富马酸替诺福韦酯单药长期治疗多药耐药慢性乙型肝炎患者的临床疗效及安全性分析
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摘要
目的探讨富马酸替诺福韦酯(TDF)单药长期治疗多药耐药慢性乙型肝炎(CHB)的临床疗效及安全性。方法选取2008年12月—2012年12月收治的多药耐药CHB 128例,根据治疗方法分为观察组60例和对照组68例,对照组在常规治疗基础上予以TDF联合恩替卡韦(ETV)治疗,观察组在常规治疗基础上仅给予TDF单药治疗,2组均治疗144周。分别于治疗48周和144周记录并比较2组肝功能及血清病毒学相关指标检查结果及临床疗效,并记录2组在治疗过程中相关不良反应的发生情况。结果 2组治疗后丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、总胆红素(TBIL)和乙型肝炎病毒(HBV)DNA水平均较治疗前下降,且治疗144周后下降程度大于治疗48周时(P<0.05),但2组同时间段比较差异无统计学意义(P>0.05)。2组治疗144周时其HBe Ag转阴、ALT复常及临床有效率均高于治疗48周(P<0.05),但2组同时间段比较差异无统计学意义(P>0.05)。2组不良反应发生率比较差异无统计学意义(P>0.05)。结论 TDF单药治疗多药耐药CHB效果较好,且安全性较高。
Objective To investigate clinical efficacy and safety of Tenofovir Disoproxil Fumarate( TDF) monotherapy in long-term treatment of patients with Multidrug Resistance chronic hepatitis B( CHB). Methods A total of128 Multidrug Resistance resistant CHB patients admitted during December 2008 and December 2012 were divided into observation group( n = 60) and control group( n = 68) according to therapeutic methods. Control group was treated with TDF combined with Entecavir( ETV) on the basis routine treatment for CHB,while observation group was treated with TDF monotherapy on the basis routine treatment for CHB. All patients were treated for 144 weeks. After treatment for 48 weeks and 144 weeks,liver function,results of serum virology-related indexes and clinical effect were compared,and incidence rates of adverse reactions were recorded in two groups. Results After treatment,levels of alanine transarninase( ALT),aspartate aminotransferase( AST),total bilirubin( TBIL) and hepatitis b virus( HBV) DNA were significantly lower than those before treatment in two groups,and decreased degrees after treatment for 144 weeks were significantly greater than those after treatment for 48 weeks( P < 0. 05),but there were no significant differences in the same time between two groups( P > 0. 05). Values of HBe Ag negative conversion,ALT normalization and clinical effective rate after treatment for 144 weeks were significantly higher than those after treatment for 48 weeks in two groups( P < 0. 05),but there were no significant differences in the same time between two groups( P > 0. 05). There was no significant difference in incidence rate of adverse reactions between two groups( P > 0. 05). Conclusion TDF monotherapy in long-term treatment of patients with Multidrug Resistance CHB has good clinical efficacy and safety.
Objective To investigate clinical efficacy and safety of Tenofovir Disoproxil Fumarate( TDF) monotherapy in long-term treatment of patients with Multidrug Resistance chronic hepatitis B( CHB). Methods A total of128 Multidrug Resistance resistant CHB patients admitted during December 2008 and December 2012 were divided into observation group( n = 60) and control group( n = 68) according to therapeutic methods. Control group was treated with TDF combined with Entecavir( ETV) on the basis routine treatment for CHB,while observation group was treated with TDF monotherapy on the basis routine treatment for CHB. All patients were treated for 144 weeks. After treatment for 48 weeks and 144 weeks,liver function,results of serum virology-related indexes and clinical effect were compared,and incidence rates of adverse reactions were recorded in two groups. Results After treatment,levels of alanine transarninase( ALT),aspartate aminotransferase( AST),total bilirubin( TBIL) and hepatitis b virus( HBV) DNA were significantly lower than those before treatment in two groups,and decreased degrees after treatment for 144 weeks were significantly greater than those after treatment for 48 weeks( P < 0. 05),but there were no significant differences in the same time between two groups( P > 0. 05). Values of HBe Ag negative conversion,ALT normalization and clinical effective rate after treatment for 144 weeks were significantly higher than those after treatment for 48 weeks in two groups( P < 0. 05),but there were no significant differences in the same time between two groups( P > 0. 05). There was no significant difference in incidence rate of adverse reactions between two groups( P > 0. 05). Conclusion TDF monotherapy in long-term treatment of patients with Multidrug Resistance CHB has good clinical efficacy and safety.
