基于替诺福韦和齐多夫定的抗人免疫缺陷病毒方案疗效比较

Efficacy comparison of tenofovir and zidovudine based antiretroviral therapy in patients with HIV infection

目的:对比富马酸替诺福韦(tenofovir disoproxil fumarate,TDF)、拉米夫定(lamivudine,3TC)、依非韦伦(efavirenz,EFV)和齐多夫定(zidovudine,AZT)、3TC、EFV两种抗逆转录病毒治疗(antiretroviral therapy,ART)方案对人免疫缺陷病毒(human immunodeficiency virus,HIV)感染者抗病毒的疗效。方法:选择461例诊断为HIV感染、CD4+T淋巴细胞<500个/μL的患者作为研究对象,351例接受TDF、3TC、EFV治疗(TDF组),110例接受AZT、3TC、EFV治疗(AZT组),检测患者基线以及治疗1年后CD4+T淋巴细胞、HIV RNA水平;按病毒学应答不同结局,采用Logistic二元回归法进行多因素分析。结果:TDF组患者治疗前CD4+T淋巴细胞为202.8(88.0,289.0)个/μL,治疗1年后为353.0(228.0,518.3)个/μL;AZT组治疗前CD4+T淋巴细胞为227.0(140.5,319.3)个/μL,治疗1年后为432.5(253.75,528.0)个/μL,两种治疗方案对提升CD4+T淋巴细胞数量差异无统计学意义(P=0.753);TDF组、AZT组免疫学应答成功率差异无统计学意义(294/351 vs 93/110,P=0.845);以HIV RNA<200 copies/mL为标准,ART 1年后病毒学应答率两种治疗方案相比差异无统计学意义(335/351 vs 107/110,P>0.05);以HIV RNA<20 copies/mL为标准,达到病毒学应答率,两种治疗方案差异有统计学意义(283/351 vs 100/110,P=0.012);Logistic二元回归分析提示TDF组病毒学应答失败率高于AZT组合(Exp(B)=2.135,95%CI:1.047~4.353,P<0.05)。结论:以AZT为基础抗逆转录病毒治疗方案对于免疫学应答疗效与以TDF为基础方案相似;以AZT为基础的方案病毒学应答失败率(以HIV RNA<20 copies/mL为标准)低于以TDF为基础的方案。

Objective:To compare the efficacy of two antiretroviral treatment(ART)plans in patients with human immunedefeciency virus(HIV)infection,which one is included tenofovir disoproxil fumarat(TDF),lamivudine(3TC)and efavirenz(EFV)(TDF group);another is included zidovudine(AZT),3TC,EFV(AZT group).Methods:461 patients with HIV infection were enrolled in the studying,whose CD+T lymphocytes were under 500/μL.HIV ribonucleic acid(RNA)and the count of CD4+T lymphocytes were detected before ART and after one year of ART.According to the different outcomes of virological response,Logistic binary regression was used for multivariate analysis.Results:In TDF group,the number of CD4+T lymphocytes was 202.8(88.0,289.0)cells/μL before treatment and 353.0(228.0,518.3)cells/μL after one year of treatment.In AZT group,The number of CD4+T lymphocytes was 227.0(140.5,319.3)cells/μL before treatment and 432.5(253.7,528.0)cells/μL after one year of treatment;there was no significant difference in improving the number of CD4+T lymphocytes between the two treatment schemes(P=0.753).There was no significant difference in the success rate of immune response between the two treatments after one year of ART(294/351 vs 93/110,P=0.845).If taking HIV RNA<200 copies/mL as standard,There was no significant difference in the virological response rate between the two regimens after ART(335/351 vs 107/110,P>0.05).Taking HIV RNA<20 copies/mL as standard,Significant difference was found in the virological response rate between the two regimens(283/351 vs 100/110,P=0.012).Logistic binary regression analysis indicated that the failure rate of virological response of TDF gruop was higher than that of AZT group if taking HIV RNA<20 copies/mL as standard(Exp(B)=2.224,95%CI:1.086-4.554,P<0.05).Conclusion:The efficacy of AZT based ART for immunological response is similar to that of TDF based therapy,the failure rate of AZT based therapy(based on HIV RNA<20 copies/mL)is lower than that of TDF based therapy.