Tzivras M, Archimandritis A, Balatsos V, Delis V, Souyioultzis S, Skandalis N, Kanellopoulou E, Manika Z, Davaris P
Department of Pathophysiology, University of Athens Medical School, Laiko General Hospital, Greece.
Eur J Gastroenterol Hepatol. 1997 Dec;9(12):1185-9.
To estimate and compare the efficacy of 'triple' 1-week regimens--omeprazole, clarithromycin and a nitroimidazole (metronidazole or ornidazole)--followed by omeprazole, for an additional 3 weeks, on Helicobacter pylori eradication and duodenal ulcer (DU) healing, in a country with a high resistance rate of H. pylori to metronidazole.
Open, prospective, two-centre study.
Patients older than 18 years with active duodenal ulcer (DU), diagnosed by endoscopy and found to be infected with H. pylori (modified Giemsa stain and CLO test, Delta West, Australia), were included in the study. Three triple-drug regimens, given for 7 days, were used. (1) omeprazole (Om) 20 mg once a day, plus clarithromycin (Cl) 250 mg twice daily, plus ornidazole (Or) 500 mg twice daily (O1COr); (2) Om 20 mg twice daily, plus Cl 250 mg twice daily, plus Or 500 mg twice daily (OCOr); and (3) Om 20 mg twice daily, plus Cl 250 mg twice daily, plus metronidazole (M) 500 mg twice daily (OCM). Two hundred and three consecutive H. pylori-positive patients were included in the study, randomly assigned as follows: 50 patients (group A1: 32 men, 18 women, age 23-77 years) on O1COr; 47 patients (group A2: 29 men, 18 women, age 27-77 years) on OCOr; and 106 (group B: 71 men, 35 women, age 18-83 years) on OCM. Ulcer healing and H. pylori eradication were assessed endoscopically, 8-9 weeks after the start of treatment. H. pylori was considered eradicated if both histology and rapid urease test (six biopsies, antrum-body) were negative.
Eleven patients were lost to follow-up; 192 patients were analysed. Group A1: 48; group A2: 44; group B: 100. 'Per-protocol' analysis: H. pylori eradication, 90-93% (P = 0.901); ulcer healing, 90-98% (P = 0.300). 'Intention to treat' analysis: H. pylori eradication, 85-88% (P = 0.887); ulcer healing, 86-91% (P = 0.657). Compliance was excellent, no serious side effects were observed and no patients withdrew due to side effects.
No differences were observed in the H. pylori eradication and the healing rate among the groups. It seems that twice daily omeprazole is no better than single daily dosage and that ornidazole is as effective as metronidazole. In addition, in the studied population which is believed to have a high prevalence of metronidazole resistance, all the regimens used were effective.
在幽门螺杆菌对甲硝唑耐药率较高的国家，评估并比较“三联”1周疗法（奥美拉唑、克拉霉素和一种硝基咪唑类药物（甲硝唑或奥硝唑）），随后再加用3周奥美拉唑，对幽门螺杆菌根除及十二指肠溃疡（DU）愈合的疗效。
开放、前瞻性、双中心研究。
纳入年龄大于18岁、经内镜诊断为活动性十二指肠溃疡（DU）且检测发现感染幽门螺杆菌（改良吉姆萨染色及CLO试验，澳大利亚Delta West公司）的患者。使用三种三联药物疗法，疗程7天。（1）奥美拉唑（Om）20mg每日1次，加克拉霉素（Cl）250mg每日2次，加奥硝唑（Or）500mg每日2次（O1COr）；（2）Om 20mg每日2次，加Cl 250mg每日2次，加Or 500mg每日2次（OCOr）；（3）Om 20mg每日2次，加Cl 250mg每日2次，加甲硝唑（M）500mg每日2次（OCM）。203例连续的幽门螺杆菌阳性患者纳入研究，随机分组如下：50例患者（A1组：男性32例，女性18例，年龄23 - 77岁）接受O1COr治疗；47例患者（A2组：男性29例，女性18例，年龄27 - 77岁）接受OCOr治疗；106例（B组：男性71例，女性35例，年龄18 - 83岁）接受OCM治疗。治疗开始8 - 9周后，通过内镜评估溃疡愈合及幽门螺杆菌根除情况。若组织学检查和快速尿素酶试验（取自胃窦 - 胃体的6块活检组织）均为阴性，则认为幽门螺杆菌已被根除。
11例患者失访；对192例患者进行分析。A1组：48例；A2组：44例；B组：100例。“符合方案”分析：幽门螺杆菌根除率为90 - 93%（P = 0.901）；溃疡愈合率为90 - 98%（P = 0.300）。“意向性治疗”分析：幽门螺杆菌根除率为85 - 88%（P = 0.887）；溃疡愈合率为86 - 91%（P = 0.657）。依从性良好，未观察到严重副作用，也无患者因副作用退出研究。
各治疗组在幽门螺杆菌根除率及愈合率方面未观察到差异。每日2次服用奥美拉唑似乎并不比每日1次服用效果更好，且奥硝唑与甲硝唑疗效相当。此外，在据信甲硝唑耐药率较高的研究人群中，所使用的所有治疗方案均有效。
