Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
N Engl J Med. 2010 Feb 25;362(8):697-706. doi: 10.1056/NEJMoa0905848.
BACKGROUND: The rates of death are high among patients with coinfection with tuberculosis and the human immunodeficiency virus (HIV). The optimal timing for the initiation of antiretroviral therapy in relation to tuberculosis therapy remains controversial. METHODS: In an open-label, randomized, controlled trial in Durban, South Africa, we assigned 642 patients with both tuberculosis and HIV infection to start antiretroviral therapy either during tuberculosis therapy (in two integrated-therapy groups) or after the completion of such treatment (in one sequential-therapy group). The diagnosis of tuberculosis was based on a positive sputum smear for acid-fast bacilli. Only patients with HIV infection and a CD4+ cell count of less than 500 per cubic millimeter were included. All patients received standard tuberculosis therapy, prophylaxis with trimethoprim-sulfamethoxazole, and a once-daily antiretroviral regimen of didanosine, lamivudine, and efavirenz. The primary end point was death from any cause. RESULTS: This analysis compares data from the sequential-therapy group and the combined integrated-therapy groups up to September 1, 2008, when the data and safety monitoring committee recommended that all patients receive integrated antiretroviral therapy. There was a reduction in the rate of death among the 429 patients in the combined integrated-therapy groups (5.4 deaths per 100 person-years, or 25 deaths), as compared with the 213 patients in the sequential-therapy group (12.1 per 100 person-years, or 27 deaths); a relative reduction of 56% (hazard ratio in the combined integrated-therapy groups, 0.44; 95% confidence interval, 0.25 to 0.79; P=0.003). Mortality was lower in the combined integrated-therapy groups in all CD4+ count strata. Rates of adverse events during follow-up were similar in the two study groups. CONCLUSIONS: The initiation of antiretroviral therapy during tuberculosis therapy significantly improved survival and provides further impetus for the integration of tuberculosis and HIV services. (ClinicalTrials.gov number, NCT00398996.)
背景：结核分枝杆菌和人类免疫缺陷病毒（HIV）合并感染患者的死亡率较高。关于开始抗逆转录病毒治疗的最佳时机与结核病治疗之间仍存在争议。
方法：在南非德班进行的一项开放性标签、随机对照试验中，我们将 642 例结核分枝杆菌和 HIV 合并感染者分为三组，分别为：接受抗结核治疗期间开始抗逆转录病毒治疗（两个整合治疗组）、抗结核治疗结束后开始抗逆转录病毒治疗（一个序贯治疗组）。结核分枝杆菌的诊断基于痰涂片抗酸杆菌阳性。仅纳入 HIV 感染且 CD4+细胞计数低于 500 个/立方毫米的患者。所有患者均接受标准抗结核治疗、复方磺胺甲噁唑预防以及二脱氧肌苷、拉米夫定和依非韦伦的每日一次抗逆转录病毒方案。主要终点为任何原因导致的死亡。
结果：本分析比较了序贯治疗组和联合整合治疗组的数据，截至 2008 年 9 月 1 日，数据和安全监测委员会建议所有患者接受整合抗逆转录病毒治疗。与序贯治疗组的 213 例患者（12.1 例/100 人年，死亡 27 例）相比，联合整合治疗组的 429 例患者的死亡率有所降低（5.4 例/100 人年，死亡 25 例）；相对减少 56%（联合整合治疗组的危险比为 0.44；95%置信区间，0.25 至 0.79；P=0.003）。在所有 CD4+计数分层中，联合整合治疗组的死亡率均较低。两组患者在随访期间的不良事件发生率相似。
结论：在抗结核治疗期间开始抗逆转录病毒治疗可显著提高生存率，并为整合结核病和 HIV 服务提供了进一步的动力。（临床试验注册号，NCT00398996。）
N Engl J Med. 2010-2-25
N Engl J Med. 2011-10-20
N Engl J Med. 2011-10-20
N Engl J Med. 2010-7-15
N Engl J Med. 2011-10-20
N Engl J Med. 2006-11-30
N Engl J Med. 2015-8-27
N Engl J Med. 2017-7-20
N Engl J Med. 2015-7-20
Proc Natl Acad Sci U S A. 2024-9-24
N Engl J Med. 2009-4-30
J Acquir Immune Defic Syndr. 2009-2-1
J Acquir Immune Defic Syndr. 2008-6-1
Int J Tuberc Lung Dis. 2007-12
J Acquir Immune Defic Syndr. 2006-9
Zotero 插件