. 5%和75%、HBV DNA转阴率分别是85%和82. 5%,HBeAg血清学转换率分别是10%和12. 5%,差异无统计学意义(P分别为0. 412、0. 762和0. 723)。结论:替诺福韦与恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者48周的临床疗效无显著差别。
Objective: To observe and compare the therapeutic effects of tenofovir disoproxil fumarate(TDF) and entecavir(ETV) HBeAg-positive patients with chronic hepatitis B(CHB).Methods: A total of 80 patients with CHB in our hospital from June 2016 to June 2018 were enrolled. All patients were randomly divided into TDF group(n=40) and ETV group(n=40). All patients were followedup for 48 weeks. Rates of alamine aminotransferase(ALT) normalization, undetectable HBV DNA levels and HBeAg seroconversion between TDF group and ETV group were compared at the end of24 and 48 weeks.Results: At the end of 24 weeks, the rates of ALT normalization were 55% and50% respectively; the rates of undetectable HBV DNA levels were 70% and 57. 5%, respectively;and the rates of HBeAg seroconversion were 2. 5% and 5% respectively in ETV group and TDF group, between which there were no statistical difference(P=0. 654, 0. 245 and 0. 556, respectively). At the end of 48 weeks, the rates of ALT normalization were 82. 5% and 75% respectively; the rates of undetectable HBV DNA levels were 85% and 82. 5% respectively; and the rates of HBeAg seroconversion were 10% and 12. 5% respectively in ETV group and TDF group, between which there were no statistical difference(P=0. 412, 0. 762 and 0. 723, respectively).Conclusion: TDF and ETV have similarly anti-viral therapeutic effects on HBeAg-positive patients with CHB.
Objective: To observe and compare the therapeutic effects of tenofovir disoproxil fumarate(TDF) and entecavir(ETV) HBeAg-positive patients with chronic hepatitis B(CHB).Methods: A total of 80 patients with CHB in our hospital from June 2016 to June 2018 were enrolled. All patients were randomly divided into TDF group(n=40) and ETV group(n=40). All patients were followedup for 48 weeks. Rates of alamine aminotransferase(ALT) normalization, undetectable HBV DNA levels and HBeAg seroconversion between TDF group and ETV group were compared at the end of24 and 48 weeks.Results: At the end of 24 weeks, the rates of ALT normalization were 55% and50% respectively; the rates of undetectable HBV DNA levels were 70% and 57. 5%, respectively;and the rates of HBeAg seroconversion were 2. 5% and 5% respectively in ETV group and TDF group, between which there were no statistical difference(P=0. 654, 0. 245 and 0. 556, respectively). At the end of 48 weeks, the rates of ALT normalization were 82. 5% and 75% respectively; the rates of undetectable HBV DNA levels were 85% and 82. 5% respectively; and the rates of HBeAg seroconversion were 10% and 12. 5% respectively in ETV group and TDF group, between which there were no statistical difference(P=0. 412, 0. 762 and 0. 723, respectively).Conclusion: TDF and ETV have similarly anti-viral therapeutic effects on HBeAg-positive patients with CHB.
引文
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[6]中华医学会肝病学分会,中华医学会感染病学分会.慢性乙型肝炎防治指南(2015年更新版)[J].临床肝胆病杂志,2015,31(12):1 941-1 960.Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association. The guideline of prevention and treatment for chronic hepatitis B:a 2015 update[J]. Journal of Clinical Hepatology,2015,31(12):1 941-1 960.
[7] Gao L, Trinh HN, Li J, et al. Tenofovir is superior to entecavir for achieving complete viral suppression in HBeAg-positive chronic hepatitis B patients with high HBV DNA[J]. Aliment Pharmacol Ther, 2014, 39(6):629-637.
[8] Ozaras R, Mete B, Ceylan B, et al. First-line monotherapies of tenofovir and entecavir have comparable efficacies in hepatitis B treatment[J]. Eur J Gastroenterol Hepatol, 2014,26(7):774-780.
[9] Chen J, Zhao SS, Liu XX, et al. Comparison of the efficacy of tenofovir versus tenofovir plus entecavir in the treatment of chronic hepatitis B in patients with poor efficacy of entecavir:a systematic review and meta-analysis[J]. Clin The, 2017,39(9):1 870-1 880.
[10]雷娜,陈新月.替诺福韦酯治疗慢性乙型肝炎研究进展[J].中国病毒病杂志,2014,4(1):68-72.Lei N, Chen XY. Recent progress of tenofovir disoproxil fumarate in the treatment of chronic hepatitis B[J]. Chinese Journal of Viral Diseases, 2014, 4(1):68-72.
[11] Kitrinos KM, Corsa A, Liu Y, et al. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B[J]. Hepatology, 2014,59(2):434-442.
[12] Batirel A, Guclu E, Arslan F, et al. Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-na?ve patients with chronic hepatitis B:a multicenter real-life study[J]. Int J Infect Dis,2014,28:153-159.
[13] Ceylan B, Yardimci C, Fincanci M, et al. Comparison of tenofovir and entecavir in patients with chronic HBV infection[J]. Eur Rev Med Pharmacol Sci, 2013,17(18):2 467-2 473.
