优化含米诺环素的铋四联疗法用于幽门螺杆菌补救治疗：一项真实世界证据研究。

Optimization of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Real-World Evidence Study.

机构信息

Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

出版信息

Helicobacter. 2024 Sep-Oct;29(5):e13138. doi: 10.1111/hel.13138.

DOI:10.1111/hel.13138

PMID:39306798

Abstract

BACKGROUND

The optimal dosage of minocycline remains unclear for Helicobacter pylori (H. pylori) eradication. We aimed to evaluate the efficacy and safety of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment.

MATERIALS AND METHODS

From March 2021 to March 2024, refractory H. pylori-infected patients with at least two previous treatment failures who received 14-day therapy with b.i.d. proton pump inhibitor 20 mg and bismuth 220 mg, plus tetracycline 400 mg q.i.d and metronidazole 400 mg q.i.d (BQT), or minocycline 50 mg q.i.d and metronidazole 400 mg q.i.d (PBMnM), or minocycline 50 mg t.i.d and metronidazole 400 mg t.i.d (PBMnM), or minocycline 50 mg b.i.d and metronidazole 400 mg q.i.d (PBMnM), or minocycline 50 mg b.i.d and metronidazole 400 mg t.i.d (PBMnM) were included in this retrospective study. H. pylori eradication was assessed by C-urea breath test at least 6 weeks after treatment. All adverse effects during treatment were recorded.

RESULTS

Totally, 823 patients were enrolled: 251 with BQT, 97 with PBMnM, 191 with PBMnM, 108 with PBMnM, and 176 with PBMnM. The eradication rates of BQT, PBMn4M4, PBMn3M3, PBMn2M4, and PBMn2M3 were 89.2%, 87.6%, 91.6%, 88.0%, and 91.5%, respectively, by intention-to-treat analysis; 96.1%, 97.7%, 97.8%, 96.9%, and 97.6%, respectively, by modified intention-to-treat analysis; 97.1%, 97.5%, 97.7%, 96.8%, and 97.6%, respectively, by per-protocol analysis. Metronidazole resistance did not affect the efficacy of all groups. PBMnM group achieved the greatest compliance and the fewest moderate and severe adverse events.

CONCLUSIONS

The novel bismuth-containing quadruple therapy with a low dose of minocycline and metronidazole is an alternative to classical bismuth quadruple therapy for H. pylori rescue treatment with superior safety and compliance.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT06332599.

摘要

背景

米诺环素治疗幽门螺杆菌（H. pylori）的最佳剂量仍不清楚。我们旨在评估米诺环素和甲硝唑的四种不同方案与经典铋四联疗法相比，在 H. pylori 补救治疗中的疗效和安全性。

材料和方法

从 2021 年 3 月至 2024 年 3 月，接受过为期 14 天的双联质子泵抑制剂 20mg 和铋 220mg，加四环素 400mg q.i.d 和甲硝唑 400mg q.i.d（BQT）治疗的难治性 H. pylori 感染患者，或米诺环素 50mg q.i.d 和甲硝唑 400mg q.i.d（PBMnM），或米诺环素 50mg t.i.d 和甲硝唑 400mg t.i.d（PBMnM），或米诺环素 50mg b.i.d 和甲硝唑 400mg q.i.d（PBMnM），或米诺环素 50mg b.i.d 和甲硝唑 400mg t.i.d（PBMnM），被纳入这项回顾性研究。治疗结束至少 6 周后，通过 C-尿素呼气试验评估 H. pylori 根除情况。记录所有治疗期间的不良反应。

结果

共有 823 名患者入组：BQT 组 251 例，PBMnM 组 97 例，PBMnM 组 191 例，PBMnM 组 108 例，PBMnM 组 176 例。BQT、PBMn4M4、PBMn3M3、PBMn2M4 和 PBMn2M3 的根除率分别为 89.2%、87.6%、91.6%、88.0%和 91.5%（意向治疗分析）；96.1%、97.7%、97.8%、96.9%和 97.6%（修正意向治疗分析）；97.1%、97.5%、97.7%、96.8%和 97.6%（按方案分析）。甲硝唑耐药性不影响所有组的疗效。PBMnM 组达到了最高的依从性和最少的中度和重度不良事件。