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替戈拉赞治疗喉咽反流病患者的疗效:一项初步可行性研究。

Efficacy of Tegoprazan in Patients with Laryngopharyngeal Reflux Disease: A Preliminary Feasibility Study.

作者信息

Jeon Hye Kyung, Kim Gwang Ha, Cheon Yong-Il, Shin Sung-Chan, Lee Byung Joo

机构信息

Department of Internal Medicine, Pusan National University School of Medicine, Busan 49241, Republic of Korea.

Biomedical Research Institute, Pusan National University Hospital, Busan 49241, Republic of Korea.

出版信息

J Clin Med. 2023 Sep 22;12(19):6116. doi: 10.3390/jcm12196116.


DOI:10.3390/jcm12196116
PMID:37834761
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10573336/
Abstract

Tegoprazan is a novel, potent, and highly selective potassium-competitive acid blocker that inhibits gastric acid secretion with rapid onset of action and prolonged control of gastric acidity. We performed a preliminary feasibility study to evaluate whether tegoprazan could control symptoms more effectively than a placebo in patients with laryngopharyngeal reflux disease (LPRD). In this double-blind, randomized, placebo-controlled trial, 35 patients with LPRD were randomly assigned to two groups: tegoprazan 50 mg daily and placebo. The primary endpoint was the complete resolution rate of LPRD symptoms after 8 weeks of medication, and the secondary endpoints were the complete resolution rate of LPRD symptoms after 4 weeks of medication and changes in the reflux symptom index (RSI) and reflux finding score (RFS) from baseline at 4 and 8 weeks of medication. There was no difference in the complete symptom resolution rates at 8 weeks between the tegoprazan and placebo groups (29.4% [5/17] vs. 27.8% [5/18], = 1.000). Moreover, there was no significant difference in the complete symptom resolution rates at 4 weeks between the two groups. Compared with the baseline, both tegoprazan and placebo significantly reduced the total RSI and RFS scores after 4 and 8 weeks of medication; however, tegoprazan was not superior to the placebo. In conclusion, tegoprazan (50 mg daily) administration improved LPRD symptoms and signs. However, tegoprazan did not show superiority over placebo. Considering the potential effectiveness of tegoprazan as an acid-suppressing therapy and the possibility of type II error due to a low number of included patients herein, prospective, large-scale, multi-center studies with a higher dose of tegoprazan for a prolonged duration are required to elucidate the efficacy of tegoprazan in patients with LPRD. (ClinicalTrials.gov: NCT05871398).

摘要

替戈拉赞是一种新型、强效且高度选择性的钾离子竞争性酸阻滞剂,能抑制胃酸分泌,起效迅速且能长期控制胃酸水平。我们进行了一项初步可行性研究,以评估替戈拉赞在喉咽反流病(LPRD)患者中控制症状是否比安慰剂更有效。在这项双盲、随机、安慰剂对照试验中,35例LPRD患者被随机分为两组:每日服用替戈拉赞50毫克组和安慰剂组。主要终点是用药8周后LPRD症状的完全缓解率,次要终点是用药4周后LPRD症状的完全缓解率以及用药4周和8周时反流症状指数(RSI)和反流发现评分(RFS)相对于基线的变化。替戈拉赞组和安慰剂组在8周时的症状完全缓解率无差异(29.4%[5/17]对27.8%[5/18],P = 1.000)。此外,两组在4周时的症状完全缓解率也无显著差异。与基线相比,替戈拉赞和安慰剂在用药4周和8周后均显著降低了RSI和RFS总分;然而,替戈拉赞并不优于安慰剂。总之,服用替戈拉赞(每日50毫克)改善了LPRD的症状和体征。然而,替戈拉赞并未显示出优于安慰剂的效果。鉴于替戈拉赞作为抑酸疗法的潜在有效性以及本文纳入患者数量较少可能导致II类错误发生的可能性,需要进行前瞻性、大规模多中心研究,使用更高剂量的替戈拉赞并延长用药时间,以阐明替戈拉赞在LPRD患者中的疗效。(ClinicalTrials.gov:NCT05871398)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4362/10573336/84d4c9ef0d61/jcm-12-06116-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4362/10573336/84d4c9ef0d61/jcm-12-06116-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4362/10573336/84d4c9ef0d61/jcm-12-06116-g001.jpg

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引用本文的文献

[1]
Structure Determination of Tegoprazan(()-4-((5,7-difluorochroman-4-yl)oxy)-,,2-trimethyl-1-benzo[]imidazole-6-formamide) Polymorphs A and B by Laboratory X-Ray Powder Diffraction.

Molecules. 2025-3-30

[2]
Potassium-competitive Acid Blockers for Treatment of Extraesophageal Symptoms and Signs.

J Neurogastroenterol Motil. 2025-4-30

[3]
Laryngopharyngeal reflux disease: Updated examination of mechanisms, pathophysiology, treatment, and association with gastroesophageal reflux disease.

World J Gastroenterol. 2024-4-28

本文引用的文献

[1]
Meta-analysis of Proton Pump Inhibitors in the Treatment of Pharyngeal Reflux Disease.

Comput Math Methods Med. 2022

[2]
Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Infection: A Randomized, Double-Blind, Phase III, Clinical Trial.

Gut Liver. 2022-7-15

[3]
Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan.

Clin Ther. 2021-8

[4]
Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease.

Aliment Pharmacol Ther. 2021-8

[5]
Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Oral Doses of Tegoprazan in Healthy Chinese Subjects.

Clin Drug Investig. 2021-1

[6]
Advances in the diagnosis and management of gastroesophageal reflux disease.

BMJ. 2020-11-23

[7]
Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer.

Aliment Pharmacol Ther. 2020-7-23

[8]
Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study).

Aliment Pharmacol Ther. 2020-1-28

[9]
Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ-12420), a novel potassium-competitive acid blocker, in healthy male subjects.

Aliment Pharmacol Ther. 2019-8-22

[10]
Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis.

Aliment Pharmacol Ther. 2019-3-6

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