难治性癫痫（1岁以内）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

执笔郁莉斐^#（复旦大学附属儿科医院），方方^#（首都医科大学附属北京儿童医院），钟建民^#（江西省儿童医院），李保敏^#（山东大学齐鲁医院），王艺（复旦大学附属儿科医院），廖建湘（深圳市儿童医院），邓劼（首都医科大学附属北京儿童医院），陈勇（江西省儿童医院），魏菊荣（深圳市儿童医院），王娟（重庆医科大学附属儿童医院），于美（深圳市儿童医院），王纪文（上海交通大学医学院附属上海儿童医学中心），周水珍（复旦大学附属儿科医院）;

Corresponding author：

中国抗癫痫协会生酮饮食专业委员会, Email: wangjiwen@scmc.com.cn

Keywords：

DOI：

10.7507/2096-0247.202403012

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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岁以内）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): 206-210. doi: 10.7507/2096-0247.202403012 Copy

1.	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.
2.	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.
3.	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.
4.	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.
5.	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.
6.	Kwon HE, Kim HD. Recent aspects of ketogenic diet in neurological disorders. Acta Epileptologica, 2021, 21(3): 1-7.
7.	Ye Y, Sun D, Li H, Zhong J, et al. A multicenter retrospective cohort study of ketogenic diet therapy in 481 children with infantile spasms. Acta Epileptologica, 2022, 1(4): 1-8.
8.	Riney K, Bogacz A, Somerville E, et al. International League Against Epilepsy classification and definition of epilepsy syndromes with onset at a variable age: position statement by the ILAE Task Force on Nosology and Definitions. Epilepsia, 2022, 63: 1443-1474.
9.	Zuberi S M, Wirrell E, Yozawitz E, et al. ILAE classification and definition of epilepsy syndromes with onset in neonates and infants: Position statement by the ILAE Task Force on Nosology and Definitions. Epilepsia, 2022, 63: 1349-1397.
10.	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.
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.	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.
13.	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.
14.	国家药监局关于发布体外诊断试剂临床试验技术指导原则的通告(2021年第72号).(nmpa. gov. cn).
15.	Elles Louw, Dorine Hurk , Elizabeth N, et al. Ketogenic diet guidelines for infants with refractory Epilepsy. European Journal of Paediatric Neurology, 2016, 20(6): 798-809.
16.	Dressler A, Trimmel-Schwahofer P. The ketogenic diet for infants: How long can you go?. Epilepsy Research, 2020, 164(1): 106339.
17.	Falsaperla R, Angelo G, Mauceri L. et al. Ketogenic diet for infants with epilepsy: a literature review. Epilepsy Behav, 2020, 112: 107361.
18.	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.
19.	Hulst J, Zwart H, Hop W, et al. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr, 2010, 29(1): 106-111.
20.	Engel J. Update on surgical treatment of the epilepsies. Summary of the second international palm desert conference on the surgical treatment of the epilepsies (1992). Neurology, 1993, 43(8): 1612-1617.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Kwon HE, Kim HD. Recent aspects of ketogenic diet in neurological disorders. Acta Epileptologica, 2021, 21(3): 1-7.
7. Ye Y, Sun D, Li H, Zhong J, et al. A multicenter retrospective cohort study of ketogenic diet therapy in 481 children with infantile spasms. Acta Epileptologica, 2022, 1(4): 1-8.
8. Riney K, Bogacz A, Somerville E, et al. International League Against Epilepsy classification and definition of epilepsy syndromes with onset at a variable age: position statement by the ILAE Task Force on Nosology and Definitions. Epilepsia, 2022, 63: 1443-1474.
9. Zuberi S M, Wirrell E, Yozawitz E, et al. ILAE classification and definition of epilepsy syndromes with onset in neonates and infants: Position statement by the ILAE Task Force on Nosology and Definitions. Epilepsia, 2022, 63: 1349-1397.
10. 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.
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. 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.
13. 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.
14. 国家药监局关于发布体外诊断试剂临床试验技术指导原则的通告(2021年第72号).(nmpa. gov. cn).
15. Elles Louw, Dorine Hurk , Elizabeth N, et al. Ketogenic diet guidelines for infants with refractory Epilepsy. European Journal of Paediatric Neurology, 2016, 20(6): 798-809.
16. Dressler A, Trimmel-Schwahofer P. The ketogenic diet for infants: How long can you go?. Epilepsy Research, 2020, 164(1): 106339.
17. Falsaperla R, Angelo G, Mauceri L. et al. Ketogenic diet for infants with epilepsy: a literature review. Epilepsy Behav, 2020, 112: 107361.
18. 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.
19. Hulst J, Zwart H, Hop W, et al. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr, 2010, 29(1): 106-111.
20. Engel J. Update on surgical treatment of the epilepsies. Summary of the second international palm desert conference on the surgical treatment of the epilepsies (1992). Neurology, 1993, 43(8): 1612-1617.

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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

难治性癫痫（1岁以内）全营养配方食品临床试验技术指导原则（草案）

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