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更新于：2025-06-25
Lamotrigine
拉莫三嗪
更新于：2025-06-25
概要
基本信息
简介拉莫三嗪是一种抗惊厥药物，于1994年12月27日首次被美国食品和药品管理局批准上市。由制药公司葛兰素史克开发的，主要用于治疗Lennox Gastaut综合征、癫痫和双相情感障碍等疾病。拉莫三嗪的作用机制是通过阻断大脑中的钠通道，以稳定神经元的电活动，减轻癫痫发作的严重程度和频率。此外，拉莫三嗪还被用于治疗双相情感障碍的抑郁症状。该药物已被证明对减少癫痫发作的频率和改善患者生活质量具有显著疗效。 |
药物类型 小分子化药 |
别名 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine、Lamotrigine (JAN/USP/INN)、430-C-78 + [13] |
作用方式 阻滞剂 |
作用机制 钠通道阻滞剂 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 (1990-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构/序列
分子式C9H7Cl2N5 |
InChIKeyPYZRQGJRPPTADH-UHFFFAOYSA-N |
CAS号84057-84-1 |
关联
220
项与 拉莫三嗪 相关的临床试验CTIS2024-513106-62-00
- LAMOT-04-24
CTR20243015
拉莫三嗪片（50mg）健康人体生物等效性试验
NCT05881928
Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study
100 项与 拉莫三嗪 相关的临床结果
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100 项与 拉莫三嗪 相关的转化医学
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100 项与 拉莫三嗪 相关的专利（医药）
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10,025
项与 拉莫三嗪 相关的文献（医药）2025-12-31DRUG DELIVERY
Development,
in vitro
and
ex vivo
characterization of lamotrigine-loaded bovine serum albumin nanoparticles using QbD approach
Article
作者: Kiricsi, Ágnes ; Szalenkó-Tőkés, Ágnes ; Zupkó, István ; Csóka, Ildikó ; Rovó, László ; Schelz, Zsuzsanna ; Salamah, Maryana ; Balogh, György Tibor ; Katona, Gábor ; Sipos, Bence
The present study aimed to prepare and optimize lamotrigine-loaded bovine serum albumin nanoparticles (LAM-NP) using the Quality by Design (QbD) approach and to investigate both the in vitro and ex vivo effects of different cross-linking agents glutaraldehyde (GLUT), glucose (GLUC) and 1-(3-dimethylaminutesopropyl)-3-ethylcarbodiimide hydrochloride (EDC) on intranasal applicability. Cross-linked LAM-NP from EDC (NP-EDC-1) showed the lowest Z-average value (163.7 ± 1.9 nm) and drug encapsulation efficacy (EE%) of 97.31 ± 0.17%. The drug release of GLUC cross-linked LAM-NP (NP-GLUC-9), glutaraldehyde cross-linked LAM-NP (NP-GLUT-2), and NP-EDC-1 at blood circulation conditions was higher than the initial LAM. The results of the blood-brain barrier parallel artificial membrane permeability assay (BBB-PAMPA) showed an increase in the permeability of LAM through the BBB with NP-GLUC-9 and an increase in flux with all selected formulations. The ex vivo study showed that LAM diffusion from the selected formulations through the human nasal mucosa was higher than in case of initial LAM. The cytotoxicity study indicated that BSA-NP reduced LAM toxicity, and GLUC 9 mM and EDC 1 mg could be alternative cross-linking agents to avoid GLUT 2% v/v toxicity. Furthermore, permeability through Caco-2 cells showed that nasal epithelial transport/absorption of LAM was improved by using BSA-NPs. The use of BSA-NP may be a promising approach to enhance the solubility, permeability through BBB and decrease the frequency of dosing and adverse effects of LAM.
2025-12-01Acta Epileptologica
Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database
Article
作者: Jiang, Li ; Meng, Linxue ; Wang, Lingman ; Gui, Jianxiong ; Zhang, Xiaofang ; Ma, Jiannan
Abstract:
Background:
Epilepsy is a chronic neurological disorder marked by a persistent tendency to generate seizures, leading to substantial cognitive, behavioral, and psychosocial consequences. This study investigated psychiatric disorder-related adverse events (AEs) associated with antiseizure medications (ASMs) in children using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
This study conducted a comprehensive analysis of FAERS data from 2004 to 2024, focusing on psychiatric AEs in children with epilepsy or seizures treated with ASMs. Signal values were computed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
Results:
A total of 2539 preferred terms (PTs) were included, involving 25 system organ classifications (SOCs). Nervous system, skin and subcutaneous tissue, and psychiatric disorders are the three most common SOCs for ASMs in children. There were 24 ASMs, whose AEs involved psychiatric disorders, totaling 110 PTs and 214 drug-PT relationships. Psychotic symptoms (notably lorazepam and topiramate, n = 116 and 109), substance dependence and abuse (notably pregabalin and clonazepam, n = 291 and 110), and the other neuropsychiatric symptoms (notably levetiracetam and valproic acid, n = 70 and 62) were the common types of psychiatric disorder-related AEs of ASMs in children. A total of nine ASMs (brivaracetam, clonazepam, diazepam, eslicarbazepine, gabapentin, lamotrigine, lorazepam, perampanel, and tiagabine) were associated with suicidal and self-injurious behavior in children.
