原創(chuàng) 李兆申，柏愚
近日，國際腫瘤學(xué)頂級期刊Journal of Hematology & Oncology發(fā)表了長海醫(yī)院李兆申院士團(tuán)隊(duì)的全國多中心臨床研究成果——“基于免疫法糞便潛血試驗(yàn)（FIT）的風(fēng)險(xiǎn)分層模型可有效篩查中國人群中的結(jié)直腸腫瘤和早期結(jié)直腸癌”（IF=23.168）。長海醫(yī)院消化內(nèi)科趙勝兵、王樹玲、潘鵬、夏天為該項(xiàng)研究共同第一作者，柏愚教授和李兆申院士為共同通訊作者。
該研究由李兆申院士牽頭，在全國175家醫(yī)院實(shí)施國家結(jié)直腸息肉管理項(xiàng)目（NCPC），歷時(shí)3年，共納入10164名患者，建立了適合中國人群的結(jié)直腸腫瘤風(fēng)險(xiǎn)分層模型——NCPC評分，為我國結(jié)直腸腫瘤的篩查工作提供了重要的理論依據(jù)和實(shí)施基礎(chǔ)，同時(shí)將年輕人群和非特異性消化道癥狀人群納入科學(xué)管理，有望在結(jié)腸鏡資源有限的國情下，探索出適合中國人群的結(jié)直腸癌篩查策略。
根據(jù)最新數(shù)據(jù)統(tǒng)計(jì)，在我國所有癌癥當(dāng)中，結(jié)直腸癌的發(fā)病數(shù)已躍居第二位，處于持續(xù)上升階段。結(jié)腸鏡檢查可有效發(fā)現(xiàn)早期結(jié)直腸癌和癌前病變，但我國人口基數(shù)大，結(jié)腸鏡資源相對匱乏。根據(jù)國外的臨床經(jīng)驗(yàn)，推薦年齡在45歲或50歲以上的人群進(jìn)行結(jié)腸鏡檢查，但這種“一刀切”式的劃分方法顯然不適合我國的國情。哪些人需要盡快接受結(jié)腸鏡檢查，而哪些人又不該浪費(fèi)寶貴的檢查資源，一直是我國消化科同道不斷探索的臨床問題。
在該項(xiàng)臨床研究中，研究者根據(jù)單變量分析確認(rèn)了11個(gè)潛在的風(fēng)險(xiǎn)因素，其中8個(gè)（性別、年齡、BMI、吸煙、飲酒、糖尿病、是否有結(jié)腸癌家族史、既往結(jié)腸鏡檢查情況）被最終確認(rèn)為NCPC評分的獨(dú)立預(yù)測因素。通過NCPC評分，可將患者的結(jié)直腸腫瘤患病風(fēng)險(xiǎn)分為低、中、高風(fēng)險(xiǎn)三類，對于中風(fēng)險(xiǎn)和高風(fēng)險(xiǎn)人群，建議進(jìn)行結(jié)腸鏡檢查。
另外，所有參與研究的患者都接受了FIT（糞便免疫化學(xué)試驗(yàn)）檢查。結(jié)果發(fā)現(xiàn)，F(xiàn)IT檢測陽性的患者無論其NCPC評分如何，結(jié)直腸癌及癌前病變的發(fā)病率均顯著增高，故FIT檢測陽性的患者亦建議接受結(jié)腸鏡檢查。
研究人員隨后對這種“NCPC評分與FIT檢測結(jié)果”相結(jié)合的結(jié)直腸腫瘤風(fēng)險(xiǎn)分層模型進(jìn)行了臨床驗(yàn)證，發(fā)現(xiàn)其可以識別71%的腺瘤等腫瘤性病變、78%的進(jìn)展期腫瘤性病變以及79%的結(jié)直腸癌，從而節(jié)約大量的結(jié)腸鏡資源。
李兆申院士表示，對于中國人群而言，這一新型的結(jié)直腸腫瘤風(fēng)險(xiǎn)分層模型能夠高效地鑒別結(jié)直腸癌高危人群，從而有效提高結(jié)腸鏡檢查效率，降低結(jié)腸鏡檢查負(fù)擔(dān)，將我國寶貴的醫(yī)療資源用在刀刃上！
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.
