在没有 CD4 计数的情况下，对于有结核病症状的 HIV 阳性患者，是否应该使用尿液 LAM 检测？来自马拉维的一项前瞻性观察队列研究。
Should Urine-LAM Tests Be Used in TB Symptomatic HIV-Positive Patients When No CD4 Count Is Available? A Prospective Observational Cohort Study From Malawi.
机构信息
Field Epidemiology Department, Epicentre, Paris, France.
Médecins Sans Frontières, Chiradzulu, Malawi.
出版信息
J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):24-30. doi: 10.1097/QAI.0000000000002206.
BACKGROUND
Current eligibility criteria for urine lateral-flow lipoarabinomannan assay (LF-LAM) in ambulatory, HIV-positive patients rely on the CD4 count. We investigated the diagnostic yield of LF-LAM and the 6-month mortality in ambulatory, TB symptomatic, HIV-positive patients regardless of their CD4 count.
METHODS
We conducted a prospective, observational study that included all ambulatory, ≥15-year-old, TB symptomatic (cough, weight loss, fever, or night sweats) HIV-positive patients presenting at 4 health facilities in Malawi. Patients received a clinical examination and were requested urine LF-LAM, sputum microscopy, and Xpert MTB/RIF. TB was defined as bacteriologically confirmed if Xpert was positive.
RESULTS
Of 485 patients included, 171 (35.3%) had a CD4 <200 and 32 (7.2%) were seriously ill. Median CD4 count was 341 cells/µL (interquartile range: 129-546). LAM was positive in 24.9% patients with CD4 < 200 (50% LAM grades 2-4) and 12.5% with CD4 ≥ 200 (12.8% LAM grades 2-4). Xpert was positive in 14.1% (44/312). Among Xpert-positive patients, LAM positivity was 56.7% (CD4 < 200) and 42.9% (CD4 ≥ 200), P = 0.393. Of the patients without an Xpert result, 13.4% (23/172) were LAM positive (ie, potentially missed patients). Overall, mortality was 9.2% (44/478). More pronounced LAM-positive patients had higher mortality than LAM-negative (grades 2-4: 36.0%; grade 1: 9.1%; negative: 7.4%; P < 0.001). LAM-positive patients with CD4 <200 cells/µL had higher risk of mortality than LAM negatives (adjusted hazard ratio: 3.2, 95% confidence interval: 1.4 to 7.2, P = 0.006), particularly those with LAM grades 2-4 (adjusted hazard ratio: 4.9, 95% confidence interval: 1.8 to 13.3, P = 0.002).
CONCLUSIONS
Urine-LAM testing can be useful for TB diagnosis in HIV-positive TB-symptomatic patients with no CD4 cell count. LAM grade can identify patients at higher risk of death in this situation.
背景
目前，对于门诊 HIV 阳性患者，尿脂阿拉伯甘露聚糖侧向流动检测（LF-LAM）的适用条件基于 CD4 计数。本研究旨在调查 LF-LAM 的诊断效果和门诊、有 TB 症状（咳嗽、体重减轻、发热或夜间盗汗）、HIV 阳性患者的 6 个月死亡率，无论其 CD4 计数如何。
方法
我们开展了一项前瞻性、观察性研究，纳入了马拉维 4 家卫生机构的所有门诊、年龄≥15 岁、有 TB 症状（咳嗽、体重减轻、发热或夜间盗汗）的 HIV 阳性患者。患者接受临床检查，并接受尿 LF-LAM、痰显微镜检查和 Xpert MTB/RIF。如果 Xpert 阳性，则将细菌学确诊的 TB 定义为阳性。
结果
在 485 名纳入患者中，171 名（35.3%）的 CD4<200 个细胞/µL，32 名（7.2%）病情严重。中位 CD4 计数为 341 个细胞/µL（四分位间距：129-546）。CD4<200 个细胞/µL 的患者中，LAM 阳性率为 24.9%（50%的 LAM 分级为 2-4 级），CD4≥200 个细胞/µL 的患者中，LAM 阳性率为 12.5%（12.8%的 LAM 分级为 2-4 级）。Xpert 阳性率为 14.1%（44/312）。在 Xpert 阳性患者中，LAM 阳性率在 CD4<200 个细胞/µL 的患者中为 56.7%（CD4<200 个细胞/µL），在 CD4≥200 个细胞/µL 的患者中为 42.9%（P=0.393）。在没有 Xpert 结果的患者中，13.4%（23/172）的患者 LAM 阳性（即可能漏诊的患者）。总体死亡率为 9.2%（44/478）。LAM 阳性程度较严重的患者死亡率更高，LAM 阳性（分级 2-4 级：36.0%；分级 1 级：9.1%；阴性：7.4%；P<0.001）。CD4<200 个细胞/µL 的 LAM 阳性患者的死亡风险高于 LAM 阴性患者（调整后的危险比：3.2，95%置信区间：1.4 至 7.2，P=0.006），尤其是 LAM 分级为 2-4 级的患者（调整后的危险比：4.9，95%置信区间：1.8 至 13.3，P=0.002）。
结论
尿-LAM 检测可用于诊断门诊、有 TB 症状、HIV 阳性患者的 TB，且无论 CD4 计数如何。LAM 分级可识别出该情况下死亡风险较高的患者。
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