FIT美国(fit美国大学)

原创 李兆申，柏愚

近日，国际肿瘤学顶级期刊Journal of Hematology & Oncology发表了长海医院李兆申院士团队的全国多中心临床研究成果——“基于免疫法粪便潜血试验（FIT）的风险分层模型可有效筛查中国人群中的结直肠肿瘤和早期结直肠癌”（IF=23.168）。长海医院消化内科赵胜兵、王树玲、潘鹏、夏天为该项研究共同第一作者，柏愚教授和李兆申院士为共同通讯作者。

该研究由李兆申院士牵头，在全国175家医院实施国家结直肠息肉管理项目（NCPC），历时3年，共纳入10164名患者，建立了适合中国人群的结直肠肿瘤风险分层模型——NCPC评分，为我国结直肠肿瘤的筛查工作提供了重要的理论依据和实施基础，同时将年轻人群和非特异性消化道症状人群纳入科学管理，有望在结肠镜资源有限的国情下，探索出适合中国人群的结直肠癌筛查策略。

根据最新数据统计，在我国所有癌症当中，结直肠癌的发病数已跃居第二位，处于持续上升阶段。结肠镜检查可有效发现早期结直肠癌和癌前病变，但我国人口基数大，结肠镜资源相对匮乏。根据国外的临床经验，推荐年龄在45岁或50岁以上的人群进行结肠镜检查，但这种“一刀切”式的划分方法显然不适合我国的国情。哪些人需要尽快接受结肠镜检查，而哪些人又不该浪费宝贵的检查资源，一直是我国消化科同道不断探索的临床问题。

在该项临床研究中，研究者根据单变量分析确认了11个潜在的风险因素，其中8个（性别、年龄、BMI、吸烟、饮酒、糖尿病、是否有结肠癌家族史、既往结肠镜检查情况）被最终确认为NCPC评分的独立预测因素。通过NCPC评分，可将患者的结直肠肿瘤患病风险分为低、中、高风险三类，对于中风险和高风险人群，建议进行结肠镜检查。

另外，所有参与研究的患者都接受了FIT（粪便免疫化学试验）检查。结果发现，FIT检测阳性的患者无论其NCPC评分如何，结直肠癌及癌前病变的发病率均显著增高，故FIT检测阳性的患者亦建议接受结肠镜检查。

研究人员随后对这种“NCPC评分与FIT检测结果”相结合的结直肠肿瘤风险分层模型进行了临床验证，发现其可以识别71%的腺瘤等肿瘤性病变、78%的进展期肿瘤性病变以及79%的结直肠癌，从而节约大量的结肠镜资源。

李兆申院士表示，对于中国人群而言，这一新型的结直肠肿瘤风险分层模型能够高效地鉴别结直肠癌高危人群，从而有效提高结肠镜检查效率，降低结肠镜检查负担，将我国宝贵的医疗资源用在刀刃上！

Abstract

No fully validated risk-stratification strategies have been established in China where colonoscopies resources are limited. We aimed to develop and validate a fecal immunochemical test (FIT)-based risk-stratification model for colorectal neoplasia (CN); 10,164 individuals were recruited from 175 centers nationwide and were randomly allocated to the derivation (n=6776) or validation cohort (n=3388). Multivariate logistic analyses were performed to develop the National Colorectal Polyp Care (NCPC) score, which formed the risk-stratification model along with FIT. The NCPC score was developed from eight independent predicting factors and divided into three levels: low risk (LR 0-14), intermediate risk (IR 15-17), and high risk (HR 18-28). Individuals with IR or HR of NCPC score or FIT+ were classified as increased-risk individuals in the risk-stratification model and were recommended for colonoscopy. The IR/HR of NCPC score showed a higher prevalence of CNs (21.8%/32.8% vs. 11.0%, P<0.001) and ACNs (4.3%/9.2% vs. 2.0%, P<0.001) than LR, which was also confirmed in the validation cohort. Similar relative risks and predictive performances were demonstrated between non-specific gastrointestinal symptoms (NSGS) and asymptomatic cohort. The risk-stratification model identified 73.5% CN, 82.6% ACN, and 93.6% CRC when guiding 52.7% individuals to receive colonoscopy and identified 55.8% early-onset ACNs and 72.7% early-onset CRCs with only 25.6% young individuals receiving colonoscopy. The risk-stratification model showed a good risk-stratification ability for CN and early-onset CRCs in Chinese population, including individuals with NSGS and young age.