Lee J M, Breslin N P, Hyde D K, Buckley M J, O'Morain C A
Department of Gastroenterology, Meath/Adelaide Hospitals, Trinity College, Dublin, Ireland.
Aliment Pharmacol Ther. 1999 Apr;13(4):489-96. doi: 10.1046/j.1365-2036.1999.00504.x.
The effectiveness of Helicobacter pylori eradication regimens has not been extensively investigated in the clinical practice setting. The optimal treatment choice after an initial failed eradication attempt has not been determined.
To evaluate proton pump inhibitor-based triple therapies as first-line eradication regimens in clinical practice, and to establish the efficacy of second-line regimens in the context of an initial failed eradication attempt.
Three hundred and eight patients with dyspepsia and evidence of H. pylori at endoscopy were recruited. As first-line therapy, 116 patients received omeprazole 20 mg b.d. in combination with amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. (OAC) while 192 patients received omeprazole 20 mg b.d. in combination with metronidazole 400 mg b.d. and clarithromycin 250 mg b.d. (OMC). H. pylori status was reassessed at least 4 weeks after therapy (25 patients failed to attend for further testing). Of 52 patients with an initial failed eradication attempt, 20 patients received a 1 week quadruple therapy regimen incorporating omeprazole 20 mg b.d., tripotassium dicitrato bismuthate 120 mg q.d.s., tetracycline 500 mg q.d.s. and metronidazole 400 mg t.d.s., 20 patients received a 2-week proton pump inhibitor-based triple therapy regimen as described, and 12 patients received a further 1-week proton pump inhibitor-based triple therapy regimen.
Including 308 patients, the intention-to-treat (ITT) eradication rates for OAC and OMC as first-line regimens were 72% (95% CI: 63-80%) and 73% (95% CI: 67-79%) respectively. A per protocol (PP) analysis on the 283 patients who completed follow-up gives an initial eradication rate of 78% (95% CI: 69-86%) for OAC and 79% (95% CI: 73-85%) for OMC. There were 60 patients (21%; 95% CI: 17-26%) in whom the initial eradication attempt was unsuccessful. With second-line therapy, H. pylori was successfully eradicated in a further 35/52 (67%; 95% CI: 58-73%) patients. The eradication rates with the quadruple regimen and 2-week triple therapy regimens were 75% (95% CI: 56-94%) and 80% (95% CI: 63-98%) respectively (P = 0. 71). The eradication rate with a repeat 1-week regimen was 33% (95% CI: 7-60%).
The eradication rates achieved in this 'in practice' study with recommended first-line 1-week proton pump inhibitor-based triple therapy regimens were lower than the rates achieved with similar regimens in the clinical trial setting. A repeat 1-week proton pump inhibitor-based triple therapy regimen was not successful as a salvage therapy. Both the 2-week proton pump inhibitor-based triple therapy regimen and the 1-week quadruple therapy regimen were successful second-line treatments in >/=75% of patients.
幽门螺杆菌根除方案的有效性在临床实践环境中尚未得到广泛研究。初次根除尝试失败后的最佳治疗选择尚未确定。
评估以质子泵抑制剂为基础的三联疗法作为临床实践中的一线根除方案，并确定在初次根除尝试失败的情况下二线方案的疗效。
招募了308例有消化不良症状且内镜检查有幽门螺杆菌感染证据的患者。作为一线治疗，116例患者接受奥美拉唑20mg，每日2次，联合阿莫西林1g，每日2次和克拉霉素500mg，每日2次（OAC），而192例患者接受奥美拉唑20mg，每日2次，联合甲硝唑400mg，每日2次和克拉霉素250mg，每日2次（OMC）。治疗至少4周后重新评估幽门螺杆菌感染状况（25例患者未参加进一步检测）。在52例初次根除尝试失败的患者中，20例患者接受了为期1周的四联疗法方案，包括奥美拉唑20mg，每日2次，枸橼酸铋钾120mg，每日4次，四环素500mg，每日4次和甲硝唑400mg，每日3次；20例患者接受了为期2周的上述以质子泵抑制剂为基础的三联疗法方案；12例患者接受了为期1周的再次以质子泵抑制剂为基础的三联疗法方案。
纳入308例患者，OAC和OMC作为一线方案的意向性治疗（ITT）根除率分别为72%（95%CI：63 - 80%）和73%（95%CI：67 - 79%）。对完成随访的283例患者进行的符合方案（PP）分析显示，OAC的初始根除率为78%（95%CI：69 - 86%），OMC为79%（95%CI：73 - �5%）。有60例患者（21%；95%CI：17 - 26%）初次根除尝试未成功。采用二线治疗，另外35/52（67%；95%CI：58 - 73%）例患者的幽门螺杆菌被成功根除。四联疗法方案和为期2周的三联疗法方案的根除率分别为75%（95%CI：56 - 94%）和80%（95%CI：63 - 98%）（P = 0.71）。再次为期1周方案的根除率为33%（95%CI：7 - 60%）。
在这项“实际应用”研究中，推荐的基于质子泵抑制剂的一线1周三联疗法方案所达到的根除率低于在临床试验环境中类似方案所达到的根除率。再次基于质子泵抑制剂的1周三联疗法方案作为挽救疗法未获成功。为期2周的基于质子泵抑制剂的三联疗法方案和为期1周的四联疗法方案在≥75%的患者中均为成功的二线治疗方案。
