Hwang Jae Jin, Lee Dong Ho, Yoon Hyuk, Shin Cheol Min, Park Young Soo, Kim Nayoung
Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea.
World J Gastroenterol. 2015 Sep 21;21(35):10234-41. doi: 10.3748/wjg.v21.i35.10234.
To evaluate the efficacy of moxifloxacin-based sequential therapy (MBST) versus hybrid therapy as a first-line treatment for Helicobacter pylori (H. pylori) infection.
From August 2014 to January 2015, 284 patients with confirmed H. pylori infection were randomized to receive a 14-d course of MBST (MBST group, n = 140) or hybrid (Hybrid group, n = 144) therapy. The MBST group received 20 mg rabeprazole and 1 g amoxicillin twice daily for 7 d, followed by 20 mg rabeprazole and 500 mg metronidazole twice daily, and 400 mg moxifloxacin once daily for 7 d. The Hybrid group received 20 mg rabeprazole and 1 g amoxicillin twice daily for 14 d. In addition, the Hybrid group received 500 mg metronidazole and 500 mg clarithromycin twice daily for the final 7 d. Successful eradication of H. pylori infection was defined as a negative (13)C-urea breath test 4 wk after the end of treatment. Patient compliance was defined as "good" if drug intake was at least 85%. H. pylori eradication rates, patient compliance with treatment, and adverse event rates were evaluated.
The eradication rates in the intention-to-treat (ITT) analysis were 91.4% (128/140; 95%CI: 90.2%-92.9%) in the MBST group and 79.2% (114/144; 95%CI: 77.3%-80.7%) in the Hybrid group (P = 0.013). The eradication rates in the per-protocol (PP) analysis were 94.1% (128/136; 95%CI: 92.9%-95.6%) in the MBST group and 82.6% (114/138; 95%CI: 80.6%-84.1%) in the Hybrid group (P = 0.003). The H. pylori eradication rate in the MBST group was significantly higher than that of the Hybrid group for both the ITT (P = 0.013) and the PP analyses (P = 0.003). Both groups exhibited full compliance with treatment (MBST/Hybrid group: 100%/100%). The rate of adverse events was 11.8% (16/136) and 19.6% (27/138) in the MBST and Hybrid group, respectively (P = 0.019). The majority of adverse events were mild-to-moderate in intensity; none were severe enough to cause discontinuation of treatment in either group.
MBST was more effective and led to fewer adverse events than hybrid therapy as a first-line treatment for H. pylori infection.
评估以莫西沙星为基础的序贯疗法（MBST）与联合疗法作为幽门螺杆菌（H. pylori）感染一线治疗方案的疗效。
2014年8月至2015年1月，284例确诊为H. pylori感染的患者被随机分为两组，分别接受为期14天的MBST治疗（MBST组，n = 140）或联合治疗（联合组，n = 144）。MBST组患者先接受雷贝拉唑20 mg及阿莫西林1 g，每日2次，共7天，随后接受雷贝拉唑20 mg及甲硝唑500 mg，每日2次，并加用莫西沙星400 mg，每日1次，共7天。联合组患者接受雷贝拉唑20 mg及阿莫西林1 g，每日2次，共14天。此外，联合组在最后7天加用甲硝唑500 mg及克拉霉素500 mg,每日2次。治疗结束4周后，（13）C-尿素呼气试验结果为阴性定义为H. pylori感染成功根除；如果药物摄入量至少达到85%则定义为患者依从性“良好”。评估H. pylori根除率、患者治疗依从性及不良事件发生率。
意向性分析（ITT）中，MBST组根除率为91.4%（128/140；95%CI：90.2%-92.9%），联合组为79.2%（114/144；95%CI：77.3%-80.7%）（P = 0.013）。符合方案分析（PP）中，MBST组根除率为94.1%（128/136；95%CI：92.9%-95.6%），联合组为82.6%（114/138；95%CI：80.6%-84.1%）（P = 0.003）。无论是ITT分析（P = 0.013）还是PP分析（P = 0.003），MBST组的H. pylori根除率均显著高于联合组。两组患者均完全依从治疗（MBST组/联合组：100%/100%）。MBST组和联合组不良事件发生率分别为11.8%（16/136）和19.6%（27/138）（P = 0.019）。大多数不良事件为轻至中度，两组均无严重到足以导致停药的不良事件。
作为H. pylori感染的一线治疗方案，MBST比联合疗法更有效，且不良事件更少。
