OBJECTIVE: To compare an optimized sequential therapy with the standard non-bismuth quadruple therapies of 10 and 14 d, in terms of efficacy, incidence of adverse effects (AEs) and cost.
METHODS: This open-label prospective study randomized 328 patients with confirmed H. pylori infection into three groups (1:1:1): The first group received quadruple therapy consisting of twice-daily (bid) omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for 10 d (QT-10), the second group received a 14 d quadruple therapy following the same regimen (QT-14), and the third group received an optimized sequential therapy consisting of bid rabeprazole 20 mg plus amoxicillin 1 g for 7 d, followed by bid rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg for the next 7 d (OST-14). AEs were recorded throughout the study, and the H. pylori eradication rate was determined 4 to 6 wk after the end of treatment, using the 13C urea breath test.
RESULTS: In the intention-to-treat and per-protocol analysis, the eradication rate was higher in the OST-14 group compared to the QT-10 group: (93.5%, 85.5% P = 0.04) and (96.2%, 89.5% P = 0.03) respectively. However, there was no statistically significant difference in eradication rates between the OST-14 and QT-14 groups: (93.5%, 91.8% P = 0.34) and (96.2%, 94.4% P = 0.35), respectively. The overall incidence of AEs was significantly lower in the OST-14 group (P = 0.01). Furthermore, OST-14 was the most cost-effective among the three groups.
CONCLUSIONS: The optimized 14-d sequential therapy is a safe and effective alternative. Its eradication rate is comparable to that of the 14-d concomitant therapy while causing fewer AEs and allowing a gain in terms of cost.
目的:比较优化的序贯疗法与标准的非铋四联疗法10和14d,就功效而言,不良反应(AE)的发生率和成本。
方法:这项开放标签的前瞻性研究将328例确诊幽门螺杆菌感染的患者随机分为三组(1:1:1):第一组接受四联疗法,包括每日两次(bid)奥美拉唑20mg,阿莫西林1克,克拉霉素500毫克,甲硝唑500毫克,连续10天(QT-10),第二组按照相同的方案(QT-14)接受14d四联疗法,第三组接受优化的序贯疗法,包括bid雷贝拉唑20mg加阿莫西林1g,持续7d,其次是雷贝拉唑20毫克,接下来的7天(OST-14),克拉霉素500mg和甲硝唑500mg。在整个研究过程中记录AE,治疗结束后4到6周确定幽门螺杆菌根除率,使用13C尿素呼气试验。
结果:在意向治疗和符合方案分析中,OST-14组的根除率高于QT-10组:(93.5%,85.5%P=0.04)和(96.2%,分别为89.5%P=0.03)。然而,OST-14和QT-14组的根除率无统计学差异:(93.5%,91.8%P=0.34)和(96.2%,94.4%P=0.35),分别。OST-14组的AEs总发生率显著降低(P=0.01)。此外,OST-14是三组中最具成本效益的。
结论:优化的14d序贯疗法是一种安全有效的选择。其根除率与14-d伴随治疗相当,同时引起较少的AE并在成本方面获得收益。