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粪便血红蛋白浓度在 FIT 结果阴性的人群中与后续轮次的肿瘤检出率相关:意大利基于人群筛查项目的前瞻性研究。

Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy.

机构信息

SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy

Clinical Epidemiology Unit, ISPRO, Florence, Italy.

出版信息

Gut. 2020 Mar;69(3):523-530. doi: 10.1136/gutjnl-2018-318198. Epub 2019 Aug 27.

DOI:10.1136/gutjnl-2018-318198
PMID:31455608
Abstract

OBJECTIVE

To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer-CRC-or advanced adenoma).

DESIGN

Prospective cohort of subjects aged 50-69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy.

METHODS

All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces). We assessed the AN risk at subsequent exams, the cumulative AN detection rate (DR) over the 4-year period following the second FIT and the interval CRC (IC) risk following two negative FITs by cumulative amount of f-Hb concentration over two consecutive negative FITs, using multivariable logistic regression models and the Kaplan-Meier method.

RESULTS

The cumulative probability of a positive FIT result over the subsequent two rounds ranged between 7.8% (95% CI 7.5 to 8.2) for subjects with undetectable f-Hb at the initial two tests (50% of the screenees) and 48.4% (95% CI 44.0 to 53.0) among those (0.7% of the screenees) with a cumulative f-Hb concentration ≥20 µg/g faeces. The corresponding figures for cumulative DR were: 1.4% (95% CI 1.3 to 1.6) and 25.5% (95% CI 21.4 to 30.2) for AN; 0.17% (95% CI 0.12 to 0.23) and 4.5% (95% CI 2.8 to 7.1) for CRC. IC risk was also associated with cumulative f-Hb levels.

CONCLUSION

The association of cumulative f-Hb concentration with subsequent AN and IC risk may allow to design tailored strategies to optimise the utilisation of endoscopy resources: subjects with cumulative f-Hb concentration ≥20 µg/g faeces over two negative tests could be referred immediately for total colonoscopy (TC), while screening interval might be extended for those with undetectable f-Hb.

摘要

目的

评估粪便血红蛋白(f-Hb)浓度在粪便免疫化学试验(FIT)结果低于阳性截断值的受试者中对后续高级别肿瘤(AN:结直肠癌-CRC-或高级腺瘤)风险的预测作用。

设计

2004 年 1 月 1 日至 2010 年 12 月 31 日,在意大利的四个基于人群的项目中,对年龄在 50-69 岁的首次接受 FIT 的受试者进行前瞻性队列研究。

方法

所有项目均采用相同的分析程序(OC Sensor,日本荣研),每两年进行一次,使用单一样本,阳性截断值(20μg Hb/g 粪便)相同。我们通过多变量逻辑回归模型和 Kaplan-Meier 方法,评估后续检查中的 AN 风险、在第二次 FIT 后 4 年内的累积 AN 检出率(DR),以及两次阴性 FIT 后通过连续两次阴性 FIT 的 f-Hb 浓度累积量计算的间隔 CRC(IC)风险。

结果

在随后的两轮中,阳性 FIT 结果的累积概率在初始两次检测中 f-Hb 未检出的受试者(筛查者的 50%)为 7.8%(95%CI 7.5 至 8.2),而在累积 f-Hb 浓度≥20μg/g 粪便的受试者(筛查者的 0.7%)中为 48.4%(95%CI 44.0 至 53.0)。累积 DR 的相应数字分别为:AN 为 1.4%(95%CI 1.3 至 1.6)和 25.5%(95%CI 21.4 至 30.2);CRC 为 0.17%(95%CI 0.12 至 0.23)和 4.5%(95%CI 2.8 至 7.1)。IC 风险也与累积 f-Hb 水平相关。

结论

累积 f-Hb 浓度与随后的 AN 和 IC 风险相关,这可能有助于设计针对特定人群的策略来优化内镜资源的利用:在两次阴性检测中累积 f-Hb 浓度≥20μg/g 粪便的受试者可以立即进行全结肠镜检查(TC),而对于未检出 f-Hb 的受试者,可以延长筛查间隔。

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