Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, RM 3A-320 (111D), 2002 Holcombe Boulevard, Houston, TX 77030, USA.
J Gastroenterol. 2010 Aug;45(8):816-20. doi: 10.1007/s00535-010-0220-x. Epub 2010 Mar 2.
Studies with CYP2C19 slow metabolizers have shown that the combination of a proton pump inhibitor (PPI) plus amoxicillin (dual therapy) can reliably cure more than 90% of Helicobacter pylori infections. Theoretically, the use of a PPI dose that provides equivalent acid suppression with fast metabolizers and slow metabolizers would achieve high cure rates irrespective of the CYP2C19 genotype.
To evaluate high-dose PPI plus amoxicillin dual therapy for H. pylori eradication.
H. pylori-infected individuals (positive by 2 tests) received esomeprazole 40 mg plus amoxicillin 750 mg every 8 h for 14 days. The protocol was planned based on the "efficient identification strategy" requiring more than 90% success, with stop criteria of 6 or more failures within 50 patients or a cure rate of less than 80%.
Thirty-six patients (5 women, 31 men), average age 58 years, were enrolled before achieving stop criteria. All were first H. pylori treatments. The intention-to-treat cure was achieved in 26/36 [72.2%; 95% confidence interval (CI) = 56-84%] and in 26/35 per protocol (74.2%; 95% CI = 56-87%). There were no significant side effects. Compliance was 85% or greater in all (100% in 91.6%).
If the hypothesis that consistently high intragastric pH is required to reliably achieve more than 90% H. pylori eradication, our regimen was not sufficient. Success may require more than every 8 h dosing, the concomitant administration of sodium bicarbonate, or the use of a long-acting PPI. However, the result was positive in that dual therapy with the doses tested here was at least as successful as empiric triple therapy.
研究表明，质子泵抑制剂（PPI）加阿莫西林（双联疗法）可有效治愈超过 90%的幽门螺杆菌感染，对于 CYP2C19 代谢缓慢的患者尤其如此。理论上，使用可提供与快代谢和慢代谢者等效抑酸作用的 PPI 剂量，无论 CYP2C19 基因型如何，均可实现高治愈率。
评估高剂量 PPI 加阿莫西林双联疗法根除幽门螺杆菌的疗效。
采用埃索美拉唑 40mg 加阿莫西林 750mg，每 8 小时 1 次，疗程 14 天，对感染幽门螺杆菌的患者（2 项检测均阳性）进行治疗。方案基于“高效鉴定策略”制定，要求成功率超过 90%，如果 50 例患者中出现 6 例或更多失败，或治愈率低于 80%，则停止试验。
在达到停止标准前，共纳入 36 例（5 例女性，31 例男性）患者，平均年龄 58 岁，均为首次接受幽门螺杆菌治疗。意向治疗的治愈率为 26/36[72.2%；95%可信区间（CI）=56-84%]，按方案分析为 26/35[74.2%；95%CI=56-87%]。无明显不良反应。所有患者的依从性均超过 85%（91.6%的患者为 100%）。
如果始终保持较高的胃内 pH 以可靠地实现超过 90%的幽门螺杆菌根除率是必要的，那么我们的方案可能是不够的。成功可能需要每 8 小时以上的给药频次、同时使用碳酸氢钠，或使用长效 PPI。然而，我们的研究结果是阳性的，即在此剂量下进行的双联疗法至少与经验性三联疗法同样有效。
