Xpert MTB/RIF 检测对乌干达住院患者结核病管理和结局的影响。
Impact of Xpert MTB/RIF testing on tuberculosis management and outcomes in hospitalized patients in Uganda.
机构信息
Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA.
出版信息
PLoS One. 2012;7(11):e48599. doi: 10.1371/journal.pone.0048599. Epub 2012 Nov 6.
RATIONALE
The clinical impact of Xpert MTB/RIF for tuberculosis (TB) diagnosis in high HIV-prevalence settings is unknown.
OBJECTIVE
To determine the diagnostic accuracy and impact of Xpert MTB/RIF among high-risk TB suspects.
METHODS
WE PROSPECTIVELY ENROLLED CONSECUTIVE, HOSPITALIZED, UGANDAN TB SUSPECTS IN TWO PHASES: baseline phase in which Xpert MTB/RIF results were not reported to clinicians and an implementation phase in which results were reported. We determined the diagnostic accuracy of Xpert MTB/RIF in reference to culture (solid and liquid) and compared patient outcomes by study phase.
RESULTS
477 patients were included (baseline phase 287, implementation phase 190). Xpert MTB/RIF had high sensitivity (187/237, 79%, 95% CI: 73-84%) and specificity (190/199, 96%, 95% CI: 92-98%) for culture-positive TB overall, but sensitivity was lower (34/81, 42%, 95% CI: 31-54%) among smear-negative TB cases. Xpert MTB/RIF reduced median days-to-TB detection for all TB cases (1 [IQR 0-26] vs. 0 [IQR 0-1], p<0.001), and for smear-negative TB (35 [IQR 22-55] vs. 22 [IQR 0-33], p=0.001). However, median days-to-TB treatment was similar for all TB cases (1 [IQR 0-5] vs. 0 [IQR 0-2], p=0.06) and for smear-negative TB (7 [IQR 3-53] vs. 6 [IQR 1-61], p=0.78). Two-month mortality was also similar between study phases among 252 TB cases (17% vs. 14%, difference +3%, 95% CI: -21% to +27%, p=0.80), and among 87 smear-negative TB cases (28% vs. 22%, difference +6%, 95% CI: -34 to +46%, p=0.77).
CONCLUSIONS
Xpert MTB/RIF facilitated more accurate and earlier TB diagnosis, leading to a higher proportion of TB suspects with a confirmed TB diagnosis prior to hospital discharge in a high HIV/low MDR TB prevalence setting. However, our study did not detect a decrease in two-month mortality following implementation of Xpert MTB/RIF possibly because of insufficient powering, differences in empiric TB treatment rates, and disease severity between study phases.
背景
Xpert MTB/RIF 检测对高 HIV 流行地区结核病（TB）诊断的临床影响尚不清楚。
目的
确定 Xpert MTB/RIF 在高危 TB 疑似病例中的诊断准确性和影响。
方法
我们前瞻性地招募了两阶段的连续住院乌干达 TB 疑似病例：基线阶段不向临床医生报告 Xpert MTB/RIF 结果，实施阶段报告结果。我们参考培养物（固体和液体）确定了 Xpert MTB/RIF 的诊断准确性，并比较了研究阶段的患者结局。
结果
共纳入 477 例患者（基线阶段 287 例，实施阶段 190 例）。Xpert MTB/RIF 对所有培养阳性的 TB 总体具有较高的敏感性（187/237，79%，95%CI：73-84%）和特异性（190/199，96%，95%CI：92-98%），但在涂片阴性的 TB 病例中敏感性较低（34/81，42%，95%CI：31-54%）。Xpert MTB/RIF 缩短了所有 TB 病例的中位 TB 检测时间（1 [IQR 0-26] vs. 0 [IQR 0-1]，p<0.001），以及涂片阴性的 TB 病例（35 [IQR 22-55] vs. 22 [IQR 0-33]，p=0.001）。然而，所有 TB 病例的中位 TB 治疗时间相似（1 [IQR 0-5] vs. 0 [IQR 0-2]，p=0.06），以及涂片阴性的 TB 病例（7 [IQR 3-53] vs. 6 [IQR 1-61]，p=0.78）。在 252 例 TB 病例中，两个阶段的 2 个月死亡率也相似（17% vs. 14%，差异+3%，95%CI：-21%至+27%，p=0.80），以及 87 例涂片阴性的 TB 病例（28% vs. 22%，差异+6%，95%CI：-34%至+46%，p=0.77）。
结论
Xpert MTB/RIF 有助于更准确和更早地诊断 TB，导致在高 HIV/低 MDR-TB 流行地区，在出院前有更高比例的 TB 疑似病例被确诊为 TB。然而，我们的研究没有发现 Xpert MTB/RIF 实施后两个月死亡率的降低，这可能是因为效力不足、经验性 TB 治疗率的差异以及两个研究阶段之间的疾病严重程度不同。
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