Song Zhi Qiang, Zhou Li Ya
Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
J Dig Dis. 2016 Apr;17(4):260-7. doi: 10.1111/1751-2980.12334.
Whether minocycline can replace tetracycline in Helicobacter pylori (H. pylori) eradication remains unclear. The aim of this study was to determine the efficacy, safety, patient compliance and risk factors of a combination regimen of esomeprazole, minocycline, metronidazole and bismuth (EMMB) for H. pylori eradication.
In this prospective single-center study, 152 patients in the first-line therapy group and 64 in the second-line therapy group received EMMB therapy (esomeprazole 20 mg twice daily, minocycline 100 mg twice daily, metronidazole 400 mg four times daily and bismuth potassium citrate 110 mg four times daily) for 14 days. The eradication outcome was assessed by (13) C-urea breath test 6-12 weeks after treatment.
EMMB therapy achieved eradication rates of 85.5% [95% confidence interval (CI) 79.6-91.4%] using intention-to-treat (ITT) analysis, 90.3% (95% CI 84.7-95.1%) using modified intention-to-treat (mITT) analysis and 92.6% (95% CI 88.1-96.3%) using per-protocol (PP) analysis as the first-line therapy; and 82.8% (95% CI 71.9-90.6%), 86.9% (95% CI 77.1-95.1%) and 89.5% (95% CI 80.7-96.5%) as the second-line therapy, respectively. In the first-line group, 35.6% of the patients experienced adverse effects, 4.7% discontinued medications because of adverse effects and good compliance was achieved in 91.3%, while the results were 36.5%, 3.2% and 90.5% in the second-line therapy group. Poor compliance was identified as an independent predictor of treatment failure.
The efficacy of EMMB therapy for H. pylori eradication as first-line and second-line regimens in a region with high rates of antibiotic resistance is satisfactory with relatively good patient compliance and high safety.
米诺环素是否能替代四环素用于根除幽门螺杆菌(H. pylori)仍不明确。本研究旨在确定埃索美拉唑、米诺环素、甲硝唑和铋剂(EMMB)联合方案用于根除H. pylori的疗效、安全性、患者依从性及危险因素。
在这项前瞻性单中心研究中,一线治疗组的152例患者和二线治疗组的64例患者接受EMMB治疗(埃索美拉唑20 mg,每日2次;米诺环素100 mg,每日2次;甲硝唑400 mg,每日4次;枸橼酸铋钾110 mg,每日4次),疗程为14天。治疗6 - 12周后通过¹³C - 尿素呼气试验评估根除结果。
采用意向性分析(ITT),EMMB治疗作为一线治疗时根除率为85.5%[95%置信区间(CI)79.6 - 91.4%],采用改良意向性分析(mITT)时为90.3%(95% CI 84.7 - 95.1%),采用符合方案分析(PP)时为92.6%(95% CI 88.1 - 96.3%);作为二线治疗时根除率分别为82.8%(95% CI 71.9 - 90.6%)、86.9%(95% CI 77.1 - 95.1%)和89.5%(95% CI 80.7 - 96.5%)。在一线治疗组中,35.6%的患者出现不良反应,4.7%因不良反应停药,91.3%的患者依从性良好;而二线治疗组的相应结果分别为36.5%、3.2%和90.5%。依从性差被确定为治疗失败的独立预测因素。
在抗生素耐药率较高的地区,EMMB治疗作为一线和二线方案根除H. pylori的疗效令人满意,患者依从性相对较好,安全性高。