治疗幽门螺杆菌感染对耐药性特发性全身性癫痫患儿癫痫发作频率的疗效：一项随机对照试验。

Efficacy of treating Helicobacter pylori infection on seizure frequency in children with drug-resistant idiopathic generalized epilepsy: a randomized controlled trial.

作者信息

Mohamed Mostafa Ashry, Mahmoud Ekram A, Basily Mina S, Mohamed Montaser M, Ahmed Omar A A, Abdelkreem Elsayed

机构信息

Department of Pediatrics, Faculty of Medicine, Sohag University, Nasser City, Sohag, Egypt.

Department of Medical Microbiology and Immunology, Faculty of Medicine, Sohag University, Nasser City, Sohag, Egypt.

出版信息

Ital J Pediatr. 2025 Apr 17;51(1):121. doi: 10.1186/s13052-025-01956-2.

DOI:10.1186/s13052-025-01956-2

PMID:40247384

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12004564/

Abstract

BACKGROUND

Helicobacter pylori (H. pylori) causes chronic infection in more than half of the population worldwide. Accumulating body of evidence indicates the possible role of H. Pylori infection in extra-intestinal health problems, including epilepsy. This study aims to investigate the efficacy of treating H. pylori infection on seizure frequency among children with drug-resistant idiopathic generalized epilepsy (IGE).

METHODS

A parallel, two-arm, open-label, randomized controlled trial was conducted on 126 children with drug-resistant IGE and positive H. pylori stool antigen test who were randomly assigned to study and comparison groups in 1.2:1 ratio. Only the study group received H. pylori eradication therapy (esomeprazole, amoxicillin, and clarithromycin) for two weeks. The primary outcome was seizure improvement (≥ 50% seizure frequency reduction compared with baseline) after 2.5 months. Secondary outcomes were occurrence of status epilepticus, escalation of antiseizure medication (ASMs), and adverse effects. Outcomes between the two groups were compared using Chi-square/Fisher exact tests on an intention-to-treat principle. Logistic regression analysis was performed to investigate possible effects of baseline variables on primary outcome.

RESULTS

Seizure improvement occurred in 23 (33%) children in the study group compared with seven (12%) children in the comparison group (Risk ratio [RR] 2.7, 95% confidence interval [CI]: 1.3-5.9; p 0.006). The study group had lower occurrence of status epilepticus (2.9% vs. 14%; RR 0.21, 95%CI: 0.05-0.93; p 0.042) and lesser need for ASMs escalation (4.4% vs. 19.3%; RR 0.23, 95%CI: 0.07-0.77; p 0.010). Adverse effects were more frequent among subjects in the study group, including nausea (15.9% vs. 10.5%) vomiting (8.7% vs. 3.5%), diarrhea (11.6% vs. 5.3%), and skin rash (4.4% vs. 1.8%), but the differences were not statistically significant (p > 0.05). None of baseline participants' variables was significantly associated with the primary outcome.

CONCLUSION

Treating H. pylori infection may improve seizure control in children with drug-resistant IGE, but further studies are warranted to confirm our findings and explore mechanisms behind seizure improvement following H. pylori eradication therapy.

TRIAL REGISTRATION

Registered on www.

CLINICALTRIALS

gov (identifier: NCT05297695) on 17 March 2022. https://clinicaltrials.gov/study/NCT05297695 .

摘要

背景

幽门螺杆菌（H. pylori）在全球超过一半的人口中引起慢性感染。越来越多的证据表明，幽门螺杆菌感染在包括癫痫在内的肠道外健康问题中可能发挥作用。本研究旨在调查治疗幽门螺杆菌感染对耐药性特发性全身性癫痫（IGE）患儿癫痫发作频率的影响。

方法

对126例耐药性IGE且幽门螺杆菌粪便抗原检测呈阳性的患儿进行了一项平行、双臂、开放标签的随机对照试验，这些患儿以1.2:1的比例随机分配到研究组和对照组。只有研究组接受了为期两周的幽门螺杆菌根除治疗（埃索美拉唑、阿莫西林和克拉霉素）。主要结局是2.5个月后癫痫发作改善（与基线相比癫痫发作频率降低≥50%）。次要结局是癫痫持续状态的发生、抗癫痫药物（ASM）的升级以及不良反应。两组之间的结局根据意向性分析原则使用卡方检验/费舍尔精确检验进行比较。进行逻辑回归分析以研究基线变量对主要结局的可能影响。

结果

研究组中有23名（33%）患儿癫痫发作得到改善，而对照组中有7名（12%）患儿癫痫发作得到改善（风险比[RR]2.7，95%置信区间[CI]：1.3 - 5.9；p = 0.006）。研究组癫痫持续状态的发生率较低（2.9%对14%；RR 0.21，95%CI：0.05 - 0.93；p = 0.042），ASM升级的需求也较少（4.4%对19.3%；RR 0.23，95%CI：0.07 - 0.77；p = 0.010）。研究组受试者的不良反应更频繁，包括恶心（15.9%对10.5%）、呕吐（8.7%对3.5%）、腹泻（11.6%对5.3%）和皮疹（4.4%对1.8%），但差异无统计学意义（p > 0.05）。基线参与者的变量均与主要结局无显著关联有关。