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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。
Objective To evaluate the efficacy of domestic 13C-urea breath test kit in the diagnosis of Helicobacter pylori (Hp) infection. Methods A total of 139 patients were randomized open-label and multicenter randomized controlled trial. Outpatients or ward patients were enrolled in this study. A total of 69 patients in the trial group and 70 in the control group were enrolled in the study. Rapid H.pylori test and WS silver staining were used to determine H. pylori infection. -UBT kit, using the mass spectrometer line 13C-urea breath test to detect Hp infection, compared with different kit diagnosis of Hp infection sensitivity, specificity, to observe the adverse drug reactions. Results The sensitivity and specificity of the experimental group were 100%, 88.2% and 94.2%, respectively. The sensitivity and specificity of Hp in the control group were 97.1%, 94.3% and 95.7% respectively. There was no significant difference between the two groups (P> 0.05). Minor adverse drug reactions. Conclusion Domestic 13C-urea breath test kit diagnosis of Hp infection and imported reagents no significant difference, simple, non-invasive Hp infection diagnostic test is safe and reliable.