Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China.
Fuzhou General Clinical Medical College, Fujian Medical University, Fuzhou, China.
Dig Dis Sci. 2022 Jan;67(1):208-215. doi: 10.1007/s10620-021-06856-z. Epub 2021 Feb 8.
Quinolone-containing triple therapy has been considered as the second-line therapy for eradication of Helicobacter pylori (H. pylori). At present, there are no data to show the efficacy and safety of antofloxacin-based rescue therapy for the eradication of H. pylori, and this pilot clinical trial was designed.
A total of 196 patients who failed H. pylori eradication using the clarithromycin-based or metronidazole-based triple or bismuth quadruple therapy were randomly allocated to one of the following rescue eradication therapy groups: AEA group (antofloxacin 200 mg once daily, esomeprazole 20 mg + amoxicillin 1000 mg twice daily) for 14 days, or LEA group (levofloxacin 500 mg once daily, esomeprazole 20 mg + amoxicillin 1000 mg twice daily) for 14 days. The minimal inhibitory concentrations were tested by the E-test method. The gyrA mutation was analyzed by sequencing. Follow-up C-urea breath test was examined at 1 month after discontinuation.
A total of 178 eligible patients were included in this study. The eradication rate was significantly higher in AEA group than in LEA group according to both ITT (87.6% vs. 68.5%; P = 0.002) and PP analyses (90.7% vs. 70.1%; P = 0.001). ITT analyses indicated that the eradication rate was significantly higher in AEA group than in LEA group with Asn87 mutation (78.9% vs. 31.3%; P = 0.005) and levofloxacin-resistant strains (76.9% vs. 44.2%; P = 0.003). Two groups exhibited similar adverse event rates (AEA 14.6% vs. LEA 20.2%, P = 0.323).
The findings showed that antofloxacin may be a promising candidate in rescue therapy for H. pylori eradication failure in China.
含喹诺酮类药物的三联疗法已被认为是根除幽门螺杆菌（H. pylori）的二线治疗方法。目前，尚无数据表明以安妥沙星为基础的补救治疗根除 H. pylori 的疗效和安全性，因此进行了这项初步临床试验。
196 例接受基于克拉霉素或甲硝唑的三联或铋四联疗法根除 H. pylori 失败的患者被随机分配至以下两种补救根除治疗组之一：AEA 组（安妥沙星 200mg 每日 1 次，埃索美拉唑 20mg+阿莫西林 1000mg 每日 2 次）治疗 14 天，或 LEA 组（左氧氟沙星 500mg 每日 1 次，埃索美拉唑 20mg+阿莫西林 1000mg 每日 2 次）治疗 14 天。采用 E 试验法检测最小抑菌浓度，通过测序分析 gyrA 突变。停药 1 个月后进行呼气试验。
本研究共纳入 178 例符合条件的患者。根据意向治疗（ITT）分析（87.6% vs. 68.5%；P=0.002）和符合方案（PP）分析（90.7% vs. 70.1%；P=0.001），AEA 组的根除率均显著高于 LEA 组。ITT 分析显示，在携带天冬酰胺 87 位突变（78.9% vs. 31.3%；P=0.005）和左氧氟沙星耐药株（76.9% vs. 44.2%；P=0.003）的患者中，AEA 组的根除率显著高于 LEA 组。两组的不良反应发生率相似（AEA 组 14.6% vs. LEA 组 20.2%，P=0.323）。
研究结果表明，安妥沙星可能是中国 H. pylori 根除失败补救治疗的有前途的候选药物。
