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Abstract：
BACKGROUND: A cure for Helicobacter pylori (H. pylori) remains a problem of global concern. The prevalence of antimicrobial resistance is widely rising and becoming a challenging issue worldwide. Optimizing sequential therapy seems to be one of the most attractive strategies in terms of efficacy, tolerability and cost. The most common sequential therapy consists of a dual therapy [proton-pump inhibitors (PPIs) and amoxicillin] for the first period (5 to 7 d), followed by a triple therapy for the second period (PPI, clarithromycin and metronidazole). PPIs play a key role in maintaining a gastric pH at a level that allows an optimal efficacy of antibiotics, hence the idea of using new generation molecules.
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.
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.
摘要：
背景：治疗幽门螺杆菌（H.幽门螺杆菌）仍然是全球关注的问题。抗菌素耐药性的流行率正在广泛上升，并成为世界范围内的一个具有挑战性的问题。就疗效而言，优化序贯疗法似乎是最有吸引力的策略之一，耐受性和成本。最常见的序贯疗法包括双重治疗[质子泵抑制剂（PPI）和阿莫西林]第一阶段（5至7天），然后是第二阶段的三联疗法(PPI，克拉霉素和甲硝唑）。PPI在将胃pH维持在允许抗生素最佳功效的水平上发挥关键作用。因此，使用新一代分子的想法。
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。
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。
