Hpylori_South_Kivu

Patients were selected by simple randomization following the order of arrivals in two different groups of treatment (1st line) Group 1 (OAC-10): amoxicillin 1 g twice daily + omeprazole 20 mg twice daily + clarithromycin 500 mg twice daily for 10 days. Group 2 (OAC-14): amoxicillin 1 g twice daily + omeprazole 20 mg twice daily + clarithromycin 500 mg twice daily during 14 days. For the second line (failure of 1st line) , two others protocols were evaluated, OAC-10 regimen+ Levofloxacin (OAC-10+) and the bismuth-based therapy during 10 days. The OAC-10+ protocol consisted to the addition of Levofloxacin 500 mg once daily while bismuth-based therapy included Pantoprazole 20 mg twice daily + bismuth salt 140 mg four times daily + metronidazole 125 mg four times daily+ tetracycline 125 mg four times daily for ten days. Our primary endpoint was H. pylori eradication (HP Ag2 or HP Ag3 for the second line) and secondarily, the compliance and adverse effects. Adverse effects were self-reported by patients and ingesting more than 90% of the regimen full dose is good compliance.

本研究纳入的患者按就诊顺序采用简单随机化法分为两组一线治疗方案：组1（OAC-10）予以阿莫西林1g每日2次+奥美拉唑20mg每日2次+克拉霉素500mg每日2次，疗程10天；组2（OAC-14）予以相同三联药物，疗程14天。针对一线治疗失败的二线治疗场景，本研究评估了另外两种治疗方案：OAC-10+左氧氟沙星方案（OAC-10+）以及为期10天的铋剂疗法。其中OAC-10+方案为在OAC-10方案基础上加用左氧氟沙星500mg每日1次；铋剂疗法方案为泮托拉唑20mg每日2次+铋盐140mg每日4次+甲硝唑125mg每日4次+四环素125mg每日4次，疗程10天。本研究的主要终点为幽门螺杆菌（Helicobacter pylori, H. pylori）根除率（二线治疗患者采用HP Ag2或HP Ag3作为检测指标），次要终点为治疗依从性与不良反应发生情况。不良反应由患者自行报告，若患者服用的药物总剂量达到方案规定全剂量的90%及以上，则判定为治疗依从性良好。