Li Cailing, Zhou Kai, Suo Baojun, Shi Yanyan, Ping Guangjie, Zhou Liya, Song Zhiqiang
Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
Digestive Disease Research Center of Peking University, Beijing, China.
Therap Adv Gastroenterol. 2025 Jun 26;18:17562848251348826. doi: 10.1177/17562848251348826. eCollection 2025.
Tailored therapy is crucial for reducing the irrational use of antibiotics and enhancing () eradication rates. Detection of antibiotic resistance gene mutations offers a rapid, accurate, and simple approach for tailored therapy, facilitating its widespread clinical implementation. However, the efficacy, safety, adherence, and cost-effectiveness of tailored therapy guided by genotypic resistance from gastric mucosa samples for first-line treatment remain unclear.
This study aims to clarify the efficacy, safety, patient compliance, and cost-effectiveness of genotypic resistance-guided tailored therapy for first-line treatment.
A systematic review and meta-analysis following the PRISMA 2020 guidelines.
The literature was searched in PubMed, Web of Science, and Wanfang databases under the keywords "," "tailored therapy," and "genotypic resistance" before March 1, 2025. Two investigators independently performed data extraction and literature quality assessment. Single-arm meta-analysis was performed using the Meta package of the R program to summarize the efficacy, safety, and compliance of tailored therapy, and classical meta-analysis was performed using Review Manager to compare tailored therapy with empirical treatment. Dichotomous outcomes were summarized using relative risks with 95% confidence intervals.
Of 1524 retrieved articles, 29 (including 4895 patients) met inclusion criteria for single-arm meta-analysis, and 17 (including 6208 patients) were included in the classical meta-analysis by further excluding studies that did not use empirical treatment as control. The single-arm meta-analysis demonstrated satisfactory efficacy of tailored therapy in first-line treatment (intention-to-treat analysis: 84.4%, per-protocol analysis: 91.7%), with good safety (adverse event rate: 26.6%) and adherence (98.0%). Tailored therapy showed a higher overall eradication rate than empirical treatment. Subgroup analysis indicated that tailored therapy outperformed standard triple therapy and was comparable to bismuth quadruple therapy and concomitant therapy in terms of efficacy, with similar safety and adherence across groups. Health economic evidence was limited, but most studies suggested that tailored therapy incurred higher costs per successful eradication than empirical treatment.
Tailored therapy guided by genotypic resistance detected from gastric mucosa samples demonstrates satisfactory eradication efficacy in first-line treatment, superior to standard triple therapy and comparable to bismuth quadruple therapy, with comparable safety and adherence. Current evidence supports bismuth quadruple therapy as the optimal first-line treatment for infection. Considering factors such as cost-effectiveness and technical accessibility, it is more appropriate to implement tailored therapy in countries and regions with adequate resources and capabilities.
This study was not registered in PROSPERO, and future systematic reviews and meta-analyses will be registered in advance.
精准治疗对于减少抗生素的不合理使用和提高（）根除率至关重要。检测抗生素耐药基因突变提供了一种快速、准确且简单的精准治疗方法，便于其在临床广泛应用。然而，由胃黏膜样本的基因型耐药性指导的一线治疗的精准治疗的疗效、安全性、依从性和成本效益仍不明确。
本研究旨在阐明基因型耐药性指导的一线治疗的精准治疗的疗效、安全性、患者依从性和成本效益。
遵循PRISMA 2020指南进行系统评价和荟萃分析。
于2025年3月1日前在PubMed、Web of Science和万方数据库中以关键词“”“精准治疗”和“基因型耐药性”检索文献。两名研究者独立进行数据提取和文献质量评估。使用R程序的Meta包进行单臂荟萃分析以总结精准治疗的疗效、安全性和依从性，并使用Review Manager进行经典荟萃分析以比较精准治疗与经验性治疗。二分结局使用具有95%置信区间的相对风险进行总结。
在检索到的1524篇文章中，29篇（包括4895例患者）符合单臂荟萃分析的纳入标准，通过进一步排除未使用经验性治疗作为对照的研究，17篇（包括6208例患者）被纳入经典荟萃分析。单臂荟萃分析表明，精准治疗在一线治疗中具有令人满意的疗效（意向性分析：84.4%，符合方案分析：91.7%），安全性良好（不良事件发生率：26.6%）且依从性高（98.0%）。精准治疗显示出比经验性治疗更高的总体根除率。亚组分析表明，精准治疗在疗效方面优于标准三联疗法，与铋剂四联疗法和伴同疗法相当，各组间安全性和依从性相似。卫生经济学证据有限，但大多数研究表明，与经验性治疗相比，精准治疗每成功根除一例患者的成本更高。
由胃黏膜样本检测到的基因型耐药性指导的精准治疗在一线治疗中显示出令人满意的根除效果，优于标准三联疗法，与铋剂四联疗法相当，安全性和依从性相当。目前的证据支持铋剂四联疗法作为幽门螺杆菌感染的最佳一线治疗方法。考虑到成本效益和技术可及性等因素，在资源和能力充足的国家和地区实施精准治疗更为合适。
本研究未在PROSPERO注册，未来的系统评价和荟萃分析将提前注册。
