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

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Helicobacter Pub Date : 2024-09-22 DOI:10.1111/hel.13138

Yu Huang, Shuhan Qiu, Yixian Guo, Jinnan Chen, Meixuan Li, Zhaohui Ding, Wei Zhang, Xiao Liang, Hong Lu

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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 (PBMn₄M₄), or minocycline 50 mg t.i.d and metronidazole 400 mg t.i.d (PBMn₃M₃), or minocycline 50 mg b.i.d and metronidazole 400 mg q.i.d (PBMn₂M₄), or minocycline 50 mg b.i.d and metronidazole 400 mg t.i.d (PBMn₂M₃) were included in this retrospective study. H. pylori eradication was assessed by ¹³C-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 PBMn₄M₄, 191 with PBMn₃M₃, 108 with PBMn₂M₄, and 176 with PBMn₂M₃. 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. PBMn₂M₃ 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

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优化米诺环素含铋四联疗法对幽门螺旋杆菌的拯救治疗：真实世界证据研究。

背景：米诺环素根除幽门螺杆菌的最佳剂量仍不明确。我们旨在评估米诺环素和甲硝唑四种不同方案与经典的铋剂四联疗法相比，在幽门螺杆菌抢救治疗中的有效性和安全性：从 2021 年 3 月到 2024 年 3 月，至少接受过两次治疗失败的难治性幽门螺杆菌感染患者接受了为期 14 天的治疗：质子泵抑制剂 20 毫克和铋 220 毫克，加上四环素 400 毫克 q.i.d 和甲硝唑 400 毫克 q.i.d (BQT)，或米诺环素 50 毫克 q.i. d 和甲硝唑 400 毫克 q.i. d (BQT)。d和甲硝唑 400 毫克 q.i.d (PBMn4M4)，或米诺环素 50 毫克 t.i.d 和甲硝唑 400 毫克 t.i.d (PBMn3M3)，或米诺环素 50 毫克 b.i.或米诺环素 50 毫克口服和甲硝唑 400 毫克 q.i.d (PBMn2M4)，或米诺环素 50 毫克口服和甲硝唑 400 毫克 t.i.d (PBMn2M3)。幽门螺杆菌根除情况在治疗后至少 6 周通过 13C- 尿素呼气试验进行评估。治疗期间的所有不良反应均记录在案：共有 823 名患者入选：251 名 BQT 患者、97 名 PBMn4M4 患者、191 名 PBMn3M3 患者、108 名 PBMn2M4 患者和 176 名 PBMn2M3 患者。通过意向治疗分析，BQT、PBMn4M4、PBMn3M3、PBMn2M4 和 PBMn2M3 的根除率分别为 89.2%、87.6%、91.6%、88.0% 和 91.5%；通过修正意向治疗分析，根除率分别为 96.1%、97.7%、97.8%、96.9% 和 97.6%；通过按方案分析，根除率分别为 97.1%、97.5%、97.7%、96.8% 和 97.6%。甲硝唑耐药性不影响各组疗效。PBMn2M3组的依从性最好，中度和严重不良反应最少：结论：新型含铋四联疗法与低剂量米诺环素和甲硝唑是经典含铋四联疗法的替代品，可用于幽门螺杆菌的抢救性治疗，具有更高的安全性和依从性：试验注册：ClinicalTrials.gov identifier：试验注册：ClinicalTrials.gov 标识符：NCT06332599。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.