Martos Maider, Bujanda Luis, Salicio Yolanda, Sarasqueta Cristina, Ibarra Begoña, Mendarte Usua, Fernández-Reyes María, Cosme Angel
aDepartment of Gastroenterology, University of Basque Country (UPV/EHU), Centro de Investigación Biomédica en Enfermedades Hepáticas y Digestivas (CIBERehd) bDepartment of Microbiology cDepartment of Epidemiology, CIBERESP, Donostia Hospital, Institute Biodonostia, San Sebastián, Spain.
Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1380-4. doi: 10.1097/MEG.0000000000000197.
Resistance to antibiotics is the major cause of treatment failure of Helicobacter pylori (HP) infection. The culture-guided triple therapy (chosen on the basis of a preliminary in-vitro susceptibility test) might help to increase treatment success in high antibiotic resistance regions. The aim of this study was to evaluate the effectiveness of treatment with clarithromycin in patients with clarithromycin-sensitive culture compared with patients treated empirically.
In this prospective and controlled trial, 111 naive HP-positive patients were randomized to receive standard triple therapy omeprazole (20 mg twice daily), amoxicillin (1 g twice daily), and clarithromycin (500 mg twice daily) for 10 days (OAC) after antimicrobial susceptibility testing if there was no resistance to clarithromycin (ClariS) or empirical 10-day OAC for first-line therapy of HP (ClariNA). Eradication was confirmed using the C-labelled urea breath test 6 weeks after therapy. Our primary outcome was HP eradication. Treatment adherence and adverse effects were recorded.
The effectiveness of eradication by protocol with 10-day OAC therapy in the ClariS was 94% [95% confidence interval (CI): 0.83-0.98], which was 22% higher than ClariNA 72% (95% CI: 0.58-0.85; P=0.006). The odds ratio of eradication in ClariS was 1.30 (95% CI: 1.10-1.60; P<0.05 by logistic regression) and the number needed to treat was 5 (95% CI: 3-13). We found no significant difference in the occurrence of adverse effects or in compliance between the two groups.
The eradication rate was significantly higher with clarithromycin-based triple therapy for patients with clarithromycin-susceptible HP isolates compared with those for whom no information on the corresponding susceptibility was available (ClinicalTrials.gov number NCT01486082).
抗生素耐药是幽门螺杆菌（HP）感染治疗失败的主要原因。基于培养结果的三联疗法（根据初步体外药敏试验选择）可能有助于提高高抗生素耐药地区的治疗成功率。本研究旨在评估与经验性治疗的患者相比，克拉霉素敏感培养的患者使用克拉霉素治疗的有效性。
在这项前瞻性对照试验中，111例初治HP阳性患者被随机分组，若对克拉霉素无耐药（ClariS组），则在抗菌药敏试验后接受标准三联疗法，即奥美拉唑（20mg，每日2次）、阿莫西林（1g，每日2次）和克拉霉素（500mg，每日2次），疗程10天（OAC）；若为HP一线治疗的经验性10天OAC（ClariNA组）。治疗6周后采用C标记尿素呼气试验确认根除情况。我们的主要结局是HP根除。记录治疗依从性和不良反应。
ClariS组采用10天OAC方案治疗的根除有效率为94%[95%置信区间（CI）：0.83 - 0.98]，比ClariNA组的72%（95%CI：0.58 - 0.85；P = 0.006）高22%。ClariS组根除的优势比为1.30（95%CI：1.10 - 1.60；经逻辑回归分析P < 0.05），治疗所需人数为5（95%CI：3 - 13）。我们发现两组之间不良反应的发生或依从性无显著差异。
与无相应药敏信息的患者相比，克拉霉素敏感HP分离株患者采用基于克拉霉素的三联疗法根除率显著更高（ClinicalTrials.gov编号NCT01486082）。
