Oueslati A, Mohamed G, Bostani S, Boughoula K, Bizid S, Ben Abdallah H, Bouali R, Abdelli M N
Department of Gastroenterology and Hepatology, Military hospital of Tunis, Tunis, Tunisia.
Tunis El Manar University, Faculty of medicine of Tunis, Tunis, Tunisia.
Future Sci OA. 2025 Dec;11(1):2527539. doi: 10.1080/20565623.2025.2527539. Epub 2025 Jul 10.
In Tunisia, concomitant quadruple therapy (QTC) has been the standard first-line treatment for () infection. However, increasing resistance to clarithromycin (28%) has raised concerns about its long-term efficacy. Bismuth-based quadruple therapy (QTB) offers an alternative, yet its higher cost and safety profile remain debated. This study aimed to compare the efficacy, safety, and cost of both regimens.
We conducted a prospective, randomized, open-label study enrolling 200 patients naïve to any anti-HP treatment. Patients were randomized to either 10 days of bismuth therapy (QTB: potassium bismuth subcitrate, metronidazole, and tetracycline hydrochloride, omeprazole) or 14 days of concomitant quadruple therapy (QTC: amoxicillin, clarithromycin, metronidazole, esomeprazole). eradication as defined by a negative urea breath test 4-6 weeks after treatment.
Among 200 patients, the intention-to-treat eradication rate was 82% for QTC and 87% for QTB (p = 0.29); per-protocol rates were 84.53% and 89.58%, respectively (p = 0.39). Compliance was high (97% in QTC vs 96% in QTB; p = 0.32). Adverse events were similar between groups (61.85% for QTB vs 69% for QTC; p = 0.29).
Bismuth and concomitant quadruple therapies were comparable in terms of efficacy and safety but didn't achieve the accepted minimum eradication rate (90%).
在突尼斯，联合四联疗法（QTC）一直是（幽门螺杆菌）感染的标准一线治疗方法。然而，对克拉霉素的耐药性不断增加（28%）引发了对其长期疗效的担忧。铋剂四联疗法（QTB）提供了一种替代方案，但其较高的成本和安全性仍存在争议。本研究旨在比较两种治疗方案的疗效、安全性和成本。
我们进行了一项前瞻性、随机、开放标签研究，纳入200例未接受过任何抗幽门螺杆菌治疗的患者。患者被随机分为接受10天铋剂治疗（QTB：次硝酸铋钾、甲硝唑、盐酸四环素和奥美拉唑）或14天联合四联疗法（QTC：阿莫西林、克拉霉素、甲硝唑和埃索美拉唑）。治疗后4-6周尿素呼气试验阴性定义为幽门螺杆菌根除。
在200例患者中，QTC的意向性治疗根除率为82%，QTB为87%（p = 0.29）；符合方案分析的根除率分别为84.53%和89.58%（p = 0.39）。依从性较高（QTC为97%，QTB为96%；p = 0.32）。两组间不良事件相似（QTB为61.85%，QTC为69%；p = 0.29）。
铋剂四联疗法和联合四联疗法在疗效和安全性方面具有可比性，但未达到公认的最低根除率（90%）。
