评价国产13C-尿素呼气试验药盒诊断幽门螺杆菌感染的效果

目的评价国产13C-尿素呼气试验药盒诊断幽门螺杆菌(Hp)感染的效果.方法用多中心随机开放平行对照试验,门诊或病房病人共139例,试验组69例,对照组70例,经快速尿素酶试验和WS银染色检查确定幽门螺杆菌感染,分别用国产或进口13C-UBT药盒,用质谱仪行13C-尿素呼气试验检测Hp感染,比较不同药盒诊断Hp感染的敏感性、特异性,观察其药物不良反应.结果试验组诊断Hp的敏感性为100%,特异性为88.2%,准确度为94.2%;对照组诊断Hp的敏感性为97.1%,特异性为94.3%,准确度为95.7%.2组比较无显著性差异(P＞0.05).药物不良反应轻微.结论用国产13C-尿素呼气试验药盒诊断Hp感染与进口试剂无明显差异,对简单、非侵入性的Hp感染诊断试验安全、可靠.

Evaluation the effects of a homemade 13C - labelled urea capsules in detectingHelicobacter pylori infection

Objective To evaluate the sensitivity, specificity and safety of a homemade13C-labelled urea capsules in detecting Helicobacter pylori infection. MethodsThe study is a randomized, open, parallel-controlled, multicentre clinical trial carriedout in 6 medical units of Beijing and Shanghai. Helicobacter pylori infection wasproven by rapid urease test and Warthin-starry staining. Patients were randomlydivided into trial group taking 75mg homemade 13C-UBT kit or control group taking75mg commercial available 13C-UBT kit. Blood routine test, liver and renal functionwere examined before and 1 week after the UBT test. Results Total 139 subjects wereenrolled into the study, 69 in trial group and 70 in control group. There were nosignificant differences in age and sex between the two groups. There were nosignificant difference in the sensitivity, specificity and precision in detectingHelicobacter pylori infections between the two groups, which were 100%, 88.2% and94.2% in trial group and 97.1%, 94.3% and 95.7% in control group. Decreased WBCin 1 patient and increased ALT level in 2 patients of trial group were mild, no otheradverse effects were found. Conclusion The homemade 13C-UBT kit was aseffective and safe as the import kit, also to be a simple, non-invasive and reliable testfor the diagnosis of Helicobacter pylori infection.