Ifi-Institute, Hamburg, Germany.
Infection. 2011 Feb;39(1):3-12. doi: 10.1007/s15010-010-0070-8. Epub 2011 Jan 11.
Hitherto, studies on highly active antiretroviral therapy (HAART) initiation have shown partly inconsistent results. Our study investigated the clinical course and course of immune status after HAART initiation at CD4-cell-count/μl of treated patients between 250 and 349 (group 1), compared to 350-449 (group 2), on the basis of the cohort of the Competence Network for HIV/AIDS (KompNet cohort).
Patients had to be HAART-naïve. Medication had to start at the earliest in 1996, being at least triple combination therapy. The primary endpoints of death, first AIDS-defining illness and first drop of CD4-cell-count/μl below 200 were evaluated as censored event times between the initiation of HAART (t (0)) and the date of the first event/date of last observation. Probabilities of event-free intervals since t (0) were calculated by Kaplan-Meier estimation, compared by logrank tests. The results were adjusted for confounders using Cox regression. Additionally, incidences were estimated.
A total of 822 patients met the inclusion criteria (group 1: 526, group 2: 296), covering 4,133 patient years (py) overall. In group 1, 0.64 death cases/100 py were found, with the corresponding vale being 0.17 in group 2. In group 1, 1.38 AIDS-defining events/100 py occurred, whereas it was 0.78 in group 2. In group 1, 2.64 events of first drop of CD4-cell-count/μl below 200 occurred per 100 py, compared to 0.77 in group 2. Kaplan-Meier estimations showed borderline significant differences regarding death (p = 0.063), no differences regarding first AIDS-defining illness (p = 0.148) and distinct differences regarding the first drop of CD4-cell-count/μl below 200 (p = 0.0004).
The results gave a strong hint for a therapy initiation at higher CD4-cell-count/μl regarding the outcome of death in treated patients. A distinct benefit was shown regarding the first decline of CD4-cell-count/μl below 200.
迄今为止，关于高效抗逆转录病毒治疗（HAART）启动的研究结果不尽相同。我们的研究基于德国艾滋病合作研究网络（KompNet 队列）的患者队列，以 CD4 细胞计数/μl 为 250-349 的治疗患者（第 1 组）和 350-449 的治疗患者（第 2 组）为基础，调查了 HAART 启动后临床病程和免疫状态的变化。
患者必须为 HAART 初治患者。药物治疗最早必须在 1996 年开始，且必须是三联以上的联合治疗。死亡、首次 AIDS 定义性疾病和首次 CD4 细胞计数/μl 下降至 200 以下的首次事件作为 HAART 启动（t（0））和首次事件/最后观察日期之间的删失事件时间进行评估。通过 Kaplan-Meier 估计计算 t（0）后无事件间隔的概率，并通过对数秩检验进行比较。使用 Cox 回归调整混杂因素。此外，还估计了发病率。
共有 822 名患者符合纳入标准（第 1 组：526 名，第 2 组：296 名），共覆盖 4133 患者年（py）。第 1 组中每 100py 有 0.64 例死亡，第 2 组中相应的死亡率为 0.17。第 1 组中每 100py 有 1.38 例 AIDS 定义性事件，而第 2 组中相应的发病率为 0.78。第 1 组中首次 CD4 细胞计数/μl 下降至 200 以下的事件为每 100py 2.64 例，而第 2 组为 0.77 例。Kaplan-Meier 估计结果显示，在死亡方面有显著差异（p=0.063），在首次 AIDS 定义性疾病方面无差异（p=0.148），在首次 CD4 细胞计数/μl 下降至 200 以下方面有显著差异（p=0.0004）。
结果强烈提示在治疗患者中，较高的 CD4 细胞计数/μl 启动治疗可降低死亡风险。在首次 CD4 细胞计数/μl 下降至 200 以下方面显示出明显的益处。
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