Arici C, Ripamonti D, Ravasio V, Maggiolo F, Rizzi M, Finazzi M G, Suter F
Divisione di Malattie Infettive, Ospedali Riuniti, Largo Barozzi 1, Bergamo 24100, Italy.
Int J STD AIDS. 2001 Sep;12(9):573-81. doi: 10.1258/0956462011923741.
Our objective was to assess, in the clinical setting, the predictors of immune reconstitution (IR) and its relation with long-term clinical benefit, in HIV patients with advanced disease after highly active antiretroviral therapy (HAART) through an observational study. A retrospective cohort study in a clinical setting of 383 consecutive adult patients with advanced HIV infection (CD4+ cells <200/mm(3) at baseline), starting their first protease inhibitor (PI)-containing regimen was observed. Immune reconstitution was defined as CD4 count >200 cells/mm(3) and an increase > or =100 cells from baseline, anytime since starting HAART. Clinical benefit was defined as decreased mortality and reduction in AIDS-defining events, AIDS-related complex (ARC) events, major infections and hospitalization (days spent in hospital). During a mean follow-up of 808 days, 261 patients (68.1%) achieved IR. About 50% of these patients reached this result within one year after starting HAART. In multivariate analysis, predictors of immune recovery were sex (female) and baseline CD4 count higher than 50 cells/mm(3). The group of patients with IR had greater clinical benefit with lower mortality, fewer AIDS-defining events, shorter lengths of stay in hospital, fewer ARC events and fewer major infections during all the follow-up (P < 0.0001, tests for trends). However, although they did less remarkably than the first group of patients, even those patients who did not achieve IR experienced a significant decrease in the incidence of all the above events, as compared with the first and sometimes the second trimester after starting their HIV therapy. About 70% of HIV patients with advanced disease achieved IR after starting HAART. Such a benefit is a time-dependent effect and may even take more than 2 years to occur. Predictors of IR were sex (female) and higher baseline CD4 count (>50 cells/mm(3)). The patients who achieved immune recovery performed clinically better than patients who did not. Also the patients who failed to gain such a strong immunological recovery experienced a long-term clinical benefit. This suggests that PI-containing regimens, in advanced HIV disease, may produce a significant clinical benefit, at least temporary, even for patients who do not achieve a substantial immune response.
我们的目标是通过一项观察性研究，在临床环境中评估接受高效抗逆转录病毒治疗（HAART）的晚期疾病HIV患者免疫重建（IR）的预测因素及其与长期临床获益的关系。对383例连续的成年晚期HIV感染患者（基线CD4+细胞<200/mm³）在临床环境中进行回顾性队列研究，这些患者开始了他们的首个含蛋白酶抑制剂（PI）方案。免疫重建定义为自开始HAART以来的任何时间，CD4计数>200细胞/mm³且较基线增加≥100个细胞。临床获益定义为死亡率降低以及艾滋病定义事件（AIDS）、艾滋病相关综合征（ARC）事件、主要感染和住院（住院天数）减少。在平均808天的随访期间，261例患者（68.1%）实现了免疫重建。这些患者中约50%在开始HAART后一年内达到这一结果。在多变量分析中，免疫恢复的预测因素为性别（女性）和基线CD4计数高于50细胞/mm³。免疫重建组在整个随访期间具有更大的临床获益，死亡率更低，艾滋病定义事件更少，住院时间更短，ARC事件更少，主要感染更少（P<0.0001，趋势检验）。然而，尽管与第一组患者相比效果不那么显著，但即使那些未实现免疫重建的患者，与开始HIV治疗后的第一孕期甚至有时第二孕期相比，上述所有事件的发生率也显著下降。约70%的晚期疾病HIV患者在开始HAART后实现了免疫重建。这种获益是一种时间依赖性效应，甚至可能需要超过2年才会出现。免疫重建的预测因素为性别（女性）和较高的基线CD4计数（>50细胞/mm³）。实现免疫恢复的患者在临床上比未实现的患者表现更好。而且那些未能获得如此强大免疫恢复的患者也经历了长期的临床获益。这表明在晚期HIV疾病中含PI方案可能产生显著的临床获益，至少是暂时的，即使对于未实现实质性免疫反应的患者也是如此。
