13C-尿素呼气试验在临床诊断幽门螺杆菌感染中的准确性。

Accuracy of 13C-urea breath test in clinical use for diagnosis of Helicobacter pylori infection.

作者信息

Riepl R L, Folwaczny C, Otto B, Klauser A, Blendinger C, Wiebecke B, König A, Lehnert P, Heldwein W

机构信息

Medizinische Klinik, Klinikum Innenstadt, Ludwig-Maximilians-Universität München, Germany.

出版信息

Z Gastroenterol. 2000 Jan;38(1):13-9. doi: 10.1055/s-2000-15278.

DOI:10.1055/s-2000-15278

PMID:10689743

Abstract

UNLABELLED

The 13C-urea breath test (UBT) is a noninvasive test for diagnosis of Helicobacter pylori infection of gastric mucosa. The aim of this prospective study was to assess the accuracy of a simple UBT in clinical routine use.

METHODS

The study population comprised of 100 patients (49 f, 51 m) requiring diagnostic upper GI endoscopy. One biopsy specimen was taken from the gastric antrum, body and fundus, respectively, for standard histological examination and one additional specimen from each location was transformed into transport medium for cultivation of H. pylori. After vaccination of the culture plates the biopsies were tested for urease activity (UAT). After recovery from endoscopy the patients had to pass an one liter endexspiratory breath sample before and 15 min after drinking 200 ml orange juice, pH 3.6, containing 75 mg of 13C-urea. 13CO2 was measured in the breath samples using isotope-selective nondispersive infrared spectrometry.

RESULTS

Defining gold standard groups with all biopsy tests (from antrum and corpus) positive or negative the 13CO2 delta over baseline (DOB) cut-off level of UBT was set at 6.5/1000 in order to best discriminate positive from negative patients (ROC analysis). UBT was positive in 37% of all subjects. Taken UAT and histological examination together (positive when both tests were positive) UBT displayed a sensitivity of 92%, a specificity of 94%, a positive predictive value of 89%, and a negative predictive value of 94%. When including the results of culture sensitivity and negative predictive value reached almost 100%. The mean of the 13CO2-DOB values from H. pylori-positive duodenal or gastric ulcer patients did not differ from controls (H. pylori-positive patients without lesions). The 13CO2-DOB values of the ulcer group were correlated significantly with the active inflammatory component of gastritis in antrum, corpus, and fundus.

CONCLUSION

UBT with this setup detects H. pylori infection in clinical routine use with high accuracy. The increase of exhaled 13CO2 does not predict ulcer disease but reflects the degree of active inflammation of gastric mucosa.

摘要

未标注

¹³C-尿素呼气试验（UBT）是一种用于诊断胃黏膜幽门螺杆菌感染的非侵入性检测方法。这项前瞻性研究的目的是评估临床常规使用的一种简单UBT的准确性。

方法

研究人群包括100例需要进行诊断性上消化道内镜检查的患者（49名女性，51名男性）。分别从胃窦、胃体和胃底各取一份活检标本进行标准组织学检查，每个部位再额外取一份标本放入转运培养基中用于培养幽门螺杆菌。接种培养平板后，对活检标本进行脲酶活性检测（UAT）。内镜检查后，患者在饮用200毫升pH值为3.6、含75毫克¹³C-尿素的橙汁前及饮用后15分钟，需呼出一升呼气样本。使用同位素选择性非分散红外光谱法测量呼气样本中的¹³CO₂。

结果

通过所有活检检测（来自胃窦和胃体）均为阳性或阴性来定义金标准组，为了最佳地区分阳性和阴性患者，将UBT的¹³CO₂基线差值（DOB）截断水平设定为6.5/1000（ROC分析）。所有受试者中37%的UBT结果为阳性。将UAT和组织学检查结果综合起来（两项检测均为阳性时判定为阳性），UBT的敏感性为92%，特异性为94%，阳性预测值为89%，阴性预测值为94%。当纳入培养敏感性结果时，阴性预测值几乎达到100%。幽门螺杆菌阳性的十二指肠或胃溃疡患者的¹³CO₂-DOB值均值与对照组（无病变的幽门螺杆菌阳性患者）无差异。溃疡组的¹³CO₂-DOB值与胃窦、胃体和胃底胃炎的活动性炎症成分显著相关。