Unidad Clínica de Enfermedades Infecciosas y Medicina Preventiva, Hospital Universitario Virgen del Rocío, Seville, Spain.
Instituto de Biomedicina de Sevilla/CSIC/Universidad de Sevilla, Seville, Spain.
Clin Infect Dis. 2019 Nov 27;69(12):2185-2192. doi: 10.1093/cid/ciz144.
Screening methods for anal squamous intraepithelial lesions (SILs) are suboptimal. We aimed to determine the diagnostic performance of a composite endpoint comprising anal liquid-based cytology (aLBC) and high-risk human papillomavirus (HR-HPV) testing to predict histological high-grade SILs (hHSILs).
From the SeVIHanal cohort, human immunodeficiency virus (HIV)-infected men who have sex with men (MSM) who had an aLBC with concomitant HR-HPV testing were included. hHSILs were determined by high-resolution anoscopy (HRA)-guided biopsy.
A total of 705 visits obtained from 426 patients were included. The prevalence of HR-HPV among aLBC results were 51.9% (133/215) normal, 87.9% (20/232) low-grade SILs (LSILs), and 90.9% (149/164) high-grade SILs; P (linear association) < .001. Low prevalence of hHSILs was only observed for the composite aLBC/HR-HPV testing endpoint "normal/noHR-HPV" (10%) and "LSIL/noHR-HPV" (4%). The prognostic values (95% confidence interval) for HR-HPV to predict hHSILs in normal cytology were positive predictive value (PPV), 29.3% (25.6%-33.3%); negative predictive value (NPV), 90.2% (82.8%-94.7%); sensitivity, 83% (69.2%-92.4%); and specificity, 44.1% (36.4%-51.9%). Corresponding figures for cytologic LSILs were PPV, 39.2% (37.4%-41.1%); NPV, 96.4% (78.9%-99.5%); sensitivity, 98.8% (93.3%-99.9%); and specificity, 17.9% (12.1%-24.9%). A positive interaction and a synergistic effect for the composite endpoint were observed (relative excess risk = 1.50, attributable proportion of histological results to interaction = 0.17, synergy index = 1.24).
HRA should not be indicated in the setting of LSILs/noHR-HPV following aLBC-based screening. In contrast, HIV-infected MSM with normal aLBC/HR-HPV infection should be considered for HRA.
NCT03713229.
肛门鳞状上皮内病变（SIL）的筛查方法并不理想。我们旨在确定包含肛门液基细胞学（aLBC）和高危型人乳头瘤病毒（HR-HPV）检测的复合终点预测组织学高级别 SIL（hHSIL）的诊断性能。
从 SeVIHanal 队列中，纳入了进行 aLBC 联合 HR-HPV 检测的感染人类免疫缺陷病毒（HIV）的男男性行为者（MSM）。通过高分辨率肛门镜（HRA）引导活检确定 hHSIL。
共纳入 426 例患者的 705 次就诊。aLBC 结果中 HR-HPV 的检出率分别为：正常（133/215）为 51.9%，低级别 SILs（LSILs）（20/232）为 87.9%，高级别 SILs（HSILs）（149/164）为 90.9%；P（线性关联）<.001。仅在复合 aLBC/HR-HPV 检测终点“正常/无 HR-HPV”（10%）和“LSIL/无 HR-HPV”（4%）中观察到 hHSIL 的低患病率。在正常细胞学中，HR-HPV 预测 hHSIL 的预后值（95%置信区间）为阳性预测值（PPV），29.3%（25.6%-33.3%）；阴性预测值（NPV），90.2%（82.8%-94.7%）；灵敏度，83%（69.2%-92.4%）；特异性，44.1%（36.4%-51.9%）。细胞学 LSIL 的相应数值分别为：PPV，39.2%（37.4%-41.1%）；NPV，96.4%（78.9%-99.5%）；灵敏度，98.8%（93.3%-99.9%）；特异性，17.9%（12.1%-24.9%）。观察到复合终点存在阳性交互作用和协同效应（相对超额风险=1.50，归因于交互作用的组织学结果比例=0.17，协同指数=1.24）。
在 aLBC 为基础的筛查后，如果 LSILs/无 HR-HPV 情况下，不应进行 HRA。相反，应考虑对 HIV 感染的 MSM 进行 aLBC/HR-HPV 感染的 HRA。
NCT03713229。
