Smarrazzo Andrea, Misak Zrinjka, Costa Stefano, Mičetić-Turk Dušanka, Abu-Zekry Mona, Kansu Aydan, Abkari Abdelhak, Bouziane-Nedjadi Karim, Ben Hariz Mongi, Roma Eleftheria, Velmishi Virtut, Legarda Tamara Maria, Attard Thomas, Djurisic Veselinka, Greco Luigi, Magazzù Giuseppe
Department of Translational Medical Sciences, School of Medicine, University "Federico II", Naples, Italy.
European Laboratory for Food Induced Diseases, Naples, Italy.
BMC Gastroenterol. 2017 Jan 21;17(1):17. doi: 10.1186/s12876-017-0577-x.
We assessed how the diagnosis of Celiac Disease (CD) is made and how the new ESPGHAN guidelines can be applied in children from countries with different resources.
A real life prospective study was performed in 14 centres of 13 different Mediterranean countries. Participants were asked to apply the usual diagnostic work-up for CD according to their diagnostic facilities.
There were 1974 patients enrolled in the study, mean age 4 years, 10 months; 865 male, 1109 female. CD was confirmed in 511 (25.9%) and was unconfirmed in 1391 (70.5%) patients; 14 patients were diagnosed as having CD according to the new ESPGHAN guidelines, 43 patients were classified as having potential CD. In all participating countries the diagnosis of CD relied on histology of duodenal biopsy; in 5 countries, HLA, and in one country endomysial antibodies (EMA) were not available. Symptoms did not add a significant increase to the pre-test probability of serological tests. The positive predictive value of tissue transglutaminase type 2 (tTG) antibodies performed with different kits but all corresponding to those recommended by ESPGHAN was 96.1% (95% CI 94-97.9%) in presence of tTG > 10xULN. In 135 patients with tTG >10xULN, HLA genotyping was performed and in all it was compatible with CD.
The results of our study show that CD diagnosis still relies on intestinal biopsy in the Mediterranean area. New ESPGHAN criteria are not applicable in 5 countries due to lack of resources needed to perform HLA genotyping and, in one country, EMA assay. Further simplification of the new ESPGHAN guidelines might be made according to what preliminarily the present results suggest if confirmed by new prospective studies.
我们评估了乳糜泻(CD)的诊断方式以及新的欧洲儿科胃肠病、肝病和营养学会(ESPGHAN)指南如何应用于来自不同资源水平国家的儿童。
在13个不同地中海国家的14个中心开展了一项真实世界前瞻性研究。要求参与者根据其诊断设备对CD进行常规诊断检查。
共有1974例患者纳入研究,平均年龄4岁10个月;男性865例,女性1109例。511例(25.9%)确诊为CD,1391例(70.5%)未确诊;根据新的ESPGHAN指南,14例患者被诊断为患有CD,43例患者被归类为可能患有CD。在所有参与国家,CD的诊断依赖于十二指肠活检组织学检查;在5个国家,无法进行HLA检测,在1个国家,无法进行肌内膜抗体(EMA)检测。症状并未显著提高血清学检测的预测试概率。使用不同试剂盒检测但均符合ESPGHAN推荐的组织转谷氨酰胺酶2(tTG)抗体,在tTG>10倍正常上限(ULN)时,阳性预测值为96.1%(95%可信区间94-97.9%)。对135例tTG>10倍ULN的患者进行了HLA基因分型,所有结果均与CD相符。
我们的研究结果表明,在地中海地区,CD诊断仍依赖于肠道活检。由于缺乏进行HLA基因分型所需的资源,新的ESPGHAN标准在5个国家不适用,在1个国家无法进行EMA检测。如果新的前瞻性研究证实了目前的初步结果,可能需要根据这些结果进一步简化新的ESPGHAN指南。