中国药物警戒 ›› 2024, Vol. 21 ›› Issue (5): 559-562.
DOI: 10.19803/j.1672-8629.20240018

• 基础与临床研究 • 上一篇    下一篇

拉考沙胺治疗4岁以下癫痫患儿疗效、安全性与血药浓度的相关性研究

于静1, 帕拉提·热合曼1, 赵婷2, 冯继荣1, 孙岩1, 何磊1,*   

  1. 1北京儿童医院新疆医院,新疆维吾尔自治区儿童医院神经内科,新疆 乌鲁木齐 830001;
    2新疆维吾尔自治区人民医院药学部,新疆 乌鲁木齐 830001
  • 收稿日期:2024-01-11 出版日期:2024-05-15 发布日期:2024-05-13
  • 通讯作者: *何磊,女,硕士,主治医师,儿科神经疾病。E-mail: 445839342@qq.com
  • 作者简介:于静,女,硕士,副主任医师,儿科神经疾病。
  • 基金资助:
    新疆维吾尔自治区自然科学基金项目（2023D01A108）; 中国抗癫痫协会-CAAE癫痫科研基金-UCB基金（CU-2022-032）

Correlation of the efficacy, safety and plasma concentration of lacosamide in the treatment of children with epilepsy under 4 years of age

YU Jing1, PALATI Reheman1, ZHAO Ting2, FENG Jirong1, SUN Yan1, HE Lei1,*   

  1. 1Department of Neurology, Children's Hospital of Xinjiang Uygur Autonomous Region Xinjiang Hospital of Beijing Children' Hospital, Urumqi Xinjiang 830001, China;
    2Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi Xinjiang 830001, China
  • Received:2024-01-11 Online:2024-05-15 Published:2024-05-13

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摘要： 目的 评估拉考沙胺（LCM）治疗4岁以下癫痫患儿的疗效、安全性与血药浓度的相关性。方法 回顾性纳入新疆维吾尔自治区儿童医院2019年1月1日至2023年12月31日期间190例使用LCM治疗的癫痫患儿,收集个人资料、记录LCM血药浓度、疗效及药品不良反应。分析疗效、安全性和血药浓度的相关性。结果 LCM治疗有效率为77.37％,不良反应发生率为31.58%。LCM血药浓度预判疗效的准确性[曲线下面积（AUC）（95%CI）=0.532（0.440~0.623）]高于给药剂量[AUC（95%CI）= 0.525（0.422~0.628）]。癫痫患儿LCM稳态血药浓度参考区间为1.50~14.65 μg·mL-1。发生不良反应患儿的LCM血药浓度显著高于未发生不良反应组患儿[（7.93±3.90）μg·mL-1 vs（6.44±3.10）μg·mL-1,P<0.05]。结论 LCM治疗4岁以下癫痫患儿的疗效和安全性均较好,可用于临床癫痫治疗。

关键词: 拉考沙胺, 癫痫, 血药浓度, 临床疗效, 安全性, 儿童, 药品不良反应

Abstract: Objective To assess the correlation of efficacy, safety and serum concentrations of lacosamide (LCM) in children with epilepsy under 4 years of age. Methods A total of 190 children with epilepsy treated with LCM from January 1, 2019 to December 31, 2023 in the Children's Hospital of Xinjiang Uygur Autonomous Region were retrospectively enrolled, and personal data were collected, and blood concentrations, efficacy, and adverse drug reactions of LCM were recorded. The correlation between efficacy, safety, and plasma concentrations was analyzed. Results The response rate of LCM treatment in children with epilepsy was 77.37%, and the incidence of adverse reactions was 31.58%. The accuracy of the LCM plasma concentration in predicting efficacy [AUC (95%CI)=0.532 (0.440~0.623)] was higher than that of the administered dose [AUC (95%CI)=0.525 (0.422~0.628)]. The reference intervals of LCM steady-state plasma concentration in children with epilepsy were 1.50~14.65 μg·mL-1, respectively. The plasma concentration of LCM in the children with adverse reactions was significantly higher than that in the children without adverse reactions [(7.93±3.90) μg·mL-1 and (6.44±3.10) μg·mL-1, P < 0.05]. Conclusion LCM has well efficacy and safety in the treatment of Childern with epicepsy under 4 years, and can be used for clinical epicepsy treatment.

Key words: lacosamide, epilepsy, plasma concentration, efficacy, safety, children, adverse drug reactions

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