Moubri Mostefa, Kalach Nicolas, Larras Rezki, Berrah Hassina, Mouffok Fouzia, Guechi Zhor, Cadranel Samy
Department of Paediatrics, Hospital N. Hamoud, CHU Hussein-Dey, Algiers, Algeria (Mostefa Moubri, Hassina Berrah).
Laboratoire Algérien de Recherche sur Helicobacter (LARH), Algiers, Algeria (Mostafa Moubri, Rezki Larras, Hassina Berrah, Fouzia Mouffok, Zhor Guechi).
Ann Gastroenterol. 2019 Jan-Feb;32(1):60-66. doi: 10.20524/aog.2018.0317. Epub 2018 Oct 3.
() infection is acquired in early life and continues to have a high prevalence, especially in developing countries. Growing antibiotic-resistant strains necessitate adapted treatments. This study aimed to compare the efficacy, side effects, and influence of resistance of strains between two different treatments.
This prospective, randomized blind study enrolled 112 symptomatic children infected with (66 girls, mean age 11.1 years). Treatments, allocated randomly irrespective of the susceptibility of the strains, were either the standard omeprazole-amoxicillin-clarithromycin combination for 7 days (OAC7; group A) or omeprazole-amoxicillin with a higher dose of metronidazole (40 instead of 20 mg/kg/d) for 10 days (OAM10; group B).
Before treatment, the resistance rates of strains to metronidazole or clarithromycin were 37% and 13%, respectively, with 7% resistant to both antibiotics and neither to amoxicillin. Eradication rates obtained with OAM10 (80% by intention-to-treat [ITT] and 88% by per protocol [PP] analysis) were higher than with OAC7 (68% in ITT and 71% PP) and the differences (12% in ITT and 17% PP) were statistically significant (P=0.03). Successful treatments with OAM10 were obtained in metronidazole resistant strains and were more effective in children aged >10 years (P=0.02 by ITT and P=0.04 by PP). Only light or moderate side effects, mainly digestive, were observed.
Because of its therapeutic efficacy, good tolerance and lower cost the OAM10 can be considered as an appropriate first-line therapeutic scheme in Algeria.
()感染在儿童早期获得且患病率持续居高不下,尤其是在发展中国家。不断增加的抗生素耐药菌株需要采用适应性治疗方法。本研究旨在比较两种不同治疗方法对菌株的疗效、副作用及耐药性影响。
本前瞻性、随机双盲研究纳入了112例有症状的()感染儿童(66例女孩,平均年龄11.1岁)。治疗方案随机分配,不考虑菌株的药敏情况,要么采用标准的奥美拉唑 - 阿莫西林 - 克拉霉素联合用药7天(OAC7;A组),要么采用奥美拉唑 - 阿莫西林联合高剂量甲硝唑(40 mg/kg/d而非20 mg/kg/d)用药10天(OAM10;B组)。
治疗前,菌株对甲硝唑或克拉霉素的耐药率分别为37%和13%,7%对两种抗生素均耐药,对阿莫西林均不耐药。OAM10组的根除率(意向性分析[ITT]为80%,符合方案分析[PP]为88%)高于OAC7组(ITT为68%,PP为71%),差异(ITT为12%,PP为17%)具有统计学意义(P = 0.03)。OAM10在甲硝唑耐药菌株中治疗成功,且对10岁以上儿童更有效(ITT分析P = 0.02,PP分析P = 0.04)。仅观察到轻度或中度副作用,主要为消化系统副作用。
鉴于其治疗效果、良好耐受性及较低成本,OAM10可被视为阿尔及利亚合适的一线治疗方案。