Bago Petra, Vcev Aleksandar, Tomic Monika, Rozankovic Marjan, Marusić Marinko, Bago Josip
Department of Gastroenterology, Internal Medicine Clinic, General Hospital Sveti Duh, Zagreb, Croatia.
Wien Klin Wochenschr. 2007;119(11-12):372-8. doi: 10.1007/s00508-007-0807-2.
Eradication of Helicobacter pylori remains a problematic treatment issue in clinical practice. The intention is to find a treatment that achieves a high rate of eradication at a low price and treatment options that are now used give us the opportunity to achieve this goal. Recently published results showing a low rate of resistance and better compliance with moxifloxacin-based treatment regimens indicate the need to investigate its efficacy in H. pylori eradication. This study is based on proving the efficacy of moxifloxacin in H. pylori eradication within the triple therapy.
The aim of the study was to compare the efficacy of one week of moxifloxacin-based treatment with the standard treatment for H. pylori eradication. Patients with H. pylori infection and non-ulcer dyspepsia (n = 277) were randomly divided into four groups to receive: moxifloxacin 400 mg/d, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (MML group); moxifloxacin 400 mg/d, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (MAL group); clarithromycin 500 mg twice daily, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (CML group); clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (CAL group). The patients were assessed for prevalence of H. pylori using the CLO test, histology and culture on gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomization and 4-6 weeks after completion of treatment. Bacterial sensitivity to clarithromycin and moxifloxacin was determined with the E-test.
265 (95.6%) patients completed the study forming the basis for PP analysis. Eradication rates of H. pylori in ITT and in PP analyses were: in the MML group 93.5% (58/62) and 96.7% (58/60), respectively; in the MAL group 86.4% (57/66) and 90.5% (57/63); in the CML group 70.4% (50/71) and 75.8% (50/66); and in the CAL group 78.2% (61/78) and 80.2% (61/76). Moxifloxacin treatment protocols were significantly more effective on both ITT and PP analyses than the clarithromycin based protocols with only one exception (MAL vs. CAL on ITT analysis). Among 238 patients (86% of the entire study group), strains showing primary resistance to clarithromycin were found in 10.8% and to moxifloxacin in 5.9%. Eradication of moxifloxacin sensitive/resistant strains was 98.1%/75% for MML (p < 0.01) and 91.1%/66.7% for MAL (p = n.s.); comparison of eradication of sensitive strains in MML and MAL regimens was 98.1%/91.1% (p < 0.05), and for resistant strains 75%/66.7% (p = n.s.). CML and CAL protocols did not differ in efficacy of eradication of clarithromycin sensitive or resistant strains.
Moxifloxacin-based triple therapies showed higher eradication rates with few side effects and good drug compliance when compared with standard H. pylori treatments. Moreover, the increased prevalence of clarithromycin resistance suggests that moxifloxacin-based regimens could be safe and effective options in treatment of H. pylori infection.
在临床实践中，根除幽门螺杆菌仍然是一个棘手的治疗问题。我们的目的是找到一种价格低廉且根除率高的治疗方法，而目前使用的治疗方案为我们实现这一目标提供了机会。最近发表的结果显示，基于莫西沙星的治疗方案耐药率低且依从性更好，这表明有必要研究其在根除幽门螺杆菌方面的疗效。本研究旨在证明莫西沙星在三联疗法中根除幽门螺杆菌的疗效。
本研究的目的是比较基于莫西沙星的一周治疗方案与幽门螺杆菌根除标准治疗方案的疗效。幽门螺杆菌感染且患有非溃疡性消化不良的患者（n = 277）被随机分为四组，接受以下治疗：莫西沙星400 mg/天、甲硝唑400 mg每日两次、兰索拉唑30 mg每日两次（MML组）；莫西沙星400 mg/天、阿莫西林1 g每日两次、兰索拉唑30 mg每日两次（MAL组）；克拉霉素500 mg每日两次、甲硝唑400 mg每日两次、兰索拉唑30 mg每日两次（CML组）；克拉霉素500 mg每日两次、阿莫西林1 g每日两次、兰索拉唑30 mg每日两次（CAL组）。在随机分组前及治疗结束后4 - 6周，通过上消化道内镜检查获取胃活检样本，采用CLO试验、组织学和培养方法评估患者幽门螺杆菌的感染情况。使用E试验测定细菌对克拉霉素和莫西沙星的敏感性。
265名（95.6%）患者完成了研究，构成了符合方案分析的基础。意向性分析（ITT）和符合方案分析（PP）中幽门螺杆菌的根除率分别为：MML组93.5%（58/62）和96.7%（58/60）；MAL组86.4%（57/66）和90.5%（57/63）；CML组70.4%（50/71）和75.8%（50/66）；CAL组78.2%（61/78）和80.2%（61/76）。在ITT和PP分析中，基于莫西沙星的治疗方案均比基于克拉霉素的方案显著更有效，只有一个例外（ITT分析中MAL组与CAL组相比）。在238名患者（占整个研究组的86%）中，发现对克拉霉素原发耐药的菌株占10.8%，对莫西沙星原发耐药的菌株占5.9%。MML组中对莫西沙星敏感/耐药菌株的根除率分别为98.1%/75%（p < 0.01），MAL组为91.1%/66.7%（p = 无显著性差异）；MML组和MAL组敏感菌株根除率的比较为98.1%/91.1%（p < 0.05），耐药菌株为75%/66.7%（p = 无显著性差异）。CML组和CAL组在根除克拉霉素敏感或耐药菌株的疗效上没有差异。
与幽门螺杆菌标准治疗相比，基于莫西沙星的三联疗法显示出更高的根除率，副作用少且药物依从性好。此外，克拉霉素耐药率的增加表明，基于莫西沙星的治疗方案可能是治疗幽门螺杆菌感染安全有效的选择。
