Magaret N, Burm M, Faigel D, Kelly C, Peterson W, Fennerty M B
Department of Medicine, Sections of Gastroenterology, Oregon Health Sciences University, Portland, OR 97201, USA.
Dig Dis. 2001;19(2):174-8. doi: 10.1159/000050674.
BACKGROUND/AIM: 10-30% of the patients treated for Helicobacter pylori fail to clear the infection after initial therapy. Little is known as to the efficacy of retreatment regimens in these patients. Proton pump inhibitor (PPI) -based triple and quadruple therapies demonstrate efficacies of 80-90% as initial therapy for H. pylori infection, but whether these regimens are as effective when used for retreatment is unknown. The efficacy of a metronidazole-containing regimen in this situation is also unknown. Our aim was to compare the efficacy of a nonmetronidazole-containing PPI-based triple versus a PPI-based quadruple therapy containing metronidazole in patients failing previous H. pylori therapy.
48 patients were enrolled in this study at two sites after failure of previous H. pylori therapy as determined by a positive (14)C-urea breath test. Patients were stratified by prior treatment with a metronidazole-containing regimen and were then randomized to either lansoprazole (L) 30 mg twice daily, amoxycillin (A) 1,000 mg twice daily, and clarithromycin (C) 500 mg twice daily for 14 days (LAC) or L 30 mg four times daily, bismuth subsalicylate (B) 2 tablets four times daily, metronidazole (M) 250 mg four times daily and tetracycline (T) 250 mg four times daily for 14 days (LBMT). Side effects and compliance (pill count) were assessed at the completion of therapy. A repeat (14)C-urea breath test was performed 4 or more weeks after completion of therapy, and cure was defined as a negative test result.
48 patients (16 males and 32 females) were enrolled in this study. 20 patients received LAC (18 prior M), and 28 received LBMT (23 prior M). Per protocol and intention-to-treat efficacies were 82% (95% CI 64-100%) and 75% (95% CI 56-94%) for LAC and 80% (96% CI 64-96%) and 71% (95% CI 54-88%) for LBMT (p = 0.85 per protocol and p = 0.78 intention to treat between LAC and LBMT), respectively. The compliance (> or =80% of pills taken) was found to be 89% in both treatment groups. Side effects were noted in 84% for LAC and in 82% for LBMT, but were mild and did not cause discontinuation of therapy.
PPI-based triple and quadruple therapy with both LAC and LBMT are effective in retreating patients failing initial metronidazole-based H. pylori therapies. LAC was not statistically superior to LBMT as a 'retreatment' regimen in this clinical situation, but the small sample size and wide confidence limits do not preclude the possibility of a smaller but significant difference in efficacy between the regimens. To determine whether LAC or LBMT is as effective for retreating patients failing non-metronidazole-containing regimens requires further study.
背景/目的：接受幽门螺杆菌治疗的患者中，有10% - 30%在初始治疗后未能清除感染。对于这些患者再治疗方案的疗效知之甚少。基于质子泵抑制剂（PPI）的三联和四联疗法作为幽门螺杆菌感染的初始治疗，显示出80% - 90%的疗效，但这些方案用于再治疗时是否同样有效尚不清楚。含甲硝唑方案在这种情况下的疗效也不清楚。我们的目的是比较在既往幽门螺杆菌治疗失败的患者中，不含甲硝唑的基于PPI的三联疗法与含甲硝唑的基于PPI的四联疗法的疗效。
在两个研究地点，48例经（14）C - 尿素呼气试验证实既往幽门螺杆菌治疗失败的患者被纳入本研究。患者根据既往是否接受含甲硝唑方案进行分层，然后随机分为两组，一组接受兰索拉唑（L）30 mg每日两次、阿莫西林（A）1000 mg每日两次和克拉霉素（C）500 mg每日两次，共14天（LAC）；另一组接受兰索拉唑30 mg每日四次、次水杨酸铋（B）2片每日四次、甲硝唑（M）250 mg每日四次和四环素（T）250 mg每日四次，共14天（LBMT）。在治疗结束时评估副作用和依从性（服药计数）。在治疗结束4周或更长时间后进行重复（14）C - 尿素呼气试验，治愈定义为试验结果阴性。
本研究共纳入48例患者（16例男性和32例女性）。20例患者接受LAC治疗（18例既往接受过含M方案治疗），28例接受LBMT治疗（23例既往接受过含M方案治疗）。按方案分析和意向性分析，LAC组的疗效分别为82%（95%CI 64 - 100%）和75%（95%CI 56 - 94%），LBMT组分别为80%（96%CI 64 - 96%）和71%（95%CI 54 - 88%）（按方案分析时LAC与LBMT组比较，p = 0.85；意向性分析时，p = 0.78）。两个治疗组的依从性（服药≥80%）均为89%。LAC组84%的患者和LBMT组82%的患者出现副作用，但均较轻微，未导致治疗中断。
基于PPI的LAC三联疗法和LBMT四联疗法在对初始含甲硝唑的幽门螺杆菌治疗失败的患者进行再治疗时均有效。在这种临床情况下，作为“再治疗”方案，LAC在统计学上并不优于LBMT，但样本量小和置信区间宽并不能排除两种方案在疗效上存在较小但显著差异的可能性。要确定LAC或LBMT对不含甲硝唑方案治疗失败的患者进行再治疗时是否同样有效，还需要进一步研究。
