Minocycline vs. tetracycline in bismuth-containing quadruple therapy for Helicobacter pylori rescue treatment: a multicentre, randomized controlled trial
Minocycline vs. tetracycline in bismuth-containing quadruple therapy for Helicobacter pylori rescue treatment: a multicentre, randomized controlled trial
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DOI：
10.1007/s00535-023-01991-y
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发表时间：
2023-04
影响因子：
6.3
通讯作者：
Yu Huang;Jinnan Chen;Zhaohui Ding;Xi Chen;Xiao Liang;Xing Zeng;Fei Xu;Yuehua Han;Hong Lu
中科院分区：
文献类型：
--
作者：
Yu Huang;Jinnan Chen;Zhaohui Ding;Xi Chen;Xiao Liang;Xing Zeng;Fei Xu;Yuehua Han;Hong Lu
BackgroundTo compare the efficacy and tolerability of minocycline vs. tetracycline in bismuth-containing quadruple therapy forHelicobacter pylori(H. pylori) rescue treatment.MethodsThis study was a multi-center, randomized-controlled, non-inferiority trial. RefractoryH. pylori-infected subjects with multiple treatment-failure were randomly (1:1) allocated to receive 14-day therapy with esomeprazole 20 mg b.i.d, bismuth 220 mg b.i.d, plus metronidazole 400 mg q.i.d and minocycline 100 mg b.i.d (minocycline group) or tetracycline 500 mg q.i.d (tetracycline group). Primary outcome wasH. pylorieradication rate evaluated by13C-urea breath test at least 6 weeks after the end of treatment. Antibiotic resistance was determined using E test method.ResultsThree hundred and sixty-eight subjects were randomized. The eradication rates in minocycline group and tetracycline group were 88.0% (162/184, 95% CI 83.3–92.8%) and 88.6% (163/184, 95% CI 83.9–93.2%) in intention-to-treat analysis, 98.0% (149/152, 95% CI 95.8–100%) and 97.4% (150/154, 95% CI 94.9–99.9%) in per-protocol analysis, 93.1% (162/174, 95% CI 89.3–96.9%) and 93.1% (163/175, 95% CI 89.4–96.9%) in modified intention-to-treat analysis. Minocycline, tetracycline and metronidazole resistance rates were 0.7%, 1.4% and 89.6%, respectively. Non-inferiority of minocycline was confirmed (P< 0.025). Metronidazole resistance did not affect the efficacy of either therapy. The two therapies exhibited comparable frequencies of adverse events (55.4% vs. 53.3%); almost half of them were mild. Dizziness was the most common adverse events in the minocycline group.ConclusionsMinocycline can be an alternative for tetracycline in bismuth-containing quadruple therapy forH. pyloriempirical rescue treatment, irrespective of metronidazole resistance. However, relatively high incidence of adverse events in both regimens should be emphasized.
