Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial
Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial
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DOI：
10.1016/s1473-3099(13)70187-7
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发表时间：
2013-10-01
影响因子：
56.3
通讯作者：
Golub, Jonathan E.
中科院分区：
文献类型：
--
作者：
Durovni, Betina;Saraceni, Valeria;Golub, Jonathan E.
背景：对艾滋病毒感染者进行结核病预防治疗是有效的，但在中等或高负担环境中尚未广泛实施。我们评估了巴西广泛使用异烟肼预防治疗对艾滋病毒感染者结核病和死亡率的影响。方法：我们在巴西里约热内卢的29家HIV诊所进行了一项阶梯楔形随机试验。诊所工作人员接受了结核病筛查、使用结核菌素皮肤试验和使用异烟肼预防疗法方面的培训。从2005年9月1日开始，每2个月有2个诊所开始干预。主要终点是2009年8月31日之前对照和干预期间的结核病发病率单独或合并死亡。该试验已在ClinicalTrials.gov注册，编号NCT00107887。结果在17413例患者中，12816例符合干预条件。总的来说，有475例结核病病例和838例死亡。干预使接受皮肤试验的患者比率从每100人年19例增加到每100人年59例，符合异烟肼预防治疗条件的患者从每100人年36例增加到每100人年144例。对照期诊断结核221例（每100人年1-31例），干预期诊断结核254例（每100人年1-10例）（未校正风险比[HR] 0-87； 95% CI 0-69-1-10）。结核病发病率或死亡率分别为每100人年3-64和3-04 （0-76;95% CI 0-66-0-87）。在调整了年龄、性别、CD4细胞计数和抗逆转录病毒治疗后，结核病的HR为0-73 (95% CI为0-54-0-99)，结核病或死亡的HR为0-69（0-57-0-83）。旨在增加结核病筛查、提供结核菌素皮肤试验和在巴西艾滋病毒诊所使用异烟肼预防疗法的业务培训大大减少了结核病发病率和死亡率。因此，在结核病发病率中等的环境中，扩大对艾滋病毒感染患者的预防性治疗是可以实现的，并应在巴西和其他地方广泛实施。
Background Preventive therapy for tuberculosis in patients with HIV is effective, but it has not been widely implemented in moderate or high-burden settings. We assessed the effect of widespread use of isoniazid preventive therapy on rates of tuberculosis and death in people with HIV in Brazil.Methods We did a stepped wedge, duster-randomised trial with patients actively enrolled in 29 HIV clinics in Rio de Janeiro. Clinic staff were trained in tuberculosis screening, use of tuberculin skin tests, and use of isoniazid preventive therapy. Clinics were randomly allocated a date to begin the intervention period, with two clinics beginning the intervention every 2 months starling from Sept 1,2005. The primary outcome was tuberculosis incidence alone or combined with death in the control versus intervention periods until Aug 31, 2009. This trial is registered at ClinicalTrials.gov, number NCT00107887.Results Of 17413 patients in the cohort, 12816 were eligible for the intervention. Overall, there were 475 tuberculosis cases and 838 deaths. The intervention increased the rate of patients receiving skin tests from 19 per 100 person-years to 59 per 100 person-years, and from 36 per 100 person-years to 144 per 100 person-years for those eligible for isoniazid preventive therapy. In the control period, 221 cases of tuberculosis were diagnosed (1-31 per 100 person-years) compared with 254 (1-10 per 100 person-years) in the intervention period (unadjusted hazard ratio [HR] 0-87; 95% CI 0-69-1-10). Rates of tuberculosis incidence or death were 3-64 and 3-04 per 100 person-years, respectively (0-76; 95% CI 0-66-0-87). When adjusted for age, sex, entry CD4 count, and use of antiretroviral therapy, the HR for tuberculosis was 0-73 (95% CI 0-54-0-99) and for tuberculosis or death was 0-69 (0-57-0-83).Interpretation Operational training aimed at increasing tuberculosis screening, provision of tuberculin skin tests, and use of isoniazid preventive therapy in Brazilian HIV clinics significantly reduced incident tuberculosis and death. Thus, scale-up of preventive therapy for HIV-infected patients in settings of moderate tuberculosis incidence is achievable and should be widely implemented in Brazil and elsewhere.