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

张家伟; 耿家宝; 卢锋; 董宇

doi:10.3969/j.issn.1001-5256.2018.02.011

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

DOI: 10.3969/j.issn.1001-5256.2018.02.011

1. 周口市中心医院感染性疾病科
2. 南京中医药大学附属八一医院感染性疾病科

详细信息

中图分类号: R512.62
计量
- 文章访问数: 3368
- HTML全文浏览量: 70
- PDF下载量: 543
- 被引次数: 0
出版历程
- 出版日期: 2018-02-20

Clinical effect of tenofovir disoproxil fumarate versus entecavir in treatment of treatment-naïve patients with chronic HBV infection

Department of Infectious Diseases, Zhoukou Central Hospital

摘要

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（HBs Ag、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...
- 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
Abstract:
Objective To investigate the antiviral effect of tenofovir disoproxil fumarate (TDF) versus entecavir (ETV) in the treatment of treatment-nave patients with chronic HBV infection.Methods A 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 (HBs Ag, 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.Results At 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) .Conclusion In 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.
- hepatitis B, chronic /
- tenofovir disoproxil fumarate /
- entecavir /
- treatment outcome

HTML全文

参考文献(19)

[1]SARIN SK, KUMAR M, LAU GK, et al.Asian-Pacific clinical practice guidelines on the management of hepatitis B:a 2015 update[J].Hepatol Int, 2016, 10 (1) :1-98.

[2]YAN YP, SU HX, JI ZH, et al.Epidemiology of hepatitis B virus infection in China:current status and challenges[J].J Clin Transl Hepatol, 2014, 2 (1) :15-22.

[3]LOK AS, MCMAHON BJ.Chronic hepatitis B:update 2009[J].Hepatology, 2009, 50 (3) :661-662.

[4]SCHUTTE K, BALBISI F, MALFERTHEINER P.Prevention of hepatocellular carcinoma[J].Gastrointest Tumors, 2016, 3 (1) :37-43.

[5]XU W, YU J, WONG VW.Mechanism and prediction of HCC development in HBV infection[J].Best Pract Res Clin Gastroenterol, 2017, 31 (3) :291-298.

[6]WANG FM, LIU JT.Clinical efficacy of entecavir combined with Ganfule capsules in treatment of 80 cases of chronic hepatitis B with hepatic fibrosis[J/CD].Chin J Liver Dis:Electronic Edition, 2016, 8 (2) :95-98. (in Chinese) 王芳梅, 刘金涛.恩替卡韦联合肝复乐胶囊治疗慢性乙型肝炎肝纤维化80例疗效观察[J/CD].中国肝脏病杂志:电子版, 2016, 8 (2) :95-98.

[7]ZHANG Y, YU YS, TANG ZH, et al.Clinical study of entecavir combined with kushenin improving the Th1/Th2 imbalance in patients with HBeAg-positive chronic hepatitis B[J].Chin J Clin Pharmacol Ther, 2016, 21 (10) :1168-1172. (in Chinese) 张毅, 余永胜, 汤正好, 等.恩替卡韦联合苦参素改善HBeAg阳性慢性乙型肝炎患者Th1/Th2失平衡临床研究[J].中国临床药理学与治疗学, 2016, 21 (10) :1168-1172.

[8]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].J Clin Hepatol, 2015, 31 (12) :1941-1960. (in Chinese) 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) :1941-1960.

[9]FAN R, SUN J, HOU JL.Antiviral therapy for chronic hepatitis B:current status and perspectives[J].J Clin Hepatol, 2016, 32 (11) :2029-2032. (in Chinese) 樊蓉, 孙剑, 侯金林.慢性乙型肝炎抗病毒治疗现状及展望[J].临床肝胆病杂志, 2016, 32 (11) :2029-2032.

[10]HA NB, TRINH HN, ROSENBLATT L, et al.Treatment outcomes with first-line therapies with entecavir and tenofovir in treatmentnaive chronic hepatitis B patients in a routine clinical practice[J].J Clin Gastroenterol, 2016, 50 (2) :169-174.

[11]IDILMAN R, GUNSAR F, KORUK M, et al.Long-term entecavir or tenofovir disoproxil fumarate therapy in treatment-na6ve chronic hepatitis B patients in the real-world setting[J].J Viral Hepat, 2015, 22 (5) :504-510.

[12]BATIREL A, GUCLU E, ARSLAN F, et al.Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-na6ve patients with chronic hepatitis B:a multicenter real-life study[J].Int J Infect Dis, 2014, 28 (11) :153-159.

[13]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.

[14]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.

[15]YOO EH, CHO HJ.Clinical response to long-term tenofovir monotherapy in Korean chronic hepatitis B patients[J].Clin Chim Acta, 2017, 471 (8) :308-313.

[16]MURAT K, FATMA S, YESIM A, et al.Head-to-head comparison of two years efficacy of entecavir and tenofovir in patients with treatment-na6ve chronic hepatitis B--The real life data[J].Hepatogastroenterology, 2015, 62 (140) :982-986.

[17]CHANG TT, GISH RG, de MAN R, et al.A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B[J].N Engl J Med, 2006, 354 (10) :1001-1010.

[18]MARCELLIN P, HEATHCOTE EJ, BUTI M, et al.Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B[J].N Engl J Med, 2008, 359 (23) :2442-2455.

[19]LOPEZ CENTENO B, COLLADO BORRELL R, PEREZ ENCINAS M, et al.Comparison of the effectiveness and renal safety of tenofovir versus entecavir in patients with chronic hepatitis B[J].Farm Hosp, 2016, 40 (4) :279-286.

施引文献

资源附件(0)

访问统计