Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-Bomb, Survivors Hospital, 1-9-6, Sendamachi, Naka-ku, Hiroshima, 730-8619, Japan.
Department of Medical Checkup Center, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, 1-9-6, Sendamachi, Naka-ku, Hiroshima, 730-8619, Japan.
Esophagus. 2021 Jul;18(3):669-675. doi: 10.1007/s10388-020-00798-7. Epub 2020 Nov 21.
The study aimed to investigate the efficacy of vonoprazan 10 mg compared with 20 mg in patients with erosive esophagitis.
Seventy-three patients with erosive esophagitis were randomly divided into two groups either vonoprazan 20 mg (n = 37) or 10 mg (n = 36). They were administered each dose for 4 weeks as the initial treatment followed by maintenance treatment with 10 mg for 8 weeks. The primary endpoints were mucosal healing rate and symptom relief at 4 weeks. The secondary endpoint was symptom relief at 12 weeks after the maintenance treatment. Mucosal healing was assessed endoscopically, and symptom relief was assessed using the FSSG score.
At 4 weeks, the endoscopic healing rates of the 20 mg and 10 mg groups were 94.6% and 94.4%, respectively. The FSSG scores of the 20 mg and 10 mg groups were significantly decreased in both treatment groups from 13 (4-39) to 4 (0-25) and 14 (4-40) to 3 (0-29), respectively. At 12 weeks, the scores further decreased to 2 (0-13) and 2 (0-26), respectively. The vonoprazan 10 mg group showed a similar therapeutic effect to the 20 mg group in mucosal healing at 4 weeks and in symptom relief throughout the study period. When stratified by esophagitis grading, these findings were still demonstrated in grade A/B patients but not in grade C/D patients.
Our findings suggest that initial treatment with vonoprazan 10 mg might be useful especially in patients with mild erosive esophagitis. Large controlled studies are warranted to confirm our investigation.
本研究旨在探讨 10mg 沃诺拉赞与 20mg 沃诺拉赞在糜烂性食管炎患者中的疗效。
73 例糜烂性食管炎患者随机分为两组，分别给予沃诺拉赞 20mg（n=37）或 10mg（n=36）。初始治疗 4 周后，两组均给予 10mg 维持治疗 8 周。主要终点为 4 周时的黏膜愈合率和症状缓解率。次要终点为维持治疗 12 周后的症状缓解率。内镜评估黏膜愈合，FSSG 评分评估症状缓解。
4 周时，20mg 组和 10mg 组的内镜愈合率分别为 94.6%和 94.4%。20mg 组和 10mg 组的 FSSG 评分均显著降低，分别从治疗前的 13（4-39）分降至 4（0-25）分和 14（4-40）分降至 3（0-29）分；治疗后 12 周时，评分分别进一步降至 2（0-13）分和 2（0-26）分。沃诺拉赞 10mg 组在 4 周时的黏膜愈合率和整个研究期间的症状缓解率与 20mg 组相似。按食管炎分级分层分析，这些发现也适用于 A/B 级患者，但不适用于 C/D 级患者。
我们的研究结果表明，初始治疗时使用沃诺拉赞 10mg 可能特别适用于轻度糜烂性食管炎患者。需要进行更大规模的对照研究来证实我们的研究结果。
