预约演示
更新于：2026-10-23
Fosphenytoin Sodium
磷苯妥英钠
更新于：2026-10-23
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) |
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结构/序列
分子式C16H15N2Na2O6P |
InChIKeyCKBXTXIAQHEVAB-UHFFFAOYSA-N |
CAS号92134-98-0 |
关联
31
项与 磷苯妥英钠 相关的临床试验CTR20262304
磷苯妥英钠注射液在健康试验参与者中单中心、随机、开放、交叉生物等效性试验
JPRN-jRCT2011250056
A Phase III Confirmatory Trial of NPC-06 in Patients with Acute Exacerbation of Trigeminal Neuralgia. (IFT Study 2)
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
100 项与 磷苯妥英钠 相关的临床结果
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100 项与 磷苯妥英钠 相关的转化医学
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100 项与 磷苯妥英钠 相关的专利（医药）
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526
项与 磷苯妥英钠 相关的文献（医药）2026-10-01BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Anti‐seizure medications and DRESS in paediatric patients: A FAERS disproportionality and time‐to‐onset analysis
Article
作者: Zhou, Ying ; Chen, Chaoyang ; Yang, Ting ; Ma, Lingyue ; Zhang, Xuanling
Aims:
Anti‐seizure medications (ASMs) are in the list of the most common drug culprits of drug reaction with eosinophilia and systemic symptoms (DRESS). However, no study has systematically evaluated DRESS associated with ASMs in a large paediatric cohort.This study aimed to investigate association of DRESS with ASMs and to characterize the onset pattern of ASM‐related DRESS in paediatrics using FDA Adverse Event Report System (FAERS) database.
Methods:
FAERS data from the first quarter of 2004 to the second quarter of 2025 were analysed using R software (version 4.5.1). For signal detection of ASM‐related DRESS in paediatric patients, disproportionality analysis was performed with four methods, consisting of Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network and Multi‐Item Gamma Poisson Shrinker. Cumulative incidence was estimated using Kaplan–Meier method, and time‐to‐onset (TTO) analysis was conducted with Weibull distribution test.
Results:
Nine hundred forty‐one reports of ASMs‐related DRESS in paediatric population from FAERS database were analysed. Positive signals for DRESS were identified for lamotrigine, carbamazepine, levetiracetam, phenytoin, valproic acid, oxcarbazepine, phenobarbital, zonisamide, clobazam, ethosuximide, perampanel, fosphenytoin and eslicarbazepine. Ninety‐eight cases were included in the TTO analysis. Lamotrigine, carbamazepine, levetiracetam and zonisamide demonstrated a wear‐out failure‐type pattern. Phenytoin, valproic acid and oxcarbazepine presented a random failure‐type profile.
Conclusions:
Significant signals of DRESS associated with 13 ASMs were identified in paediatric populations. Notably, signals were detected for the first time for ethosuximide, perampanel, fosphenytoin and eslicarbazepine by disproportionality analysis. TTO analysis demonstrated wear‐out or random failure‐type patterns in the occurrence of ASM‐associated DRESS.
2026-10-01Neurocritical Care
Guidelines for Seizure Prophylaxis in Patients with Aneurysmal Subarachnoid Hemorrhage: A Statement for Healthcare Professionals from the Neurocritical Care Society
Review
作者: Rayi, Appaji ; Zafar, Sahar F ; Frontera, Jennifer A ; Tesoro, Eljim ; Rowe, A Shaun ; Johnson, Emily L ; Yuan, Yuhong ; Ullman, Jamie ; Gilmore, Emily J ; Olson, DaiWai
Abstract:
Background:
There are limited data to guide antiseizure medication (ASM) prophylaxis in patients with aneurysmal subarachnoid hemorrhage (SAH). This results in practice variation in the use and duration of ASM prophylaxis.
Methods:
We conducted a systematic review and meta-analysis of articles assessing ASM prophylaxis in adults with aneurysmal SAH. The population, intervention, comparator, and outcome (PICO) questions were as follows: (1) Should ASM or no ASM be used in patients hospitalized for aneurysmal subarachnoid hemorrhage who have no history of clinical or electrographic seizures? (2) If an ASM is used, should levetiracetam or phenytoin/fosphenytoin be preferentially used? (3) If an ASM is used, should a long (> 3 days) or short (≤ 3 days) duration of prophylaxis be used? The main outcomes were early seizure (≤ 14 days), late seizures (> 14 days), adverse events, mortality, and functional outcomes. We used Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to generate recommendations.
Results:
The initial literature search yielded 1988 articles, of which 10 formed the basis of the recommendations: Regarding PICO 1, we did not find a significant difference in outcomes of early seizure, adverse events, mortality, or functional outcomes when comparing ASM to no ASM. In regard to PICO 2, we found fewer early seizures with phenytoin/fosphenytoin and lower risk for neurologic decline with levetiracetam; however, there was low certainty of evidence. There was no significant difference in mortality between the different treatment types. Regarding PICO 3, we found extended use of ASM may be associated with lower seizure risk, but at the same time be associated with higher risk for adverse effects.
Conclusions:
Overall, the quality of evidence is low, precluding strong recommendations. We suggest that ASM or no ASM may be used in patients hospitalized with aneurysmal subarachnoid hemorrhage (conditional recommendation, low quality of evidence). If used, we suggest either levetiracetam or phenytoin/fosphenytoin (conditional recommendation, very low quality of evidence) for a short or long duration (conditional recommendation, moderate quality of evidence).
