Lerang F, Moum B, Ragnhildstveit E, Haug J B, Hauge T, Tolås P, Aubert E, Henriksen M, Efskind P S, Nicolaysen K, Søberg T, Odegaard A, Berge T
Department of Internal Medicine, Ostfold Central Hospital, Fredrikstad, Norway.
Am J Gastroenterol. 1997 Apr;92(4):653-8.
To compare the efficacy and side effects of standard bismuth triple therapy with those of omeprazole-based triple therapy in patients with Helicobacter pylori infection and duodenal ulcer disease.
One hundred patients were prospectively recruited and randomized to receive either bismuth subnitrate 75 mg q.i.d., oxytetracycline 500 mg q.i.d., and metronidazole 400 mg b.i.d. (regimen BTM), or omeprazole 20 mg b.i.d., amoxicillin 750 mg b.i.d., and metronidazole 400 mg b.i.d. (regimen OAM), both for 14 days. Upper endoscopy (with antral biopsy specimens for microbiology and antral and corpus biopsy specimens for histology) was performed before treatment, after 2 months, and again 1 yr after treatment. Serum samples for serology (IgG) were taken. Patients with in vitro metronidazole-resistant (M-R) H. pylori strains were excluded. In a nonrandomized study, 41 patients with M-R strains were given either BTM or OAM.
According to intention-to-treat analysis, H. pylori cure rates were 91% and 96% with BTM and OAM, respectively (p = 0.45). In the BTM group, the mean total side effect score was higher (p < 0.001), and more severe side effects were reported (32% vs. 4%, p < 0.001). In the nonrandomized group of patients with M-R strains, H. pylori cure rates were 88% and 67% with BTM and OAM, respectively. All of the successfully treated patients were still H. pylori-negative after 1 yr.
Both treatment regimens were highly effective in curing H. pylori infection in patients with metronidazole-sensitive strains. Omeprazole-based triple therapy was tolerated better than standard bismuth-based triple therapy.
比较标准铋剂三联疗法与基于奥美拉唑的三联疗法对幽门螺杆菌感染合并十二指肠溃疡患者的疗效及副作用。
前瞻性招募100例患者，随机分为两组，分别接受次硝酸铋75毫克每日4次、土霉素500毫克每日4次和甲硝唑400毫克每日2次（BTM方案），或奥美拉唑20毫克每日2次、阿莫西林750毫克每日2次和甲硝唑400毫克每日2次（OAM方案），疗程均为14天。治疗前、治疗2个月后及治疗1年后进行上消化道内镜检查（取胃窦活检标本进行微生物学检查，取胃窦和胃体活检标本进行组织学检查）。采集血清样本进行血清学（IgG）检测。排除体外对甲硝唑耐药（M-R）的幽门螺杆菌菌株患者。在一项非随机研究中，41例M-R菌株患者接受了BTM或OAM治疗。
根据意向性分析，BTM组和OAM组的幽门螺杆菌根除率分别为91%和96%（p = 0.45）。BTM组的平均总副作用评分更高（p < 0.001），且报告的严重副作用更多（32%对4%，p < 0.001）。在M-R菌株的非随机分组患者中，BTM组和OAM组的幽门螺杆菌根除率分别为88%和67%。所有成功治疗的患者在1年后幽门螺杆菌仍为阴性。
两种治疗方案对甲硝唑敏感菌株患者的幽门螺杆菌感染均有很高的治愈率。基于奥美拉唑的三联疗法耐受性优于标准铋剂三联疗法。
