目的:喉咽反流病(LPRD)主要用质子泵抑制剂(PPI)如埃索美拉唑治疗,有吸收延迟和骨质疏松症增加等缺点。Fexuprazan是一种新型有效的钾竞争性酸阻滞剂,可快速起效且作用持续时间长,抑制胃酸分泌。评估非索普拉赞与埃索美拉唑在LPRD患者中的疗效和安全性。
方法:这种前瞻性,随机化,双盲,多中心,在9个耳鼻喉诊所进行了主动对照试验.将反流症状指数(RSI)≥13且反流发现评分(RFS)≥7的患者随机分配到非索普拉康组或埃索美拉唑组,并接受40mg非克苏普拉坦或40mg埃索美拉唑,每日1次,共8周。结果是(1)平均变化,变化率,和RSI中的有效汇率,RFS,和LPR相关问卷;(2)不良事件。
结果:共136例患者(非克苏普拉坦68例,埃索美拉唑68例)随访时间≥1个月。各组各参数在4周和8周后显著改善,两组之间无显著差异。对于那些有严重症状(RSI≥18)的人,与艾司奥美拉唑组(n=31)相比,非克苏普拉康组(n=32)在4周后RSI的平均变化和变化率有更多改善(分别为p=.036和.045).在声音嘶哑和麻烦的咳嗽中尤其观察到这种现象。
结论:Fexuprazan改善了LPRD患者的症状和体征,没有严重的不良事件。在有严重症状的患者中,Fexuprazan比PPI更快地改善了症状。
背景:KCT0007251,https://cris。nih.走吧。kr/cris/search/detailSearch.做?seq=22100。
OBJECTIVE: Laryngopharyngeal reflux disease (LPRD) is mainly treated with proton pump inhibitors (PPI) such as esomeprazole, which have shortcomings like delayed absorption and increased osteoporosis. Fexuprazan is a novel potent potassium-competitive acid blocker that inhibits gastric acid secretion with rapid onset and long duration of action. To assess the efficacy and safety of fexuprazan compared to esomeprazole in patients with LPRD.
METHODS: This prospective, randomized, double-blinded, multicenter, active-controlled trial was conducted in nine otolaryngologic clinics. Patients with reflux symptom index (RSI) ≥ 13 and reflux finding score (RFS) ≥ 7 were randomly assigned to the fexuprazan or esomeprazole groups, and received fexuprazan 40-mg or esomeprazole 40-mg once daily for 8 weeks. The outcomes were (1) mean change, change rate, and valid rate in RSI, RFS, and LPR-related questionnaires; and (2) adverse events.
RESULTS: A total of 136 patients (fexuprazan n = 68, esomeprazole n = 68) were followed up for ≥ 1 month. Each parameter significantly improved after 4 and 8 weeks in each group, with no significant differences between the two groups. For those with severe symptoms (RSI ≥ 18), the fexuprazan group (n = 32) showed more improvement in the mean change and change rate in the RSI than esomeprazole group (n = 31) after 4 weeks (p = .036 and .045, respectively). This phenomenon was especially observed in hoarseness and troublesome cough.
CONCLUSIONS: Fexuprazan improved symptoms and signs without no serious adverse events in patients with LPRD. In patients with severe symptoms, fexuprazan resulted in a faster symptom improvement than PPI.
BACKGROUND: KCT0007251, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22100 .