Ji Jeong-Yeon, Huh Gene, Ji Eunjeong, Lee Jin Yi, Kang Seung Heon, Cha Wonjae, Jeong Woo-Jin, Jung Young Ho
Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.
Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea.
J Neurogastroenterol Motil. 2024 Oct 30;30(4):459-467. doi: 10.5056/jnm23118. Epub 2024 Aug 14.
BACKGROUND/AIMS: Proton pump inhibitors (PPIs) play a crucial role in managing laryngopharyngeal reflux (LPR), but the optimal dosing regimen remains unclear. We aim to compare the effectiveness of the same total PPI dose administered twice daily versus once daily in LPR patients.
We conducted a prospective randomized controlled trial at a tertiary referral hospital, enrolling a total of 132 patients aged 19 to 79 with LPR. These patients were randomly assigned to receive either a 10 mg twice daily (BID) or a 20 mg once daily (QD) dose of ilaprazole for 12 weeks. The Reflux Symptom Index (RSI) and Reflux Finding Score (RFS) were assessed at 8 weeks and 16 weeks. The primary endpoint was the RSI response, defined as a reduction of 50% or more in the total RSI score from baseline. We also analyzed the efficacy of the dosing regimens and the impact of dosing and duration on treatment outcomes.
The BID group did not display a higher response rate for RSI than the QD group. The changes in total RSI scores at the 8-week and 16- week visits showed no significant differences between the 2 groups. Total RFS alterations were also comparable between both groups. Each dosing regimen demonstrated significant decreases in RSI and RFS.
Both BID and QD PPI dosing regimens improved subjective symptom scores and objective laryngoscopic findings. There was no significant difference in RSI improvement between the 2 dosing regimens, indicating that either dosing regimen could be considered a viable treatment option.
背景/目的：质子泵抑制剂（PPIs）在治疗喉咽反流（LPR）中起着关键作用，但最佳给药方案仍不明确。我们旨在比较在LPR患者中，每日两次给予相同总剂量PPI与每日一次给药的有效性。
我们在一家三级转诊医院进行了一项前瞻性随机对照试验，共纳入132例年龄在19至79岁之间的LPR患者。这些患者被随机分配接受每日两次10毫克（BID）或每日一次20毫克（QD）的艾普拉唑治疗12周。在第8周和第16周评估反流症状指数（RSI）和反流发现评分（RFS）。主要终点是RSI反应，定义为总RSI评分较基线降低50%或更多。我们还分析了给药方案的疗效以及给药方式和疗程对治疗结果的影响。
每日两次给药组的RSI反应率并不高于每日一次给药组。在第8周和第16周访视时，两组的总RSI评分变化无显著差异。两组的总RFS变化也相当。每种给药方案的RSI和RFS均显著降低。
每日两次和每日一次的PPI给药方案均改善了主观症状评分和客观喉镜检查结果。两种给药方案在RSI改善方面无显著差异，表明两种给药方案均可被视为可行的治疗选择。
