Sue Soichiro, Oka Hiroyuki, Kunishi Yosuke, Suzuki Yuichi, Suzuki Shingo, Kaneko Takashi, Komatsu Kazuo, Naito Makoto, Kato Yoshio, Sasaki Tomohiko, Kaneko Hiroaki, Irie Kuniyasu, Kondo Masaaki, Maeda Shin
Department of Gastroenterology Yokohama City University Graduate school of Medicine Yokohama Japan.
Department of Gastroenterology Yokohama Minami Kyousai Hospital Yokohama Japan.
JGH Open. 2024 Apr 22;8(4):e13069. doi: 10.1002/jgh3.13069. eCollection 2024 Apr.
To date, no randomized trials have compared the efficacy of 7-day vonoprazan, amoxicillin, and metronidazole triple therapy (VAM) 7-day vonoprazan, amoxicillin, and clarithromycin triple therapy (VAC) as a first-line treatment for eradication. This study was performed to compare the efficacy of VAM and VAC as first-line treatments.
This prospective multicenter randomized trial was performed in Japan and involved 124 -positive patients without a history of eradication. Patients without antibiotic resistance testing of were eligible. The patients were randomized to receive either VAC (vonoprazan 20 mg + amoxicillin 750 mg + clarithromycin 200 or 400 mg twice a day) or VAM (vonoprazan 20 mg + amoxicillin 750 mg + metronidazole 250 mg twice a day) for 7 days, with stratification by age and sex. Eradication success was evaluated using the C-urea breath test. We evaluated safety using patient questionnaires (UMIN000025773).
The intention-to-treat and per-protocol eradication rates of VAM were 91.3% (95% confidence interval [CI], 82.0-96.7%) and 92.6% (95% CI, 83.7-97.6%), respectively, and those of VAC were 89.1% (95% CI, 77.8-95.9%) and 96.1% (95% CI, 86.5-99.5%), respectively. No significant difference was observed between VAM and VAC in either analysis ( = 0.76 and = 0.70, respectively). Abdominal fullness was more frequent in patients who received VAM than VAC.
These findings suggest that VAM as a first-line treatment in Japan can be categorized as grade B (intention-to-treat cure rate of 90-95%) and have potential as a first-line national insurance -approved regimen.
迄今为止，尚无随机试验比较7天伏诺拉生、阿莫西林和甲硝唑三联疗法（VAM）与7天伏诺拉生、阿莫西林和克拉霉素三联疗法（VAC）作为根除幽门螺杆菌一线治疗方案的疗效。本研究旨在比较VAM和VAC作为一线治疗方案的疗效。
这项前瞻性多中心随机试验在日本进行，纳入了124例无根除治疗史的幽门螺杆菌阳性患者。未进行抗生素耐药性检测的患者符合入选条件。患者按年龄和性别分层，随机接受VAC（伏诺拉生20 mg + 阿莫西林750 mg + 克拉霉素200或400 mg，每日2次）或VAM（伏诺拉生20 mg + 阿莫西林750 mg + 甲硝唑250 mg，每日2次）治疗7天。采用碳-尿素呼气试验评估根除成功率。通过患者问卷（UMIN000025773）评估安全性。
VAM的意向性分析和符合方案分析的根除率分别为91.3%（95%置信区间[CI]，82.0 - 96.7%）和92.6%（95% CI，83.7 - 97.6%），VAC的分别为89.1%（95% CI，77.8 - 95.9%）和96.1%（95% CI，86.5 - 99.5%）。两种分析中VAM和VAC之间均未观察到显著差异（分别为P = 0.76和P = 0.70）。接受VAM治疗的患者腹胀比接受VAC治疗的患者更常见。
这些结果表明，在日本VAM作为一线治疗可归类为B级（意向性治愈率为90 - 95%），有潜力成为国家医保批准的一线治疗方案。
