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前瞻性多中心临床研究幽门螺杆菌抗菌耐药的种内和种间遗传变异性。

Prospective multicentre clinical study on inter- and intrapatient genetic variability for antimicrobial resistance of Helicobacter pylori.

机构信息

Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine, Austria.

Department of Laboratory Medicine, Division of Clinical Microbiology, Austria.

出版信息

Clin Microbiol Infect. 2018 Mar;24(3):267-272. doi: 10.1016/j.cmi.2017.06.025. Epub 2017 Jun 29.

DOI:10.1016/j.cmi.2017.06.025
PMID:28669844
Abstract

OBJECTIVES

We report on a large prospective, multicentre clinical investigation on inter- and intrapatient genetic variability for antimicrobial resistance of Helicobacter pylori.

METHODS

Therapy-naive patients (n = 2004) who had undergone routine diagnostic gastroscopy were prospectively included from all geographic regions of Austria. Gastric biopsy samples were collected separately from antrum and corpus. Samples were analysed by histopathology and real-time PCR for genotypic resistance to clarithromycin and quinolones. Clinical and demographic information was analysed in relation to resistance patterns.

RESULTS

H. pylori infection was detected in 514 (26%) of 2004 patients by histopathology and confirmed in 465 (90%) of 514 patients by real-time PCR. PCR results were discordant for antrum and corpus in 27 (5%) of 514 patients, indicating inhomogeneous infections. Clarithromycin resistance rates were 17% (77/448) and 19% (84/455), and quinolone resistance rates were 12% (37/310) and 10% (32/334) in antrum and corpus samples, respectively. Combination of test results per patient yielded resistance rates of 21% (98/465) and 13% (50/383) for clarithromycin and quinolones, respectively. Overall, infection with both sensitive and resistant H. pylori was detected in 65 (14%) of 465 patients.

CONCLUSIONS

Anatomically inhomogeneous infection with different, multiple H. pylori strains is common. Prospective clinical study design, collection of samples from multiple sites and microbiologic methods that allow the detection of coinfections are mandatory for collection of reliable data on antimicrobial resistance patterns in representative patient populations. (ClinicalTrials.gov identifier: NCT02925091).

摘要

目的

我们报告了一项关于幽门螺杆菌抗菌药物耐药性的跨患者和患者内遗传变异的大型前瞻性、多中心临床研究。

方法

从奥地利所有地理区域的常规诊断性胃镜检查中前瞻性纳入了未经治疗的患者(n=2004)。分别从胃窦和胃体采集胃活检样本。通过组织病理学和实时 PCR 分析对克拉霉素和喹诺酮类药物的基因型耐药性进行分析。分析了临床和人口统计学信息与耐药模式的关系。

结果

通过组织病理学在 2004 例患者中检测到幽门螺杆菌感染 514 例(26%),通过实时 PCR 在 514 例患者中的 465 例(90%)中得到证实。在 27 例(5%)514 例患者中,胃窦和胃体的 PCR 结果不一致,表明存在异质性感染。胃窦样本中克拉霉素耐药率为 17%(77/448)和 19%(84/455),喹诺酮耐药率为 12%(37/310)和 10%(32/334),胃体样本中克拉霉素耐药率为 17%(77/448)和 19%(84/455),喹诺酮耐药率为 12%(37/310)和 10%(32/334)。对每位患者的检测结果进行组合,克拉霉素和喹诺酮的耐药率分别为 21%(98/465)和 13%(50/383)。总体而言,在 465 例患者中检测到 65 例(14%)同时感染敏感和耐药的幽门螺杆菌。

结论

不同的、多重的幽门螺杆菌菌株的解剖学异质性感染很常见。前瞻性临床研究设计、从多个部位采集样本以及允许检测合并感染的微生物学方法对于在代表性患者人群中收集抗菌药物耐药模式的可靠数据是强制性的。(ClinicalTrials.gov 标识符:NCT02925091)。

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