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Abstract：
BACKGROUND: Vonoprazan (VPZ)-based regimens are an effective first-line therapy for Helicobacter pylori (H. pylori) infection. However, their value as a rescue therapy needs to be explored.
OBJECTIVE: To assess a VPZ-based regimen as H. pylori rescue therapy.
METHODS: This prospective, single-center, clinical trial was conducted between January and August 2022. Patients with a history of H. pylori treatment failure were administered 20 mg VPZ twice daily, 750 mg amoxicillin 3 times daily, and 250 mg Saccharomyces boulardii (S. boulardii) twice daily for 14 d (14-d VAS regimen). VPZ and S. boulardii were taken before meals, while amoxicillin was taken after meals. Within 3 d after the end of eradication therapy, all patients were asked to fill in a questionnaire to assess any adverse events they may have experienced. At least 4-6 wk after the end of eradication therapy, eradication success was assessed using a 13C-urea breath test, and factors associated with eradication success were explored.
RESULTS: Herein, 103 patients were assessed, and 68 patients were finally included. All included patients had 1-3 previous eradication failures. The overall eradication rates calculated using intention-to-treat and per-protocol analyses were 92.6% (63/68) and 92.3% (60/65), respectively. The eradication rate did not differ with the number of treatment failures (P = 0.433). The rates of clarithromycin, metronidazole, and levofloxacin resistance were 91.3% (21/23), 100.0% (23/23), and 60.9% (14/23), respectively. There were no cases of resistance to tetracycline, amoxicillin, or furazolidone. In 60.9% (14/23) patients, the H. pylori isolate was resistant to all 3 antibiotics (clarithromycin, metronidazole, and levofloxacin); however, eradication was achieved in 92.9% (13/14) patients. All patients showed metronidazole resistance, and had an eradication rate of 91.3% (21/23). The eradication rate was higher among patients without anxiety (96.8%) than among patients with anxiety (60.0%, P = 0.025). No severe adverse events occurred; most adverse events were mild and disappeared without intervention. Good compliance was seen in 95.6% (65/68) patients. Serological examination showed no significant changes in liver and kidney function.
CONCLUSIONS: VAS is a safe and effective rescue therapy, with an acceptable eradication rate (> 90%), regardless of the number of prior treatment failures. Anxiety may be associated with eradication failure.
OBJECTIVE: To assess a VPZ-based regimen as H. pylori rescue therapy.
METHODS: This prospective, single-center, clinical trial was conducted between January and August 2022. Patients with a history of H. pylori treatment failure were administered 20 mg VPZ twice daily, 750 mg amoxicillin 3 times daily, and 250 mg Saccharomyces boulardii (S. boulardii) twice daily for 14 d (14-d VAS regimen). VPZ and S. boulardii were taken before meals, while amoxicillin was taken after meals. Within 3 d after the end of eradication therapy, all patients were asked to fill in a questionnaire to assess any adverse events they may have experienced. At least 4-6 wk after the end of eradication therapy, eradication success was assessed using a 13C-urea breath test, and factors associated with eradication success were explored.
RESULTS: Herein, 103 patients were assessed, and 68 patients were finally included. All included patients had 1-3 previous eradication failures. The overall eradication rates calculated using intention-to-treat and per-protocol analyses were 92.6% (63/68) and 92.3% (60/65), respectively. The eradication rate did not differ with the number of treatment failures (P = 0.433). The rates of clarithromycin, metronidazole, and levofloxacin resistance were 91.3% (21/23), 100.0% (23/23), and 60.9% (14/23), respectively. There were no cases of resistance to tetracycline, amoxicillin, or furazolidone. In 60.9% (14/23) patients, the H. pylori isolate was resistant to all 3 antibiotics (clarithromycin, metronidazole, and levofloxacin); however, eradication was achieved in 92.9% (13/14) patients. All patients showed metronidazole resistance, and had an eradication rate of 91.3% (21/23). The eradication rate was higher among patients without anxiety (96.8%) than among patients with anxiety (60.0%, P = 0.025). No severe adverse events occurred; most adverse events were mild and disappeared without intervention. Good compliance was seen in 95.6% (65/68) patients. Serological examination showed no significant changes in liver and kidney function.
