Wu D C, Hsu P I, Chen A, Lai K H, Tsay F W, Wu C J, Lo G H, Wu J Y, Wu I C, Wang W M, Tseng H H
Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Eur J Clin Invest. 2006 Nov;36(11):803-9. doi: 10.1111/j.1365-2362.2006.01725.x.
Bismuth salts are not available worldwide. It remains unknown whether clarithromycin can replace bismuth salts as an adjuvant agent in the rescue regimens for Helicobacter pylori infection. We therefore designed the prospective study to compare the efficacies of two rescue therapies for H. pylori infection after standard triple therapies.
Ninety-three patients who failed H. pylori eradication using proton pump inhibitor plus clarithromycin and amoxicillin were randomly assigned to undergo rescue therapy with esomeprazole, clarithromycin, tetracycline and metronidazole (ECTM group, n = 46) or esomeprazole, bismuth subcitrate, tetracycline and metronidazole (EBTM group, n = 47). Follow-up endoscopy was performed at 8 weeks after the end of treatment to assess the treatment response.
Intention-to-treat analysis demonstrated both groups had similar eradication rates (ECTM 74% vs. EBTM 77%; P = 0.76) and drug compliance (ECTM 94% vs. EBTM 96%; P = 0.68). However, the frequency of adverse events in the ECTM group was higher than that in EBTM group (ECTM 57% vs. EBTM 36%, P = 0.05). In the EBTM group, eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (67%[8/12] vs. 100%[9/9], P = 0.05). However, eradication rates were similar between metronidazole-susceptible and metronidazole-resistant strains in ECTM group (69%[9/13] vs. 70%[7/10], P = 1.00).
The new ECTM second-line therapy can achieve similar eradication rate as standard EBTM therapy. It may be very useful in countries where bismuth salts are not available.
铋盐在全球并非都可获得。目前尚不清楚克拉霉素是否能替代铋盐作为幽门螺杆菌感染挽救治疗方案中的辅助药物。因此，我们设计了这项前瞻性研究，以比较标准三联疗法后两种幽门螺杆菌感染挽救治疗的疗效。
93例使用质子泵抑制剂加克拉霉素和阿莫西林根除幽门螺杆菌失败的患者被随机分配接受埃索美拉唑、克拉霉素、四环素和甲硝唑的挽救治疗（ECTM组，n = 46）或埃索美拉唑、枸橼酸铋钾、四环素和甲硝唑的挽救治疗（EBTM组，n = 47）。治疗结束后8周进行随访内镜检查以评估治疗反应。
意向性分析表明，两组的根除率相似（ECTM组为74%，EBTM组为77%；P = 0.76），药物依从性也相似（ECTM组为94%，EBTM组为96%；P = 0.68）。然而，ECTM组的不良事件发生率高于EBTM组（ECTM组为57%，EBTM组为36%，P = 0.05）。在EBTM组中，甲硝唑耐药菌株的根除率低于甲硝唑敏感菌株（67%[8/12]对100%[9/9]，P = 0.05）。然而，ECTM组中甲硝唑敏感和耐药菌株的根除率相似（69%[9/13]对70%[7/10]，P = 1.00）。
新的ECTM二线疗法可达到与标准EBTM疗法相似的根除率。在无法获得铋盐的国家，它可能非常有用。
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