Clinical study on the treatment of refractory epilepsy in children by adding Chinese medicine_Journal of Epilepsy

Authors：

YAO Yanyang ¹ , ZHANG Jingwen ² , CHEN Zhihong ^1,2 ,  ZHAI Qiongxiang ² , SHI Gang’an ³ , LI Xueping ⁴

1. Department of Neurology, Guangdong Provincial People's Hospital, Southern Medical University, Guangzhou 519041, China;
2. Department of Neurology, Guangdong Provincial People's Hospital, Guangzhou 519041, China;
3. School of Medicine, South China University of Teconology, Guangzhou 511400, China;
4. Department of Neurology, Foshan Maternal and Child Health Care Hospital, Foshan 528000, China;

Corresponding?author：

ZHAI Qiongxiang, Email: zhaiqiongxiang@sina.com

Keywords：

Xiao’er kang xian capsule; Refractory epilepsy; Neuron specific enolase; Cludter of differentiation19⁺

DOI：

10.7507/2096-0247.202502015

Video：

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Objective To observe the clinical efficacy of Xiao’er kang xian capsule added to anti-seizure medications (ASMs) in the treatment of children with refractory epilepsy and its influence on serum neuron-specific enolase (NSE) and cludter of differentiation 19⁺ (CD19⁺) levels. Methods A total of 60 children with refractory epilepsy were selected from the pediatric outpatient department and ward of Guangdong Provincial People's Hospital from February 2021 to June 2023. The study subjects were divided into two groups by numerical random method,with 30 cases in each group. The children with Xiao’er kang xian capsule added to the original treatment were the treatment group and the children without Xiao’er kang xian capsule added to the original treatment were the control group. The frequency, duration, EEG characteristics, adverse reactions and changes in serum NSE and CD19⁺ levels of the two groups were compared after treatment. Results Self-control before and after treatment in the treatment group: the frequency and duration of seizures were significantly reduced, with statistical difference (P<0.05). EEG discharge index in awake period and sleep period were significantly decreased, with statistical difference (P<0.05). After 6 months of treatment, comparison between the two groups of children: the seizure frequency of children in the treatment group was significantly decreased compared with the control group (P=0.03). There was a statistical difference (P<0.05), and the seizure duration in the treatment group was less than that in the control group (P=0.863), the clinical effective rate of treatment group 83.33% was higher than that of control group 63.33% (P=0.08), the effective rate of EEG in treatment group 80% was higher than that of control group 60% (P=0.091), serum NSE and CD19⁺ in treatment group were lower than that of control group, with no statistical difference (P>0.05). After 12 months of treatment, the frequency and duration of seizures in the treatment group were significantly decreased (P<0.05). The clinical efficacy and effectiveness of treatment group were significantly higher than that of control group (P=0.038). The incidence of adverse reactions in both groups was 16.67% (P>0.05). The effective rate of EEG in treatment group was significantly higher than that in control group (P=0.053). Serum NSE and CD19⁺ in treatment group were significantly lower than those in control group (P<0.05). Conclusion For children with refractory epilepsy, the addition of Xiao’er kang xian capsule on the basis of the original treatment has obvious effect low adverse reaction and high safety. NSE and CD19⁺ can be used as monitoring indicators for the influence of the disease and prognosis evaluation during the treatment of children with epilepsy.

Citation： YAO Yanyang, ZHANG Jingwen, CHEN Zhihong, ZHAI Qiongxiang, SHI Gang’an, LI Xueping. Clinical study on the treatment of refractory epilepsy in children by adding Chinese medicine. Journal of Epilepsy, 2025, 11(3): 214-219. doi: 10.7507/2096-0247.202502015 Copy

1.	中國抗癲癇協會. 臨床診療指南: 癲癇病分冊. 北京: 人民衛生出版社, 2023.
2.	Song L, Liu F, Liu Y, et al. Clonazepam add-on therapy for refractory epilepsy in adults and children. Cochrane Database Syst Rev, 2018, 5(5): CD01 2253.
3.	張宇昕, 翟瓊香, 湯志鴻, 等. 左乙拉西坦添加治療小兒額葉癲癇: 附 105 例報告. 南方醫科大學學報, 2014, 34(3): 364-367.
4.	鄭筱萸. 中藥新藥臨床研究指導原則: 試行. 北京: 中國醫藥科技出版社, 2002.
5.	馬融, 李新民, 張德芹, 等. 小兒抗癇膠囊治療兒童癲癇及其神經生化機制的研究. 醫學研究雜志, 2 006, 35(9): 39-40.
6.	錢悠悠. 拉莫三嗪聯合小劑量丙戊酸鈉治療初診癲癇的療效及對神經認知功能的影響. 實用臨床醫藥雜志, 2020, 24(2): 80-82,86.
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10.	孫秋玲, 申興田, 董爭清, 等. 小兒抗癇膠囊聯合左乙拉西坦治療小兒癲癇伴智力低下療效及血清瘦素、白細胞介素6和胰島素樣生長因子1的影響. 實驗與檢驗醫學, 2019, 37(5): 944-947.
11.	盧俞任, 毛中臣. 小兒抗癇膠囊聯合奧卡西平治療小兒癲癇的療效觀察. 藥物評價研究, 2020, 43(2): 277-282.
12.	耿麗娟, 王葆輝, 張現娥, 等. 小兒抗癇膠囊聯合丙戊酸鈉治療兒童原發性全身強直– 陣攣發作型癲癇的臨床研究及其對GFAP、S100β水平的影響. 現代藥物與臨床, 2021, 36(5): 995-999.
13.	郭娜, 馬英, 王琳瑩, 等. 腦卒中患者血清 Hcy及NSE水平與癲癇發作的相關性研究. 現代檢驗醫學雜志, 2022, 37(1): 177-181.
14.	黎素清, 鄭鳳麗, 譚志軍, 等. 癲癇患兒血清及腦脊液 CRP、S100β、NSE 含量變化與臨床意義. 現代醫學與健康研究, 2020, 4(5): 84-85.
15.	ZhaoYL , Li JM, Fan Y, et al. Sodium valproate combined with levetiracetam in pediatric epilepsy and its influence on NSE, IL6, hsCRP and electroencephalogram improvement. Experimental And Therapeutic Medicine, 2020, 20: 2043-2048.
16.	Mu RZ, Liu S, Liang KG, et al. A meta-analysis of neuron-specifific enolase levels in cerebrospinal fluid and serum in children with epilepsy. Front Mol Neurosci, 2020, 10(13): 24.
17.	Hanak TJ, Libbey JE, Doty DJ, et al. Positive modulation of m GluR5 attenuates seizures and reduces TNF-a+macrophages and microglia in the brain in a murine model of virus-induced temporal lobe epilepsy. Exp l Neuro1, 2019, 311: 194-204.
18.	黃永洪, 康穎, 韓登科, 等. 125例癲癇患兒外周血B淋巴細胞、NK 細胞和NKT 細胞的檢測與分析. 國際檢驗醫學雜志, 2017, 38(27): 3286-3290.
19.	黎雪萍, 陳志紅. 小兒癲癇外周血淋巴細胞亞群水平的變化及其意義. 汕頭大學醫學院, 碩士學位論文, 2022.

