脆弱拟杆菌(BF839)有效辅助治疗难治性癫痫：初步临床研究
【摘要】目的：寻找新方法治疗难治性癫痫。研究脆弱拟杆菌(BF839)辅助治疗难治性癫痫的有效性和安全性以及共患病的改善情况。方法：入组47例难治性癫痫患者，辅助添加BF839治疗。比较1-4月治疗期间每月(28天)癫痫发作频率相对于干预前基线的中位降低百分比；反应率(癫痫发作减少≥50％的患者比例)；干预12个月的无发作率和保留率，并初步观察副作用与共患病变化。结果：干预后1-4月包括所有类型的总发作频率月均中位降低百分比为-53.5%(P=0.002)，反应率为61.1%(22/36)；12月无发作率是8.5%(4/47)；12个月的保留率是57.4%(27/47)；副作用为腹泻4.3%(2/47)，便秘4.3%(2/47)；48.9%(23 /47)患者报告共患病好转，其中认知改善21.2% (10/47)。结论：脆弱拟杆菌(BF839) 可安全、有效辅助治疗难治性癫痫，还有利于共患病的改善，这是世界首次报道口服单一肠道菌株可能有效治疗难治性癫痫的研究，有重要意义。
邓宇虹1,2 林楚慧2 操德智3
1 广州医科大学附属第二医院神经科学研究所、神经内科，中国广东省和卫生部神经遗传和离子通道病重点实验室，广州市昌岗东路250号， 510260，中国
2广州医科大学附属第二医院 临床营养科，广州市昌岗东路250号， 510260，中国
3深圳市儿童医院癫痫中心，广东省深圳市福田区益田路7019号， 518026，中国
第一作者及通讯作者：邓宇虹 主任医师 研究方向：癫痫的生酮饮食、肠道微生态及临床营养免疫治疗。邮箱：1376708863@qq.com
联系电话：18926179290
关键词：癫痫；脆弱拟杆菌(BF839)；微生物群，自身免疫相关性癫痫
The beneficial effect of Bacteroides Fragilis (BF839) as a supplementary treatment in drug-resistant epilepsy: a pilot study
Yu-Hong DENG1,2 Chu-Hui LIN2
1 Institute of Neuroscience and Department of Neurology of the Second Affiliated Hospital of Guangzhou Medical University; Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou, 510260, China
2 Department of Clinical Nutrition ,The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510260, China
Corresponding author: Yu-Hong DENG，E-mail：1376708863@qq.com
【Abstract】Objective The purpose of this study was to find a new method for the treatment of drug-resistant epilepsy. Study the efficacy and safety of Bacteroides fragilis (BF839) in the adjunctive treatment of refractory epilepsy, as well as the improvement of comorbidity. Methods A prospective, single-arm, open, pilot clinical study using Bacteroides Fragilis 839 (BF839) in the additive treatment of drug-resistant epilepsy was designed. 47 patients with drug-resistant epilepsy were enrolled and treated with BF839. The primary efficacy endpoint was median percent reduction from baseline in monthly (28-day) seizure frequency for the 16-week treatment period. Other efficacy analyses included proportion of patients with ≥ 50% seizure reduction, proportion of patients seizure free and retention rate after12 months intervention, and the side effects and comorbidities were observed. Results The Median reduction percent of all seizure types was- 53.5% (P=0.002). 61.1%(22/36)of patients reduced seizures≥50%. 8.5%(4/47)patients seizure free at 12 months. The retention rate at 12 months was 57.4% (27/47). The side effects were diarrhea in 4.3% (2/47) and constipation in 4.3% (2/47).48.9% (23/47) of the patients reported improvement in comorbidities, with cognitive improvement of 21.2% (10/47).Conclusion BF839 can be used as an effective additive therapy to treat drug-resistant epilepsy , it is safe and beneficial to the improvement of comorbidities. This is the first time in the world that a single intestinal strain has been reported to be effective in treating drug-resistant epilepsy .This research has important implications.
【Keywords】：Epilepsy,Bacteroides Fragilis, microbiota, autoimmune-associated epilepsy
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