Nishida Tsutomu, Tsujii Masahiko, Tanimura Hirohisa, Tsutsui Shusaku, Tsuji Shingo, Takeda Akira, Inoue Atsuo, Fukui Hiroyuki, Yoshio Toshiyuki, Kishida Osamu, Ogawa Hiroyuki, Oshita Masahide, Kobayashi Ichizo, Zushi Shinichiro, Ichiba Makoto, Uenoyama Naoto, Yasunaga Yuichi, Ishihara Ryu, Yura Mamoru, Komori Masato, Egawa Satoshi, Iijima Hideki, Takehara Tetsuo
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
World J Gastroenterol. 2014 Apr 21;20(15):4362-9. doi: 10.3748/wjg.v20.i15.4362.
To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori (H. pylori) in usual post-marketing use in Japan, where the clarithromycin (CAM) resistance rate is 30%.
For this multicenter, randomized, open-label, non-inferiority trial, we recruited patients (≥ 20 years of age) with H. pylori infection from 20 hospitals in Japan. We randomly allocated patients to esomeprazole therapy (esomeprazole 20 mg, CAM 400 mg, amoxicillin (AC) 750 mg for the first 7 d, with all drugs given twice daily) or lansoprazole therapy (lansoprazole 30 mg, CAM 400 mg, AC 750 mg for the first 7 d, with all drugs given twice daily) using a minimization method with age, sex, and institution as adjustment factors. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. H. pylori eradication was confirmed by a urea breath test from 4 to 8 wk after cessation of therapy.
ITT analysis revealed the eradication rates of 69.4% (95%CI: 61.2%-76.6%) for esomeprazole therapy and 73.9% (95%CI: 65.9%-80.6%) for lansoprazole therapy (P = 0.4982). PP analysis showed eradication rate of 76.9% (95%CI: 68.6%-83.5%) for esomeprazole therapy and 79.8% (95%CI: 71.9%-86.0%) for lansoprazole therapy (P = 0.6423). There were no differences in adverse effects between the two therapies.
Esomeprazole showed non-inferiority and safety in a 7 day-triple therapy for eradication of H. pylori compared with lansoprazole.
在日本，克拉霉素（CAM）耐药率为30%的情况下，评估在常规上市后使用中，以埃索美拉唑为基础的三联疗法与兰索拉唑疗法作为幽门螺杆菌（H. pylori）患者一线根除疗法的疗效和安全性。
在这项多中心、随机、开放标签、非劣效性试验中，我们从日本20家医院招募了年龄≥20岁的幽门螺杆菌感染患者。我们采用最小化法，以年龄、性别和机构作为调整因素，将患者随机分配至埃索美拉唑疗法组（埃索美拉唑20 mg，CAM 400 mg，阿莫西林（AC）750 mg，疗程前7天，所有药物均每日服用两次）或兰索拉唑疗法组（兰索拉唑30 mg，CAM 400 mg，AC 750 mg，疗程前7天，所有药物均每日服用两次）。我们的主要结局是意向性分析（ITT）和符合方案分析（PP）的根除率。治疗停止后4至8周通过尿素呼气试验确认幽门螺杆菌根除情况。
ITT分析显示，埃索美拉唑疗法的根除率为69.4%（95%CI：61.2%-76.6%），兰索拉唑疗法的根除率为73.9%（95%CI：65.9%-80.6%）（P = 0.4982）。PP分析显示，埃索美拉唑疗法的根除率为76.9%（95%CI：68.6%-83.5%），兰索拉唑疗法的根除率为79.8%（95%CI：71.9%-86.0%）（P = 0.6423）。两种疗法的不良反应无差异。
与兰索拉唑相比，埃索美拉唑在7天三联疗法根除幽门螺杆菌方面显示出非劣效性和安全性。