引文
[1]Kim H J,Cho J Y,Kim Y J,et al.Long-term efficacy of tenofovir disoproxil fumarate therapy after multiple nucleos(t)ide analogue failure in chronic hepatitis B patients[J].Korean J Intern Med,2015,30(1):32-41.
[2]戚敬虎,鞠金昌,徐雷,等.富马酸替诺福韦二吡呋酯单药治疗拉米夫定耐药慢性乙型肝炎的疗效观察[J].中华肝脏病杂志,2016,24(4):307-309.
[3]颜悦蓉,冯继红.替诺福韦酯治疗核苷和核苷酸类药物耐药慢性乙型肝炎患者的研究进展[J].临床肝胆病杂志,2016,32(11):2182-2185.
[4]钱贤峰,吴昌平,徐君,等.慢性乙型肝炎抗病毒治疗对乙型肝炎病毒X蛋白表达的影响[J].江苏大学学报:医学版,2015,25(6):498-502.
[5]潘静,陆伦根.核苷(酸)类似物初始治疗慢性乙型肝炎患者疗效和安全性的网络Meta分析[J].实用肝脏病杂志,2017,20(1):29-33.
[6]冯淑焕,唐克诚,李谦.替诺福韦酯治疗多重耐药慢性乙型肝炎的回顾性分析[J].中国药房,2015,25(23):3251-3252.
[7]李杰,刘红云,王小莉.聚乙二醇干扰素α-2b对慢性乙型肝炎患者的免疫调节及抗病毒效果分析[J].解放军医药杂志,2017,29(8):86-89.
[8]周晶,黄建荣.替诺福韦酯治疗其他核苷类似物耐药慢性乙型肝炎的研究进展[J].国际流行病学传染病学杂志,2016,43(4):267-269.
[9]潘家超,王蒙,杨洋,等.替诺福韦酯与阿德福韦酯治疗HBe Ag阳性慢性乙型肝炎的临床对比[J].中华传染病杂志,2017,35(6):364-366.
[10]沈国栋,陈治宇,单来友,等.血栓弹力图联合常规凝血实验指导乙型肝炎患者成分血液输注[J].江苏大学学报:医学版,2015,25(4):356-359.
[11]王贵强.慢性乙型肝炎抗病毒治疗药物选择——2017年版欧洲肝病学会《慢性乙型肝炎病毒感染管理临床实践指南》解读[J].中国病毒病杂志,2017,7(5):330-332.
[12]Kim H J,Cho J Y,Kim Y J,et al.Long-term efficacy of tenofovir disoproxil fumarate therapy after multiple nucleos(t)ide analogue failure in chronic hepatitis B patients[J].Korean J Intern Med,2015,30(1):32-41.
[13]张文娟,张静洁,郑志兵.乙肝治疗新药——替诺福韦艾拉酚胺半富马酸[J].临床药物治疗杂志,2017,15(3):10-13.
[14]耿爱文,肖丽,咸建春,等.慢性乙型肝炎核苷酸类似物耐药患者外周血IL-21、γ-IFN、IL-10及β-TGF变化的临床研究[J].解放军医药杂志,2016,28(9):69-71.
[15]王红艳,郎丽巍,朱珍真,等.富马酸替诺福韦二吡呋酯片在健康人体的生物等效性研究[J].中国临床药理学杂志,2016,32(23):2145-2147.
[16]孙文霞,张舒,田媛,等.新型前药富马酸泰诺福韦双特戊酯在beagle犬的毒动学研究[J].中国抗生素杂志,2016,41(2):153-158.
[17]王宇,饶友义,郭军,等.报告比值比法挖掘富马酸替诺福韦二吡呋酯不良反应信号[J].中国药房,2016,27(32):4515-4518.
[18]Huang M,Jie Y,Lin G,et al.Long-Term Efficacy of Tenofovir Disoproxil Fumarate Therapy in Nucleos(t)ideExperienced Chronic Hepatitis B Patients[J].Clin Drug Investig,2016,36(6):471-478.
[19]张洋.乙型肝炎患者的血清病毒学检查结果分析[J].保健医学研究与实践,2016,13(6):47-49.
