比较两种一周三联疗法根除幽门螺杆菌感染及治愈十二指肠溃疡的随机临床试验。

Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing.

作者信息

Forné M, Viver J M, Esteve M, Fernández-Bañares F, Lite J, Espinós J C, Quintana S, Salas A, Garau J

机构信息

Department of Gastroenterology, Hospital Mútua de Terrassa, University of Barcelona, Spain.

出版信息

Am J Gastroenterol. 1998 Jan;93(1):35-8. doi: 10.1111/j.1572-0241.1998.035_c.x.

DOI:10.1111/j.1572-0241.1998.035_c.x

PMID:9448170

Abstract

OBJECTIVE

One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing.

METHODS

On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment.

RESULTS

H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98).

CONCLUSIONS

High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.

摘要

目的

为期一周的三联疗法已被证明在根除幽门螺杆菌及治愈十二指肠溃疡方面有效。然而，最佳治疗组合尚未确定。含铋剂方案的优势在于仅需一种抗生素。有人提出高剂量奥美拉唑可提高抗菌方案对幽门螺杆菌的杀菌效果。我们评估了两种为期1周的三联疗法方案在根除幽门螺杆菌及治愈十二指肠溃疡方面的疗效。

方法

基于意向性分析，将182例幽门螺杆菌相关性十二指肠溃疡患者随机分组。OCB组（n = 91）患者接受奥美拉唑40毫克，每日2次，克拉霉素500毫克，每日2次，以及枸橼酸铋钾120毫克，每日4次，共7天。OCA组（n = 91）患者接受相同剂量的奥美拉唑和克拉霉素，加阿莫西林1克，每日2次，同样治疗7天。在入组时及治疗结束后第4周进行内镜检查。通过尿素酶试验、组织学检查、革兰氏染色及培养评估幽门螺杆菌的存在情况。无患者接受后续治疗。

结果

无论是在意向性分析中（82.4% 对88.9%；p = 0.21）还是按方案分析中（83.3% 对89.9%；p = 0.19），OCB组和OCA组的幽门螺杆菌根除率相似。在意向性分析（91.2% 对91.1%）和按方案分析（92.2% 对92.1%）中，OCB组和OCA组的十二指肠溃疡愈合率也相同（p = 0.98）。