• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Application of Fluorescence ROSE-Based Real-Time Visualized Technology for Helicobacter pylori in the Dynamic Evaluation of the Entire Course of Eradication Therapy

Corresponding author: Zhanglin, stepinghuns2@163.com
DOI: 10.12201/bmr.202606.00007
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Background: Fluorescence rapid on-site evaluation (ROSE) enables real-time visualization of Helicobacter pylori (HP) and distinguishes between viable (yellow-green) and non-viable (orange-red) bacteria. However, the patterns of bacterial viability and morphological changes throughout the entire course of eradication therapy remain unclear. Objective: To dynamically observe bacterial viability and coccoid morphological changes in HP-positive patients at different stages of eradication therapy, synchronously compare them with endoscopic and urea breath test (UBT) results, and clarify the value of fluorescence ROSE in therapeutic efficacy assessment and recurrence warning. Methods: A total of 224 HP-positive patients receiving standard bismuth-based quadruple therapy (14 days) were enrolled and divided into four groups: pre-treatment (Group A, n=62), during treatment (Group B, n=55), early post-treatment (Group C, n=58), and late post-treatment (Group D, n=49). All patients underwent gastroscopy plus fluorescence ROSE examination. The proportion of viable/dead bacteria, coccoid formation rate, endoscopic classification, and UBT optical density (OD) value were recorded. Results: The proportion of viable bacteria decreased from Group A (57.3±11.2%) to Group C (5.8±3.9%). In Group D, the successful eradication subgroup (n=36) showed nearly zero viable bacteria, whereas the recurrence/drug resistance subgroup (n=13) showed a rebound to 38.2±10.5% (P<0.001). The coccoid formation rate significantly increased in Group B (65.3±12.1%), and in the recurrence subgroup, viable bacteria accounted for 17.9±6.1% of coccoid forms. During treatment and early post-treatment, the decline in viable bacterial proportion significantly preceded the decrease in UBT OD values (r=0.79, P<0.001), and some patients showed delayed endoscopic improvement. A viable bacterial proportion >30% during treatment predicted eradication failure with an AUC of 0.887 (95%CI: 0.834–0.940). Conclusion: Fluorescence ROSE enables real-time, dynamic tracking of changes in bacterial viability throughout the entire course of HP eradication, reflects therapeutic efficacy earlier than UBT, identifies risks of drug resistance and recurrence, and provides an important tool for real-time monitoring and individualized adjustment of eradication therapy.

    Key words: Fluorescence ROSE; Helicobacter pylori; Eradication therapy; Dynamic monitoring; Bacterial viability; Coccoid formation; Urea breath test

    Submit time: 8 June 2026

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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  • ID Submit time Number Download
    1 2026-06-02

    10.12201/bmr.202606.00007V1

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Zhanglin, Houyanhong, Libinghui, Wukai, Zhangjing, Yangmi. Application of Fluorescence ROSE-Based Real-Time Visualized Technology for Helicobacter pylori in the Dynamic Evaluation of the Entire Course of Eradication Therapy. 2026. biomedRxiv.202606.00007

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