短程三联疗法根除幽门螺杆菌的多中心临床研究

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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,可能与我 OBJECTIVE: In recent years, the problem of drug resistance of H. pylori strains has become increasingly prominent. It is currently an extremely important issue to find effective antibiotic-resistant antibiotics and combination therapy. This article aims to evaluate the effects of furazolidone (F, 100 mg) or metronidazole (M, 400 mg) on ​​omeprazole (O, 20 mg) or colloidal bismuth citrate (B, 240 mg) Four short-haul (one week) triple therapy Hs for penicillin (A, 1000 mg) or clarithromycin (C, 250 mg). Eradication rate of pylori. Methods: A multicenter randomized clinical trial was conducted in 20 hospitals in East China, South China, West China, North China and Central China. 892 patients with inactive duodenal ulcer (DU) and non-ulcer dyspepsia (NUD) were diagnosed by gastroscope, H. Pylori positivity was confirmed by rapid urease test in combination with smear and / or histology. Patients were randomly divided into four treatment groups: OMC group, OFC group, OFA group and BFC group, taking 2 times a day for 1 week. After treatment for 4 to 8 weeks for 13C urea breath test to determine H. Efficacy of Pylori eradication. Results: Of the 892 patients, 881 were actually completed and 11 were missed (1.2%). H Pylori eradication rates (by program analysis) were 65.9% in the OMC group, 69.2% in the OFC group, 86.6% in the OFA group and 80.4% in the BFC group. OFA therapy for DU patients. The eradication rate of Pylori (90.2%) was higher than that of NUD patients (83.5%). Four kinds of side effects are mild treatment, mainly gastrointestinal reactions, patients with good compliance. CONCLUSIONS: The efficacy of OMC therapy in this study was significantly lower compared to earlier reports in Western countries, probably with me
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