预约演示
更新于：2025-09-01
Fosphenytoin Sodium
磷苯妥英钠
更新于：2025-09-01
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) |
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结构/序列
分子式C16H15N2Na2O6P |
InChIKeyCKBXTXIAQHEVAB-UHFFFAOYSA-N |
CAS号92134-98-0 |
关联
23
项与 磷苯妥英钠 相关的临床试验CTR20251417
磷苯妥英钠注射液人体生物等效性研究
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磷苯妥英钠注射液（T）、磷苯妥英钠注射液（R1）和苯妥英钠注射液（R2）在健康受试者中静脉输注给药的生物等效性试验
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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580
项与 磷苯妥英钠 相关的文献（医药）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.
2025-08-01BMJ Open
Perampanel for alleviation of secondary injury in traumatic brain injury (PEACE-TBI): a protocol for a phase-II multicentre randomised clinical trial
Article
作者: Morimoto, Yukina ; Ishikawa, Konosuke ; Nakaya, Masato ; Sasao, Ryota ; Oishi, Yumiko ; Ozaki, Tatsuro ; Toda, Masahiro ; Murakami, Ryosuke ; Tamura, Ryota ; Nakamura, Akiyoshi ; