Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Helicobacter. 2019 Apr;24(2):e12570. doi: 10.1111/hel.12570. Epub 2019 Feb 14.
Bismuth-containing quadruple therapy has been suggested as first-line and rescue alternative for Helicobacter pylori eradication. Our objective was to perform a meta-analysis evaluating the efficacy and safety of single capsule Pylera (bismuth, metronidazole, and tetracycline) plus a proton-pump inhibitor (PPI) in any line of treatment.
Studies were selected up to October 2018. Outcomes were eradication and adverse events (AEs) rates pooled using the generic inverse variance method.
In total, 30 studies (6482 patients) were included in the systematic review. The intention-to-treat (ITT) efficacy was 90% (95% CI: 87%-92%, 21 studies, I = 88%) in first-line therapy, 89% (95% CI: 86%-93%, 12 studies, I = 78%) in second-line and 82% (95% CI: 78%-87%, nine studies, I = 60%) in third-line; with no differences by the type or dosage of PPI used. For metronidazole-resistant infection, the ITT efficacy as first-line therapy was 93% (95% CI: 90%-96%, six studies, I = 0%). In second-line therapies where patients had been previously treated with clarithromycin, the ITT efficacy was 90% (95% CI: 87%-93%, 11 studies, I = 78%). The overall incidence of AEs was 43% (95% CI: 35%-50%, 24 studies, I = 92%) and they were mostly mild. In nearly 3% of the cases, treatment was interrupted due to AEs.
A 10-day treatment with Pylera achieved an effective eradication rate of approximately 90% both in first- and second-line therapy. This applies regardless of the type and dose of the PPI, in patients with clarithromycin- or metronidazole-resistant strains, and in those previously treated with clarithromycin.
含铋四联疗法已被推荐为幽门螺杆菌根除的一线和补救替代方案。我们的目的是进行一项荟萃分析，评估任何治疗线中单胶囊 Pylera（铋、甲硝唑和四环素）加质子泵抑制剂（PPI）的疗效和安全性。
研究截至 2018 年 10 月进行选择。使用通用倒数方差法汇总根除和不良事件（AE）发生率。
共纳入 30 项研究（6482 例患者）进行系统评价。意向治疗（ITT）疗效在一线治疗中为 90%（95%CI：87%-92%，21 项研究，I²=88%），二线治疗中为 89%（95%CI：86%-93%，12 项研究，I²=78%），三线治疗中为 82%（95%CI：78%-87%，9 项研究，I²=60%），且与使用的 PPI 类型或剂量无关。对于甲硝唑耐药感染，一线治疗的 ITT 疗效为 93%（95%CI：90%-96%，6 项研究，I²=0%）。在二线治疗中，患者之前曾接受过克拉霉素治疗，ITT 疗效为 90%（95%CI：87%-93%，11 项研究，I²=78%）。总的 AE 发生率为 43%（95%CI：35%-50%，24 项研究，I²=92%），大多为轻度。近 3%的病例因 AE 而中断治疗。
Pylera 治疗 10 天，在一线和二线治疗中均可实现约 90%的有效根除率。这适用于无论 PPI 的类型和剂量如何，对于克拉霉素或甲硝唑耐药菌株的患者，以及那些之前接受过克拉霉素治疗的患者。
