Zullo Angelo, Ridola Lorenzo, Efrati Cesare, Giorgio Floriana, Nicolini Giorgia, Cannaviello Claudio, Alvaro Domenico, Hassan Cesare, Gatta Luigi, Francesco Vincenzo De
Gastroenterology and Digestive Endoscopy, "Nuovo Regina Margherita" Hospital Rome (Angelo Zullo, Cesare Hassan), Italy.
Gastroenterology Unit, Sapienza University of Rome, "Polo Pontino" Hospital, Latina (Lorenzo Ridola, Domenico Alvaro), Italy.
Ann Gastroenterol. 2014;27(4):357-361.
Helicobacter pylori () treatment remains a challenge for physicians. Although highly effective, the standard sequential therapy fails in a certain number of patients. Moreover, the cure rate following a levofloxacin-amoxicillin second-line triple therapy seems to be decreasing. We tested the efficacy of modified 10-day sequential therapy, and an intensified levofloxacin-amoxicillin regimen as first- and second-line therapy respectively.
In this prospective, open label, multicenter, pilot study -infected patients received a first-line modified 10-day sequential therapy regimen including rabeprazole 20 mg, and amoxicillin 1 g for the first 3 days, followed by rabeprazole 20 mg, clarithromycin 250 mg, and metronidazole 250 mg, for the remaining 7 days, all drugs given thrice daily. An 8-day therapy regimen with rabeprazole 20 mg, levofloxacin 250 mg, and amoxicillin 1 g, all thrice daily, was administered a second-line therapy.
A total of 99 and 15 patients were enrolled for first- and second-line therapy. The eradication rates were 85.9% (95% CI 80-93) and 93.4% (95% CI 88-98) according to ITT and PP analyses following modified sequential therapy, and 60% (95% CI 35-86) and 64.3% (95% CI 39-89) following the intensified second-line therapy.
A modified sequential 3- plus 7-day regimen with thrice daily drug administration failed to achieve very high eradication rate at ITT analysis. The intensified second-line regimen achieved disappointingly low eradication rate. Novel levofloxacin-free second-line therapies are urged in Italy.
幽门螺杆菌（Hp）治疗对医生来说仍是一项挑战。尽管标准序贯疗法效果显著，但仍有一定数量的患者治疗失败。此外，左氧氟沙星 - 阿莫西林二线三联疗法后的治愈率似乎在下降。我们分别测试了改良的10天序贯疗法以及强化的左氧氟沙星 - 阿莫西林方案作为一线和二线疗法的疗效。
在这项前瞻性、开放标签、多中心的试点研究中，Hp感染患者接受一线改良10天序贯治疗方案，前3天服用雷贝拉唑20毫克和阿莫西林1克，随后7天服用雷贝拉唑20毫克、克拉霉素250毫克和甲硝唑250毫克，所有药物均每日服用三次。二线治疗采用8天治疗方案，即每日三次服用雷贝拉唑20毫克、左氧氟沙星250毫克和阿莫西林1克。
共有99名和15名患者分别接受一线和二线治疗。根据改良序贯治疗后的意向性分析（ITT）和符合方案分析（PP），根除率分别为85.9%（95%可信区间80 - 93）和93.4%（95%可信区间88 - 98），强化二线治疗后的根除率分别为60%（95%可信区间35 - 86）和64.3%（95%可信区间39 - 89）。
在ITT分析中，改良的3加7天序贯方案，每日三次给药未能达到很高的根除率。强化二线方案的根除率低得令人失望。意大利迫切需要新型无左氧氟沙星的二线治疗方法。
