2009年至2013年河南省艾滋病患者二线抗病毒治疗效果的回顾性研究

Retrospective study on the treatment effect of second-line antiretroviral therapy for acquired immunodeficiency syndrome patients in Henan Province from 2009 to 2013

目的评价含洛匹那韦／利托那韦（LPV／r）抗反转录病毒治疗（ART）方案作为二线方案的疗效及患者的耐受性。方法收集2009年1月1日至2013年12月31日河南省免费抗病毒治疗数据库中一线ART方案治疗1年以上、更换含有LPV／r的二线ART方案治疗1年以上的艾滋病患者相关资料，根据更换方案时HIV抑制情况，分为一线治疗病毒学失败组、病毒抑制成功但免疫功能重建不良组，分析两组含LPV／r二线方案治疗后6、12、24个月CD4^＋T淋巴细胞计数变化趋势，6-12个月、12-24个月病毒学抑制率，以及不良事件发生情况。非正态分布的计量资料比较采用秩和检验，计数资料比较采用卡方检验。结果共纳入研究4113例，其中一线方案失败组3802例，免疫重建不良组311例。一线方案失败组和免疫重建不良组患者更换为含有LPV／r的二线方案治疗6、12及24个月时CD4^＋T淋巴细胞计数均较基线逐步升高（均P〈0．01）。一线方案失败组更换二线方案治疗6～12月病毒抑制率为61．65％（1408／2284），12～24个月为68．91％（2044／2966）。一线方案失败组不良反应发生率为21．88％（832／3802），免疫重建不良组为22．19％（69／311），两组不良反应发生率的差异无统计学意义（χ^2=0．015 P=0．901）。结论含有LPV／r ART方案对于初始治疗失败及免疫功能重建不良的艾滋病患者仍具有较好的病毒抑制效果及免疫重建效果。

Objective To evaluate the efficacy and tolerance of antiretroviral therapy （ART） regimen containing lopinavir/ritonavir （LPV/r） as a second-line regimen. Methods Data of acquired immunodeficiency syndrome （AIDS） patients who have received the first-line therapy for over a year and changed to the second-line antiviral therapy regimen containing LPV/r for more than one year were collected retrospectively from the database of free antiviral therapy in Henan Province from January 1, 2009 to December 31, 2013. Based on the viral load inhibition status after the alteration of the regimen, the patients were assigned to virology failure with first-line therapy group, and successful viral inhibition but poor immunological reconstruction with first-line therapy group. The variation trend of CD4^＋ T lymphocyte counts of the two groups in 6, 12, 24 months after changed to the second-line regimen of LPV/r, the virology inhibition rates between 6 and 12 months, 12 and 24 months, and occurrence of adverse events were analyzed. Quantitative data were analyzed by rank sum test, and qualitative data were analyzed by chi-square test. Results A total of 4113 patients were divided into two groups, including the first-line therapy failure group （n=3 802） and poor immunological reconstruction group （n=311）. At 6, 12 and 24 months after the alteration of the regimen, the CD4^＋ T lymphocyte counts increased gradually （all P;0.01）. Between 6 and 12 months after the first-line therapy failure group changed to the second- line regimen, viral inhibition rate was 61.65% （1408/2 284）, while that 12 and 24 months was 68. 91%（2 044/2 966）. The incidences of adverse reaction of the two groups were 21. 88% （832/3 802） and 22.19 % （ 69 / 311 ）, respectively, which were not significantly different （χ^2=0. 015, P; 0. 901）. Conclusion The ART regimen containing LPV/r still has good viral inhibition effect and immunological reconstruction effect for AIDS patients who failed the initial therapy with poor immunological reconstruction.