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验证胶囊内镜诊断克罗恩病的活动指数(CECDAI或Niv得分):一项多中心前瞻性研究

发布日期:2014-1-29 12:40:34 文章来源:Endoscopy 作者次数:1439
    验证胶囊内镜诊断克罗恩病的活动指数(CECDAINiv得分):一项多中心前瞻性研究

    Y. Niv1, S. Ilani1, Z. Levi1, M. Hershkowitz1, E. Niv2, Z. Fireman2, S. ODonnel3, C. OMorain3, R. Eliakim4, E. Scapa5, N. Kalantzis6, C. Kalantzis6, P. Apostolopoulos6, E. Gal1

    1以色列特拉维夫大学拉宾医学中心消化科

    2以色列理工大学,哈代拉Hillel Jafa医疗中心消化科

    3爱尔兰都柏林三一学院消化科

    4以色列海法市理工大学医学院瑞本医护校区消化科

    5以色列特拉维夫大学ZrifinAsaf-Harofe医学中心消化科

    6希腊雅典NIMTS医院消化科

    背景和研究目的:胶囊内镜诊断克罗恩病的活动指数(CECDAINiv 得分)是为了采用视屏胶囊内镜(VCE)测定黏膜病活性。当前研究的目的是前瞻性验证评分系统在日常实践中的使用情况。

    方法:这是一项对VCE视频的多中心、双盲、前瞻性对照研究,这些VCE视频来自于62例孤立性小肠克罗恩病患者。此CECDAI是为了评估克罗恩病的三个主要参数:位于小肠近端和远端两部分的炎症(A)、疾病发展程度(B)和狭窄(C)。最终得分是通过将两端得分相加而得出:CECDAI = ([A1 × B1] + C1) + ([A2 × B2] + C2)。每位测试者在每个部位判读6-10个视屏,之后计算CECDAI。然后将去识别后的CD-ROMs进行编码,并将其发送至CECDAI计算的主要研究者。

    结果:根据现场研究人员研究结果,可知有72%的检查达到盲肠,而且近端小肠病患者占56%,然而根据主要研究者研究结果,可知有86%的检查达到盲肠,近端小肠病患者占62%。个体现场研究人员和主要研究者所得的CECDAI计算值之间存在显著相关性。来自不同研究中心的内镜医师之间总体相关性良好,r=0.0767(范围:0.717-0.985Kappa值为0.66P < 0.001)CECDAI与克罗恩病活动指数或炎症性肠病生存质量研究或其中的任何部分之间不存在相关性。

    结论:CECDAI是一个新的小肠克罗恩病中黏膜损伤的评分系统,而且它已获得验证。我们提倡在对这些患者的对照试验和/或定期随访中尽量使用该体系。

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    Validation of the Capsule Endoscopy Crohns Disease Activity Index (CECDAI or Niv score): a multicenter prospective study

    Y. Niv1, S. Ilani1, Z. Levi1, M. Hershkowitz1, E. Niv2, Z. Fireman2, S. ODonnel3, C. OMorain3, R. Eliakim4, E. Scapa5, N. Kalantzis6, C. Kalantzis6, P. Apostolopoulos6, E. Gal1

    1Department of Gastroenterology, Rabin MedicalCenter, Tel Aviv University,Israel

    2Division of Gastroenterology, Hillel Jafa MedicalCenter, Hadera, Technion,Israel

    3Department of Gastroenterology, Trinity College,Dublin,Ireland

    4Division of Gastroenterology, Rambam Health Care Campus, Technion SchoolofMedicine,Haifa,Israel

    5Division of Gastroenterology, Asaf-HarofeMedicalCenter, Zrifin, Tel Aviv University,Israel

    6Department of Gastroenterology,NIMTSHospital,Athens,Greece



    Background and study aims: The Capsule Endoscopy Crohns Disease Activity Index (CECDAI or Niv score) was devised to measure mucosal disease activity using video capsule endoscopy (VCE). The aim of the current study was to prospectively validate the use of the scoring system in daily practice.

    Methods: This was a multicenter, double-blind, prospective, controlled study of VCE videos from 62 consecutive patients with isolated small-bowel Crohns disease. The CECDAI was designed to evaluate three main parameters of Crohns disease: inflammation (A), extent of disease (B), and stricture (C), in both the proximal and distal segments of the small bowel. The final score was calculated by adding the two segmental scores: CECDAI = ([A1 × B1] + C1) + ([A2 × B2] + C2). Each examiner in every site interpreted 6 - 10 videos and calculated the CECDAI. The de-identified CD-ROMs were then coded and sent to the principal investigator for CECDAI calculation.

    Results: The cecum was reached in 72 % and 86 % of examinations, and proximal small-bowel involvement was found in 56 % and 62 % of the patients, according to the site investigators and principal investigator, respectively. Significant correlation was demonstrated between the calculation of the CECDAI by the individual site investigators and that performed by the principal investigator. Overall correlation between endoscopists from the different study centers was good, with r = 0.767 (range 0.717 - 0.985; Kappa 0.66; P < 0.001). There was no correlation between the CECDAI and the Crohns Disease Activity Index or the Inflammatory Bowel Disease Quality of Life Questionnaire or any of their components.

    Conclusion: A new scoring system of mucosal injury in Crohns disease of the small intestine, the CECDAI, was validated. Its use in controlled trials and/or regular follow-up of these patients is advocated.

     

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