Jeon Hye Kyung, Kim Gwang Ha, Cheon Yong-Il, Shin Sung-Chan, Lee Byung Joo
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.
J Clin Med. 2023 Sep 22;12(19):6116. doi: 10.3390/jcm12196116.
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).
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)
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