伊索尼亚齐德加抗逆转录病毒疗法预防结核病:一个随机双盲,安慰剂控制的随机试验
Molebogeng X Rangaka1, Robert J Wilkinson2, Andrew Boulle3
1Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa; Clinical Infectious Disease Research Initiative, Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa; London School of Hygiene & Tropical Medicine, London, UK.
Lancet (London, England)
|May 20, 2014
概括
在接受抗逆转录病毒治疗的HIV-1患者中,异尼预防治疗显著降低了结核病的风险. 无论结核素皮肤试验或干扰素玛释放试验结果如何,都观察到这种益处,支持其广泛的建议.
科学领域:
- 传染性疾病 传染性疾病
- 公共卫生 公共卫生
- 临床试验 临床试验
背景情况:
- 结核病 (TB) 在艾滋病毒感染者中比一般人群更为普遍,尽管抗逆转录病毒治疗 (ART).
- 伊索尼亚兹预防疗法 (IPT) 是减少结核病发病率的关键策略.
研究的目的:
- 评估异化预防疗法在同时接受抗逆转录病毒治疗的HIV-1感染个体中降低结核病风险的疗效.
主要方法:
- 一项实用,随机,双盲,安慰剂对照试验在南非的Khayelitsha进行.
- 1329名参与者被分配接受12个月的IPT或安慰剂.
- 主要终点是发生结核病的时间,经过修改的治疗意图分析.
主要成果:
- 与安慰剂相比,IPT观察到结核病发病率减少了37%,每100人/年有3.6例,每100人/年有2.3例,危险比为0.63 (95%CI为0.41-0.94).
- 无论基线结核素皮肤试验或干扰素玛释放试验状态如何,IPT的疗效在所有参与者中都是一致的.
- 三级或四级氨酸转胺酶升高导致IPT组2.9%和安慰剂组1.5%的研究药物中止.
结论:
- 建议对所有接受抗逆转录病毒治疗的患者在有中度至高结核病发病率的地区进行异化预防性治疗.
- 在没有更具预测性的诊断工具的情况下,无论结核素皮肤测试或干扰素玛释放试验状态如何,都建议推.
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