短程三联疗法根除幽门螺杆菌的多中心临床研究

A Multicenter Clinical Study on Eradication of Helicobacter pylori Using Four Regimens of One-week Triple Therapy in China

目的：近年幽门螺杆菌（H.pylori）菌株的耐药性问题日益突出，寻找有效且无耐药性的抗生素及联合治疗方案是当前十分重要的课题。本文旨在评价以奥美拉唑（O，20mg）或胶体次拘橼酸铋（B，240mg）为基础的含呋喃唑酮（F，100mg）或甲硝唑（M，400mg）同时加用羟氨于青霉素（A，1000mg）或克拉霉素（C，250mg）的4种短程（1周）三联疗法的H．pylori根除率。方法：采用由华东、华南、华西、华北及华中地区20家医院参加的多中心随机临床试验。892例患者的非活动性十二指肠球部溃疡（DU）和非溃疡性消化不良（NUD）均经胃镜诊断，H．Pylori阳性由快速尿素酶试验结合涂片和／或组织学检查证实。患者随机分为4个治疗组：OMC组、OFC组、OFA组和BFC组，每日服药2次，疗程均为1周。治疗结束后4～8周作13C尿素呼气试验判断H．Pylori根除的效果。结果：892例患者中实际完成881例，失访11例（1．2％）。不同方案的H．Pylori根除率（按方案分析）分别为：OMC组65.9％、OFC组69.2％、OFA组86.6％及BFC组80.4％。OFA疗法对DU患者H．Pylori的根除率（90．2％）高于NUD患者（83．5％）。4种疗法副作用均较轻微，主要为胃肠道反应，患者依从性良好。结论：本研究中OMC疗法的效果与西方国家早期报道相比显著降低。

Background/Aims: Short-term therapies for eradication of Helicobacter Pylori (H. pylori) have been reported worldwide with varying results. The purpose of this study was to evaluate the efficacy of one-week regimens containing three medications: omeprazole (O) or colloidal bismuth subcitrate (B),furazolidone (F) or metronidazole (M), and amoxicillin (A) or clarithromycin (C) at eradicating H. Pylori in a multicenter study involving 20 hospitals in China. Methods: 892 patients with non-ulcer dyspepsia (NUD) or healed duodenal ulcer (DU) disease confirmed by endoscopy were randomized to receive OMC, OFC, OFA, or BFC, twice daily for 7 days. 13C-urea breath test was performed 4~8 weeks after completion of treatment. Results: By protocol analysis, the eradication rate in patients receiving OMC was 65.9%, OFC 69.2%, OFA 86.6%, and BFC 80.4%. In patients with DU, the eradication rate of H. Pylori by OFA was higher than that in NUD (90.2% vs 83.5%, P<0.05). The adverse effects of the four regimens were mild, and mainly gastrointestinal. Conclusions: The efficacy of OMC was relatively low in this study. We suspect that this is the result of rising resistance of H. pylori to metronidazole and clarithromycin. The highest eradication rate is by OFA. We propose OFA to be the preferred regimen in areas where metronidazole and clarithromycin resistances are increasing.