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基于胃液 PCR 的个体化药敏指导一线幽门螺杆菌根除治疗:一项随机对照研究。

Tailored susceptibility-guided therapy via gastric juice PCR for the first-line H. pylori eradication, a randomized controlled trial.

机构信息

Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan.

School of Medicine, College of Medicine, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan.

出版信息

J Formos Med Assoc. 2022 Aug;121(8):1450-1457. doi: 10.1016/j.jfma.2021.10.011. Epub 2021 Nov 23.

Abstract

BACKGROUND/PURPOSE: Clarithromycin-based standard triple therapy is still commonly adopted by 81.4% of physicians in real-world practice but yields low eradication rates. Therefore, we conducted this study to compare the efficacy of gastric juice-guided therapy for first-line eradication with the standard triple therapy, in order to provide an alternative to real-world practice.

METHODS

A total of 182 treatment-naïve Hp-infected patients were included and randomly allocated to either susceptibility-guided therapy (SGT) with gastric juice PCR or Clarithromycin-based standard triple therapy (STT) for 7 days.

RESULTS

The intention-to-treat eradication rates were 89% (81/91) in SGT and 75.8% in STT (p < 0.031). The per-protocol eradication rates were 91.0% (81/89) in SGT and 79.3% (69/87) in STT (p < 0.034). Among the subgroups of different antibiotic resistance, patients with SGT demonstrated superior eradication rates (91.7% vs 45.5%, p < 0.027) in the subgroup of both clarithromycin resistance and levofloxacin resistance.

CONCLUSION

This prospective randomized controlled trial demonstrated the reliable efficacy of susceptibility-guided therapy via gastric juice PCR for the first-line Hp eradication. In Asia-Pacific area, where standard triple therapy is still adopted by the majority of the physicians, it is a recommended alternative to overcome the increasing antibiotic resistance.

摘要

背景/目的:基于克拉霉素的标准三联疗法在实际应用中仍被 81.4%的医生广泛采用,但根除率较低。因此,我们进行了这项研究,旨在比较胃液指导下一线根除治疗与标准三联疗法的疗效,为实际应用提供一种替代方案。

方法

共纳入 182 例初次接受治疗的 Hp 感染患者,随机分为胃液 PCR 指导的药敏指导治疗(SGT)组和基于克拉霉素的标准三联疗法(STT)组,疗程均为 7 天。

结果

意向治疗根除率在 SGT 组为 89%(81/91),在 STT 组为 75.8%(p<0.031)。按方案治疗根除率在 SGT 组为 91.0%(81/89),在 STT 组为 79.3%(69/87)(p<0.034)。在不同抗生素耐药亚组中,SGT 组的根除率(91.7% vs 45.5%,p<0.027)在克拉霉素和左氧氟沙星耐药的亚组中更高。

结论

这项前瞻性随机对照试验证明了通过胃液 PCR 进行药敏指导治疗对一线 Hp 根除的可靠疗效。在亚太地区,标准三联疗法仍被大多数医生采用,这是一种推荐的替代方案,可以克服日益增加的抗生素耐药性。

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