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一项关于幽门螺杆菌快速尿素酶试验假阴性的前瞻性研究:是否是时候将其限制使用了?

A prospective study on Helicobacter pylori rapid urease test false negativity: is it time for its use in restricted situations?

机构信息

Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy -

Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy -

出版信息

Minerva Gastroenterol (Torino). 2023 Sep;69(3):382-387. doi: 10.23736/S2724-5985.22.03207-7. Epub 2022 Jun 15.

DOI:10.23736/S2724-5985.22.03207-7
PMID:35708038
Abstract

BACKGROUND

Rapid urease test (RUT) is a diagnostic tool for Helicobacter pylori (H. pylori) diagnosis, based on the ability of the bacterium to produce urease. Despite it is considered simple, fast, and cheap, some conditions may cause false negativity. Therefore, the aim of this study was to compare RUT with currently recommended tests for H. pylori diagnosis.

METHODS

We enrolled consecutive patients who underwent upper endoscopy with histology, RUT, and urea breath test (UBT). Delta over baseline (DOB) >4% was considered positive for UBT. Diagnosis of infection was achieved when at least two tests were positive. The rate of false positivity of RUT was computed, and DOB value in RUT+ versus RUT- was compared by Mann-Whitney Test.

RESULTS

One hundred and sixteen consecutive patients with H. pylori infection were recruited. The male/female ratio was 35/81 and the mean age 45.2±13.1. Twenty-five patients (21.5%) were RUT-, despite being positive at both histology and UBT. On the other hand, in only two patients UBT and histology had discordant results. A full concordance of the three tests was observed in 89 patients (76.7%). DOB, additionally, was significantly higher in RUT+ patients (39.2±24.2%) than RUT- ones (26.3±18.5%; P=0.005).

CONCLUSIONS

RUT shows false negativity rate higher than 20%. Moreover, the RUT-negative patients showed a lower DOB at UBT, which is an indirect indicator of intragastric bacterial load. Therefore, it is presumable that H. pylori low amount may be a concurrent cause of false negativity. This study suggests that RUT-based H. pylori detection should be restricted to some specific conditions.

摘要

背景

快速尿素酶试验(RUT)是一种基于细菌产生脲酶的能力来诊断幽门螺杆菌(H. pylori)的诊断工具。尽管它被认为简单、快速且廉价,但某些情况下可能会导致假阴性。因此,本研究旨在比较 RUT 与目前推荐的 H. pylori 诊断测试。

方法

我们招募了接受上消化道内镜检查、组织学检查、RUT 和尿素呼气试验(UBT)的连续患者。UBT 的 Delta 基线(DOB)>4% 被认为是阳性。当至少两种检测结果为阳性时,即可诊断为感染。计算了 RUT 的假阳性率,并通过 Mann-Whitney 检验比较了 RUT+与 RUT-的 DOB 值。

结果

共招募了 116 例 H. pylori 感染的连续患者。男女比例为 35/81,平均年龄为 45.2±13.1。尽管组织学和 UBT 均为阳性,但仍有 25 例患者(21.5%)为 RUT-。另一方面,仅在 2 例患者中,UBT 和组织学的结果不一致。三种检测方法完全一致的患者有 89 例(76.7%)。此外,RUT+患者的 DOB 显著高于 RUT-患者(39.2±24.2%比 26.3±18.5%;P=0.005)。

结论

RUT 的假阴性率高于 20%。此外,RUT 阴性患者的 UBT 时 DOB 较低,这是胃内细菌负荷的间接指标。因此,可以推测 H. pylori 数量较少可能是假阴性的一个共同原因。本研究表明,基于 RUT 的 H. pylori 检测应限于某些特定情况。

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