Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.
PLoS One. 2011;6(10):e26957. doi: 10.1371/journal.pone.0026957. Epub 2011 Oct 31.
To establish optimal cutoff values for serologic diagnosis of fundic atrophy in a high-risk area for oesophageal squamous cell carcinoma and gastric cancer with high prevalence of Helicobacter pylori (H. pylori) in Northern Iran, we performed an endoscopy-room-based validation study.
We measured serum pepsinogens I (PGI) and II (PGII), gastrin 17 (G-17), and antibodies against whole H. pylori, or cytotoxin-associated gene A (CagA) antigen among 309 consecutive patients in two major endoscopy clinics in northeastern Iran. Updated Sydney System was used as histology gold standard. Areas under curves (AUCs), optimal cutoff and predictive values were calculated for serum biomarkers against the histology.
309 persons were recruited (mean age: 63.5 years old, 59.5% female). 84.5% were H. pylori positive and 77.5% were CagA positive. 21 fundic atrophy and 101 nonatrophic pangastritis were diagnosed. The best cutoff values in fundic atrophy assessment were calculated at PGI<56 µg/l (sensitivity: 61.9%, specificity: 94.8%) and PGI/PGII ratio<5 (sensitivity: 75.0%, specificity: 91.0%). A serum G-17<2.6 pmol/l or G-17>40 pmol/l was 81% sensitive and 73.3% specific for diagnosing fundic atrophy. At cutoff concentration of 11.8 µg/l, PGII showed 84.2% sensitivity and 45.4% specificity to distinguish nonatrophic pangastritis. Exclusion of nonatrophic pangastritis enhanced diagnostic ability of PGI/PGII ratio (from AUC = 0.66 to 0.90) but did not affect AUC of PGI. After restricting study samples to those with PGII<11.8, the sensitivity of using PGI<56 to define fundic atrophy increased to 83.3% (95%CI 51.6-97.9) and its specificity decreased to 88.8% (95%CI 80.8-94.3).
Among endoscopy clinic patients, PGII is a sensitive marker for extension of nonatrophic gastritis toward the corpus. PGI is a stable biomarker in assessment of fundic atrophy and has similar accuracy to PGI/PGII ratio among populations with prevalent nonatrophic pangastritis.
在伊朗北部,由于存在高发的幽门螺杆菌(Helicobacter pylori,H. pylori)和食管癌及胃癌的高发,我们进行了一项内镜室验证研究,旨在为胃底萎缩的血清学诊断建立最佳截断值。
我们在伊朗东北部的两个主要内镜诊所连续招募了 309 例患者,测量了血清胃蛋白酶原 I(PGI)和 II(PGII)、胃泌素 17(G-17)以及针对全 H. pylori 或细胞毒素相关基因 A(CagA)抗原的抗体。采用更新的悉尼系统作为组织学金标准。针对组织学,计算了血清生物标志物的曲线下面积(AUCs)、最佳截断值和预测值。
共招募了 309 名患者(平均年龄 63.5 岁,59.5%为女性)。84.5%的患者 H. pylori 阳性,77.5%的患者 CagA 阳性。诊断出 21 例胃底萎缩和 101 例非萎缩性全胃炎。胃底萎缩评估的最佳截断值计算为 PGI<56 µg/l(敏感性:61.9%,特异性:94.8%)和 PGI/PGII 比值<5(敏感性:75.0%,特异性:91.0%)。血清 G-17<2.6 pmol/l 或 G-17>40 pmol/l 对胃底萎缩的敏感性为 81%,特异性为 73.3%。PGII 浓度为 11.8 µg/l 时,对非萎缩性全胃炎的敏感性为 84.2%,特异性为 45.4%。排除非萎缩性全胃炎后,PGI/PGII 比值的诊断能力增强(从 AUC=0.66 到 0.90),但对 PGI 的 AUC 没有影响。将研究样本限制在 PGII<11.8 的患者中后,使用 PGI<56 定义胃底萎缩的敏感性增加至 83.3%(95%CI 51.6-97.9),特异性降低至 88.8%(95%CI 80.8-94.3)。
在内镜诊所患者中,PGII 是一种用于评估非萎缩性胃炎向胃体扩展的敏感标志物。PGI 是评估胃底萎缩的一种稳定的生物标志物,在非萎缩性全胃炎高发人群中,其准确性与 PGI/PGII 比值相似。