早期与延迟抗逆转录病毒疗法对HIV感染者生存的影响。
Effect of early versus deferred antiretroviral therapy for HIV on survival.
作者信息
Kitahata Mari M, Gange Stephen J, Abraham Alison G, Merriman Barry, Saag Michael S, Justice Amy C, Hogg Robert S, Deeks Steven G, Eron Joseph J, Brooks John T, Rourke Sean B, Gill M John, Bosch Ronald J, Martin Jeffrey N, Klein Marina B, Jacobson Lisa P, Rodriguez Benigno, Sterling Timothy R, Kirk Gregory D, Napravnik Sonia, Rachlis Anita R, Calzavara Liviana M, Horberg Michael A, Silverberg Michael J, Gebo Kelly A, Goedert James J, Benson Constance A, Collier Ann C, Van Rompaey Stephen E, Crane Heidi M, McKaig Rosemary G, Lau Bryan, Freeman Aimee M, Moore Richard D
机构信息
University of Washington, Harborview Medical Center, 325 Ninth Ave., Box 359931, Seattle, WA 98104, USA.
出版信息
N Engl J Med. 2009 Apr 30;360(18):1815-26. doi: 10.1056/NEJMoa0807252. Epub 2009 Apr 1.
BACKGROUND
The optimal time for the initiation of antiretroviral therapy for asymptomatic patients with human immunodeficiency virus (HIV) infection is uncertain.
METHODS
We conducted two parallel analyses involving a total of 17,517 asymptomatic patients with HIV infection in the United States and Canada who received medical care during the period from 1996 through 2005. None of the patients had undergone previous antiretroviral therapy. In each group, we stratified the patients according to the CD4+ count (351 to 500 cells per cubic millimeter or >500 cells per cubic millimeter) at the initiation of antiretroviral therapy. In each group, we compared the relative risk of death for patients who initiated therapy when the CD4+ count was above each of the two thresholds of interest (early-therapy group) with that of patients who deferred therapy until the CD4+ count fell below these thresholds (deferred-therapy group).
RESULTS
In the first analysis, which involved 8362 patients, 2084 (25%) initiated therapy at a CD4+ count of 351 to 500 cells per cubic millimeter, and 6278 (75%) deferred therapy. After adjustment for calendar year, cohort of patients, and demographic and clinical characteristics, among patients in the deferred-therapy group there was an increase in the risk of death of 69%, as compared with that in the early-therapy group (relative risk in the deferred-therapy group, 1.69; 95% confidence interval [CI], 1.26 to 2.26; P<0.001). In the second analysis involving 9155 patients, 2220 (24%) initiated therapy at a CD4+ count of more than 500 cells per cubic millimeter and 6935 (76%) deferred therapy. Among patients in the deferred-therapy group, there was an increase in the risk of death of 94% (relative risk, 1.94; 95% CI, 1.37 to 2.79; P<0.001).
CONCLUSIONS
The early initiation of antiretroviral therapy before the CD4+ count fell below two prespecified thresholds significantly improved survival, as compared with deferred therapy.
背景
对于无症状的人类免疫缺陷病毒（HIV）感染者，开始抗逆转录病毒治疗的最佳时机尚不确定。
方法
我们进行了两项平行分析，共纳入了1996年至2005年期间在美国和加拿大接受医疗护理的17517例无症状HIV感染者。所有患者均未接受过抗逆转录病毒治疗。在每组中，我们根据开始抗逆转录病毒治疗时的CD4+细胞计数（每立方毫米351至500个细胞或>500个细胞）对患者进行分层。在每组中，我们比较了CD4+细胞计数高于两个感兴趣阈值中的每一个时开始治疗的患者（早期治疗组）与将治疗推迟到CD4+细胞计数降至这些阈值以下的患者（延迟治疗组）的相对死亡风险。
结果
在第一项分析中，涉及8362例患者，2084例（25%）在CD4+细胞计数为每立方毫米351至500个细胞时开始治疗，6278例（75%）推迟治疗。在对年份、患者队列以及人口统计学和临床特征进行调整后，与早期治疗组相比，延迟治疗组患者的死亡风险增加了69%（延迟治疗组的相对风险为1.69；95%置信区间[CI]，1.26至2.26；P<0.001）。在第二项分析中，涉及9155例患者，2220例（24%）在CD4+细胞计数超过每立方毫米500个细胞时开始治疗，6935例（76%）推迟治疗。在延迟治疗组患者中，死亡风险增加了94%（相对风险，1.94；95%CI，1.37至2.79；P<0.001）。
结论
与延迟治疗相比，在CD4+细胞计数降至两个预先设定的阈值之前尽早开始抗逆转录病毒治疗可显著提高生存率。
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