Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan.
School of Medicine, College of Medicine, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan.
J Formos Med Assoc. 2022 Aug;121(8):1450-1457. doi: 10.1016/j.jfma.2021.10.011. Epub 2021 Nov 23.
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.
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.
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.
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.
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。
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。
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。
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。
