预约演示
更新于：2026-02-01
Fosphenytoin Sodium
磷苯妥英钠
更新于：2026-02-01
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
登录后查看时间轴
结构/序列
分子式C16H15N2Na2O6P |
InChIKeyCKBXTXIAQHEVAB-UHFFFAOYSA-N |
CAS号92134-98-0 |
关联
24
项与 磷苯妥英钠 相关的临床试验CTR20253943
磷苯妥英钠注射用浓溶液在中国健康受试者中单中心、随机、开放、单次给药、两制剂、两周期交叉人体生物等效性试验
CTR20253692
磷苯妥英钠注射液在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹生物等效性试验
CTR20252099
磷苯妥英钠注射用浓溶液健康人体生物等效性研究
100 项与 磷苯妥英钠 相关的临床结果
登录后查看更多信息
100 项与 磷苯妥英钠 相关的转化医学
登录后查看更多信息
100 项与 磷苯妥英钠 相关的专利（医药）
登录后查看更多信息
539
项与 磷苯妥英钠 相关的文献（医药）2026-01-01AMERICAN JOURNAL OF EMERGENCY MEDICINE
Benzodiazepine-refractory status epilepticus: A narrative review
Review
作者: Koyfman, Alex ; Pelletier, Jessica ; Long, Brit ; Merriman, Walter
INTRODUCTION:
Seizures are a common complaint in the emergency department, with status epilepticus (SE) associated with significant morbidity and mortality. While the typical first-line therapy for seizures includes benzodiazepines, patients with SE may be refractory to benzodiazepines. Seizures of longer duration are harder to break, and SE becomes a self-sustaining cycle; thus, benzodiazepine-refractory SE is a particularly challenging condition facing emergency clinicians.
OBJECTIVES:
This narrative review provides a focused evaluation of SE refractory to first-line therapy, highlighting potential underlying causes and management strategies.
DISCUSSION:
SE may occur in 22 % of seizure cases presenting to the emergency department, and up to 40 % of these patients will have seizure activity refractory to benzodiazepine therapy. Prolonged seizure activity is associated with long-term neurologic consequences. Potential underlying causes of SE include endocrine, metabolic, infectious, neurologic, obstetric, toxicologic, and traumatic etiologies. Reversing these underlying causes can help terminate seizure activity. Benzodiazepines (lorazepam, diazepam, and midazolam) are considered first-line anti-seizure medications (ASMs) and must be administered in adequate doses to reach their maximum therapeutic potential. Patients who continue seizing should receive a second dose of benzodiazepines at the 5-min mark, combined with a second-line ASM, such as fosphenytoin (preferred over phenytoin), levetiracetam, or valproic acid. Patients who continue seizing are considered to have refractory SE and should receive third-line agents, such as ketamine, pentobarbital, propofol, or thiopental, as the clinician prepares for intubation. Continuous electroencephalography (EEG) should be considered when moving from second- to third-line ASMs or when intubation is necessary. Early aggressive therapy is key for terminating seizure activity.
CONCLUSION:
Recognizing and treating SE early is critical for preserving neurologic function. Emergency clinicians must be prepared to reverse the underlying causes of SE and utilize second- and third-line ASMs to abort seizure activity when necessary.
2025-12-01JOURNAL OF CLINICAL NEUROSCIENCE
A retrospective comparison of prophylactic fosphenytoin and levetiracetam in awake craniotomy
Article
作者: Yaylali, Ilker ; Raslan, Ahmed M. ; Ernst, Lia ; Fecker, Adeline L. ; Collins, Kelly L. ; Bushlin, Ittai ; Sengupta, Sidharth
BACKGROUND:
Awake craniotomy with direct cortical stimulation (DCS) mapping is the gold standard for resection of pathology in eloquent regions. Prophylactic anti-seizure medications (ASMs) are commonly used to prevent intraoperative seizure. There is a preference for levetiracetam (LEV), due to its low side effect profile. We investigated whether a prophylactic dose of fosphenytoin (FOS) compared to LEV reduced the risk of intraoperative complications.
METHODS:
We performed a retrospective analysis of consecutive adult and pediatric awake craniotomy cases from 2018 to 2024 who received either 1 g LEV or 10 mg/kg FOS at the start of surgery. Data was collected on intraoperative events including seizure and new neurologic deficits during mapping, aborted stimulation mapping, and 24-hour neurologic deficits and seizures. A composite outcome was counted if one or more of the complications occurred.
