Division of Pulmonology, Department of Medicine and UCT Lung Institute, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe; Lung Infection and Immunity Unit, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Department of Immunology, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Lancet Infect Dis. 2017 Apr;17(4):441-450. doi: 10.1016/S1473-3099(16)30384-X. Epub 2017 Jan 5.
Inadequate case detection results in high levels of undiagnosed tuberculosis in sub-Saharan Africa. Data for the effect of new diagnostic tools when used for community-based intensified case finding are not available, so we investigated whether the use of sputum Xpert-MTB/RIF and the Determine TB LAM urine test in two African communities could be effective.
In a pragmatic, randomised, parallel-group trial with individual randomisation stratified by country, we compared sputum Xpert-MTB/RIF, and if HIV-infected, the Determine TB LAM urine test (novel diagnostic group), with laboratory-based sputum smear microscopy (routine diagnostic group) for intensified case finding in communities with high tuberculosis and HIV prevalence in Cape Town, South Africa, and Harare, Zimbabwe. Participants were randomly assigned (1:1) to these groups with computer-generated allocation lists, using culture as the reference standard. In Cape Town, participants were randomised and tested at an Xpert-equipped mobile van, while in Harare, participants were driven to a local clinic where the same diagnostic tests were done. The primary endpoint was the proportion of culture-positive tuberculosis cases initiating tuberculosis treatment in each study group at 60 days. This trial is registered at ClinicalTrials.gov, number NCT01990274.
Between Oct 18, 2013, and March 31, 2015, 2261 individuals were screened and 875 (39%) of these met the criteria for diagnostic testing. 439 participants were randomly assigned to the novel group and 436 to the routine group. 74 (9%) of 875 participants had confirmed tuberculosis. If late culture-based treatment initiation was excluded, more patients with culture-positive tuberculosis were initiated on treatment in the novel group at 60 days (36 [86%] of 42 in the novel group vs 18 [56%] of 32 in the routine group). Thus the difference in the proportion initiating treatment between groups was 29% (95% CI 9-50, p=0·0047) and 53% more patients initiated therapy in the novel diagnostic group than in the routine diagnostic group. One culture-positive patient was treated based only on a positive LAM test.
Compared with traditional tools, Xpert-MTB/RIF for community-based intensified case finding in HIV and tuberculosis-endemic settings increased the proportion of patients initiating treatment. By contrast, urine LAM testing was not found to be useful for intensive case finding in this setting.
European and Developing Countries Clinical Trials Partnership and South African Medical Research Council.
在撒哈拉以南非洲地区，由于病例检出率低，导致大量结核病未被诊断。目前尚无新诊断工具用于社区强化病例检出的效果数据，因此我们研究了在两个非洲社区中使用痰 Xpert-MTB/RIF 和尿液检测试剂盒（新诊断组）是否有效。
这是一项在南非开普敦和津巴布韦哈拉雷的高结核和高艾滋病毒流行社区中开展的基于人群的、随机化、平行组试验，采用个体分层随机化，比较了痰 Xpert-MTB/RIF 和如果艾滋病毒感染者，则进行尿液检测试剂盒（新诊断组）与基于实验室的痰涂片显微镜检查（常规诊断组）用于强化病例检出。参与者按照 1:1 的比例随机分配到这些组中，使用培养作为参考标准。在开普敦，参与者在配备 Xpert 的移动车中进行随机和检测，而在哈拉雷，参与者被送往当地诊所进行相同的诊断测试。主要终点是每组在 60 天内开始接受结核病治疗的培养阳性结核病病例的比例。这项试验在 ClinicalTrials.gov 注册，编号为 NCT01990274。
2013 年 10 月 18 日至 2015 年 3 月 31 日，共筛查了 2261 人，其中 875 人（39%）符合诊断检测标准。439 名参与者被随机分配到新诊断组，436 名参与者被随机分配到常规诊断组。74 名（9%）875 名参与者确诊患有结核病。如果排除延迟基于培养的治疗启动，新诊断组中更多培养阳性结核病患者在 60 天内开始接受治疗（新诊断组 42 例中 36 例[86%]，常规诊断组 32 例中 18 例[56%]）。因此，两组之间开始治疗的比例差异为 29%（95%CI 9-50，p=0·0047），新诊断组中开始治疗的患者比常规诊断组多 53%。一名培养阳性患者仅根据 LAM 检测阳性就接受了治疗。
与传统工具相比，Xpert-MTB/RIF 用于艾滋病毒和结核病流行地区的社区强化病例检出，增加了开始治疗的患者比例。相比之下，尿液 LAM 检测在这种情况下并未发现对强化病例检出有用。
欧洲和发展中国家临床试验伙伴关系和南非医学研究理事会。
