A controlled trial of isoniazid in persons with anergy and human immunodeficiency virus infection who are at high risk for tuberculosis
A controlled trial of isoniazid in persons with anergy and human immunodeficiency virus infection who are at high risk for tuberculosis
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DOI：
10.1056/nejm199707313370505
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发表时间：
1997-07-31
影响因子：
158.5
通讯作者：
ElSadr, W
中科院分区：
文献类型：
--
作者：
Gordin, FM;Matts, JP;ElSadr, W
背景人类免疫缺陷病毒（HIV）感染和潜伏性结核病患者有发展为活动性结核病的巨大风险。作为一项公共卫生措施，异烟肼预防性治疗已被建议为艾滋病毒感染者谁有无能，并在组结核病的高患病率。方法我们进行了一项多中心，随机，双盲，安慰剂对照试验，6个月的预防性异烟肼治疗艾滋病毒感染患者无能谁有结核病感染的危险因素。主要终点是培养确诊的tuberculosis.Results本研究从1991年11月至1996年6月进行。超过90%的患者有两个或两个以上的结核病感染风险因素，近75%的患者来自大纽约市。在平均随访33个月后，安慰剂组257例患者中只有6例被诊断为结核病，而异烟肼组260例患者中只有3例被诊断为结核病（风险比为0.48; 95%可信区间为0.12 ~ 1.91; P=0.30）。两组之间的死亡，HIV疾病的进展或死亡，或不良事件没有显着差异。结论即使在HIV感染者的无能和多个危险因素的潜伏性结核感染，活动性结核病的发展率低。这一发现不支持在HIV感染和无反应性的高危患者中使用异烟肼预防，除非他们曾暴露于活动性结核病。(C)1997年，马萨诸塞州医学会。
Background Patients with human immunodeficiency virus (HIV) infection and latent tuberculosis are at substantial risk for the development of active tuberculosis. As a public health measure, prophylactic treatment with isoniazid has been suggested for HIV-infected persons who have anergy and are in groups with a high prevalence of tuberculosis.Methods We conducted a multicenter, randomized, double-blind, placebo-controlled trial of six months of prophylactic isoniazid treatment in HIV-infected patients with anergy who have risk factors for tuberculosis infection. The primary end point was culture-confirmed tuberculosis.Results The study was conducted from November 1991 through June 1996. Over 90 percent of the patients had two or more risk factors for tuberculosis infection, and nearly 75 percent of patients were from greater New York City. After a mean follow-up of 33 months, tuberculosis was diagnosed in only 6 of 257 patients in the placebo group and 3 of 260 patients in the isoniazid group (risk ratio, 0.48; 95 percent confidence interval, 0.12 to 1.91; P=0.30). There were no significant differences between the two groups with regard to death, the progression of HIV disease or death, or adverse events.Conclusions Even in HIV-infected patients with anergy and multiple risk factors for latent tuberculosis infection, the rate of development of active tuberculosis is low. This finding does not support the use of isoniazid prophylaxis in high-risk patients with HIV infection and anergy unless they have been exposed to active tuberculosis. (C) 1997, Massachusetts Medical Society.