难治性癫痫（1 ~ 10岁）全营养配方食品临床试验技术指导原则（草案）_Journal of Epilepsy

Authors：

 中国抗癫痫协会生酮饮食专业委员会

执笔操德智^#（深圳市儿童医院），叶园珍^#（深圳市儿童医院），孙丹^#（武汉儿童医院），张捷^#（北京大学第一医院），刘智胜（武汉儿童医院），张月华（北京大学第一医院），姜玉武（北京大学第一医院），杨光（解放军总医院第一医学中心），邹丽萍（解放军总医院第一医学中心），杨志仙（北京大学人民医院），吉萍（深圳北京大学香港科技大学医学中心），伍焰冰（深圳市儿童医院），秦炯（北京大学人民医院），廖建湘（深圳市儿童医院）;

Corresponding author：

中国抗癫痫协会生酮饮食专业委员会, Email: qinjiong@263.net

Keywords：

DOI：

10.7507/2096-0247.202403011

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Citation： 中国抗癫痫协会生酮饮食专业委员会. 难治性癫痫（1 ~ 10岁）全营养配方食品临床试验技术指导原则（草案）. Journal of Epilepsy, 2024, 10(3): 211-215. doi: 10.7507/2096-0247.202403011 Copy

1.	廖建湘. 生酮饮食疗法的临床方案. 中华实用儿科临床杂志, 2013, 28(12): 881-883.
2.	中华医学会儿科学分会神经学组, 中国抗癫痫协会, 中华儿科杂志编辑委员会. 生酮饮食疗法在癫痫及相关神经系统疾病中的应用专家共识. 中华儿科杂志, 2019, 57(11): 820-825.
3.	肿瘤全营养配方食品临床试验技术指导原则. 肿瘤代谢与营养电子杂志, 2019, 6(4): 427-429.肿瘤全营养配方食品临床试验技术指导原则. 肿瘤代谢与营养电子杂志, 2019, 6(4): 427-429.
4.	国家市场监督管理总局规章. 特殊医学用途配方食品注册管理办法. https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_9b1a9daffc084d819bb4d7a31d909452.html.
5.	国家市场监督管理总局行政规范性文件. 关于发布特殊医学用途配方食品临床试验质量管理规范(试行)的公告. https://www.samr.gov.cn/zw/zfxxgk/zc/xzgfxwj/art/2020/art_8973ef7fe4db438791cbb7520de7df61.html.
6.	食品药品监管总局(2016年第48号). 儿科人群药物临床试验技术指导原则. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20160307164401912.html.
7.	Jiang W, Liao J, Zhou D, et al. Ketogenic diet therapy for epilepsy: past 100 years of practice. Acta Epileptologica, 2022, 15(4): 1-4.
8.	Kwon HE, Kim HD. Recent aspects of ketogenic diet in neurological disorders. Acta Epileptologica, 2021, 21(3): 1-7.
9.	Ye Y, Sun D, Li H, et al. A multicenter retrospective cohort study of ketogenic diet therapy in 481 children with infantile spasms. Acta Epileptologica, 2022, 1(4): 1-8.
10.	Dou X, Wang Z, Li X, et al. Efficacy and tolerability of ketogenic diet therapy in 55 Chinese children with drug-resistant epilepsy in Northwest China. Acta Epileptologica, 2022, 10(4): 1-7.
11.	Trinka E, Cock H, Hesdorffer D, et al. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia, 2015, 56(10): 1515-1523.
12.	Tong X, Cai Q, Cao D, et al. Chinese expert recommendations on ketogenic diet therapy for super-refractory status epilepticus. Acta Epileptologica, 2022, 8(4): 1-11.
13.	Wang X, Gao X, Lu G, et al. The ketogenic diet for paediatric patients with super-refractory status epilepticus in febrile infection-related epilepsy syndrome. Acta Epileptologica, 2020, 4(2): 1-7.
14.	Zeng Y, Mu J, Zhou D. Calculation and management of ketogenic diet parenteral nutrition in super-refractory status epilepticus. Acta Epileptologica, 2022, 32(4): 1-9.
15.	Cai M, Xu W, Zheng Y, et al. Ketogenic dietary therapy in adult status epilepticus: current progress and clinical application. Acta Epileptologica, 2022, 16(4): 1-7.
16.	Kossoff EH, Zupec-Kania BA, Auvin S, et al. Optimal clinical management of children receiving dietary therapies for epilepsy: Updated recommendations of the International Ketogenic Diet Study Group. Epilepsia Open, 2018, 3(2): 175-192.
17.	Kossoff EH, Al-Macki N, Cervenka MC, et al. What are the minimum requirements for ketogenic diet services in resource-limited regions? Recommendations from the International League Against Epilepsy Task Force for Dietary Therapy. Epilepsia, 2015, 56(9): 1337-1342.
18.	Kaul N, Nicolo JP, O’Brien TJ, et al. Practical considerations of dietary therapies for epilepsy in adults. Acta Epileptologica, 2021, 16(3): 1-7.
19.	Neal EG, Chaffe H, Schwartz RH, et al. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol, 2008, 7(6): 500-506.
20.	Schoeler NE, Marston L, Lyons L, et al. Classic ketogenic diet versus further antiseizure medicine in infants with drug-resistant epilepsy (KIWE): a UK, multicentre, open-label, randomised clinical trial. Lancet Neurol, 2023, 22(12): 1113-1124.
21.	Manral M, Dwivedi R, Gulati S, et al. Safety, efficacy, and tolerability of modified atkins diet in persons with drug-resistant epilepsy: a randomized controlled trial. Neurology, 2023, 100(13): e1376-e1385.

