Department of Tropical Medicine & Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.
Department of Microbiology, Faculty of Medicine, Tanta University, Tanta, Egypt.
Helicobacter. 2017 Oct;22(5). doi: 10.1111/hel.12395. Epub 2017 May 19.
Helicobacter pylori infection has become more and more resistant to conventional first-line treatment regimens. So, there is a considerable interest in evaluating new antibiotic combinations and regimens. Nitazoxanide is an anti-infective drug with demonstrated activity against protozoa and anaerobic bacteria including H. pylori. This work is designed to evaluate the efficacy and safety of a unique triple nitazoxanide-containing regimen as a treatment regimen in Egyptian patients with H. pylori infection.
Two hundred and 24 patients with upper gastrointestinal tract (GIT) dyspeptic symptoms in whom H. pylori -induced GIT disease was confirmed were included in the study. They have been randomized to receive either nitazoxanide 500 mg b.i.d., clarithromycin 500 mg b.i.d., and omeprazole 40 mg twice daily for 14 days or metronidazole 500 mg b.i.d., clarithromycin 500 mg b.i.d., and omeprazole 40 mg twice daily for 14 days. Laboratory evaluation for H. pylori antigen within the stool was performed 6 weeks after cessation of H. pylori treatment regimens to assess the response.
The response to treatment was significantly higher in group 1 of nitazoxanide treatment regimen than group 2 of traditional treatment regimen. One hundred and six cases (94.6%) of 112 patients who completed the study in group 1 showed complete cure, while only 63 cases (60.6%) of 104 patients who completed the study in group 2 showed the same response according to per-protocol (PP) analysis (P<.001). The regimen was well tolerated by all the patients enrolled in the study.
Nitazoxanide-containing triple therapy is a promising therapy for the first-line eradication of H. pylori. (ClinicalTrials.gov Identifier: NCT02422706).
幽门螺杆菌感染对抗生素常规一线治疗方案的耐药性越来越强。因此，人们对评估新的抗生素组合和方案产生了浓厚的兴趣。硝唑尼特是一种抗感染药物，已被证明对原生动物和包括幽门螺杆菌在内的厌氧菌具有活性。本研究旨在评估一种独特的包含硝唑尼特的三联疗法作为治疗埃及幽门螺杆菌感染患者的治疗方案的疗效和安全性。
224 例上胃肠道（GI）消化不良症状患者，经证实存在幽门螺杆菌引起的 GI 疾病，被纳入本研究。他们被随机分为两组，分别接受硝唑尼特 500mg 每日 2 次、克拉霉素 500mg 每日 2 次和奥美拉唑 40mg 每日 2 次治疗 14 天，或甲硝唑 500mg 每日 2 次、克拉霉素 500mg 每日 2 次和奥美拉唑 40mg 每日 2 次治疗 14 天。在停止幽门螺杆菌治疗方案后 6 周，通过粪便中幽门螺杆菌抗原的实验室评估来评估反应。
硝唑尼特治疗组的治疗反应明显高于传统治疗组。在完成研究的 112 例患者中，有 106 例（94.6%）完全治愈，而在完成研究的 104 例患者中，只有 63 例（60.6%）在按方案（PP）分析时显示出相同的反应（P<.001）。所有入组患者均能耐受该方案。
硝唑尼特三联疗法是一种有前途的一线幽门螺杆菌根除疗法。（临床试验标识符：NCT02422706）。
