Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai, 200001, China.
Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX, USA.
Dig Dis Sci. 2020 Dec;65(12):3639-3646. doi: 10.1007/s10620-020-06115-7. Epub 2020 Feb 4.
Amoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy had been shown to reliably achieve high eradication rates. The role of individual components remains undefined.
To identify the additional benefit/role of bismuth in amoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy for Helicobacter pylori (H. pylori) treatment.
This was a non-inferiority factorial design trial. Treatment-naive H. pylori-infected subjects were randomly (1:1) assigned to receive 14-day amoxicillin- and metronidazole-containing triple therapy consisting of esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg both thrice daily with or without 220 mg bismuth twice a day. Six weeks after treatment, H. pylori eradication was assessed by C-urea breath test. Antimicrobial susceptibility was assessed by the twofold agar dilution method.
From July 2018 to June 2019, a total of two hundred and sixteen subjects were randomized. Both therapies achieved high eradication rates. Per-protocol with bismuth = 97.9% (94/96, 95% CI 95.1-100%) and without bismuth = 94.7% (90/95, 95% CI 90.3-99.1%) (P = 0.43). Intent-to-treat analysis = 90.7% (98/108, 95% CI 85.2-96.2%) versus 88.9% (96/108, 95% CI 82.8-95.0%) with and without bismuth (P = 0.65). The two regimens were not inferior by intent-to-treat or per-protocol analyses. Metronidazole resistance did not affect the efficacy of either therapy.
Neither the presence nor absence of bismuth or metronidazole resistance reduced the effectiveness of triple therapy containing esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg thrice daily in this population. The clinical trial was registered with ClinicalTrials.gov, NCT03557437.
阿莫西林、甲硝唑、质子泵抑制剂、铋四联疗法已被证明能可靠地达到高根除率。其各个成分的作用仍未确定。
确定铋在阿莫西林、甲硝唑、质子泵抑制剂、铋四联疗法治疗幽门螺杆菌（H. pylori）中的额外作用/作用。
这是一项非劣效性析因设计试验。未经治疗的 H. pylori 感染受试者被随机（1:1）分为两组，分别接受为期 14 天的阿莫西林和甲硝唑三联疗法，包括埃索美拉唑 20mg，每日两次，阿莫西林 1g，甲硝唑 400mg，每日三次，加或不加每日两次 220mg 铋剂。治疗 6 周后，通过 C-尿素呼气试验评估 H. pylori 根除情况。抗菌药物敏感性通过两倍琼脂稀释法评估。
2018 年 7 月至 2019 年 6 月，共随机分配了 216 名受试者。两种疗法均达到了较高的根除率。含铋的方案为 97.9%（94/96，95%可信区间 95.1-100%），无铋的方案为 94.7%（90/95，95%可信区间 90.3-99.1%）（P=0.43）。意向治疗分析为 90.7%（98/108，95%可信区间 85.2-96.2%）与 88.9%（96/108，95%可信区间 82.8-95.0%）（P=0.65），含或不含铋剂。意向治疗和方案均无差异。甲硝唑耐药并不影响两种疗法的疗效。
在该人群中，埃索美拉唑 20mg，每日两次，阿莫西林 1g，甲硝唑 400mg，每日三次三联疗法中，无论是否存在铋剂或甲硝唑耐药，均不影响疗效。临床试验在 ClinicalTrials.gov 注册，NCT03557437。
