Randomized Clinical Trial Comparing Concomitant and Tailored Therapy for Eradication of Helicobacter pylori Infection.
Randomized Clinical Trial Comparing Concomitant and Tailored Therapy for Eradication of Helicobacter pylori Infection.
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DOI：
10.3390/jpm11060534
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发表时间：
2021-06-09
影响因子：
--
通讯作者：
Tonkic A
中科院分区：
文献类型：
--
作者：
Perkovic N;Mestrovic A;Bozic J;Ivelja MP;Vukovic J;Kardum G;Sundov Z;Tonkic M;Puljiz Z;Vukojevic K;Tonkic A
由于克罗地亚分裂-达尔马蒂亚地区克拉霉素耐药性高（>20%）阻碍了H. pylori感染，本研究的主要目的是比较合并四联疗法与定制的个性化治疗作为一线根除H.幽门。在一项开放标签、随机临床试验中，80例H。根据抗菌药物敏感性试验的结果，将幽门螺杆菌感染患者随机分配至合并治疗组（埃索美拉唑40 mg，阿莫西林1 gr，甲硝唑500 mg，克拉霉素500 mg，每日两次，持续14天）或定制治疗组。治疗4周后评估根除状态。在抗生素耐药性增加（克拉霉素37.5%，甲硝唑17.5%，双重耐药10%）的情况下，在意向治疗（70% vs. 92.5%，p = 0.010）和符合方案（87.5% vs. 100%，p = 0.030）分析中，定制组的根除率显著高于合并组。伴随治疗组的不良反应更常见（32.5% vs. 7.5%，p = 0.006）。定制化治疗可实现更高的根除率和更低的不良事件发生率。随着H.幽门螺杆菌菌株的抗生素治疗，根除制度与这些特点应强烈认为是一个合理的选择，一线治疗。
As high clarithromycin resistance (>20%) in the Split-Dalmatia region of Croatia hinders the treatment of H. pylori infection, the primary objective of this study was to compare concomitant quadruple with the tailored, personalized therapy as first-line eradication treatment of H. pylori. In an open-label, randomized clinical trial, 80 patients with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 gr, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or tailored therapy in accordance with the results of the antimicrobial susceptibility testing. Eradication status was assessed 4 weeks after treatment. Eradication rates were significantly higher in tailored group than in concomitant group both in intention-to-treat (70 vs. 92.5%, p = 0.010) and per-protocol (87.5 vs. 100%, p = 0.030) analysis in the setting of increasing antibiotic resistance (clarithromycin 37.5%, metronidazole 17.5%, dual resistance 10%). Adverse effects were more frequent in the concomitant group (32.5 vs. 7.5%, p = 0.006). Tailored therapy achieves higher eradication with a lower adverse events rate. With the increasing resistance of H. pylori strains to antibiotic treatment, eradication regimes with such characteristics should be strongly considered as a reasonable choice for first-line treatment.
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通讯作者：
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