CONCLUSIONS: VAS is a safe and effective rescue therapy, with an acceptable eradication rate (> 90%), regardless of the number of prior treatment failures. Anxiety may be associated with eradication failure.
摘要：
背景：基于Vonoprazan（VPZ）的方案是幽门螺杆菌的有效一线疗法（H。幽门螺杆菌)感染。然而,它们作为救援疗法的价值需要探索。
目的：评估以VPZ为基础的治疗方案作为幽门螺杆菌抢救治疗。
方法：这种前瞻性，单中心,临床试验于2022年1月至8月间进行.有幽门螺杆菌治疗失败史的患者每天两次服用20mgVPZ，750毫克阿莫西林，每日3次，和250毫克布拉氏酵母菌(S.boulardii）每日两次，共14d（14dVAS方案）。VPZ和布拉氏链球菌在饭前服用，而阿莫西林是在饭后服用的。根除治疗结束后3d内，所有患者均被要求填写问卷,以评估他们可能经历的任何不良事件.根除治疗结束后至少4-6周，使用13C-尿素呼气试验评估根除成功，并探讨了与根除成功相关的因素。
结果：这里，对103名患者进行了评估，最终纳入68例患者。所有纳入的患者先前有1-3次根除失败。使用意向治疗和符合方案分析计算的总体根除率为92.6%(63/68)和92.3%(60/65)，分别。根除率与治疗失败的次数没有差异（P=0.433）。克拉霉素的比率，甲硝唑,左氧氟沙星耐药率为91.3%(21/23)，100.0%（23/23），和60.9%（14/23），分别。没有四环素耐药的病例,阿莫西林,或者呋喃唑酮.在60.9%(14/23)的患者中，幽门螺杆菌分离株对所有3种抗生素(克拉霉素，甲硝唑,和左氧氟沙星)；然而，92.9%(13/14)的患者达到根除。所有患者均出现甲硝唑耐药,根除率为91.3%(21/23)。无焦虑患者的根除率(96.8%)高于有焦虑患者的根除率(60.0%,P=0.025)。无严重不良事件发生；大多数不良事件为轻度且无干预消失。95.6％（65/68）的患者依从性良好。血清学检查显示肝肾功能无明显变化。
结论：VAS是一种安全有效的抢救疗法，具有可接受的根除率（>90％），不管以前治疗失败的次数。焦虑可能与根除失败有关。
目的：评估以VPZ为基础的治疗方案作为幽门螺杆菌抢救治疗。
方法：这种前瞻性，单中心,临床试验于2022年1月至8月间进行.有幽门螺杆菌治疗失败史的患者每天两次服用20mgVPZ，750毫克阿莫西林，每日3次，和250毫克布拉氏酵母菌(S.boulardii）每日两次，共14d（14dVAS方案）。VPZ和布拉氏链球菌在饭前服用，而阿莫西林是在饭后服用的。根除治疗结束后3d内，所有患者均被要求填写问卷,以评估他们可能经历的任何不良事件.根除治疗结束后至少4-6周，使用13C-尿素呼气试验评估根除成功，并探讨了与根除成功相关的因素。
结果：这里，对103名患者进行了评估，最终纳入68例患者。所有纳入的患者先前有1-3次根除失败。使用意向治疗和符合方案分析计算的总体根除率为92.6%(63/68)和92.3%(60/65)，分别。根除率与治疗失败的次数没有差异（P=0.433）。克拉霉素的比率，甲硝唑,左氧氟沙星耐药率为91.3%(21/23)，100.0%（23/23），和60.9%（14/23），分别。没有四环素耐药的病例,阿莫西林,或者呋喃唑酮.在60.9%(14/23)的患者中，幽门螺杆菌分离株对所有3种抗生素(克拉霉素，甲硝唑,和左氧氟沙星)；然而，92.9%(13/14)的患者达到根除。所有患者均出现甲硝唑耐药,根除率为91.3%(21/23)。无焦虑患者的根除率(96.8%)高于有焦虑患者的根除率(60.0%,P=0.025)。无严重不良事件发生；大多数不良事件为轻度且无干预消失。95.6％（65/68）的患者依从性良好。血清学检查显示肝肾功能无明显变化。
结论：VAS是一种安全有效的抢救疗法，具有可接受的根除率（>90％），不管以前治疗失败的次数。焦虑可能与根除失败有关。