1. 廖建湘. 生酮饮食疗法的临床方案. 中华实用儿科临床杂志, 2013, 28(12): 881-883.
2. 中华医学会儿科学分会神经学组, 中国抗癫痫协会, 中华儿科杂志编辑委员会. 生酮饮食疗法在癫痫及相关神经系统疾病中的应用专家共识. 中华儿科杂志, 2019, 57(11): 820-825.
3. 肿瘤全营养配方食品临床试验技术指导原则. 肿瘤代谢与营养电子杂志, 2019, 6(4): 427-429.肿瘤全营养配方食品临床试验技术指导原则. 肿瘤代谢与营养电子杂志, 2019, 6(4): 427-429.
4. 国家市场监督管理总局规章. 特殊医学用途配方食品注册管理办法. https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_9b1a9daffc084d819bb4d7a31d909452.html.
5. 国家市场监督管理总局行政规范性文件. 关于发布特殊医学用途配方食品临床试验质量管理规范(试行)的公告. https://www.samr.gov.cn/zw/zfxxgk/zc/xzgfxwj/art/2020/art_8973ef7fe4db438791cbb7520de7df61.html.
6. 食品药品监管总局(2016年第48号). 儿科人群药物临床试验技术指导原则. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20160307164401912.html.
7. Jiang W, Liao J, Zhou D, et al. Ketogenic diet therapy for epilepsy: past 100 years of practice. Acta Epileptologica, 2022, 15(4): 1-4.
8. Kwon HE, Kim HD. Recent aspects of ketogenic diet in neurological disorders. Acta Epileptologica, 2021, 21(3): 1-7.
9. Ye Y, Sun D, Li H, et al. A multicenter retrospective cohort study of ketogenic diet therapy in 481 children with infantile spasms. Acta Epileptologica, 2022, 1(4): 1-8.
10. Dou X, Wang Z, Li X, et al. Efficacy and tolerability of ketogenic diet therapy in 55 Chinese children with drug-resistant epilepsy in Northwest China. Acta Epileptologica, 2022, 10(4): 1-7.
11. Trinka E, Cock H, Hesdorffer D, et al. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia, 2015, 56(10): 1515-1523.
12. Tong X, Cai Q, Cao D, et al. Chinese expert recommendations on ketogenic diet therapy for super-refractory status epilepticus. Acta Epileptologica, 2022, 8(4): 1-11.
13. Wang X, Gao X, Lu G, et al. The ketogenic diet for paediatric patients with super-refractory status epilepticus in febrile infection-related epilepsy syndrome. Acta Epileptologica, 2020, 4(2): 1-7.
14. Zeng Y, Mu J, Zhou D. Calculation and management of ketogenic diet parenteral nutrition in super-refractory status epilepticus. Acta Epileptologica, 2022, 32(4): 1-9.
15. Cai M, Xu W, Zheng Y, et al. Ketogenic dietary therapy in adult status epilepticus: current progress and clinical application. Acta Epileptologica, 2022, 16(4): 1-7.
16. Kossoff EH, Zupec-Kania BA, Auvin S, et al. Optimal clinical management of children receiving dietary therapies for epilepsy: Updated recommendations of the International Ketogenic Diet Study Group. Epilepsia Open, 2018, 3(2): 175-192.
17. Kossoff EH, Al-Macki N, Cervenka MC, et al. What are the minimum requirements for ketogenic diet services in resource-limited regions? Recommendations from the International League Against Epilepsy Task Force for Dietary Therapy. Epilepsia, 2015, 56(9): 1337-1342.
18. Kaul N, Nicolo JP, O’Brien TJ, et al. Practical considerations of dietary therapies for epilepsy in adults. Acta Epileptologica, 2021, 16(3): 1-7.
19. Neal EG, Chaffe H, Schwartz RH, et al. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol, 2008, 7(6): 500-506.
20. Schoeler NE, Marston L, Lyons L, et al. Classic ketogenic diet versus further antiseizure medicine in infants with drug-resistant epilepsy (KIWE): a UK, multicentre, open-label, randomised clinical trial. Lancet Neurol, 2023, 22(12): 1113-1124.
21. Manral M, Dwivedi R, Gulati S, et al. Safety, efficacy, and tolerability of modified atkins diet in persons with drug-resistant epilepsy: a randomized controlled trial. Neurology, 2023, 100(13): e1376-e1385.

Journal of Epilepsy

难治性癫痫（1 ~ 10岁）全营养配方食品临床试验技术指导原则（草案）

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