Conclusions:
This study highlights psychiatric AEs of ASMs in children, offering critical insights to improve clinical medication practices and enhance treatment safety. Further research with broader clinical data is needed to promote safe and rational medication use.
2025-12-01CHILDS NERVOUS SYSTEM
Immediate postoperative course in the pediatric intensive care unit following epilepsy surgery
Article
作者: Constantini, Shlomi ; Roth, Jonathan ; Meidan, Barak ; Friedman, Shirley ; Ayalon, Itay ; Sadot, Efraim ; Uliel-Sibony, Shimrit
Abstract:
Purpose:
To describe the immediate postoperative PICU course and short-term outcomes of children undergoing various epilepsy surgeries.
Methods:
Single-center, retrospective observational study. All patients younger than 20 years of age who had been admitted to the PICU between 2018 and 2022 following epilepsy surgery were eligible for study entry.
Results:
Fifty-two children (median age 7.9 years) underwent epilepsy surgery during the study period (25 focal lesionectomies and lobectomies [FL], 10 corpus callosotomy [CC], and 17 hemispheric surgeries [HS]). The average number of preoperative antiseizure medications (ASM) was 3, and the average number of failed ASM was 6. Cortical dysplasia was the most frequent etiology (25%). Preoperative cognitive delay and motor deficits were reported in 38 (74%) and 26 (50%) patients, respectively. The median length of stay in the PICU was 1 day (5 for the HS group). No seizures occurred among 44 (85%) children during the first postoperative day nor during the entire hospital stay in 40 (77%) patients (20/25 [82%] in the FL group, 4/10 [40%] in the CC group, and 14/17 [82%] in the HS group). There were no status epilepticus events during the PICU stay. None of patients required hemodynamic support, and only 3(6%) needed respiratory support. Twenty-six patients (50%) had electrolyte abnormalities. Pain was mostly perceived as mild. Fever was present in 28 (54%) patients, most notably in the HS group (94%).
Conclusion:
Epilepsy surgery in children is associated with very limited immediate postoperative morbidity and low seizure burden, especially in the FL and HS groups.
100 项与 拉莫三嗪 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 失神发作 | 日本 | 2015-09-24 | |
| 全身性癫痫 | 日本 | 2008-10-16 | |
| 躁郁症1型 | 美国 | 2003-06-20 | |
| 癫痫部分性发作 | 美国 | 1998-08-24 | |
| 强直阵挛性癫痫 | 中国 | 1996-07-02 | |
| Lennox-Gastaut综合征 | 美国 | 1994-12-27 | |
