{"title":"抗整合素αvβ6抗体作为诊断溃疡性结肠炎的生物标记物：一项全国性多中心验证研究。","authors":"Makoto Okabe, Shuji Yamamoto, Masahiro Shiokawa, Tadakazu Hisamatsu, Hajime Yamazaki, Risa Nakanishi, Kensuke Hamada, Hiroki Kitamoto, Takeshi Kuwada, Norimitsu Uza, Aki Sakatani, Toshimitsu Fujii, Masashi Ohno, Minoru Matsuura, Tomoyoshi Shibuya, Naoki Ohmiya, Makoto Ooi, Namiko Hoshi, Kei Moriya, Kiichiro Tsuchiya, Yoshiharu Yamaguchi, Reiko Kunisaki, Masahiro Takahara, Tomohisa Takagi, Tetsuo Takehara, Fumihito Hirai, Kazuki Kakimoto, Motohiro Esaki, Hiroshi Nakase, Fukunori Kinjo, Takehiro Torisu, Shuji Kanmura, Kazuyuki Narimatsu, Katsuyoshi Matsuoka, Hiroto Hiraga, Kaoru Yokoyama, Yusuke Honzawa, Makoto Naganuma, Masayuki Saruta, Yuzo Kodama, Tsutomu Chiba, Hiroshi Seno","doi":"10.1007/s00535-024-02176-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study.</p><p><strong>Methods: </strong>We measured V6 Ab titers in patients definitively diagnosed with UC, Crohn's disease (CD), or other gastrointestinal disorders (OGDs). The primary outcome was the diagnostic value of V6 Ab. Secondary outcomes were factors associated with false-negative results in patients with UC and false-positive results in patients without UC and the heterogeneity of the diagnostic value of V6 Ab among the participating facilities.</p><p><strong>Results: </strong>We enrolled 1241, 796, and 206 patients with UC, CD, and OGD, respectively, from 28 Japanese high-volume referral centers. The diagnostic sensitivity of V6 Ab for UC was 87.7%, and its specificities for CD and OGDs were 82.0% and 87.4%, respectively. Multivariable logistic regression analysis showed that false-negative results were associated with older age at the time of sample collection, current smokers, lower partial Mayo score, and not receiving advanced therapies in patients with UC, and false-positive results were associated with colonic CD in patients with CD. No factor was associated with false-positive results in patients with OGDs. There were no significant differences in the diagnostic value of V6 Ab among the centers.</p><p><strong>Conclusions: </strong>The diagnostic value of V6 Ab for UC was validated in the large-scale nationwide multicenter study.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":6.9000,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Anti-integrin αvβ6 antibody as a biomarker for diagnosing ulcerative colitis: a nationwide multicenter validation study.\",\"authors\":\"Makoto Okabe, Shuji Yamamoto, Masahiro Shiokawa, Tadakazu Hisamatsu, Hajime Yamazaki, Risa Nakanishi, Kensuke Hamada, Hiroki Kitamoto, Takeshi Kuwada, Norimitsu Uza, Aki Sakatani, Toshimitsu Fujii, Masashi Ohno, Minoru Matsuura, Tomoyoshi Shibuya, Naoki Ohmiya, Makoto Ooi, Namiko Hoshi, Kei Moriya, Kiichiro Tsuchiya, Yoshiharu Yamaguchi, Reiko Kunisaki, Masahiro Takahara, Tomohisa Takagi, Tetsuo Takehara, Fumihito Hirai, Kazuki Kakimoto, Motohiro Esaki, Hiroshi Nakase, Fukunori Kinjo, Takehiro Torisu, Shuji Kanmura, Kazuyuki Narimatsu, Katsuyoshi Matsuoka, Hiroto Hiraga, Kaoru Yokoyama, Yusuke Honzawa, Makoto Naganuma, Masayuki Saruta, Yuzo Kodama, Tsutomu Chiba, Hiroshi Seno\",\"doi\":\"10.1007/s00535-024-02176-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study.