Mansour-Ghanaei Fariborz, Joukar Farahnaz, Naghipour Mohammad Reza, Forouhari Atena, Saadat Seyed Mohammad Seyed
Fariborz Mansour-Ghanaei, Division of Gastroenterology and Hepatology, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Guilan University of Medical Sciences, Rasht 41448-95655, Iran.
World J Gastroenterol. 2015 Jan 14;21(2):661-6. doi: 10.3748/wjg.v21.i2.661.
To determine the efficacy of two quintuple regimens for eradication of Helicobacter pylori (H. pylori) in patients who failed previous therapies.
This prospective, open-label, randomized controlled trial was a phase II study conducted from April 2011 to March 2012 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran. A total of 208 patients with dyspepsia who failed previous H. pylori eradication with a ten-day quadruple therapy were enrolled. A random block method was used to assign patients to one of two treatment groups. Patients in the first group were treated with 240 mg bismuth subcitrate, 20 mg omeprazole, 1000 mg amoxicillin, 500 mg clarithromycin and 500 mg tinidazole (BOACT group). Patients in the second group received a regimen containing 240 mg bismuth subcitrate, 20 mg omeprazole, 500 mg tetracycline, 500 mg metronidazole and 200 mg ofloxacin (BOTMO group). Both regimens were given twice daily for a duration of seven days. The eradication was confirmed by a (14)C urea breath test 12 wk after completion of therapy. Patient compliance and drug side effects were evaluated at the end of the treatment period. The success rates were calculated by intention-to-treat and per-protocol analyses.
A total of 205 patients completed the course of treatment, with three patients excluded due to drug intolerance. The mean age of patients did not differ between the BOACT and BOTMO groups (41.6 ± 12.2 years vs 39.6 ± 11.8 years), and no significant differences were found between the two groups in terms of age, sex, smoking habits or the initial eradication regimen. The intention-to-treat and per-protocol eradication rates were significantly higher in the BOTMO group (86.5%, 95%CI: 0.85-0.87 and 86.7%, 95%CI: 0.80-0.89, respectively) compared with the BOACT group (75.5%, 95%CI: 0.73-0.76 and 76%, 95%CI: 0.69-0.80, respectively) (P < 0.05). Univariate analyses for both groups did not show any association of sex, smoking and initial therapeutic regimen with eradiation rate (P > 0.05 for all). Significantly more patients experienced side effects in the BOACT group compared to the BOTMO group (77.4% vs 36.6%, P < 0.01). This difference was exemplified by increases in headache and taste disturbance (P < 0.05).
Quintuple therapy with a BOTMO regimen is an alternative second-line rescue therapy for Iranian patients with failed first-line eradication treatment of H. pylori.
确定两种五联疗法对先前治疗失败的幽门螺杆菌（H. pylori）感染患者的根除疗效。
这项前瞻性、开放标签、随机对照试验是一项II期研究，于2011年4月至2012年3月在伊朗拉什特的胃肠和肝病研究中心进行。共有208例消化不良患者入组，这些患者先前接受为期10天的四联疗法根除幽门螺杆菌失败。采用随机区组法将患者分配到两个治疗组之一。第一组患者接受240mg枸橼酸铋、20mg奥美拉唑、1000mg阿莫西林、500mg克拉霉素和500mg替硝唑治疗（BOACT组）。第二组患者接受含240mg枸橼酸铋、20mg奥美拉唑、500mg四环素、500mg甲硝唑和200mg氧氟沙星的治疗方案（BOTMO组）。两种方案均每日给药两次，疗程为7天。治疗结束12周后通过（14）C尿素呼气试验确认根除情况。在治疗期结束时评估患者的依从性和药物副作用。通过意向性分析和符合方案分析计算成功率。
共有205例患者完成治疗疗程，3例因药物不耐受被排除。BOACT组和BOTMO组患者的平均年龄无差异（分别为41.6±12.2岁和39.6±11.8岁），两组在年龄、性别、吸烟习惯或初始根除方案方面均未发现显著差异。与BOACT组（意向性分析和符合方案分析的根除率分别为75.5%，95%CI：0.73 - 0.76和76%，95%CI：0.69 - 0.80）相比，BOTMO组的意向性分析和符合方案分析的根除率显著更高（分别为86.5%，95%CI：0.85 - 0.87和86.7%，95%CI：0.80 - 0.89）（P<0.05）。两组的单因素分析均未显示性别、吸烟和初始治疗方案与根除率有任何关联（所有P>0.05）。与BOTMO组相比，BOACT组有更多患者出现副作用（77.4%对36.6%，P<0.01）。这种差异在头痛和味觉障碍的增加方面得到体现（P<0.05）。
对于伊朗幽门螺杆菌一线根除治疗失败的患者，BOTMO方案的五联疗法是一种替代性的二线挽救疗法。
