Karatapanis S, Georgopoulos S D, Papastergiou V, Skorda L, Papantoniou N, Lisgos Ph, Kouvidou C, Fragkou P, Mentis A
First Department of Internal Medicine, General Hospital of Rhodes, Greece.
Acta Gastroenterol Belg. 2011 Sep;74(3):407-12.
BACKGROUND & STUDY AIMS: Increasing data suggests that the efficiency of standard triple therapies of 7-10-14 days duration has fallen below the threshold for acceptability (80% cure rates in intention to treat analysis). Use of rabeprazole, a PPI less influenced by CYP2C19 gene polymorphisms is reported to lead to improved eradication rates. This study aims to re-examine the effectiveness of 7-10-14 days triple therapies based on rabeprazole in Greek patients.
307 patients, from 2 endoscopic centers in Greece, were randomized to receive Rabeprazole 20 mg bid, Clarithromycin 500 mg bid, and Amoxycillin 1gr bid for 7-days, for 10-days or for 14-days. Cure rates were assessed by CLO-test and histology. Clarithromycin sensitivity tests were carried out in the cultured pre-treatment H.pylori strains. The success rates were calculated by both intention-to-treat (ITT) and per protocol (PP) analyses.
The eradication rates according to ITT analyses were 74.5% (95% CI: 66.5-82.9%) for 7-days, 80.6% (95% CI: 73.2-88.2%) for 10-days and 90.2% (95% CI: 84.5-95.9%) for 14-days treatment. PP cure rates were 76% (95% CI: 68.4-85.0%) for 7-days, 83% (95% CI: 76.6-91.0%) for 10-days and 93.9% (95% CI: 86.7-973%) for 14-days treatment. Side effects were generally minor and comparable in all treatment groups.
Both 10- and 14-days rabeprazole-based triple regimens reached eradication rates above the threshold of 80% on an intention to treat basis. In our setting, the current regimen using rabeprazole, amoxicillin and clarithromycin was well tolerated, is still effective and should continue to be recommended as first-line therapy for H. pylori eradication.
越来越多的数据表明,疗程为7 - 10 - 14天的标准三联疗法的有效性已降至可接受阈值以下(意向性治疗分析中的治愈率达80%)。据报道,使用受CYP2C19基因多态性影响较小的质子泵抑制剂雷贝拉唑可提高根除率。本研究旨在重新审视基于雷贝拉唑的7 - 10 - 14天三联疗法对希腊患者的有效性。
来自希腊2个内镜中心的307例患者被随机分为3组,分别接受雷贝拉唑20 mg每日2次、克拉霉素500 mg每日2次和阿莫西林1 g每日2次的治疗,疗程分别为7天、10天或14天。通过CLO试验和组织学评估治愈率。对培养的治疗前幽门螺杆菌菌株进行克拉霉素敏感性试验。成功率通过意向性治疗(ITT)分析和符合方案(PP)分析计算。
根据ITT分析,7天疗程的根除率为74.5%(95%CI:66.5 - 82.9%),10天疗程为80.6%(95%CI:73.2 - 88.2%),14天疗程为90.2%(95%CI:84.5 - 95.9%)。PP治愈率7天疗程为76%(95%CI:68.4 - 85.0%),10天疗程为83%(95%CI:76.6 - 91.0%),14天疗程为93.9%(95%CI:86.7 - 97.3%)。副作用一般较轻,在所有治疗组中相当。
基于雷贝拉唑的10天和14天三联方案在意向性治疗基础上的根除率均达到了80%的阈值以上。在我们的研究中,目前使用雷贝拉唑、阿莫西林和克拉霉素的方案耐受性良好,仍然有效,应继续推荐作为幽门螺杆菌根除的一线治疗方案。