Bazzoli F, Zagari R M, Pozzato P, Fossi S, Ricciardiello L, Nicolini G, De Luca L, Berretti D, Alampi G, Di Pietro C, Morelli P, Roda E
Dipartimento di Medicina Interna e Gastroenterologia, Università degli Studi di Bologna, Italy.
Aliment Pharmacol Ther. 2002 Jan;16(1):153-8. doi: 10.1046/j.1365-2036.2002.01141.x.
To compare, in a randomized controlled trial, the efficacy and tolerability of two 1-week triple therapies for Helicobacter pylori eradication.
One hundred and thirty-four consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive lansoprazole 30 mg once daily, clarithromycin 250 mg twice daily, and metronidazole 500 mg twice daily (LCM group), or lansoprazole 30 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1000 mg twice daily (LCA group). H. pylori status was assessed by rapid urease test, histology and 13C-urea breath test before and after therapy.
At 3 months, H. pylori eradication (intention- to-treat/per protocol analysis) was 92.4%/93.8% in the LCM group and 83.1%/85.7% in the LCA group (P=N.S.). Side-effects were more frequently reported in the LCA group (37.9%) than in the LCM group (19.7%) (P < 0.05).
In this open, randomized controlled trial, eradication of H. pylori by low-dose lansoprazole and clarithromycin plus metronidazole was higher with significantly less side-effects than by full-dose lansoprazole and clarithromycin plus amoxicillin. This finding may be related to the stronger synergism of clarithromycin plus metronidazole, even at lower doses, than of clarithromycin plus amoxicillin. Considering the lower cost as well, LCM should be preferred to LCA in the eradication of H. pylori.
在一项随机对照试验中比较两种为期1周的三联疗法根除幽门螺杆菌的疗效和耐受性。
134例连续的非溃疡性消化不良且感染幽门螺杆菌的患者被随机分为两组,一组接受每日一次30mg兰索拉唑、每日两次250mg克拉霉素和每日两次500mg甲硝唑治疗(LCM组),另一组接受每日两次30mg兰索拉唑、每日两次500mg克拉霉素和每日两次1000mg阿莫西林治疗(LCA组)。在治疗前后通过快速尿素酶试验、组织学检查和13C尿素呼气试验评估幽门螺杆菌感染状况。
3个月时,LCM组幽门螺杆菌根除率(意向性分析/符合方案分析)为92.4%/93.8%,LCA组为83.1%/85.7%(P=无显著性差异)。LCA组(37.9%)比LCM组(19.7%)更频繁地报告有副作用(P<0.05)。
在这项开放性随机对照试验中,低剂量兰索拉唑、克拉霉素加甲硝唑根除幽门螺杆菌的效果优于全剂量兰索拉唑、克拉霉素加阿莫西林,且副作用明显更少。这一发现可能与克拉霉素加甲硝唑(即使是低剂量)比克拉霉素加阿莫西林具有更强的协同作用有关。考虑到成本较低,在根除幽门螺杆菌方面,LCM方案应优于LCA方案。