Vlahov David, Galai Noya, Safaeian Mahboobeh, Galea Sandro, Kirk Gregory D, Lucas Greg M, Sterling Timothy R
Center for Urban Epidemiologic Studies, New York Academy of Medicine, New York, NY 10029, USA.
Am J Epidemiol. 2005 Jun 1;161(11):999-1012. doi: 10.1093/aje/kwi133.
Highly active antiretroviral therapy (HAART) has been shown to be effective in different populations, but data among injection drug users are limited. Human immunodeficiency virus-infected injection drug users recruited into the Acquired Immunodeficiency Syndrome Link to Intravenous Experiences (ALIVE) Study as early as 1988 were tested semiannually to identify their first CD4-positive T-lymphocyte cell count below 200/microl; they were followed for mortality through 2002. Visits were categorized into the pre-HAART (before mid-1996) and the HAART eras and further categorized by HAART use. Survival analysis with staggered entry was used to evaluate the effect of HAART on acquired immunodeficiency syndrome-related mortality, adjusting for other medications and demographic, clinical, and behavioral factors. Among 665 participants, 258 died during 2,402 person-years of follow-up. Compared with survival in the pre-HAART era, survival in the HAART era was shown by multivariate analysis to be improved for both those who did and did not receive HAART (relative hazards = 0.06 and 0.33, respectively; p < 0.001). Inferences were unchanged after restricting analyses to data starting with 1993 and considerations of lead-time bias and human immunodeficiency viral load. The annual CD4-positive T-lymphocyte cell decline was less in untreated HAART-era participants than in pre-HAART-era participants (-10/microl vs. -37/microl, respectively), suggesting that changing indications for treatment may have contributed to improved survival and that analyses restricted to the HAART era probably underestimate HAART effectiveness.
高效抗逆转录病毒疗法（HAART）已被证明在不同人群中有效，但针对注射吸毒者的数据有限。早在1988年就被招募进“获得性免疫缺陷综合征与静脉注射经历关联研究”（ALIVE研究）的人类免疫缺陷病毒感染注射吸毒者每半年接受一次检测，以确定其首次CD4阳性T淋巴细胞计数低于200/微升的情况；对他们进行随访直至2002年观察死亡率。访视被分为HAART治疗前（1996年年中之前）和HAART治疗时代，并根据HAART的使用情况进一步分类。采用交错进入的生存分析来评估HAART对获得性免疫缺陷综合征相关死亡率的影响，并对其他药物以及人口统计学、临床和行为因素进行调整。在665名参与者中，258人在2402人年的随访期间死亡。多变量分析显示，与HAART治疗前时代的生存情况相比，接受和未接受HAART治疗的患者在HAART治疗时代的生存情况均有所改善（相对风险分别为0.06和0.33；p<0.001）。在将分析限制在1993年开始的数据并考虑领先时间偏倚和人类免疫缺陷病毒载量后，推论不变。未接受治疗的HAART治疗时代参与者每年CD4阳性T淋巴细胞的下降幅度小于HAART治疗前时代的参与者（分别为-10/微升和-37/微升），这表明治疗指征的改变可能有助于提高生存率，并且仅局限于HAART治疗时代的分析可能低估了HAART的有效性。
