Labenz J, Bärsch G, Peitz U, Aygen S, Hennemann O, Tillenburg B, Becker T, Stolte M
Department of Internal Medicine and Gastroenterology, Elisabeth Hospital, Essen, Germany.
Digestion. 1996 Nov-Dec;57(6):391-7. doi: 10.1159/000201366.
This prospective study was designed to validate a novel biopsy urease test as well as a simplified 13C-urea breath test for the detection of Helicobacter pylori. In addition, the hypothesis was tested that both the reaction velocity of the urease test and the 13CO2 excess of the urea breath test may allow a prediction of the severity of gastritis. Seventy dyspeptic patients with unknown H. pylori status were included. The H. pylori status was assessed by means of culture and histology after Warthin and Starry stain. One antral and one body biopsy specimen were separately analyzed by the novel biopsy urease test (HUT). Also, a 13C-urea breath test using 75 mg 13C-labelled urea and orange juice as test meal was performed in all patients. Forty-seven patients (67%) were H. pylori positive as judged from histology and culture. In 46 patients, H. pylori infection was also detected by the novel biopsy urease test and by the urea breath test as well (sensitivity 97.9%). False-positive results were not observed by either method (specificity 100%). Both the reaction velocity of the urease test and the 13CO2 excess of the breath test significantly correlated with H. pylori density and grade and activity of gastritis. The determination coefficients, however, indicated that both methods allow a reliable prediction of the severity of gastritis only in about 40-50% of the patients. In conclusion, the novel biopsy urease test and the simplified 13C-urea breath test proved to be highly accurate in diagnosing H. pylori infection. Despite a significant correlation, neither the reaction velocity of the urease test nor the 13CO2 excess of the breath test are clinically useful for the prediction of the severity of gastritis.
本前瞻性研究旨在验证一种新型活检尿素酶试验以及一种简化的¹³C尿素呼气试验用于检测幽门螺杆菌的效果。此外，还检验了这样一个假设，即尿素酶试验的反应速度和尿素呼气试验的¹³CO₂过量情况可能有助于预测胃炎的严重程度。纳入了70例幽门螺杆菌感染状况不明的消化不良患者。通过培养以及经Warthin和Starry染色后的组织学检查来评估幽门螺杆菌感染状况。分别用新型活检尿素酶试验（HUT）对一块胃窦活检标本和一块胃体活检标本进行分析。同时，对所有患者进行了使用75mg¹³C标记尿素和橙汁作为测试餐的¹³C尿素呼气试验。根据组织学和培养结果判断，47例患者（67%）幽门螺杆菌呈阳性。在46例患者中，新型活检尿素酶试验和尿素呼气试验也均检测到幽门螺杆菌感染（敏感性97.9%）。两种方法均未观察到假阳性结果（特异性100%）。尿素酶试验的反应速度和呼气试验的¹³CO₂过量情况均与幽门螺杆菌密度以及胃炎的分级和活动度显著相关。然而，决定系数表明，两种方法仅能在约40% - 50%的患者中可靠地预测胃炎的严重程度。总之，新型活检尿素酶试验和简化的¹³C尿素呼气试验在诊断幽门螺杆菌感染方面被证明具有高度准确性。尽管存在显著相关性，但尿素酶试验的反应速度和呼气试验的¹³CO₂过量情况在临床上均无助于预测胃炎的严重程度。
