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首页> 外文期刊>JAMA: the Journal of the American Medical Association >Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Hea
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Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Hea

机译：利福平和吡嗪酰胺与异烟肼预防艾滋病毒感染者的肺结核：一项国际随机试验。特里·贝恩（Terry Beirn）艾滋病临床研究社区计划，成人艾滋病临床试验小组，泛美Hea

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CONTEXT: Because of problems with adherence, toxicity, and increasing resistance associated with 6- to 12-month isoniazid regimens, an alternative short-course tuberculosis preventive regimen is needed. OBJECTIVE: To compare a 2-month regimen of daily rifampin and pyrazinamide with a 12-month regimen of daily isoniazid in preventing tuberculosis in persons with human immunodeficiency virus (HIV) infection. DESIGN: Randomized, open-label controlled trial conducted from September 1991 to May 1996, with follow-up through October 1997. SETTING: Outpatient clinics in the United States, Mexico, Haiti, and Brazil. PARTICIPANTS: A total of 1583 HIV-positive persons aged 13 years or older with a positive tuberculin skin test result. INTERVENTIONS: Patients were randomized to isoniazid, 300 mg/d, with pyridoxine hydrochloride for 12 months (n = 792) or rifampin, 600 mg/d, and pyrazinamide, 20 mg/kg per day, for 2 months (n = 791). MAIN OUTCOME MEASURES: The primary end point was culture-confirmed tuberculosis; secondary end points were proven or probable tuberculosis, adverse events, and death, compared by treatment group. RESULTS: Of patients assigned to rifampin and pyrazinamide, 80% completed the regimen compared with 69% assigned to isoniazid (P<.001). After a mean follow-up of 37 months, 19 patients (2.4%) assigned to rifampin and pyrazinamide and 26 (3.3%) assigned to isoniazid developed confirmed tuberculosis at rates of 0.8 and 1.1 per 100 person-years, respectively (risk ratio, 0.72 [95% confidence interval, 0.40-1.31]; P = .28). In multivariate analysis, there were no significant differences in rates for confirmed or probable tuberculosis (P = .83), HIV progression and/or death (P = .09), or overall adverse events (P = .27), although drug discontinuation was slightly higher in the rifampin and pyrazinamide group (P = .01). Neither regimen appeared to lead to the development of drug-resistant tuberculosis. CONCLUSIONS: Our data suggest that for preventing tuberculosis in HIV-infected patients, a daily 2-month regimen of rifampin and pyrazinamide is similar in safety and efficacy to a daily 12-month regimen of isoniazid. This shorter regimen offers practical advantages to both patients and tuberculosis control programs.
机译：背景：由于与6到12个月的异烟肼治疗方案有关的依从性，毒性和耐药性增加的问题，需要一种替代的短期结核病预防方案。目的：比较每日2个月的利福平和吡嗪酰胺治疗方案与12个月的每日异烟肼治疗方案，以预防人类免疫缺陷病毒（HIV）感染者的结核病。设计：1991年9月至1996年5月进行的随机，开放标签对照试验，随访至1997年10月。地点：美国，墨西哥，海地和巴西的门诊诊所。参与者：总共1583名13岁或13岁以上的HIV阳性者，结核菌素皮肤试验结果阳性。干预措施：将患者随机分为300毫克/天的异烟肼，12个月的盐酸吡x醇（n = 792）或600毫克/天的利福平和每天20毫克/千克的吡嗪酰胺2个月（n = 791）。 。主要观察指标：主要研究终点是培养确诊的结核病。与治疗组相比，次要终点被证实为或可能是结核病，不良事件和死亡。结果：在接受利福平和吡嗪酰胺治疗的患者中，有80％完成了该方案，而分配给异烟肼的患者为69％（P <.001）。在平均随访37个月后，分别被确定为利福平和吡嗪酰胺的19例患者（2.4％）和接受异烟肼的26例（3.3％）的确诊为结核病，其发病率分别为每100人年0.8和1.1。 0.72 [95％置信区间，0.40-1.31]; P = 0.28）。在多变量分析中，尽管已停药，但确诊或可能的结核病发生率（P = .83），HIV进展和/或死亡（P = .09）或总体不良事件（P = .27）均无显着差异。利福平和吡嗪酰胺组的血脂略高（P = 0.01）。两种方案均未导致耐药性结核病的发展。结论：我们的数据表明，为了预防HIV感染患者的肺结核，利福平和吡嗪酰胺的每日2个月疗程与异烟肼的每日12个月疗程在安全性和功效上相似。这种较短的方案为患者和结核病控制计划都提供了实际的优势。

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