Bermejo San José F, Boixeda de Miguel D, Gisbert J P, Martin de Argila de Prados C, Sanz Sacristán J M, Defarges Pons V, Moreno Almazán L, García Plaza Plaza A
Servicio de Gastroenterología, Hospital Universitario Ramón y Cajal.
Rev Clin Esp. 2000 Sep;200(9):475-9. doi: 10.1016/s0014-2565(00)70699-0.
To study the accuracy of four currently used tests for the diagnostic of Helicobacter pylori infection among gastric ulcer patients with a gold standard as reference which combines several diagnostic methods.
Seventy-three consecutive gastric ulcer patients were prospectively studied. From all patients, three biopsies each were obtained from both antrum and body (two for haematoxylin-eosin staining and one for rapid urease test--Jatrox H.p. Test--. Also, IgG ELISA serology (Helico G) and 13C-urea breath test were performed. According to the gold standard, a patient was considered to be infected with H. pylori when at least two tests were positive; a patient was considered not to be infected with H. pylori when at least three tests were negative.
Among gastric ulcer patients, the prevalence of H. pylori infection was 87.6% (95% CI: 78%-93%) with the gold standard as reference. The sensitivity and specificity values were as follows: histology (antrum), 96.8% (89%-99%) and 100% (66%-100%), respectively; histology (body), 98.4% (91%-100%) and 100% (66%-100%); urease test (antrum), 71.8% (60%-81%) and 100% (66%-100%); urease test (body), 96.8% (89%-99%) and 100% (66%-100%); breath test, 100% (94%-100%) and 100% (66%-100%), and serology, 95.3% (87%-98%) and 100% (66%-100%). The sensitivity of the urease test was higher with a body biopsy specimen (McNemar: 15; p < 0.001).
All diagnostic tests (histology, rapid urease test, 13C-urea breath test and serology) are highly accurate for the diagnosis of H. pylori infection among gastric ulcer patients with the exception of the rapid urease test performed with antrum biopsy specimens, where this test displays a lower sensitivity for bacterial detection.
以结合多种诊断方法的金标准为参照，研究目前用于诊断胃溃疡患者幽门螺杆菌感染的四种检测方法的准确性。
对73例连续的胃溃疡患者进行前瞻性研究。从所有患者的胃窦和胃体各取三块活检组织（两块用于苏木精-伊红染色，一块用于快速尿素酶试验——Jatrox H.p. Test）。此外，还进行了IgG ELISA血清学检测（Helico G）和13C-尿素呼气试验。根据金标准，当至少两项检测呈阳性时，患者被认为感染幽门螺杆菌；当至少三项检测呈阴性时，患者被认为未感染幽门螺杆菌。
以金标准为参照，胃溃疡患者中幽门螺杆菌感染率为87.6%（95%可信区间：78%-93%）。各项检测的敏感性和特异性值如下：胃窦组织学检查，分别为96.8%（89%-99%）和100%（66%-100%）；胃体组织学检查，分别为98.4%（91%-100%）和100%（66%-100%）；胃窦尿素酶试验，分别为71.8%（60%-81%）和100%（66%-100%）；胃体尿素酶试验，分别为96.8%（89%-99%）和100%（66%-100%）；呼气试验，分别为100%（94%-100%）和100%（66%-100%）；血清学检测，分别为95.3%（87%-98%）和100%（66%-100%）。胃体活检标本的尿素酶试验敏感性更高（McNemar检验：15；p<0.001）。
除胃窦活检标本的快速尿素酶试验对细菌检测的敏感性较低外，所有诊断检测（组织学检查、快速尿素酶试验、13C-尿素呼气试验和血清学检测）对胃溃疡患者幽门螺杆菌感染的诊断都具有很高的准确性。
