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无症状、非妊娠青少年和成年人的 HIV 感染筛查:美国预防服务工作组的更新证据报告和系统评价。

Screening for HIV Infection in Asymptomatic, Nonpregnant Adolescents and Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

机构信息

Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland.

Division of General Internal Medicine and Geriatrics, Oregon Health & Science University, Portland.

出版信息

JAMA. 2019 Jun 18;321(23):2337-2348. doi: 10.1001/jama.2019.2592.

Abstract

IMPORTANCE

Untreated HIV infection can result in significant morbidity, mortality, and HIV transmission. A 2012 review for the US Preventive Services Task Force (USPSTF) found antiretroviral therapy (ART) associated with improved clinical outcomes and decreased transmission risk in persons with CD4 cell counts less than 500/mm3.

OBJECTIVE

To update the 2012 review on HIV screening to inform the USPSTF.

DATA SOURCES

Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews from 2012 to June 2018, with surveillance through January 2019.

STUDY SELECTION

Nonpregnant individuals 12 years and older; randomized clinical trials (RCTs) and controlled observational studies of screening vs no screening, alternative screening strategies, earlier vs later initiation of ART, and long-term harms of ART.

DATA EXTRACTION AND SYNTHESIS

One investigator abstracted data; a second checked accuracy. Two investigators independently rated study quality.

MAIN OUTCOMES AND MEASURES

Mortality, AIDS events, quality of life, function, and HIV transmission; harms of screening and long-term (≥2 years) harms of ART; screening yield.

RESULTS

Eighteen new studies (5 RCTs, 11 cohort studies, and 2 systematic reviews; N = 266 563) were included, and 11 studies (2 RCTs and 9 cohort studies; N = 218 542) were carried forward from the prior USPSTF report. No study directly evaluated effects of HIV screening vs no screening on clinical outcomes or harms, or the yield of alternative screening strategies. Two newly identified RCTs conducted completely or partially in low-resource settings found ART initiation at CD4 cell counts greater than 500/mm3 associated with lower risk of a composite outcome of mortality, AIDS-defining events, or serious non-AIDS events (relative risk [RR], 0.44 [95% CI, 0.31-0.63] and RR, 0.57 [95% CI, 0.35-0.95]); results were consistent with those from a large observational study. Early ART was not associated with increased risk of cardiovascular events. Early ART initiation was associated with sustained reduction in risk of HIV transmission at 5.5 years (RR, 0.07 [95% CI, 0.02-0.22] for linked transmission). New evidence regarding the association between abacavir use and risk of cardiovascular events was inconsistent. Certain antiretroviral regimens were associated with increased risk of long-term neuropsychiatric, renal, hepatic, and bone adverse events.

CONCLUSIONS AND RELEVANCE

In nonpregnant adolescents and adults there was no direct evidence on the clinical benefits and harms of screening for HIV infections vs no screening, or the yield of repeat or alternative screening strategies. New evidence extends effectiveness of ART to asymptomatic individuals with CD4 cell counts greater than 500/mm3 and shows sustained reduction in risk of HIV transmission at longer-term follow-up, although certain ART regimens may be associated with increased risk of long-term harms.

摘要

重要性

未经治疗的 HIV 感染可导致显著的发病率、死亡率和 HIV 传播。2012 年,美国预防服务工作组(USPSTF)的一项审查发现,抗逆转录病毒疗法(ART)可改善 CD4 细胞计数低于 500/mm3 的患者的临床结局,并降低传播风险。

目的

更新 2012 年关于 HIV 筛查的审查,为 USPSTF 提供信息。

数据来源

从 2012 年到 2018 年 6 月,通过 2019 年 1 月的监测,对 Ovid MEDLINE、Cochrane 对照试验中心注册库和 Cochrane 系统评价数据库进行了检索。

研究选择

12 岁及以上的非孕妇;随机临床试验(RCT)和对照观察性研究,比较筛查与不筛查、替代筛查策略、早期与晚期开始 ART 以及 ART 的长期危害。

数据提取和综合

一名调查员提取数据;第二名调查员检查准确性。两名调查员独立评估研究质量。

主要结果和措施

死亡率、艾滋病事件、生活质量、功能和 HIV 传播;筛查和长期(≥2 年)ART 危害;筛查收益。

结果

纳入了 18 项新研究(5 项 RCT、11 项队列研究和 2 项系统评价;N=266563),并从之前的 USPSTF 报告中纳入了 11 项研究(2 项 RCT 和 9 项队列研究;N=218542)。没有研究直接评估 HIV 筛查与不筛查对临床结局或危害的影响,或替代筛查策略的收益。两项新确定的 RCT 在资源有限的环境中完全或部分进行,发现 CD4 细胞计数大于 500/mm3 时开始 ART 与死亡率、艾滋病定义事件或严重非艾滋病事件的复合结局风险降低相关(相对风险 [RR],0.44 [95% CI,0.31-0.63]和 RR,0.57 [95% CI,0.35-0.95]);结果与一项大型观察性研究一致。早期 ART 与心血管事件风险增加无关。早期 ART 与 5.5 年时 HIV 传播风险的持续降低相关(RR,0.07 [95% CI,0.02-0.22],用于关联传播)。关于 abacavir 使用与心血管事件风险之间关联的新证据不一致。某些抗逆转录病毒方案与长期神经精神、肾脏、肝脏和骨骼不良事件风险增加相关。

结论和相关性

在非孕妇和成人中,没有直接证据表明 HIV 感染筛查与不筛查、重复或替代筛查策略的收益相比具有临床益处和危害。新证据将 ART 的有效性扩展到 CD4 细胞计数大于 500/mm3 的无症状个体,并显示在更长时间的随访中持续降低 HIV 传播风险,尽管某些 ART 方案可能与长期危害风险增加有关。

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