Tailored Therapy Guided by Antibiotic Genotypic Resistances and CYP2C19 Polymorphisms Detected From Fecal Specimens for the First-Line Helicobacter pylori Eradication: A Randomized Controlled Trial

IF 4.6 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-10-20 DOI:10.1111/hel.70082

Baojun Suo, Xinlu Ren, Cailing Li, Yanyan Shi, Xueli Tian, Kai Zhou, Liya Zhou, Zhiqiang Song

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引用次数: 0

Abstract

Background

Tailored therapy based on genetic testing of fecal samples is a promising method for Helicobacter pylori eradication, but relevant research is still lacking, and the effectiveness remains unclear.

Objective

This study conducted a randomized controlled trial to evaluate the efficacy, safety, and compliance of triple plus bismuth therapy (TBT) guided by clarithromycin and levofloxacin genotypic resistances and CYP2C19 polymorphisms from stool samples. A preliminary health economics analysis was also conducted.

Design

Six hundred and sixteen treatment-naïve patients were randomly divided into tailored (individualized drug selection based on genetic testing for 7 or 14 days) and empiric (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all twice daily for 14 days) TBT groups. Safety and compliance were assessed within 1–3 days after eradication. ¹³C-urea breath test was performed within 4–8 weeks after eradication to evaluate the therapeutic outcome.

Results

The eradication rates of the tailored TBT group were non-inferior to those of the empiric TBT group [intention-to-treat analysis 87.7% vs. 80.8%, rate difference 6.8% (95% confidence interval 0.8%–12.9%); modified intention-to-treat analysis 93.4% vs. 86.8%, rate difference 6.7% (95% confidence interval 1.5%–11.9%); per-protocol analysis 95.7% vs. 88.7%, rate difference 7.0% (95% confidence interval 2.2%–11.8%)]. The tailored TBT group achieved satisfactory efficacies (acceptable in intention-to-treat and excellent in per-protocol analyses). Safety and compliance were similar between the two groups. The average cost of each successful eradication case in the tailored TBT group is lower than that in the empiric TBT group.

Conclusion

The tailored TBT guided by antibiotic genotypic resistances and CYP2C19 polymorphisms detected from fecal specimens achieved satisfactory efficacy, safety, and compliance in the first-line Helicobacter pylori eradication with less expenses (ChiCTR2300068620).

Trial Registration

Chinese Clinical Trials Registration: ChiCTR2300068620

查看原文本刊更多论文

基于抗生素基因型耐药和粪便标本检测CYP2C19多态性的个体化治疗用于幽门螺杆菌一线根除：一项随机对照试验

背景：基于粪便样本基因检测的定制治疗是一种很有前景的根除幽门螺杆菌的方法，但相关研究尚缺乏，有效性尚不清楚。目的：本研究通过随机对照试验，评价由克拉霉素和左氧氟沙星基因型耐药和粪便样本CYP2C19多态性引导的三联加铋治疗（TBT）的疗效、安全性和依从性。还进行了初步的卫生经济学分析。设计：616名treatment-naïve患者随机分为量身定制（基于基因检测的个性化药物选择）和经验（埃索美拉唑20毫克，阿莫西林1000毫克，克拉霉素500毫克，柠檬酸铋钾220毫克，每天两次，持续14天）TBT组。根除后1-3天内评估安全性和依从性。根除后4 ~ 8周进行13c -尿素呼气试验，评价治疗效果。结果：定制TBT组的根除率不低于经验TBT组[意向治疗分析87.7%对80.8%，率差6.8%(95%可信区间为0.8% ~ 12.9%)；改良意向治疗分析93.4% vs. 86.8%，率差6.7%(95%置信区间1.5% ~ 11.9%)；每个方案分析95.7% vs. 88.7%，率差7.0%(95%可信区间2.2%-11.8%)]。量身定制的TBT组取得了令人满意的疗效（治疗意向可接受，每个方案分析优秀）。两组之间的安全性和依从性相似。定制型TBT组每个成功根除病例的平均成本低于经验型TBT组。结论：以抗生素基因型耐药和粪便标本检测CYP2C19多态性为指导的定制TBT在一线根除幽门螺杆菌（ChiCTR2300068620）中获得了满意的疗效、安全性和依从性，且费用较少。试验注册：中国临床试验注册：ChiCTR2300068620。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.