1. 中國抗癲癇協會. 臨床診療指南: 癲癇病分冊. 北京: 人民衛生出版社, 2023.
2. Song L, Liu F, Liu Y, et al. Clonazepam add-on therapy for refractory epilepsy in adults and children. Cochrane Database Syst Rev, 2018, 5(5): CD01 2253.
3. 張宇昕, 翟瓊香, 湯志鴻, 等. 左乙拉西坦添加治療小兒額葉癲癇: 附 105 例報告. 南方醫科大學學報, 2014, 34(3): 364-367.
4. 鄭筱萸. 中藥新藥臨床研究指導原則: 試行. 北京: 中國醫藥科技出版社, 2002.
5. 馬融, 李新民, 張德芹, 等. 小兒抗癇膠囊治療兒童癲癇及其神經生化機制的研究. 醫學研究雜志, 2 006, 35(9): 39-40.
6. 錢悠悠. 拉莫三嗪聯合小劑量丙戊酸鈉治療初診癲癇的療效及對神經認知功能的影響. 實用臨床醫藥雜志, 2020, 24(2): 80-82,86.
7. Rigo JM, Hans G, Nguyen L, et al. The anti-epileptic drug levetiracetam reverses the inhibition by negative allosteric modulators of neuronal GABA- and glycine-gated currents. BriT J Pharmacol, 2002, 136(5): 659-672.
8. Preuss RGWT. OxcarbazepineIn: Stat Pearls. Treasure Island (FL): StatPearls Publishing, 2022.
9. 彭夢婕, 鄒建華. Development of overseas Chinese medicine and legislative status. World Journal of Integrated Traditional and Western Medicine, 2022, 5(6): 24-33.
10. 孫秋玲, 申興田, 董爭清, 等. 小兒抗癇膠囊聯合左乙拉西坦治療小兒癲癇伴智力低下療效及血清瘦素、白細胞介素6和胰島素樣生長因子1的影響. 實驗與檢驗醫學, 2019, 37(5): 944-947.
11. 盧俞任, 毛中臣. 小兒抗癇膠囊聯合奧卡西平治療小兒癲癇的療效觀察. 藥物評價研究, 2020, 43(2): 277-282.
12. 耿麗娟, 王葆輝, 張現娥, 等. 小兒抗癇膠囊聯合丙戊酸鈉治療兒童原發性全身強直– 陣攣發作型癲癇的臨床研究及其對GFAP、S100β水平的影響. 現代藥物與臨床, 2021, 36(5): 995-999.
13. 郭娜, 馬英, 王琳瑩, 等. 腦卒中患者血清 Hcy及NSE水平與癲癇發作的相關性研究. 現代檢驗醫學雜志, 2022, 37(1): 177-181.
14. 黎素清, 鄭鳳麗, 譚志軍, 等. 癲癇患兒血清及腦脊液 CRP、S100β、NSE 含量變化與臨床意義. 現代醫學與健康研究, 2020, 4(5): 84-85.
15. ZhaoYL , Li JM, Fan Y, et al. Sodium valproate combined with levetiracetam in pediatric epilepsy and its influence on NSE, IL6, hsCRP and electroencephalogram improvement. Experimental And Therapeutic Medicine, 2020, 20: 2043-2048.
16. Mu RZ, Liu S, Liang KG, et al. A meta-analysis of neuron-specifific enolase levels in cerebrospinal fluid and serum in children with epilepsy. Front Mol Neurosci, 2020, 10(13): 24.
17. Hanak TJ, Libbey JE, Doty DJ, et al. Positive modulation of m GluR5 attenuates seizures and reduces TNF-a+macrophages and microglia in the brain in a murine model of virus-induced temporal lobe epilepsy. Exp l Neuro1, 2019, 311: 194-204.
18. 黃永洪, 康穎, 韓登科, 等. 125例癲癇患兒外周血B淋巴細胞、NK 細胞和NKT 細胞的檢測與分析. 國際檢驗醫學雜志, 2017, 38(27): 3286-3290.
19. 黎雪萍, 陳志紅. 小兒癲癇外周血淋巴細胞亞群水平的變化及其意義. 汕頭大學醫學院, 碩士學位論文, 2022.

Journal of Epilepsy

Clinical study on the treatment of refractory epilepsy in children by adding Chinese medicine

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