以培养为基础的敏感性为指导的量身定制与实证并发疗法作为一线Helicobacter pylori治疗:一项随机临床试验
Jeong Hoon Lee1, Byung-Hoon Min2, Eun Jeong Gong3
1Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
针对Helicobacter pylori感染的灵敏度指导的量身定制疗法显示了与实证并发治疗相比的根除率. 然而,量身定制的疗法在双抗菌株中显示出更好的结果,并减少了不良事件.
科学领域:
- 胃肠病学 胃肠病学
- 传染性疾病 传染性疾病
- 临床微生物学 临床微生物学
背景情况:
- 抗菌素耐药性需要针对Helicobacter pylori进行量身定制的治疗策略.
- 敏感性导向疗法提供个性化治疗,但涉及更高的成本,时间和侵入性程序.
- 针对第一线H. pylori治疗的量身定制与经验治疗的比较疗效仍在研究中.
研究的目的:
- 为了比较基于培养的敏感性导向量身定制治疗与第一线H. pylori治疗的实证并发治疗的疗效.
- 评估两种治疗方法之间的根除率,不良事件和治疗中止情况.
主要方法:
- 一项开放的随机试验,涉及312名先前未接受过治疗的H. pylori阳性培养患者.
- 患者被随机分配 (3:1) 接受10天的量身定制治疗 (n=234) 或经验同步治疗 (n=78).
- 在治疗后至少4周使用13C尿素呼吸试验来评估消除的成功.
主要成果:
- 在量身定制 (84.2% ITT) 和并发 (83.3% ITT) 治疗组之间没有观察到H. pylori根除率的显著差异.
- 量身定制的治疗显示,对双抗性菌株 (克拉里胺素和美特罗尼达醇耐药性) 的根除率显著更高.
- 在量身定制治疗组中,不良事件的发生率明显较低,治疗中断率相似.
结论:
- 基于培养的敏感性引导的量身定制疗法在整体H. pylori根除率方面没有表现出对实证并发疗法的优越性.
- 治疗选择应考虑抗菌素耐药性模式,资源的可用性和敏感性测试的成本.
- 针对性治疗可能有利于患有双抗性H. pylori菌株的患者,并提供更好的安全性.
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