RESULTS:
112 patients met inclusion criteria; 61 (55 %) were included in the LEV group and 51 (45 %) were included in the FOS group. There was no significant difference in number of recorded or clinical intraoperative seizure between treatment groups (p = 0.925). There were no observed side effects from FOS or LEV prophylaxis. FOS was the factor most associated with all the outcomes of interest, followed by home ASM regimen (other and LEV), year of surgery, GBM, and preoperative seizures. In a multivariable model of these top variables, only prophylactic FOS was significantly associated with lower odds of composite events (OR = 0.20, 95 % CI 0.05-0.65, p = 0.011), intraoperative events (OR = 0.26, 95 % CI 0.06-0.91, p = 0.045) and 24-hour deficits (OR = 0.25, 95 % CI 0.07-0.79, p = 0.024). FOS prophylaxis was significantly associated with reduced risk of transient neurologic deficits (OR = 0.20, 95 % CI 0.04-0.82, p = 0.036).
CONCLUSION:
Though there was no difference in rate of intraoperative and postoperative seizure, the lower rate of transient neurologic deficit and intraoperative events suggests prophylactic fosphenytoin may improve safety of awake craniotomy with DCS compared to levetiracetam.
2025-09-01PEDIATRIC DRUGS
Levetiracetam Versus Fosphenytoin Infusions as Second-Line Treatment for Pediatric Status Epilepticus: A Multicenter Study Examining Effectiveness, Tolerability, and Ease of Use
Article
作者: Severac, François ; Haupt, Sandrine ; Baer, Sarah ; de Feraudy, Yvan ; de Saint Martin, Anne ; Bansept, Claire ; Abi Wardé, Marie-Thérèse ; Hornard, Armelle ; Eyer, Didier ; Spitz, Marie-Aude ; Laugel, Vincent
BACKGROUND AND OBJECTIVES:
Status epilepticus is a life-threatening neurological emergency that requires rapid and effective treatment to prevent long-term complications or death. Traditionally, phenytoin and its prodrug fosphenytoin have been used as second-line therapies following benzodiazepines. However, intravenous levetiracetam has emerged as a promising alternative because of its favorable safety profile and ease of administration, particularly in pediatric populations. This study aimed to evaluate whether intravenous levetiracetam was non-inferior to intravenous fosphenytoin as a second-line treatment for managing pediatric status epilepticus.
METHODS:
From November 2021 to May 2023, we implemented an updated local protocol that replaced fosphenytoin with levetiracetam as the second-line treatment for status epilepticus. Following this change, we conducted a 2-year multicenter study to evaluate its impact. For comparison, we also included patients treated under the previous protocol during the 2 years prior to the change, as a control group. An inverse probability of treatment weighting approach, based on the propensity score, was used to adjust for baseline characteristics between the two groups. Bayesian regression models were used to assess treatment effects in the weighted cohort. Treatment effectiveness was assessed using a composite measure of need for subsequent interventions, recurrence of status epilepticus within 24 h, seizure duration and length of hospital stay. We tested non-inferiority hypotheses for effectiveness criteria and if the probability of non-inferiority was greater than 95%, we also tested a superiority hypothesis. Safety was assessed by analyzing adverse events, mortality, admission to the intensive care unit, and transfer to the resuscitation unit. For safety criteria, only superiority was tested.
RESULTS:
In total, 127 patients with status epilepticus were evaluated during the study period; 84 patients in the fosphenytoin group (66%) and 43 patients in the levetiracetam group (34%). Of these, 52 patients had febrile status epilepticus (40.9%), 27 patients were treated with oral levetiracetam as part of their daily treatment regimen at the time of status epilepticus (21.3%), and 12 (9.4%) patients had been treated with levetiracetam during their lifetime but stopped at the time of status epilepticus. With intravenous levetiracetam, 62.8% of children were seizure free, compared with 37.2% of children taking fosphenytoin. The length of hospital stay was significantly shorter with levetiracetam than with fosphenytoin (reduction of 1.9 days with levetiracetam) and children were less likely to be admitted to the intensive care unit (reduction of 18.1% with levetiracetam). The need for third-line treatment or seizure recurrence was significantly lower in the levetiracetam group (16.3% reduction compared with fosphenytoin). Adverse effects and seizure duration were not significantly different between the two groups.