</p><p><strong>Methods: </strong>We measured V6 Ab titers in patients definitively diagnosed with UC, Crohn's disease (CD), or other gastrointestinal disorders (OGDs). The primary outcome was the diagnostic value of V6 Ab. Secondary outcomes were factors associated with false-negative results in patients with UC and false-positive results in patients without UC and the heterogeneity of the diagnostic value of V6 Ab among the participating facilities.</p><p><strong>Results: </strong>We enrolled 1241, 796, and 206 patients with UC, CD, and OGD, respectively, from 28 Japanese high-volume referral centers. 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引用次数: 0
摘要
背景：诊断溃疡性结肠炎（UC）的血清生物标志物仍有待确定。尽管我们最近报道了一种抗整合素αvβ6抗体（V6 Ab）用于诊断溃疡性结肠炎，具有较高的灵敏度和特异性，但目前还没有大规模的验证研究。本研究旨在通过一项全国性多中心队列研究验证 V6 Ab 对 UC 的诊断价值：我们测量了明确诊断为 UC、克罗恩病（CD）或其他胃肠道疾病（OGD）患者的 V6 Ab 滴度。主要结果是V6抗体的诊断价值。次要结果是与 UC 患者假阴性结果和非 UC 患者假阳性结果相关的因素，以及 V6 Ab 诊断价值在参与机构间的异质性：我们从 28 个日本高流量转诊中心分别招募了 1241、796 和 206 名 UC、CD 和 OGD 患者。V6 Ab 对 UC 的诊断敏感性为 87.7%，对 CD 和 OGD 的特异性分别为 82.0% 和 87.4%。多变量逻辑回归分析显示，假阴性结果与 UC 患者采集样本时年龄较大、目前吸烟、梅奥部分评分较低以及未接受先进疗法有关，而假阳性结果与 CD 患者的结肠 CD 有关。没有任何因素与OGD患者的假阳性结果相关。各中心的 V6 Ab 诊断价值无明显差异：结论：V6抗体对UC的诊断价值在这项大规模全国性多中心研究中得到了验证。
Anti-integrin αvβ6 antibody as a biomarker for diagnosing ulcerative colitis: a nationwide multicenter validation study.
Background: A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study.
Methods: We measured V6 Ab titers in patients definitively diagnosed with UC, Crohn's disease (CD), or other gastrointestinal disorders (OGDs). The primary outcome was the diagnostic value of V6 Ab. Secondary outcomes were factors associated with false-negative results in patients with UC and false-positive results in patients without UC and the heterogeneity of the diagnostic value of V6 Ab among the participating facilities.
Results: We enrolled 1241, 796, and 206 patients with UC, CD, and OGD, respectively, from 28 Japanese high-volume referral centers. The diagnostic sensitivity of V6 Ab for UC was 87.7%, and its specificities for CD and OGDs were 82.0% and 87.4%, respectively. Multivariable logistic regression analysis showed that false-negative results were associated with older age at the time of sample collection, current smokers, lower partial Mayo score, and not receiving advanced therapies in patients with UC, and false-positive results were associated with colonic CD in patients with CD. No factor was associated with false-positive results in patients with OGDs. There were no significant differences in the diagnostic value of V6 Ab among the centers.
Conclusions: The diagnostic value of V6 Ab for UC was validated in the large-scale nationwide multicenter study.
期刊介绍：
The Journal of Gastroenterology, which is the official publication of the Japanese Society of Gastroenterology, publishes Original Articles (Alimentary Tract/Liver, Pancreas, and Biliary Tract), Review Articles, Letters to the Editors and other articles on all aspects of the field of gastroenterology. Significant contributions relating to basic research, theory, and practice are welcomed. These publications are designed to disseminate knowledge in this field to a worldwide audience, and accordingly, its editorial board has an international membership.
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