Efficacy of trimethoprim-sulphamethoxazole prophylaxis to decrease morbidity and mortality in HIV-1-infected patients with tuberculosis in Abidjan, Cote d'Ivoire: a randomised controlled trial
Efficacy of trimethoprim-sulphamethoxazole prophylaxis to decrease morbidity and mortality in HIV-1-infected patients with tuberculosis in Abidjan, Cote d'Ivoire: a randomised controlled trial
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DOI：
10.1016/s0140-6736(99)03465-0
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发表时间：
1999-05-01
期刊：
影响因子：
168.9
通讯作者：
Greenberg, AE
中科院分区：
文献类型：
--
作者：
Wiktor, SZ;Sassan-Morokro, M;Greenberg, AE
背景：在非洲，HIV-1感染的结核病患者机会性感染的发生率很高，因此死亡率很高。方法1995年10月至1998年4月，在阿比让4个最大的门诊结核病治疗中心，我们收集了771例HIV1阳性和HIV1、HIV2双阳性肺结核患者，年龄中位数32岁[范围18-]，中位数317个/亩L。患者被随机分配到标准的6个月结核病方案开始后1个月，每天服用一片复方新诺明(n=386)或安慰剂(n=385)。我们评估了5个月和之后每3个月的药物依从性和耐受性，以及住院率。实验室和临床不良事件的发现率在两组中相似。复方新诺明组51例(13.8/100人年)和安慰剂组86例(25.4/100人年)死亡(风险降低46%[95%可信区间23-62]，P<0.05)。
Background There is a high incidence of opportunistic infection among HIV-1-infected patients with tuberculosis in Africa and, consequently, high mortality. We assessed the safety and efficacy of trimethoprim-sulphamethoxazole 800 mg/160 mg (co-trimoxazole) prophylaxis in prevention of such infections and in decrease of morbidity and mortality.Methods Between October, 1995, and April, 1998, we enrolled 771 HIV-1 seropositive and HIV-1 and HIV-2 dually seroreactive patients who had sputum-smear-positive pulmonary tuberculosis (median age 32 years [range 18-64], median CD4-cell count 317 cells/mu L) attending Abidjan's four largest outpatient tuberculosis treatment centres. Patients were randomly assigned one daily tablet of co-trimoxazole (n=386) or placebo (n=385) 1 month after the start of a standard 6-month tuberculosis regimen. We assessed adherence to study drug and tolerance monthly for 5 months and every 3 months thereafter, as well as rates of admission to hospital.Findings Rates of laboratory and clinical adverse events were similar in the two groups. 51 patients in the co-trimoxazole group (13.8/100 person-years) and 86 in the placebo group (25.4/100 person-years) died (decrease In risk 46% [95% CI 23-62], p