Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
Lancet. 2013 Oct 5;382(9899):1183-94. doi: 10.1016/S0140-6736(13)61131-9. Epub 2013 Aug 1.
Southern Africa has had an unprecedented increase in the burden of tuberculosis, driven by the HIV epidemic. The Zambia, South Africa Tuberculosis and AIDS Reduction (ZAMSTAR) trial examined two public health interventions that aimed to reduce the burden of tuberculosis by facilitating either rapid sputum diagnosis or integrating tuberculosis and HIV services within the community.
ZAMSTAR was a community-randomised trial done in Zambia and the Western Cape province of South Africa. Two interventions, community-level enhanced tuberculosis case-finding (ECF) and household level tuberculosis-HIV care, were implemented between Aug 1, 2006, and July 31, 2009, and assessed in a 2×2 factorial design between Jan 9, 2010, and Dec 6, 2010. All communities had a strengthened tuberculosis-HIV programme implemented in participating health-care centres. 24 communities, selected according to population size and tuberculosis notification rate, were randomly allocated to one of four study groups using a randomisation schedule stratified by country and baseline prevalence of tuberculous infection: group 1 strengthened tuberculosis-HIV programme at the clinic alone; group 2, clinic plus ECF; group 3, clinic plus household intervention; and group 4, clinic plus ECF and household interventions. The primary outcome was the prevalence of culture-confirmed pulmonary tuberculosis in adults (≥18 years), defined as Mycobacterium tuberculosis isolated from one respiratory sample, measured 4 years after the start of interventions in a survey of 4000 randomly selected adults in each community in 2010. The secondary outcome was the incidence of tuberculous infection, measured using tuberculin skin testing in a cohort of schoolchildren, a median of 4 years after a baseline survey done before the start of interventions. This trial is registered, number ISRCTN36729271.
Prevalence of tuberculosis was evaluated in 64,463 individuals randomly selected from the 24 communities; 894 individuals had active tuberculosis. Averaging over the 24 communities, the geometric mean of tuberculosis prevalence was 832 per 100,000 population. The adjusted prevalence ratio for the comparison of ECF versus non-ECF intervention groups was 1·09 (95% CI 0·86-1·40) and of household versus non-household intervention groups was 0·82 (0·64-1·04). The incidence of tuberculous infection was measured in a cohort of 8809 children, followed up for a median of 4 years; the adjusted rate ratio for ECF versus non-ECF groups was 1·36 (95% CI 0·59-3·14) and for household versus non-household groups was 0·45 (0·20-1·05).
Although neither intervention led to a statistically significant reduction in tuberculosis, two independent indicators of burden provide some evidence of a reduction in tuberculosis among communities receiving the household intervention. By contrast the ECF intervention had no effect on either outcome.
Bill & Melinda Gates Foundation.
由于艾滋病的流行，南部非洲的结核病负担空前增加。赞比亚、南非结核病和艾滋病减少（ZAMSTAR）试验研究了两种公共卫生干预措施，旨在通过促进快速痰检或在社区内整合结核病和艾滋病服务来减轻结核病负担。
ZAMSTAR 是在赞比亚和南非西开普省进行的一项社区随机试验。2006 年 8 月 1 日至 2009 年 7 月 31 日实施了两种干预措施，即社区强化结核病病例发现（ECF）和家庭层面的结核病-艾滋病护理，并在 2010 年 1 月 9 日至 2010 年 12 月 6 日之间进行了 2×2 析因设计评估。所有社区都在参与的医疗保健中心实施了强化结核病-艾滋病方案。根据人口规模和结核病报告率，选择了 24 个社区，使用按国家和基线结核感染率分层的随机时间表，随机分为四个研究组：第 1 组仅在诊所实施强化结核病-艾滋病方案；第 2 组在诊所加 ECF；第 3 组在诊所加家庭干预；第 4 组在诊所加 ECF 和家庭干预。主要结局是在每个社区的 4000 名随机选择的成年人中，在 2010 年进行的一项调查中，4 年后成年人（≥18 岁）培养确认的肺结核患病率，定义为从一个呼吸道样本中分离出结核分枝杆菌。次要结局是在一组接受基线调查之前开始干预的小学生中，使用结核菌素皮肤试验测量结核感染的发病率，中位随访时间为 4 年。这项试验在 ISRCTN 注册，编号 ISRCTN36729271。
在 24 个社区中随机选择了 64463 名个体进行结核病患病率评估；894 人患有活动性结核病。在 24 个社区平均水平上，肺结核患病率的几何平均值为每 100,000 人 832 人。ECF 与非 ECF 干预组相比，调整后的患病率比为 1.09（95%CI 0.86-1.40），家庭干预与非家庭干预组相比，调整后的患病率比为 0.82（0.64-1.04）。对 8809 名儿童的队列进行了结核感染发病率测量，中位随访时间为 4 年；ECF 与非 ECF 组相比，调整后的发病率比为 1.36（95%CI 0.59-3.14），家庭与非家庭组相比，调整后的发病率比为 0.45（0.20-1.05）。
尽管两种干预措施都没有导致结核病负担的统计学显著降低，但两个独立的负担指标提供了一些证据，表明接受家庭干预的社区的结核病负担有所减轻。相比之下，ECF 干预措施对这两种结果都没有影响。
比尔和梅琳达·盖茨基金会。