[14] Zuo SR, Zuo XC, Wang CJ, et al. A meta-analysis comparing the efficacy of entecavir and tenofovir for the treatment of chronic hepatitis B infection[J]. J Clin Pharmacol, 2015,55(3):288-297.
[15] Gao L, Trinh HN, Li J, et al. Tenofovir is superior to entecavir for achieving complete viral suppression in HBeAg-positive chronic hepatitis B patients with high HBV DNA[J]. Aliment Pharmacol Ther, 2014, 39(6):629-637.
[16] Shi H, Huang M, Lin G, et al. Efficacy comparison of tenofovir and entecavir in HBeAg-positive chronic hepatitis B patients with high HBV DNA[J]. Biomed Res Int, 2016,2016:6725073.
[17] Fong TL, Tien A, Jo KJ, et al. Durability of hepatitis B e antigen seroconversion in chronic hepatitis B patients treated with entecavir or tenofovir[J]. Dig Dis Sci, 2015,60(11):3 465-3 472.
[18] Ke W, Liu L, Zhang C, et al. Comparison of efficacy and safety of tenofovir and entecavir in chronic hepatitis B virus infection:a systematic review and meta-analysis[J]. PLoS One, 2014,9(6):e98865.
[2] Rowe IA. Lessons from Epidemiology:The Burden of Liver Disease[J]. Dig Dis, 2017,35(4):304-309.
[3] GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, allcause mortality, and cause-specific mortality for 249causes of death, 1980-2015a systematic analysis for the Global Burden of Disease Study 2015[J]. Lancet,2016,388(10 053):1 459-1 544.
[4] Omata M, Cheng AL, Kokudo N, et al. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma:a 2017 update[J]. Hepatol Int,2017,11(4):317-370.
[5] European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection[J]. J Hepatol, 2017,67(2):370-398.
[6]中华医学会肝病学分会,中华医学会感染病学分会.慢性乙型肝炎防治指南(2015年更新版)[J].临床肝胆病杂志,2015,31(12):1 941-1 960.Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association. The guideline of prevention and treatment for chronic hepatitis B:a 2015 update[J]. Journal of Clinical Hepatology,2015,31(12):1 941-1 960.
[7] Gao L, Trinh HN, Li J, et al. Tenofovir is superior to entecavir for achieving complete viral suppression in HBeAg-positive chronic hepatitis B patients with high HBV DNA[J]. Aliment Pharmacol Ther, 2014, 39(6):629-637.
[8] Ozaras R, Mete B, Ceylan B, et al. First-line monotherapies of tenofovir and entecavir have comparable efficacies in hepatitis B treatment[J]. Eur J Gastroenterol Hepatol, 2014,26(7):774-780.
[9] Chen J, Zhao SS, Liu XX, et al. Comparison of the efficacy of tenofovir versus tenofovir plus entecavir in the treatment of chronic hepatitis B in patients with poor efficacy of entecavir:a systematic review and meta-analysis[J]. Clin The, 2017,39(9):1 870-1 880.
[10]雷娜,陈新月.替诺福韦酯治疗慢性乙型肝炎研究进展[J].中国病毒病杂志,2014,4(1):68-72.Lei N, Chen XY. Recent progress of tenofovir disoproxil fumarate in the treatment of chronic hepatitis B[J]. Chinese Journal of Viral Diseases, 2014, 4(1):68-72.
[11] Kitrinos KM, Corsa A, Liu Y, et al. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B[J]. Hepatology, 2014,59(2):434-442.
[12] Batirel A, Guclu E, Arslan F, et al. Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-na?ve patients with chronic hepatitis B:a multicenter real-life study[J]. Int J Infect Dis,2014,28:153-159.
[13] Ceylan B, Yardimci C, Fincanci M, et al. Comparison of tenofovir and entecavir in patients with chronic HBV infection[J]. Eur Rev Med Pharmacol Sci, 2013,17(18):2 467-2 473.
[14] Zuo SR, Zuo XC, Wang CJ, et al. A meta-analysis comparing the efficacy of entecavir and tenofovir for the treatment of chronic hepatitis B infection[J]. J Clin Pharmacol, 2015,55(3):288-297.
[15] Gao L, Trinh HN, Li J, et al. Tenofovir is superior to entecavir for achieving complete viral suppression in HBeAg-positive chronic hepatitis B patients with high HBV DNA[J]. Aliment Pharmacol Ther, 2014, 39(6):629-637.
[16] Shi H, Huang M, Lin G, et al. Efficacy comparison of tenofovir and entecavir in HBeAg-positive chronic hepatitis B patients with high HBV DNA[J]. Biomed Res Int, 2016,2016:6725073.
[17] Fong TL, Tien A, Jo KJ, et al. Durability of hepatitis B e antigen seroconversion in chronic hepatitis B patients treated with entecavir or tenofovir[J]. Dig Dis Sci, 2015,60(11):3 465-3 472.
[18] Ke W, Liu L, Zhang C, et al. Comparison of efficacy and safety of tenofovir and entecavir in chronic hepatitis B virus infection:a systematic review and meta-analysis[J]. PLoS One, 2014,9(6):e98865.