Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Helicobacter. 2020 Aug;25(4):e12699. doi: 10.1111/hel.12699. Epub 2020 May 19.
Helicobacter pylori (H pylori) treatment remains a challenge for penicillin-allergic patients.
To evaluate the efficacy and tolerability of susceptibility-guided first-line and rescue treatment in H pylori-infected penicillin-allergic patients.
Consecutive H pylori-infected patients with penicillin allergy received a 14-day triple or quadruple therapy based on susceptibility to clarithromycin, levofloxacin, and metronidazole. All received esomeprazole 20 mg twice a day. Metronidazole-susceptible infections received metronidazole plus clarithromycin or levofloxacin triple therapy if susceptible. Clarithromycin- and levofloxacin-resistant infections received metronidazole plus tetracycline triple therapy. Metronidazole-resistant infections received a bismuth-high-dose metronidazole plus clarithromycin or levofloxacin quadruple therapy. Triple-resistant infections received classical bismuth quadruple therapy with high-dose metronidazole. Antimicrobial susceptibility was assessed using the E test method.
112 patients were entered (34.8% men, average 47.1 years). Infections in 83.8% (31/37) of treatment-naive subjects and 12.0% (9/75) (P < .001) receiving rescue treatment were susceptible to at least one of the three tested antibiotics. Overall, susceptibility-guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%-97.7%) by intent-to-treat analysis and 99% (100/101, 95% CI 97.1%-100%) by per-protocol analysis. All regimens achieved eradication rates greater than 90% (P = .327) in the PP populations. Adverse events were relatively frequent; however, compliance remained high.
Susceptibility-guided therapy proved highly effective for penicillin-allergic patients. When available and proven locally effective, the alternative was empiric classical bismuth quadruple therapy. This trial is registered with ClinicalTrials.gov as NCT03708848.
幽门螺杆菌(H pylori)的治疗仍然是对青霉素过敏患者的挑战。
评估在对青霉素过敏的 H pylori 感染患者中,基于药敏指导的一线和补救治疗的疗效和耐受性。
连续接受 H pylori 感染且对青霉素过敏的患者接受 14 天三联或四联治疗,方案基于克拉霉素、左氧氟沙星和甲硝唑的药敏。所有患者均接受埃索美拉唑 20mg,每日两次。甲硝唑敏感感染且对克拉霉素或左氧氟沙星敏感者接受甲硝唑加克拉霉素或左氧氟沙星三联治疗。克拉霉素和左氧氟沙星耐药感染者接受甲硝唑加四环素三联治疗。甲硝唑耐药感染者接受铋剂高剂量甲硝唑加克拉霉素或左氧氟沙星四联治疗。三重耐药感染者接受高剂量甲硝唑的经典铋剂四联治疗。使用 E 试验方法评估抗菌药物敏感性。
共纳入 112 例患者(34.8%为男性,平均年龄 47.1 岁)。83.8%(31/37)的初治患者和 12.0%(9/75)(P<0.001)的补救治疗患者的感染对三种测试抗生素中的至少一种敏感。总体而言,意向治疗分析中,基于药敏指导的治疗根除率为 92.9%(104/112,95%CI 88.1%-97.7%),按方案分析为 99%(100/101,95%CI 97.1%-100%)。所有方案在 PP 人群中的根除率均大于 90%(P=0.327)。不良事件相对频繁,但依从性仍然很高。
药敏指导的治疗对青霉素过敏患者非常有效。在当地可用且有效的情况下,替代方案是经验性的经典铋剂四联治疗。该试验在 ClinicalTrials.gov 上注册,编号为 NCT03708848。