CONCLUSIONS:
Using a composite outcome measure, we demonstrated that levetiracetam was not inferior to fosphenytoin with respect to seizure recurrence, the need for third-line therapy, intensive care unit admission, and the total length of hospital stays.
100 项与 磷苯妥英钠 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 强直阵挛性癫痫 | 中国 | 2023-03-15 | |
| 癫痫 | 日本 | 2011-07-01 | |
| 癫痫发作 | 美国 | 1996-08-05 | |
| 癫痫持续状态 | 美国 | 1996-08-05 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 急性疼痛 | 临床3期 | 日本 | 2022-08-05 | |
| 带状疱疹 | 临床3期 | 日本 | 2022-08-05 | |
| 癌症疼痛 | 临床2期 | 日本 | 2019-04-03 | |
| 多发性骨髓瘤 | 临床2期 | 日本 | 2019-04-03 | |
| 神经痛 | 临床2期 | 日本 | 2019-04-03 | |
| 肉瘤 | 临床2期 | 日本 | 2019-04-03 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 15 | Intravenous fosphenytoin plus oral tapering of phenytoin | 選淵蓋壓願廠衊鹹鑰餘(鏇範鹽觸顧糧窪選獵鬱) = 觸餘獵鏇遞鏇顧廠鑰壓 製壓願網衊齋廠獵糧窪 (積觸觸鬱鑰襯壓積鏇網 ) | 积极 | 2022-04-25 | ||
临床3期 | 癫痫持续状态 二线 | 462 | (children (aged <18 years)) | 鬱範憲範觸鑰蓋獵願觸(衊夢蓋鬱願糧廠艱齋築) = 繭齋蓋獵廠鹹淵壓餘窪 窪積餘獵網壓積簾繭醖 (夢廠襯構構願壓膚鑰鹹, 41 ~ 62) | 积极 | 2020-04-11 | |
(adults) | 鬱範憲範觸鑰蓋獵願觸(衊夢蓋鬱願糧廠艱齋築) = 艱襯齋蓋蓋壓窪夢鬱製 窪積餘獵網壓積簾繭醖 (夢廠襯構構願壓膚鑰鹹, 33 ~ 55) | ||||||
临床3期 | 478 | (Fosphenytoin (FOS)) | 製鏇繭壓廠製築網糧淵 = 鑰衊選顧醖繭鹹範膚鹹 簾願獵觸廠艱鹽觸顧繭 (簾壓積夢獵築窪鹽淵淵, 遞醖顧簾遞淵鑰範觸鏇 ~ 鹹齋鹽繭糧窪衊窪艱鑰) 更多 | - | 2020-02-28 | ||
(Valproic Acid) | 製鏇繭壓廠製築網糧淵 = 網鹹廠膚選鹹淵壓夢鬱 簾願獵觸廠艱鹽觸顧繭 (簾壓積夢獵築窪鹽淵淵, 觸遞淵鏇膚餘鏇襯鹽窪 ~ 廠獵鹹膚選鏇壓鬱壓遞) 更多 | ||||||
临床2期 | 74 | 顧艱糧壓淵衊艱淵觸淵 = 憲餘顧窪鹽鑰蓋齋鏇鹹 願觸積餘鹽醖繭製餘餘 (構繭鹹積鏇顧膚製製願, 積襯網糧構範構網鹽選 ~ 糧憲選淵夢糧網鹽衊艱) 更多 | - | 2018-06-11 | |||
临床4期 | 158 | (Phenytoin/Fosphenytoin) | 壓廠鏇鏇艱襯襯願醖廠 = 鏇餘觸觸網構範膚憲襯 窪鹽蓋鏇願網衊窪襯獵 (鹹鑰膚鹽餘淵蓋糧夢蓋, 遞鏇蓋構壓積網壓廠範 ~ 獵鏇顧遞觸襯淵積醖範) 更多 | - | 2013-08-05 | ||
(Levetiracetam) | 壓廠鏇鏇艱襯襯願醖廠 = 獵膚醖獵夢顧廠鬱鹽艱 窪鹽蓋鏇願網衊窪襯獵 (鹹鑰膚鹽餘淵蓋糧夢蓋, 繭艱衊膚範艱積鬱簾艱 ~ 獵觸觸築窪窪廠鑰積觸) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用