含铋四联疗法补救治疗中米诺环素与四环素的疗效比较：一项多中心、随机对照临床试验。
Minocycline vs. tetracycline in bismuth-containing quadruple therapy for Helicobacter pylori rescue treatment: a multicentre, randomized controlled trial.
机构信息
NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
出版信息
J Gastroenterol. 2023 Jul;58(7):633-641. doi: 10.1007/s00535-023-01991-y. Epub 2023 Apr 12.
BACKGROUND
To compare the efficacy and tolerability of minocycline vs. tetracycline in bismuth-containing quadruple therapy for Helicobacter pylori (H. pylori) rescue treatment.
METHODS
This study was a multi-center, randomized-controlled, non-inferiority trial. Refractory H. 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 was H. pylori eradication rate evaluated by C-urea breath test at least 6 weeks after the end of treatment. Antibiotic resistance was determined using E test method.
RESULTS
Three 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.
CONCLUSIONS
Minocycline can be an alternative for tetracycline in bismuth-containing quadruple therapy for H. pylori empirical rescue treatment, irrespective of metronidazole resistance. However, relatively high incidence of adverse events in both regimens should be emphasized.
背景
比较米诺环素和四环素在铋四联疗法补救治疗幽门螺杆菌（H. pylori）中的疗效和耐受性。
方法
这是一项多中心、随机对照、非劣效性试验。将多次治疗失败的难治性 H. pylori 感染患者随机（1:1）分为两组，分别接受 14 天埃索美拉唑 20mg 每日 2 次、枸橼酸铋 220mg 每日 2 次，加上甲硝唑 400mg 每日 4 次和米诺环素 100mg 每日 2 次（米诺环素组）或四环素 500mg 每日 4 次（四环素组）治疗。主要终点为治疗结束至少 6 周后通过 C-尿素呼气试验评估的 H. pylori 根除率。采用 E 试验法测定抗生素耐药性。
结果
共纳入 368 例患者。意向治疗分析中，米诺环素组和四环素组的根除率分别为 88.0%（162/184，95%CI 83.3-92.8%）和 88.6%（163/184，95%CI 83.9-93.2%），按方案分析分别为 98.0%（149/152，95%CI 95.8-100%）和 97.4%（150/154，95%CI 94.9-99.9%），改良意向治疗分析中分别为 93.1%（162/174，95%CI 89.3-96.9%）和 93.1%（163/175，95%CI 89.4-96.9%）。米诺环素、四环素和甲硝唑耐药率分别为 0.7%、1.4%和 89.6%。证实米诺环素具有非劣效性（P<0.025）。甲硝唑耐药并不影响两种治疗的疗效。两种治疗方案的不良反应发生率相似（55.4% vs. 53.3%）；几乎一半为轻度。米诺环素组最常见的不良反应是头晕。
结论
米诺环素可替代四环素用于铋四联疗法补救治疗幽门螺杆菌，无论甲硝唑耐药与否。然而，两种方案均应强调较高的不良反应发生率。
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