[20]陈玉兰,刘洁,陈立宇.三种核苷类似物对慢性乙型肝炎患者肾功能影响的长期随访研究[J].解放军医药杂志,2016,28(6):83-86.
[2]戚敬虎,鞠金昌,徐雷,等.富马酸替诺福韦二吡呋酯单药治疗拉米夫定耐药慢性乙型肝炎的疗效观察[J].中华肝脏病杂志,2016,24(4):307-309.
[3]颜悦蓉,冯继红.替诺福韦酯治疗核苷和核苷酸类药物耐药慢性乙型肝炎患者的研究进展[J].临床肝胆病杂志,2016,32(11):2182-2185.
[4]钱贤峰,吴昌平,徐君,等.慢性乙型肝炎抗病毒治疗对乙型肝炎病毒X蛋白表达的影响[J].江苏大学学报:医学版,2015,25(6):498-502.
[5]潘静,陆伦根.核苷(酸)类似物初始治疗慢性乙型肝炎患者疗效和安全性的网络Meta分析[J].实用肝脏病杂志,2017,20(1):29-33.
[6]冯淑焕,唐克诚,李谦.替诺福韦酯治疗多重耐药慢性乙型肝炎的回顾性分析[J].中国药房,2015,25(23):3251-3252.
[7]李杰,刘红云,王小莉.聚乙二醇干扰素α-2b对慢性乙型肝炎患者的免疫调节及抗病毒效果分析[J].解放军医药杂志,2017,29(8):86-89.
[8]周晶,黄建荣.替诺福韦酯治疗其他核苷类似物耐药慢性乙型肝炎的研究进展[J].国际流行病学传染病学杂志,2016,43(4):267-269.
[9]潘家超,王蒙,杨洋,等.替诺福韦酯与阿德福韦酯治疗HBe Ag阳性慢性乙型肝炎的临床对比[J].中华传染病杂志,2017,35(6):364-366.
[10]沈国栋,陈治宇,单来友,等.血栓弹力图联合常规凝血实验指导乙型肝炎患者成分血液输注[J].江苏大学学报:医学版,2015,25(4):356-359.
[11]王贵强.慢性乙型肝炎抗病毒治疗药物选择——2017年版欧洲肝病学会《慢性乙型肝炎病毒感染管理临床实践指南》解读[J].中国病毒病杂志,2017,7(5):330-332.
[12]Kim H J,Cho J Y,Kim Y J,et al.Long-term efficacy of tenofovir disoproxil fumarate therapy after multiple nucleos(t)ide analogue failure in chronic hepatitis B patients[J].Korean J Intern Med,2015,30(1):32-41.
[13]张文娟,张静洁,郑志兵.乙肝治疗新药——替诺福韦艾拉酚胺半富马酸[J].临床药物治疗杂志,2017,15(3):10-13.
[14]耿爱文,肖丽,咸建春,等.慢性乙型肝炎核苷酸类似物耐药患者外周血IL-21、γ-IFN、IL-10及β-TGF变化的临床研究[J].解放军医药杂志,2016,28(9):69-71.
[15]王红艳,郎丽巍,朱珍真,等.富马酸替诺福韦二吡呋酯片在健康人体的生物等效性研究[J].中国临床药理学杂志,2016,32(23):2145-2147.
[16]孙文霞,张舒,田媛,等.新型前药富马酸泰诺福韦双特戊酯在beagle犬的毒动学研究[J].中国抗生素杂志,2016,41(2):153-158.
[17]王宇,饶友义,郭军,等.报告比值比法挖掘富马酸替诺福韦二吡呋酯不良反应信号[J].中国药房,2016,27(32):4515-4518.
[18]Huang M,Jie Y,Lin G,et al.Long-Term Efficacy of Tenofovir Disoproxil Fumarate Therapy in Nucleos(t)ideExperienced Chronic Hepatitis B Patients[J].Clin Drug Investig,2016,36(6):471-478.
[19]张洋.乙型肝炎患者的血清病毒学检查结果分析[J].保健医学研究与实践,2016,13(6):47-49.
[20]陈玉兰,刘洁,陈立宇.三种核苷类似物对慢性乙型肝炎患者肾功能影响的长期随访研究[J].解放军医药杂志,2016,28(6):83-86.