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本文引用的文献

1
Estimating efficacy in a randomized trial with product nonadherence: application of multiple methods to a trial of preexposure prophylaxis for HIV prevention.在存在产品不依从性的随机试验中评估疗效:多种方法在HIV预防暴露前预防试验中的应用
Am J Epidemiol. 2015 Nov 15;182(10):848-56. doi: 10.1093/aje/kwv202. Epub 2015 Oct 19.
2
Tenofovir-based preexposure prophylaxis for HIV infection among African women.基于替诺福韦的暴露前预防用于非洲女性的HIV感染
N Engl J Med. 2015 Feb 5;372(6):509-18. doi: 10.1056/NEJMoa1402269.
3
From exposures to population interventions: pregnancy and response to HIV therapy.从暴露于人群干预措施:妊娠与抗 HIV 治疗反应。
Am J Epidemiol. 2014 Apr 1;179(7):797-806. doi: 10.1093/aje/kwt328. Epub 2014 Feb 25.
4
Commentary: extending organizational schema for causal effects.评论:扩展因果效应的组织模式。
Epidemiology. 2014 Jan;25(1):98-102. doi: 10.1097/EDE.0000000000000023.
5
Intention-to-treat analyses and missing data approaches in pharmacotherapy trials for alcohol use disorders.酒精使用障碍药物治疗试验中的意向治疗分析和缺失数据方法。
BMJ Open. 2013 Nov 12;3(11):e003464. doi: 10.1136/bmjopen-2013-003464.
6
Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial.在曼谷泰国注射吸毒者中预防艾滋病毒感染的抗逆转录病毒预防(曼谷替诺福韦研究):一项随机、双盲、安慰剂对照的 3 期临床试验。
Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.
7
Preexposure prophylaxis for HIV infection among African women.预防非洲女性感染 HIV 的暴露前预防措施。
N Engl J Med. 2012 Aug 2;367(5):411-22. doi: 10.1056/NEJMoa1202614. Epub 2012 Jul 11.
8
Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.博茨瓦纳异性传播 HIV 中抗逆转录病毒的预先暴露预防。
N Engl J Med. 2012 Aug 2;367(5):423-34. doi: 10.1056/NEJMoa1110711. Epub 2012 Jul 11.
9
Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.抗逆转录病毒预防治疗用于异性恋男性和女性的 HIV 预防。
N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
10
The parametric g-formula to estimate the effect of highly active antiretroviral therapy on incident AIDS or death.评估高效抗逆转录病毒疗法对艾滋病事件或死亡影响的参数 g 公式。
Stat Med. 2012 Aug 15;31(18):2000-9. doi: 10.1002/sim.5316. Epub 2012 Apr 11.

特邀评论:每一次良好的随机分组都值得观察。

Invited commentary: every good randomization deserves observation.

作者信息

Westreich Daniel, Edwards Jessie K

出版信息

Am J Epidemiol. 2015 Nov 15;182(10):857-60. doi: 10.1093/aje/kwv200. Epub 2015 Oct 19.

DOI:10.1093/aje/kwv200
PMID:26487342
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4634305/
Abstract

Preexposure prophylaxis (PrEP) is a promising approach to prevention of human immunodeficiency virus (HIV) transmission, in which an HIV-negative individual takes a single daily dose of an antiretroviral drug so that, if exposed to HIV, an active antiretroviral drug is already present in his or her system. In this issue of the Journal, Murnane et al. (Am J Epidemiol. 2015;182(10):848-856) use data from the Partners PrEP Study (Kenya and Uganda, 2008-2011) to estimate the efficacy of PrEP under perfect adherence. We discuss Murnane et al.'s work and then examine the larger issues of generalizability or transportability of findings from a randomized trial to a new setting when adherence to an intervention determines its effectiveness. We discuss sufficient conditions for generalizability and use causal directed acyclic graphs to show how these assumptions might play out when trials are used to make inferences about the effect of PrEP in current and future real-world target populations.

摘要

暴露前预防(PrEP)是一种很有前景的预防人类免疫缺陷病毒(HIV)传播的方法,即HIV阴性个体每日服用一剂抗逆转录病毒药物,这样如果接触到HIV,其体内已存在活性抗逆转录病毒药物。在本期《杂志》中,莫纳内等人(《美国流行病学杂志》。2015年;182(10):848 - 856)利用来自伴侣PrEP研究(肯尼亚和乌干达,2008 - 2011年)的数据来估计完全依从情况下PrEP的疗效。我们讨论了莫纳内等人的工作,然后探讨了一个更大的问题,即当对一种干预措施的依从性决定其有效性时,如何将随机试验的结果推广或迁移到新的环境中。我们讨论了可推广性的充分条件,并使用因果有向无环图来展示当利用试验推断PrEP在当前和未来现实世界目标人群中的效果时,这些假设可能如何发挥作用。