两种^(13)C-尿素呼气试验试剂诊断幽门螺杆菌感染临床可靠性比较

Comparison of Reliability of ^(13)C-Urea Breath Tests Using Two Different Reagents for Clinical Diagnosis of Helicobacter pylori Infection

背景:13C鄄尿素呼气试验快捷、无创伤,敏感性和特异性高,在临床上被广泛应用于幽门螺杆菌(H.pylori)感染的检测。从加拿大进口的13C鄄尿素试剂已获得国家食品药品监督管理局许可并应用于临床。目的:与加拿大进口的13C鄄尿素试剂进行比较,评估美国Isotec公司生产的13C鄄尿素试剂用于诊断H.pylori感染的临床可靠性。方法:114例因上消化道症状接受胃镜检查者随机分为A、B两组,取胃窦活检标本分别作快速尿素酶试验、组织学检查和H.pylori培养,三项中有两项或以上阳性,或H.pylori培养单项阳性判为H.pylori感染,否则判为无H.pylori感染,以此作为诊断H.pylori感染的金标准。A组使用加拿大进口的13C鄄尿素试剂,B组使用美国Isotec公司生产的13C鄄尿素试剂,分别进行13C鄄尿素呼气试验。根据金标准分别计算和比较两组13C鄄尿素呼气试验的准确性、敏感性、特异性和阳性预测值、阴性预测值。结果:A组13C鄄尿素呼气试验诊断H.pylori感染的准确性为92.8%,敏感性为94.1%,特异性为90.9%,阳性预测值为94.1%,阴性预测值为90.9%;B组准确性为98.3%,敏感性为96.9%,特异性为100%,阳性预测值为100%,阴性预测值为96.3%。两组上述各项指标均无显著差异。结论:A组和B组13C鄄尿素呼气试验诊断H.pylori感染的准确性、敏感性。

13C-Urea breath test (13C-UBT) is a kind of rapid, uninvasive test with high sensitivity and specificity for clinical diagnosis of Helicobacter pylori () infection. 13C-labelled urea imported from Canada has been permitted by the State Food and Drug Administration to be used in 13C-UBT in clinic. Aims: Compared with the reagent imported from Canada, to evaluate the reliability of 13C-UBT using 13C-labelled urea produced by Isotec Company in USA for clinical diagnosis of infection. Methods: One hundred and fourteen patients having upper gastrointestinal symptoms and receiving endoscopy were randomly divided into group A and B. status was assessed by rapid urease test (RUT), histology and culture of antral biopsy specimens. Patients were defined as positive for if at least two of the above three tests were positive or only the culture was positive, and as negative for H. pylori if all three tests were negative. The result was then used as gold standard for the diagnosis of infection. 13C-UBT was also performed for patients of the two groups, using two types of 13C-labelled urea imported from Canada (group A) and produced by Isotec Company in USA (group B), respectively. According to the gold standard, the accuracy rate, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the two groups were calculated and compared, respectively. Results: The accuracy rate, sensitivity, specificity, PPV and NPV in the diagnosis of infection were 92.8%, 94.1%, 90.9%, 94.1% and 90.9%, respectively in group A, and 98.3%, 96.9%, 100%, 100% and 96.3%, respectively in group B. No significant difference was found between the two groups. Conclusions: The accuracy rate, sensitivity, specificity, PPV and NPV in the diagnosis of H. pylori infection in both group A and B are high. The clinical diagnosis of infection using 13C-UBT with 13C-labelled urea produced by Isotec Company in USA is proven to be reliable.