Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.
Pharmacotherapy. 2011 Mar;31(3):227-38. doi: 10.1592/phco.31.3.227.
To determine the factors that may influence Helicobacter pylori eradication in patients receiving omeprazole-amoxicillin dual therapy.
Prospective, randomized study.
University-affiliated hospital in Taiwan.
A total of 128 adults (age range 20-75 yrs) with H. pylori-positive duodenal ulcer were enrolled; 121 completed the final evaluation.
Patients were randomly assigned to one of four omeprazole-amoxicillin treatment groups, with each treatment administered for 2 weeks: O2A2 group (33 patients)--omeprazole 20 mg twice/day plus amoxicillin 500 mg 4 times/day; O2A1 group (32 patients)--omeprazole 20 mg twice/day plus amoxicillin 250 mg 4 times/day; O1A2 group (32 patients)--omeprazole 20 mg once/day plus amoxicillin 500 mg 4 times/day; and O1A1 group (31 patients)--omeprazole 20 mg once/day plus amoxicillin 250 mg 4 times/day.
Data were collected on H. pylori status, histologic parameters, antibiotic resistance, intragastric pH, cytochrome P450 (CYP) 2C19 genotype, and adverse reactions. The intent-to-treat cure rates (95% confidence interval [CI]) in groups O2A2, O2A1, O1A2, and O1A1 were 76% (95% CI 59-87%), 72% (95% CI 54-84%), 50% (95% CI 34-66%) and 52% (95% CI 35-68%), respectively. Eradication of H. pylori infection was statistically significantly dependent on omeprazole dosage, CYP2C19 genotype, age, gastritis status, and H. pylori density. All CYP2C19 poor metabolizers were cured, whereas the H. pylori cure rate in CYP2C19 extensive metabolizers varied from 44-76% in the different treatment groups. Eradication of H. pylori was favored in the omeprazole higher dose groups versus the lower dose groups (79% vs 53%, p=0.004). No secondary antibiotic resistance was found. Thirty-seven (95%) of 39 patients who failed with the initial treatment were cured by subsequent antibiotic susceptibility-driven proton pump inhibitor-based triple therapy.
Provided a maintenance dose of amoxicillin is given every 6 hours, eradication of H. pylori infection was significantly dependent on omeprazole dosage, CYP2C19 genotype, age, gastritis status, and H. pylori density.
确定可能影响接受奥美拉唑-阿莫西林双联疗法的患者中幽门螺杆菌根除的因素。
前瞻性、随机研究。
中国台湾的一所大学附属医院。
共纳入 128 例年龄在 20-75 岁之间的 H. pylori 阳性十二指肠溃疡患者；121 例完成了最终评估。
患者被随机分配到四个奥美拉唑-阿莫西林治疗组中的一个，每组治疗 2 周：O2A2 组（33 例）-奥美拉唑 20mg，每日 2 次，阿莫西林 500mg，每日 4 次；O2A1 组（32 例）-奥美拉唑 20mg，每日 2 次，阿莫西林 250mg，每日 4 次；O1A2 组（32 例）-奥美拉唑 20mg，每日 1 次，阿莫西林 500mg，每日 4 次；O1A1 组（31 例）-奥美拉唑 20mg，每日 1 次，阿莫西林 250mg，每日 4 次。
收集了幽门螺杆菌状态、组织学参数、抗生素耐药性、胃内 pH 值、细胞色素 P450（CYP）2C19 基因型和不良反应的数据。O2A2、O2A1、O1A2 和 O1A1 组的意向治疗治愈率（95%置信区间[CI]）分别为 76%（95%CI 59-87%）、72%（95%CI 54-84%）、50%（95%CI 34-66%）和 52%（95%CI 35-68%）。幽门螺杆菌感染的根除在统计学上与奥美拉唑剂量、CYP2C19 基因型、年龄、胃炎状态和幽门螺杆菌密度有关。所有 CYP2C19 弱代谢者均被治愈，而 CYP2C19 广泛代谢者在不同治疗组中的幽门螺杆菌治愈率为 44-76%。在奥美拉唑高剂量组与低剂量组之间，幽门螺杆菌的根除率较高（79%比 53%，p=0.004）。未发现继发抗生素耐药性。39 例初始治疗失败的患者中有 37 例（95%）经后续基于抗生素敏感性的质子泵抑制剂三联疗法治愈。
在给予维持剂量的阿莫西林每 6 小时一次的情况下，幽门螺杆菌感染的根除与奥美拉唑剂量、CYP2C19 基因型、年龄、胃炎状态和幽门螺杆菌密度显著相关。
