Detels R, Muñoz A, McFarlane G, Kingsley L A, Margolick J B, Giorgi J, Schrager L K, Phair J P
School of Public Health, University of California, Los Angeles 90095-1772, USA.
JAMA. 1998 Nov 4;280(17):1497-503. doi: 10.1001/jama.280.17.1497.
Time to development of acquired immunodeficiency syndrome (AIDS) and time to death have been extended with the increased use of combination therapy and protease inhibitors. Cohort studies following up persons with human immunodeficiency virus (HIV) infection in periods characterized by different therapies offer the opportunity to estimate therapy effectiveness at the population level.
To assess the effectiveness of self-reported, long-term potent antiretroviral therapy in a cohort of 536 men whose duration of HIV infection was known (seroconverters).
Cohort study. The cohort was compared for time to development of AIDS and time to death in 1984 to 1990, 1990 to 1993, 1993 to July 1995, and July 1995 to July 1997 when the major treatments were no therapy, monotherapy, combined therapy, and potent antiretroviral therapy, respectively. Survival analysis methods with time zero set as the date of seroconversion and incorporating staggered entries into each period were used. Mean CD4 cell change, stratified by infection duration, was determined for each period using a random effects model.
The Multicenter AIDS Cohort Study (MACS) in 4 urban areas (Baltimore, Md; Chicago, III; Los Angeles, Calif; and Pittsburgh, Pa).
A total of 5622 men who were 18 years or older were enrolled into MACS. Of the 5622, there were 2191 HIV-positive individuals at enrollment. Of the 3431 men who were HIV-negative, 536 were observed to seroconvert and were followed up for up to 13 years. The group of 536 who seroconverted constituted the study population.
Time from seroconversion to development of AIDS and to death and change in CD4 cell count.
A total of 231 seroconverters developed AIDS, and 200 men died. Using 1990 to 1993 as the reference period, the relative hazard of AIDS was 1.04 (95% confidence interval [CI], 0.73-1.48) during 1993 to July 1995 and 0.35 (95% CI, 0.20-0.61) during July 1995 to July 1997. Relative hazards of death were 0.87 (95% CI, 0.58-1.31) and 0.62 (95% CI, 0.38-1.01 ) for the same periods. The relative time (the factor by which times are contracted or expanded) to development of AIDS was 0.97 (95% CI, 0.86-1.09) for 1993 to July 1995 and 1.63 (95% CI, 1.40-1.89) for July 1995 to July 1997. Relative survival time for 1993 to July 1995 was 1.01 (95% CI, 0.91-1.12) and for July 1995 to July 1997 was 1.21 (95% CI, 1.07-1.36) relative to 1990 to 1993. The rate of CD4 cell count decline in July 1995 to July 1997 was significantly lower (P<.05) compared with the previous 2 periods.
In the calendar period when potent antiretroviral therapy was introduced, the time to development of AIDS and time to death were extended, and rate of CD4 cell count decline was arrested.
随着联合疗法和蛋白酶抑制剂使用的增加，获得性免疫缺陷综合征（艾滋病）的发病时间和死亡时间得以延长。在以不同疗法为特征的时期对感染人类免疫缺陷病毒（HIV）的人群进行队列研究，为在人群水平评估治疗效果提供了机会。
评估自我报告的长期高效抗逆转录病毒疗法对536名已知HIV感染持续时间的男性（血清转化者）队列的疗效。
队列研究。该队列在1984年至1990年、1990年至1993年、1993年至1995年7月以及1995年7月至1997年7月期间，分别对应主要治疗方法为无治疗、单一疗法、联合疗法和高效抗逆转录病毒疗法时，比较艾滋病发病时间和死亡时间。采用生存分析方法，将时间零点设定为血清转化日期，并纳入每个时期的交错进入情况。使用随机效应模型确定每个时期按感染持续时间分层的平均CD4细胞变化。
4个城市地区（马里兰州巴尔的摩市；伊利诺伊州芝加哥市；加利福尼亚州洛杉矶市；宾夕法尼亚州匹兹堡市）的多中心艾滋病队列研究（MACS）。
共有5622名18岁及以上男性纳入MACS。其中，入组时2191人为HIV阳性个体。在3431名HIV阴性男性中，536人被观察到发生血清转化，并随访长达13年。发生血清转化的536人组构成研究人群。
从血清转化到艾滋病发病和死亡的时间以及CD4细胞计数变化。
共有231名血清转化者发展为艾滋病，200名男性死亡。以1990年至1993年为参照期，1993年至1995年7月期间艾滋病的相对风险为1.04（95%置信区间[CI]，0.73 - 1.48），1995年7月至1997年7月期间为0.35（95%CI，0.20 - 0.61）。同期死亡的相对风险分别为0.87（95%CI，0.58 - 1.31）和0.62（95%CI，0.38 - 1.01）。1993年至1995年7月艾滋病发病的相对时间（时间收缩或扩展的因子）为0.97（95%CI，0.86 - 1.09），1995年7月至199
