Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.
Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.
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DOI：
10.1371/journal.pone.0018358
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发表时间：
2011-04-11
期刊：
影响因子：
3.7
通讯作者：
Goldberg S
中科院分区：
文献类型：
--
作者：
Mac Kenzie WR;Heilig CM;Bozeman L;Johnson JL;Muzanye G;Dunbar D;Jost KC Jr;Diem L;Metchock B;Eisenach K;Dorman S;Goldberg S
Tuberculosis Trials Consortium Study 28是一项双盲、随机、安慰剂对照、2期临床试验，检查涂片阳性肺结核分枝杆菌。在强化阶段治疗过程中，与非非洲患者相比，来自非洲研究中心的患者在液体培养基中的培养物转阴时间显著延迟且转化率较低。我们探讨了这一发现的可能解释。在TBTC研究28中，方案正确的患者（n = 328）提供了用于M的痰液斑点标本。 在基线和研究治疗的第2、4、6和8周，在液体培养基中进行结核病培养。我们比较了非洲和非非洲患者的痰培养转化率，这些患者根据疾病严重程度的四个基线指标进行分层：AFB涂片定量、胸片上的疾病程度、空洞大小和检测到M的天数。使用Kaplan-Meier乘积极限法测定液体培养基中的结核菌。我们评估了27个研究中心的29个研究实验室使用的标本处理和培养程序。非洲结核病患者在入组时比非非洲患者有更广泛的疾病。然而，通过4种疾病严重程度测量，疾病最少的非洲患者在液体培养基上的转化率大大低于疾病程度最大的非非洲患者的转化率。艾滋病毒感染、吸烟和糖尿病并不能解释非洲的延迟转换。在临床诊断实验室公认的实践中，实验室处理和培养程序的一些研究中心之间的差异被发现。与来自非非洲研究中心的患者相比，非洲结核病患者接受治疗的痰培养转化延迟，液体培养基中痰转化率较低，这不能用基线疾病严重程度、艾滋病毒感染状况、年龄、吸烟、糖尿病或种族来解释。有必要进一步研究实验室过程的适度变化是否会对2期TB治疗试验的疗效结果产生实质性影响，或者是否存在其他因素（例如，营养、宿主反应）。ClinicalTrials.gov NCT00144417
Tuberculosis Trials Consortium Study 28, was a double blind, randomized, placebo-controlled, phase 2 clinical trial examining smear positive pulmonary Mycobacterium tuberculosis. Over the course of intensive phase therapy, patients from African sites had substantially delayed and lower rates of culture conversion to negative in liquid media compared to non-African patients. We explored potential explanations of this finding. In TBTC Study 28, protocol-correct patients (n = 328) provided spot sputum specimens for M. tuberculosis culture in liquid media, at baseline and weeks 2, 4, 6 and 8 of study therapy. We compared sputum culture conversion for African and non-African patients stratified by four baseline measures of disease severity: AFB smear quantification, extent of disease on chest radiograph, cavity size and the number of days to detection of M. tuberculosis in liquid media using the Kaplan-Meier product-limit method. We evaluated specimen processing and culture procedures used at 29 study laboratories serving 27 sites. African TB patients had more extensive disease at enrollment than non-African patients. However, African patients with the least disease by the 4 measures of disease severity had conversion rates on liquid media that were substantially lower than conversion rates in non-African patients with the greatest extent of disease. HIV infection, smoking and diabetes did not explain delayed conversion in Africa. Some inter-site variation in laboratory processing and culture procedures within accepted practice for clinical diagnostic laboratories was found. Compared with patients from non-African sites, African patients being treated for TB had delayed sputum culture conversion and lower sputum conversion rates in liquid media that were not explained by baseline severity of disease, HIV status, age, smoking, diabetes or race. Further investigation is warranted into whether modest variation in laboratory processes substantially influences the efficacy outcomes of phase 2 TB treatment trials or if other factors (e.g., nutrition, host response) are involved. ClinicalTrials.gov NCT00144417
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作者：
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通讯作者：
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DOI：
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