Cestari R
I Department of Surgery, University of Brescia, Italy.
Aliment Pharmacol Ther. 1998 Oct;12(10):991-6. doi: 10.1046/j.1365-2036.1998.00394.x.
Ranitidine bismuth citrate (RBC) in co-prescription with clarithromycin for 2 weeks has been shown to be effective for the eradication of Helicobacter pylori. Moreover, several studies have reported good H. pylori eradication rates with RBC plus two antibiotics for 1 week.
To compare the H. pylori eradication rates and safety of two different RBC co-prescription regimens.
Patients undergoing endoscopy for upper gastrointestinal symptoms were randomized to open treatment with either RBC 400 mg b.d. plus clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for 1 week (RbcCT) or RBC 400 mg b.d. plus clarithromycin 500 mg b.d. (RbcC) for 2 weeks. H. pylori infection was detected by CLO-test on antral biopsy and confirmed by histology on antral and corpus biopsies and by 13C-urea breath test (UBT). A further UBT was performed at least 4 weeks after the end of treatment to assess the H. pylori eradication. H. pylori eradication was calculated for an intention-to-treat (ITT) population (all H. pylori-positive patients who received at least one treatment dose) and for an all-patients-treated (APT) population (patients of the ITT population assessed for H. pylori at least 4 weeks after the end of treatment).
Two hundred and ninety-five patients (142 males, 153 females, mean age 48 years) were recruited to the study. Of these, 239 had H. pylori infection confirmed by all three tests required by the protocol. The two treatment groups were similar with respect to all the demographic data. H. pylori ITT eradication rates were 85% (104/123) for RbcCT and 67% (78/116) for RbcC. APT eradication rates were 92% (104/113) for RbcCT and 76% (78/103) for RbcC. A significant statistical difference was found between the two treatments, irrespective of the population analysis (P = 0.001). Adverse events occurred in 7% of patients on RbcCT and in 13% on RbcC. No serious adverse events were reported.
The 1-week treatment with RBC plus clarithromycin and tinidazole yielded higher eradication rates than the 2-week treatment with RBC plus clarithomycin. Both treatments were well tolerated.
枸橼酸铋雷尼替丁（RBC）与克拉霉素联合使用2周已被证明对根除幽门螺杆菌有效。此外，多项研究报告了RBC加两种抗生素治疗1周的幽门螺杆菌根除率良好。
比较两种不同的RBC联合用药方案的幽门螺杆菌根除率和安全性。
因上消化道症状接受内镜检查的患者被随机分为开放治疗组，一组接受RBC 400mg，每日2次，加克拉霉素250mg，每日2次和替硝唑500mg，每日2次，治疗1周（RbcCT）；另一组接受RBC 400mg，每日2次，加克拉霉素500mg，每日2次（RbcC），治疗2周。通过对胃窦活检进行CLO试验检测幽门螺杆菌感染，并通过胃窦和胃体活检的组织学检查以及13C-尿素呼气试验（UBT）进行确认。在治疗结束后至少4周进行进一步的UBT以评估幽门螺杆菌的根除情况。计算意向性治疗（ITT）人群（所有接受至少一剂治疗的幽门螺杆菌阳性患者）和所有接受治疗患者（APT）人群（ITT人群中在治疗结束后至少4周接受幽门螺杆菌评估的患者）的幽门螺杆菌根除率。
295名患者（142名男性，153名女性，平均年龄48岁）被纳入研究。其中，239名患者通过方案要求的所有三项检测确诊为幽门螺杆菌感染。两个治疗组在所有人口统计学数据方面相似。RbcCT组的幽门螺杆菌ITT根除率为85%（104/123），RbcC组为67%（78/116）。RbcCT组的APT根除率为92%（104/113），RbcC组为76%（78/103）。两种治疗之间存在显著的统计学差异，无论人群分析如何（P = 0.001）。RbcCT组7%的患者和RbcC组13%的患者发生了不良事件。未报告严重不良事件。
RBC联合克拉霉素和替硝唑治疗1周的根除率高于RBC联合克拉霉素治疗2周。两种治疗耐受性均良好。
