中国现代神经疾病杂志 ›› 2014, Vol. 14 ›› Issue (11): 966-971. doi: 10.3969/j.issn.1672-6731.2014.11.009

• 癫痫基础与临床研究 • 上一篇    下一篇

2 硫酸镁联合促肾上腺皮质激素治疗婴儿痉挛症开放性临床研究

鞠俊, 黄静, 李慧, 庞领玉, 史泽宁, 张君嗣, 苏小俊, 陈小桥, 邹丽萍   

  1. 100853 北京,解放军总医院儿童医学中心[鞠俊,黄静(现在苏州大学附属儿童医院神经内科,邮政编码:215003),李慧,庞领玉,史泽宁,张君嗣,苏小俊,陈小桥,邹丽萍];100069 北京脑重大疾病研究院癫研究所(邹丽萍)
  • 出版日期:2014-11-25 发布日期:2014-11-29
  • 通讯作者: 邹丽萍 (Email:zouliping21@hotmail.com)
  • 基金资助:

    国家重点基础研究发展计划(973 计划)项目(项目编号:2012CB517903);国家自然科学基金国际合作与交流项目(项目编号:81211140048);国家自然科学基金资助项目(项目编号:30770747);国家自然科学基金资助项目(项目编号:81071036);北京市自然科学基金重点资助项目(项目编号:7081002);首都医学发展科研基金资助项目(项目编号:2003-2037);卫生公益性行业科研专项项目(项目编号:200802074);中国博士后科学基金资助项目(项目编号:201150M1529)

An open-label clinical study on the efficacy and tolerability of magnesium sulfate combined with adrenocorticotropic hormone treatment on infantile spasm

JU Jun1, HUANG Jing1, LI Hui1, PANG Ling-yu1, SHI Ze-ning1, ZHANG Jun-si1, SU Xiao-jun1, CHEN Xiao-qiao1, ZOU Li-ping1, 2   

  1. 1Department of Pediatrics, Chinese PLA General Hospital, Beijing 100853, China
    2Center of Epilepsy, Beijing Institute for Brain Disorders, Beijing 100069, China
  • Online:2014-11-25 Published:2014-11-29
  • Contact: ZOU Li-ping (Email: zouliping21@hotmail.com)
  • Supported by:

    This study was supported by Major State Basic Research Development Program of China (973 Program, No. 2012CB517903), International Cooperation and Communication Program in National Natural Science Foundation of China (No. 81211140048), National Natural Science Foundation of China (No. 30770747, 81071036), Key Program of Natural Science Foundation of Beijing (No. 7081002), Capital Medical Development Foundation of Beijing (No. 2003-2037), Hygiene Industry?Specific Research Project of China (No. 200802074) and China Post Doctoral Science Foundation Grant (No. 201150M1529).

摘要: 研究背景 婴儿痉挛症是一种以痉挛发作、脑电图高度失律和精神运动发育迟滞为特征的难治性癫痫,抗癫痫药物治疗效果欠佳。促肾上腺皮质激素作为一线治疗药物存在感染和高血压等不良反应,本研究旨在通过开放性临床试验评价硫酸镁联合促肾上腺皮质激素治疗婴儿痉挛症的疗效和耐受性。方法 共计55 例婴儿痉挛症患儿接受统一标准的硫酸镁联合促肾上腺皮质激素治疗,比较治疗前后痉挛发作频率和脑电图改变,治疗过程中通过监测患儿生命体征、实验室指标和药物不良事件评价药物耐受性。结果 治疗2 周后痉挛发作控制有效率为78.18%(43/55)、脑电图改善率为55.77%(29/52),其中无发作25 例(45.45%)、脑电图恢复正常6 例(11.54%)。不同发病年龄[≤ 4 个月和> 4 个月(χ2 = 0.595,P = 0.441)]、病程[≤ 2 个月和> 2 个月(Fisher确切概率法:P = 0.735)]和病因学[特发性或隐源性和症状性婴儿痉挛症(Fisher确切概率法:P = 1.000)]对痉挛发作控制有效率,以及不同发病年龄(χ2 = 1.325,P = 0.250)、病程(χ2 = 2.668,P = 0.102)和病因学(χ2 = 2.215,P = 0.145)对脑电图改善率之差异均无统计学意义;治疗期间无一例患儿发生高血压等不良事件。29 例患儿经长期随访(治疗后1、3 和12 个月)无痉挛发作患儿比例基本维持不变(χ2 = 0.945,P = 0.815)。结论 硫酸镁联合促肾上腺皮质激素方案治疗婴儿痉挛症疗效肯定且耐受性良好。

关键词: 痉挛, 婴儿, 硫酸镁, 促肾上腺皮质激素, 脑电描记术

Abstract: Background  Infantile spasm (IS) is characterized by spasm seizure, hypsarrhythmia in EEG, and psychomotor retardation. It is refractory to conventional antiepileptic drugs (AEDs). As firstline therapy for IS, adrenocorticotropic hormone (ACTH) has side effects, such as infection and hypertension. This study aims to evaluate the efficacy and tolerability of magnesium sulfate combined with ACTH treatment by open-label clinical trial.  Methods  An open-label clinical study was designed. According to inclusion and exclusion criteria, objects were inpatients with IS. A total of 55 patients with IS were enrolled. After clinical data collection, standard magnesium sulfate combined with ACTH was given to the patients for 2 weeks. Efficacy and safety were assessed regularly. The evaluation parameters of efficacy included change of spasm seizure frequency and EEG after treatment. During administration process, vital signs were monitored, laboratory items were tested regularly, and adverse events were daily recorded by guardian.  Results  After treatment of magnesium sulfate combined with ACTH for 2 weeks, seizure control efficiency was 78.18%(43/55), and the improvement rate of EEG was 55.77% (29/52), wherein 25 patients (45.45%) acquired seizure free, 6 patients (11.54%) presented normal in EEG examination. There were no statistical differences of the effect of different onset ages (≤ 4 months, > 4 months) on seizure control efficiency rate (χ2 = 0.595, P = 0.441) and EEG improvement rate (χ2 = 1.325, P = 0.250), the effect of different courses of disease (≤ 2 months, > 2 months) on seizure control efficiency rate (Fisher's exact test: P = 0.735) and EEG improvement rate ( χ2 = 2.668, P = 0.102), and the effect of different etiologies (idiopathic or cryptogenic IS, symptomatic IS) on seizure control efficiency rate (Fisher's exact test: P = 1.000) and EEG improvement rate ( χ2 = 2.215, P = 0.145). No adverse events, such as hypertension, occurred. After long-term (1 month, 3 months and 12 months) follow-up for 29 patients, seizure free rate remained roughly unchanged (χ2 = 0.945, P = 0.815).  Conclusions  For patients with IS, magnesium sulfate combined with ACTH treatment is effective and well tolerated.

Key words: Spasms, infantile, Magnesium sulfate, Adrenocorticotropic hormone, Electroencephalography