在幽门螺旋杆菌一线治疗中,基于培养的药敏性指导定制疗法与经验性联合疗法的比较:随机临床试验。

IF 5.8 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY United European Gastroenterology Journal Pub Date : 2024-09-01 Epub Date: 2024-06-17 DOI:10.1002/ueg2.12609
Jeong Hoon Lee, Byung-Hoon Min, Eun Jeong Gong, Jun Young Kim, Hee Kyong Na, Ji Yong Ahn, Do Hoon Kim, Kee Don Choi, Yang Won Min, Hyuk Lee, Jun Haeng Lee, Hwoon-Yong Jung, Jae J Kim
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引用次数: 0

摘要

背景:随着抗菌药物耐药性的不断增加,药敏性指导下的定制疗法逐渐成为治疗幽门螺旋杆菌的理想策略。然而,药敏性指导下的定制疗法需要额外的成本、时间消耗和侵入性程序(内窥镜检查),与经验性四联疗法相比,其作为幽门螺杆菌一线治疗的优越性仍不明确。目的:比较基于培养的药敏性指导下的定制疗法与经验性联合疗法作为幽门螺杆菌一线治疗的疗效:这项开放标签、随机试验在韩国四家医疗机构进行。共有312名幽门螺杆菌培养检测呈阳性且未接受过治疗的患者按照3:1的比例被随机分配到以培养为基础的药敏性指导定制疗法(针对易感菌株的克拉霉素或甲硝唑三联疗法,或针对双重耐药菌株的铋剂四联疗法,n = 234)或经验性联合疗法(n = 78)中,为期10天。治疗至少 4 周后,通过 13C 尿素呼气试验评估根除成功率:结果:对克拉霉素和甲硝唑的双重耐药性发生率为8%。根据意向治疗分析(P=0.859),定制治疗组和同时治疗组的幽门螺杆菌根除率分别为84.2%和83.3%,根据协议分析(P=0.702),定制治疗组和同时治疗组的幽门螺杆菌根除率分别为92.9%和91.5%,两组之间具有可比性。不过,定制组中双重耐药菌株的根除率明显高于并用组。根据《不良事件通用术语标准》,所有不良事件均为 1 级或 2 级,定制组的发生率明显较低。两组患者因不良事件中断治疗的比例相当(2.1% 对 2.6%):结论:在根除率方面,以培养易感性为指导的定制疗法未能显示出优于经验性配合疗法。基于这些发现,临床实践中的治疗选择将取决于抗菌素耐药的背景率、可用资源以及与培养和药敏试验相关的成本。
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Culture-based susceptibility-guided tailored versus empirical concomitant therapy as first-line Helicobacter pylori treatment: A randomized clinical trial.

Background: With the increasing resistance to antimicrobial agents, susceptibility-guided tailored therapy has been emerging as an ideal strategy for Helicobacter pylori treatment. However, susceptibility-guided tailored therapy requires additional cost, time consumption, and invasive procedure (endoscopy) and its superiority over empirical quadruple therapy as the first-line H. pylori treatment remains unclear.

Aims: To compare the efficacy of culture-based susceptibility-guided tailored versus empirical concomitant therapy as the first-line Helicobacter pylori treatment.

Methods: This open-label, randomized trial was performed in four Korean institutions. A total of 312 Patients with H. pylori-positive culture test and naïve to treatment were randomly assigned in a 3:1 ratio to either culture-based susceptibility-guided tailored therapy (clarithromycin-based or metronidazole-based triple therapy for susceptible strains or bismuth quadruple therapy for dual-resistant strains, n = 234) or empirical concomitant therapy (n = 78) for 10 days. Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment.

Results: Prevalence of dual resistance to both clarithromycin and metronidazole was 8%. H. pylori eradication rates for tailored and concomitant groups were 84.2% and 83.3% by intention-to-treat analysis (p = 0.859), respectively, and 92.9% and 91.5% by per-protocol analysis, respectively (p = 0.702), which were comparable between the two groups. However, eradication rates for dual-resistant strains were significantly higher in the tailored group than in the concomitant group. All adverse events were grade 1 or 2 based on the Common Terminology Criteria for Adverse Events and the incidence was significantly lower in the tailored group. The proportion of patients discontinuing treatment for adverse events was comparable between the two groups (2.1% vs. 2.6%).

Conclusions: The culture-based susceptibility-guided tailored therapy failed to show superiority over the empirical concomitant therapy in terms of eradication rate. Based on these findings, the treatment choice in clinical practice would depend on the background rate of antimicrobial resistance, availability of resources and costs associated with culture and susceptibility testing.

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来源期刊
United European Gastroenterology Journal
United European Gastroenterology Journal GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
10.50
自引率
13.30%
发文量
147
期刊介绍: United European Gastroenterology Journal (UEG Journal) is the official Journal of the United European Gastroenterology (UEG), a professional non-profit organisation combining all the leading European societies concerned with digestive disease. UEG’s member societies represent over 22,000 specialists working across medicine, surgery, paediatrics, GI oncology and endoscopy, which makes UEG a unique platform for collaboration and the exchange of knowledge.
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