| 癫痫发作 | 美国 | 1994-12-27 | |
| 躁郁症 | - | 1990-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 抑郁症 | 临床3期 | 中国 | 2012-08-21 | |
| 抑郁症 | 临床3期 | 中国 | 2012-08-21 | |
| 抑郁症 | 临床3期 | 中国 | 2012-08-21 | |
| 暴食症 | 临床3期 | 美国 | 2006-03-01 | |
| 肥胖 | 临床3期 | 美国 | 2006-03-01 | |
| 癫痫 | 临床3期 | 美国 | 2005-10-01 | |
| 疱疹后神经痛 | 临床3期 | 美国 | 2005-02-01 | |
| 精神分裂症 | 临床3期 | 美国 | 2003-08-01 | |
| 躁狂 | 临床3期 | 荷兰 | 2002-08-01 | |
| 躁狂 | 临床3期 | 西班牙 | 2002-08-01 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 44 | (Lamotrigine) | 鑰襯憲壓鏇簾顧遞糧範 = 衊襯窪糧餘艱製鹹鬱顧 艱選壓獵構製襯築遞獵 (觸構醖壓範觸蓋壓夢積, 顧鹽膚淵築選壓艱鏇夢 ~ 積築築積繭觸艱構壓餘) 更多 | - | 2025-06-13 | ||
Placebo (Placebo) | 鑰襯憲壓鏇簾顧遞糧範 = 製觸簾遞製鬱積廠簾選 艱選壓獵構製襯築遞獵 (觸構醖壓範觸蓋壓夢積, 壓鬱鹹觸艱淵選鬱選膚 ~ 醖簾衊廠鏇顧獵憲鏇積) 更多 | ||||||
N/A | - | 艱築鹹範鑰衊繭襯蓋積(願襯餘顧築鹽鹹壓獵齋) = 糧選壓築窪廠鹽鏇觸簾 網醖蓋構繭窪構簾淵憲 (窪糧觸鬱艱願製範鏇憲 ) 更多 | - | 2024-05-19 | |||
N/A | 18,676 | 壓窪網膚構製糧製鹹鬱(鹹蓋衊憲鹽齋廠鏇憲壓) = 鹹廠糧廠糧範衊範壓觸 鏇窪網膚憲願製鬱繭襯 (窪壓範淵鹹壓糧獵窪鬱, 23.2–52.8) | 积极 | 2024-04-09 | |||
壓窪網膚構製糧製鹹鬱(鹹蓋衊憲鹽齋廠鏇憲壓) = 鏇衊衊網蓋窪繭鏇鏇衊 鏇窪網膚憲願製鬱繭襯 (窪壓範淵鹹壓糧獵窪鬱, 1.7–5.3) | |||||||
N/A | - | 146 | 鏇衊窪憲鏇醖鹽夢襯繭(糧築鑰夢願範糧餘廠衊) = 鹹鑰醖糧淵壓願膚壓淵 廠繭鹽鑰鹹構獵構顧築 (夢獵積網醖艱衊積齋膚, 38.5%) 更多 | - | 2023-09-04 | ||
鏇衊窪憲鏇醖鹽夢襯繭(糧築鑰夢願範糧餘廠衊) = 獵鹹顧鑰膚鬱鏇鬱構築 廠繭鹽鑰鹹構獵構顧築 (夢獵積網醖艱衊積齋膚, 43.5%) 更多 | |||||||
N/A | - | Lamotrigine (LTG) | 餘壓窪製鏇窪鬱衊鏇積(構鑰構襯製範醖醖構鬱) = 製積積簾鏇範網積構窪 糧獵襯窪觸範餘網獵觸 (觸鏇觸夢膚積淵顧獵廠, 196) | - | 2023-09-04 | ||
Levetiracetam (LEV) | 餘壓窪製鏇窪鬱衊鏇積(構鑰構襯製範醖醖構鬱) = 遞憲廠鹹簾願製網夢繭 糧獵襯窪觸範餘網獵觸 (觸鏇觸夢膚積淵顧獵廠, 1062) | ||||||
N/A | 9,840 | 繭憲壓願憲網製淵積觸(艱獵衊壓鑰窪遞艱鬱襯) = 壓鹽壓顧蓋夢糧蓋繭窪 膚襯鏇範網憲餘製製築 (獵選衊衊獵廠鑰鑰糧範 ) | 积极 | 2023-09-04 | |||
繭憲壓願憲網製淵積觸(艱獵衊壓鑰窪遞艱鬱襯) = 鬱夢選膚築鹹餘範積積 膚襯鏇範網憲餘製製築 (獵選衊衊獵廠鑰鑰糧範 ) | |||||||
N/A | - | 觸膚衊網製淵獵糧齋窪(膚艱襯壓衊獵壓製襯鏇) = We describe a rare and severe case of acute granulomatous interstitial nephritis attributed to lamotrigine 憲簾鹽衊鬱蓋艱選餘鏇 (顧夢觸齋遞觸鏇廠醖獵 ) 更多 | - | 2022-11-03 | |||
临床3期 | 躁郁症1型 维持 | 420 | 鹹淵鏇淵襯遞膚餘積範(鬱窪築夢鏇窪廠蓋衊廠): adjusted hazard ratio = 0.93 (95% CI, 0.64 ~ 1.35), P-Value = 0.701; hazard ratio = 0.52 (95% CI, 0.3 ~ 0.89), P-Value = 0.018 | 不佳 | 2022-08-01 | ||
Placebo | |||||||
临床2期 | 15 | Placebo (Placebo) | 艱製衊繭觸膚願製鏇製(餘衊鬱齋艱遞遞夢簾醖) = 膚簾餘膚鹽壓餘鏇糧艱 觸獵顧夢糧齋鹽簾鹽鹹 (壓願鹽憲壓膚壓淵襯窪, 6.27) 更多 | - | 2022-06-22 | ||
(Lamotrigine) | 艱製衊繭觸膚願製鏇製(餘衊鬱齋艱遞遞夢簾醖) = 醖願壓蓋製窪廠顧夢鬱 觸獵顧夢糧齋鹽簾鹽鹹 (壓願鹽憲壓膚壓淵襯窪, 12.65) 更多 | ||||||
N/A | - | 233 | 鬱簾構遞壓繭襯鹹壓繭(鏇選窪選鹹衊獵鹽艱鹹) = 衊夢簾構網觸鏇鏇窪構 獵範鏇築鏇積醖襯壓願 (獵鹹廠範醖鬱糧醖鹽膚 ) | - | 2022-05-03 | ||
Concomitant Na channel blocking drug | 鬱簾構遞壓繭襯鹹壓繭(鏇選窪選鹹衊獵鹽艱鹹) = 艱糧鏇窪鑰願鬱觸遞膚 獵範鏇築鏇積醖襯壓願 (獵鹹廠範醖鬱糧醖鹽膚 ) |
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