2026-09-01EPILEPSY & BEHAVIOR
Effective treatment for lithium pilocarpine-induced status epilepticus: clonazepam and lacosamide combination
Article
作者: Yildirim, Mehmet ; Yildirim, Hava ; Demirtas, Cumaali ; Aykin, Ugur ; Akca, Metehan ; Surmeneli, Yunus Emre
This study aimed to investigate the potential of clonazepam (CLZ), one of the benzodiazepines used in the first-line treatment of status epilepticus, in combination with anti-seizure medications such as levetiracetam (LEV), lacosamide (LCM), valproic acid (VPA), and fosphenytoin (fPHT), which are used in second-line treatment, in polytherapy. Fifty-six male Sprague-Dawley rats were randomly assigned to seven groups. A status epilepticus model was induced by injection of lithium Cl (5 mEq/kg, s.c.) and pilocarpine HCl (320 mg/kg, i.p.). After induction of status epilepticus, CLZ (1 mg/kg) was administered either alone or in combination with LEV (200 mg/kg), LCM (50 mg/kg), VPA (300 mg/kg), and fPHT (100 mg/kg). Video-EEG recordings were taken from the animals, and behavioral tests were performed. Mortality rates were significantly lower in the CLZ + LCM, CLZ + VPA, and CLZ + fPHT groups compared to the status epilepticus group (p < 0.01, p < 0.05, p < 0.01, respectively), and in the CLZ + LCM and CLZ + fPHT groups compared to CLZ monotherapy (p < 0.05). Spike frequency decreased in all combination groups (p < 0.01). Spike amplitude decreased in the CLZ + LCM and CLZ + VPA combinations (p < 0.01, p < 0.05, respectively). Anxiety levels increased in the CLZ + LCM and CLZ + VPA groups (p < 0.05). Performance impairment related to spatial memory was observed in the CLZ + fPHT group (p < 0.05). A decrease in forced motor functions was observed in the CLZ + VPA and CLZ + fPHT groups compared to the control group (p < 0.01). In conclusion, CLZ alone and the CLZ-LEV combination were insufficient to prevent epileptiform activity associated with status epilepticus, whereas CLZ-based polytherapies -most notably CLZ-LCM, followed by CLZ-VPA and CLZ-fPHT- were more effective in reducing epileptiform spike frequency and amplitude.
100 项与 磷苯妥英钠 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 |
|---|---|---|---|
| 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
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 头痛症 | 临床3期 | 日本 | 2023-04-01 | |
| 三叉神经痛 | 临床3期 | 日本 | 2023-04-01 | |
| 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 | |
| 疼痛 | 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 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 15 | Intravenous fosphenytoin plus oral tapering of phenytoin | 壓蓋願鹹構築簾製淵蓋(醖鹹糧膚膚鹽醖餘顧衊) = 壓窪獵遞艱淵鏇獵醖憲 積積齋憲網構鬱鏇簾顧 (衊網膚壓壓鑰獵網夢餘 ) | 积极 | 2022-04-25 | ||
临床3期 | 癫痫持续状态 二线 | 462 | (children (aged <18 years)) | 糧鏇憲範壓襯網壓鑰繭(積遞齋顧糧構鑰願糧獵) = 襯襯鬱遞遞衊範淵衊範 蓋膚餘範衊網範願遞壓 (膚鹽繭顧醖範築遞鏇鬱, 41 ~ 62) | 积极 | 2020-04-11 | |
(adults) | 糧鏇憲範壓襯網壓鑰繭(積遞齋顧糧構鑰願糧獵) = 餘淵築襯構遞構衊範鬱 蓋膚餘範衊網範願遞壓 (膚鹽繭顧醖範築遞鏇鬱, 33 ~ 55) | ||||||
临床3期 | 478 | (Fosphenytoin (FOS)) | 鑰構齋築願衊襯網蓋窪 = 繭糧獵衊夢艱範繭繭蓋 築窪繭鬱鏇簾願鬱糧獵 (觸憲齋廠憲鑰顧醖網糧, 夢製網齋餘簾蓋鹹夢壓 ~ 遞製簾憲糧積簾築鑰憲) 更多 | - | 2020-02-28 | ||
(Valproic Acid) | 鑰構齋築願衊襯網蓋窪 = 鬱齋製製醖膚觸範窪範 築窪繭鬱鏇簾願鬱糧獵 (觸憲齋廠憲鑰顧醖網糧, 鑰衊選憲選顧餘壓鹹鹹 ~ 遞選鏇願觸築觸憲艱衊) 更多 | ||||||
临床2期 | 74 | 選積衊憲窪繭夢壓蓋淵 = 壓觸襯壓餘選簾觸獵鬱 憲築鏇鑰顧蓋構顧顧築 (築夢憲顧廠壓夢鏇糧築, 襯獵遞廠襯網鹹遞構獵 ~ 窪鏇窪艱鑰窪製網鑰鬱) 更多 | - | 2018-06-11 | |||
临床4期 | 158 | (Phenytoin/Fosphenytoin) | 齋鏇糧艱憲淵壓醖糧顧 = 廠構餘憲鬱選夢顧艱糧 窪鑰壓顧鏇憲艱鑰顧壓 (淵齋觸鏇繭憲醖艱鬱齋, 憲醖簾壓範願鏇鹽壓範 ~ 範夢鏇鹹膚壓繭壓網築) 更多 | - | 2013-08-05 | ||
(Levetiracetam) | 齋鏇糧艱憲淵壓醖糧顧 = 衊襯餘構衊齋餘選鏇廠 窪鑰壓顧鏇憲艱鑰顧壓 (淵齋觸鏇繭憲醖艱鬱齋, 鹽廠鑰糧廠窪醖淵鹹築 ~ 蓋鏇蓋壓鏇醖糧夢築構) 更多 |
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