背景:尚未研究餐前或餐后给予阿莫西林对沃诺拉赞-阿莫西林双重疗法(VA双重疗法)治疗幽门螺杆菌的疗效的影响。目前还不清楚阿莫西林每天给药四次是否比每天给药三次更有效。我们旨在研究不同的阿莫西林给药方案对VA双重疗法疗效的影响。
方法:H.幽门螺杆菌感染的受试者以1:1:1的比例随机分为三组,接受14天双重治疗,包括伏诺拉赞20mg每日2次+阿莫西林1000mg每日3次餐前(BM-TID)或1000mg每日3次餐后(AM-TID)或750mg每日4次餐后(AM-QID).幽门螺杆菌根除率,不良事件发生率,合规,并对抗生素耐药性进行了比较。
结果:在2021年5月至2023年4月之间,共招募了327名受试者。BM-TID的根除率,AM-TID,AM-QID双重治疗占88.1%,89.9%,意向治疗(ITT)分析为93.6%,90.6%,94.2%,在修改后的ITT(MITT)分析中为99.0%,90.4%,94.1%,在符合方案(PP)分析中占99.0%。尽管BM-TID和AM-TID之间存在非劣效性,以及AM-TID和AM-QID之间,AM-QID比BM-TID更有效。不良事件发生率无显著差异,合规,三组之间的抗生素耐药性。
结论:餐后给药和阿莫西林给药频率的增加可能有助于VA双重疗法的更好疗效,尤其是抢救治疗。我们研究中的所有VA双重疗法都可以获得一线治疗的良好疗效。
背景:clinicaltrials.gov:NCT05901051。
BACKGROUND: The effect of preprandial or postprandial administration of amoxicillin on the efficacy of vonoprazan-amoxicillin dual therapy (VA-dual therapy) for Helicobacter pylori treatment has not been studied. It is also unclear whether amoxicillin dosing four times daily is more effective than three times daily. We aimed to investigate the effect of different amoxicillin administration regimens on the efficacy of VA-dual therapy.
METHODS: H. pylori-infected subjects were randomly assigned to three groups in a 1:1:1 ratio to receive a 14-day dual therapy consisting of vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily before meals (BM-TID) or 1000 mg three times daily after meals (AM-TID) or 750 mg four times daily after meals (AM-QID). H. pylori eradication rates, adverse events rates, compliance, and antibiotic resistance were compared.
RESULTS: Between May 2021 to April 2023, 327 subjects were enrolled. The eradication rates of BM-TID, AM-TID, and AM-QID dual therapy were 88.1%, 89.9%, and 93.6% in intention-to-treat (ITT) analysis, 90.6%, 94.2%, and 99.0% in modified ITT (MITT) analysis, and 90.4%, 94.1%, and 99.0% in per-protocol (PP) analysis. Although there was non-inferiority between BM-TID and AM-TID, as well as between AM-TID and AM-QID, AM-QID was significantly more effective than BM-TID. There were no significant differences in adverse event rates, compliance, and antibiotic resistance among the three groups.
CONCLUSIONS: Postprandial administration and the increased frequency of administration of amoxicillin may contribute to a better efficacy of VA-dual therapy, especially for rescue therapy. All VA-dual therapy in our study could achieve good efficacy for first-line treatment.
BACKGROUND: clinicaltrials.gov: NCT05901051.