Sheu B S, Lee S C, Yang H B, Lin X Z
Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.
Hepatogastroenterology. 1999 May-Jun;46(27):2057-62.
BACKGROUND/AIMS: We tried to test the diagnostic efficacy of a new 13C-labeled urea agent made in Taiwan for urea breath test (UBT) of H. pylori infection, and to assess the correlation between the bacterial load of H. pylori in the stomach and the results of UBT from different timings.
One hundred and ninety-six dyspeptic patients without usage of antibiotics and proton pump inhibitors in the last 4 weeks were recruited for endoscopy, which included CLO test and H. pylori culture. Three additional bits of gastric biopsy (each one from antrum, body, and cardia) were taken for histology to assess the H. pylori density (HPD, range 0-5) in each specimen and the total bacterial density (TBD, a sum of HPD from three sites, range 0-15). Every study patient had been assigned to complete the UBT protocol. The gas samplings of UBT at baseline, 15 min and 30 min after ingestion of 100 mg 13C-labeled urea (INER-Hp 13C-tester, Taiwan) were collected for the ratio of 13CO2/12CO2 and labeled A, B, and C respectively. Both delta15 (B minus A) & delta30 (C minus A) were recorded to express the excess delta13CO2 per milliliter. During the 30 min period of UBT, the patient was scheduled to change lying positions every 5 minutes for even coating of the stomach with test agent.
Based on two positive results of three invasive methods (CLO test, culture, and histology), 91 cases were confirmed to have H. pylori infection. The diagnostic efficacy of UBT was quite good with 96.7% sensitivity for both delta15 and delta30, and with 97.1% and 96.2% specificity for delta15 and delta30 respectively. Both delta15 and delta30 of UBT were well correlated with the TBD of H. pylori in histology (delta15: r=0.7574; delta30: r=0.7432, p<0.0001).
The new C13-labeled urea for UBT can achieve a high diagnostic yield for H. pylori infection. Furthermore, the density of H. pylori in the stomach can be assessed indirectly by UBT by applying 15-minute gas sampling.
背景/目的：我们试图测试一种台湾制造的新型13C标记尿素试剂用于幽门螺杆菌感染尿素呼气试验（UBT）的诊断效能，并评估胃内幽门螺杆菌细菌载量与不同时间点UBT结果之间的相关性。
招募196例在过去4周内未使用抗生素和质子泵抑制剂的消化不良患者进行内镜检查，包括CLO试验和幽门螺杆菌培养。另外取三块胃活检组织（分别取自胃窦、胃体和贲门）进行组织学检查，以评估每个标本中的幽门螺杆菌密度（HPD，范围0 - 5）和总细菌密度（TBD，三个部位HPD之和，范围0 - 15）。每位研究患者均被安排完成UBT方案。在摄入100 mg 13C标记尿素（台湾产INER - Hp 13C测试仪）后，分别在基线、15分钟和30分钟采集UBT的气体样本，检测13CO2/12CO2的比值，并分别标记为A、B和C。记录δ15（B减去A）和δ30（C减去A）以表示每毫升过量的δ13CO2。在UBT的30分钟期间，患者每隔5分钟更换一次卧位，以使测试剂均匀覆盖胃部。
基于三种侵入性方法（CLO试验、培养和组织学）中的两项阳性结果，91例患者被确诊为幽门螺杆菌感染。UBT的诊断效能相当好，δ15和δ30的敏感性均为96.7%，δ15和δ30的特异性分别为97.1%和96.2%。UBT的δ15和δ30与组织学中幽门螺杆菌的TBD均具有良好的相关性（δ15：r = 0.7574；δ30：r = 0.7432，p < 0.0001）。
用于UBT的新型C13标记尿素对幽门螺杆菌感染可实现高诊断率。此外，通过应用15分钟气体采样，可通过UBT间接评估胃内幽门螺杆菌的密度。
