Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
Department of Gastroenterology, Beijing No. 6 Hospital, Beijing, China.
J Dig Dis. 2024 Jan;25(1):36-43. doi: 10.1111/1751-2980.13250. Epub 2024 Feb 7.
We aimed to explore the efficacy and safety of tailored therapy guided by genotypic resistance in the first-line treatment of Helicobacter pylori (H. pylori) infection in treatment-naive patients.
Gastric mucosal specimens were taken during gastroscopy, and main mutations of clarithromycin- and levofloxacin-resistant genes were detected by polymerase chain reaction (PCR). Sensitive antibiotics were selected individually for treating H. pylori infection with tailored bismuth-containing quadruple therapy (BQT) consisting of esomeprazole 20 mg twice daily, bismuth potassium citrate 220 mg twice daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily, or levofloxacin 500 mg once daily, or metronidazole 400 mg four times daily. Safety and patient compliance were assessed 1-3 days after eradication. Treatment outcome was evaluated by urea breath test 4-8 weeks after eradication.
One hundred and thirty-two treatment-naive patients with H. pylori infection were included. PCR results suggested resistance rates of 47.7% and 34.9% for clarithromycin and levofloxacin, respectively, and a dual resistance rate of 18.2%. Eradication rates of tailored BQT were 87.1% and 95.8% by intention-to-treat (ITT) analysis and per-protocol (PP) analysis, respectively. There was no statistically significant difference in the efficacy of 7-day clarithromycin-containing, 7-day levofloxacin-containing, and 14-day full-dose metronidazole-containing BQT (ITT analysis: P = 0.488; PP analysis: P = 0.833). The incidence of adverse events was 19.7%, and patient compliance was 97.7%.
Tailored BQT guided by genotypic resistance can achieve satisfactory efficacy, safety, and patient compliance in the first-line treatment of H. pylori infection.
本研究旨在探索基于基因耐药性的个体化治疗在初治未经治疗的幽门螺杆菌(H. pylori)感染患者中的疗效和安全性。
胃镜检查时取胃黏膜标本,采用聚合酶链反应(PCR)检测克拉霉素和左氧氟沙星耐药基因的主要突变。根据个体化选择敏感抗生素,采用含铋四联疗法(BQT)进行治疗,具体方案为埃索美拉唑 20mg,每日 2 次;枸橼酸铋钾 220mg,每日 2 次;阿莫西林 1g,每日 2 次;克拉霉素 500mg,每日 2 次;或左氧氟沙星 500mg,每日 1 次;或甲硝唑 400mg,每日 4 次。治疗结束后 1-3 天评估安全性和患者依从性。治疗结束后 4-8 周行尿素呼气试验评估治疗效果。
共纳入 132 例初治未经治疗的 H. pylori 感染患者。PCR 结果提示克拉霉素和左氧氟沙星耐药率分别为 47.7%和 34.9%,双重耐药率为 18.2%。意向性治疗(ITT)和符合方案(PP)分析的个体化 BQT 根除率分别为 87.1%和 95.8%。7 天含克拉霉素方案、7 天含左氧氟沙星方案和 14 天全剂量甲硝唑方案的疗效无统计学差异(ITT 分析:P=0.488;PP 分析:P=0.833)。不良反应发生率为 19.7%,患者依从性为 97.7%。
基于基因耐药性的个体化 BQT 可在一线治疗 H. pylori 感染中获得满意的疗效、安全性和患者依从性。