三种不同抗病毒方案对初治HIV感染者免疫疗效的分析

Effect of immune reconstruction from three different antiretroviral regimens on HIV/AIDS treated na■ve patients

目的比较奈韦拉平(nevirapine,NVP)、依非韦伦(efavirenz,EFV)、洛匹那韦/利托那韦(lopinavir/ritonavir,LPV/r)联合2种核苷类反转录酶抑制剂(NRTIs)对初治人类免疫缺陷病毒(human immunodeficiency virus,HIV)感染者的免疫疗效差异,为HIV感染者抗病毒治疗提供指导。方法采用双盲法随机选择初治的CD4^+T淋巴细胞计数<250个/μl的HIV感染者入组,通过Spw-Pb网络数据平台按1∶1∶1随机分配为A、B、C组,分别采用NVP、EFV、LPV/r为基础的3种抗病毒方案,对治疗前(0周)和随访过程中(12、24、36和48周)的CD4^+T淋巴细胞计数进行统计分析。统计软件为SPSS19.0,多组间比较采用One-way ANOVA,组间两两比较采用LSD-t检验,运用广义估计方程(GEE)模型分析。结果共入组300例患者,其中280例患者按照原方案完成随访至48周,3组患者基线信息匹配。3组的CD4+T淋巴细胞计数均较基线有明显的增长。3组患者随访12周、24周、36周、48周的CD4^+T淋巴细胞计数两两比较差异均无统计学意义(P均>0.05),抗病毒治疗48周后CD4^+T淋巴细胞增长值比较差异亦无统计学意义(P均>0.05)。通过GEE统计学模型对随访48周各组CD4^+T淋巴细胞计数进行分析,3组之间两两比较差异无统计学意义(P均>0.05)。结论分别含NVP、EFV、LPV/r的不同初治方案治疗的HIV感染者均获良好的免疫学恢复,且48周内免疫疗效相当,提示不同抗病毒药物免疫疗效不应成为临床医生为患者选择高效抗病毒方案时考虑的因素。

Objective To compare the efficacy of three kinds of immune reconstructions among nevirapine(NVP),efavirenz(EFV)and lopinavir/ritonavir(LPV/r)plus two nucleoside reverse transcriptase inhibitors(NRTIs)on treated naive HIV/AIDS patients.Methods The treated naive HIV infected patients with CD4^+T lymphocyte(CD4 cell)below 250 cells/μl were recruited from our clinic and then allocated to A,B,C groups equally(NVP,EFV,LPV/r containing regimens),blindly and randomly by Spw-Pb network data platform.CD4 cell counts at baseline and during the period of follow-up(12,24,36 and 48 weeks)were analyzed.SPSS 19.0 software was used for data analysis.One-way ANOVA was used in comparison among groups,and LSD-r test was used in comparison between two groups.Because of the repeated measure data,general estimate equation(GEE)was also used in this study.Results Totally 300 patients were enrolled into the study and 280 patients finished the 48 weeks follow-up.Baseline information matched between three groups.Comparing to baseline,CD4 cells increased significantly in each group.There was no statistical significance in the comparisons of CD4 cell counts between groups in each follow-up time point(P>0.05)and no statistical significance in the comparisons of increase of CD4 cells among groups at the 48th week either(P>0.05).Applying GEE statistical model in the analysis of CD4 cells for the follow-up period of 48 weeks,the comparisons among groups did not show statistical significance(P>0.05).Conclusions NVP?EFV or LPV/r regimens on treated naive HIV/AIDS patients resulted in good immune reconstruction,but no statistical differences within 48 weeks follow-up were found.