Helicobacter pylori 감염진단을 위한 13C - 효소호기검사의 유용성 평가 : 다기관 공개 비비교 임상시험 = Clinical Validity of 13C - Urea Breath Test for the Diagnosis of Helicobacter pylori Infection : A Multi-Center , Open , and Noncomparative Trial

다국어 초록 (Multilingual Abstract)

Objective : Helicobacter pylori(H. pylori) infection plays an importanat role in the pathophysiology of gastrointestinal diseases, and its diagnosis is crucial in clinical practice. Currently many diagnostic methods are introduced for its simple, and accurate diagnosis. 13C urea breath test(13C-UBT) is a convenient, non-invasive and reliable test for the diagnosis of H. pylori infection. To assess the clinical value of the 13C-UBT, we examined the sensitivity, specificity of 13C-UBT with regard to other tests. Methods : A prospective multicenter study was done in 107 subjects(mean age 36 years, 55 males, 52 females) presenting for endoscopy from three university hospitals. We tested for H. pylori infection by 13C-UBT, serum IgG antibody level, and multiple biopsies for rapid urease testing and histology. Either a positive histology result or a combined positive CLO test and IgG ELISA in the presence of a negative histology results, was interpreted as a positive finding for H. pylori infection. 13C-UBT was performed after 4hrs fast. Breath samples were collected at 0 and 30 minutes after giving 75mg 13C-urea.
Results: Results were analysed by isotope ratio mass spectrometry and expressed as units of delta( 13C, 13CO2 /12CO2) and considered as positive for H. pylori if delta value was greater than 4.0. Sensitivity and specificity of 13C-UBT were 94.5%, and 100% respectively. No significant adverse events were noted. Conclusions : The 13C-UBT offers an easy, safe and accurate approach to the diagnosis of H. pylori infection in routine clinical practice