Bardhan K D, Wurzer H, Marcelino M, Jahnsen J, Lotay N, Roberts P M
Rotherham General Hospitals National Health Service Trust, UK.
Am J Gastroenterol. 1998 Mar;93(3):380-5. doi: 10.1111/j.1572-0241.1998.00380.x.
Ranitidine bismuth citrate (RBC) b.i.d. with clarithromycin q.i.d. eradicates Helicobacter pylori (H. pylori) in 82-94% of patients, and heals duodenal ulcers in 88-90% of patients. This double blind, placebo-controlled study examines the efficacy of a simpler b.i.d. treatment regimen, and examines the potential benefit of including a second antibiotic, metronidazole, to the b.i.d. treatment regimen.
A total of 648 patients with active duodenal ulcer received RBC 400 mg b.i.d. for 4 wk, coprescribed with clarithromycin 250 mg q.i.d., clarithromycin 500 mg b.i.d., or clarithromycin 500 mg b.i.d. with metronidazole 400 mg b.i.d. for the first 2 wk of treatment. Endoscopies were performed prestudy, after 4 wk of treatment, and at least 4 wk posttreatment. H. pylori status was assessed by CLOtest, 13C-urea breath test (UBT), and histology prestudy, and by UBT and histology at least 4 wk posttreatment. Adverse events were recorded at each visit.
All three regimens were highly effective and well tolerated. H. pylori eradication rates were 84-94% and duodenal ulcer healing rates were 92-96% (observed data). Highest H. pylori eradication and ulcer healing rates were achieved with RBC 400 mg b.i.d. with clarithromycin 500 mg b.i.d.
Ranitidine bismuth citrate with clarithromycin 500 mg b.i.d. provides an effective, simple and well tolerated regimen for the eradication of H. pylori and healing of duodenal ulcers.
枸橼酸铋雷尼替丁（RBC）每日两次，克拉霉素每日四次，可使82%至94%的患者根除幽门螺杆菌（H. pylori），并使88%至90%的患者十二指肠溃疡愈合。这项双盲、安慰剂对照研究考察了一种更简单的每日两次治疗方案的疗效，并考察了在每日两次治疗方案中加入第二种抗生素甲硝唑的潜在益处。
共有648例活动性十二指肠溃疡患者接受RBC 400毫克每日两次，共治疗4周，同时在治疗的前2周联合使用克拉霉素250毫克每日四次、克拉霉素500毫克每日两次，或克拉霉素500毫克每日两次加甲硝唑400毫克每日两次。在研究前、治疗4周后以及治疗后至少4周进行内镜检查。在研究前通过CLO检测、13C-尿素呼气试验（UBT）和组织学评估幽门螺杆菌状态，在治疗后至少4周通过UBT和组织学评估。每次就诊时记录不良事件。
所有三种方案都非常有效且耐受性良好。幽门螺杆菌根除率为84%至94%，十二指肠溃疡愈合率为92%至96%（观察数据）。RBC 400毫克每日两次联合克拉霉素500毫克每日两次时，幽门螺杆菌根除率和溃疡愈合率最高。
枸橼酸铋雷尼替丁联合克拉霉素500毫克每日两次为根除幽门螺杆菌和治愈十二指肠溃疡提供了一种有效、简单且耐受性良好的方案。
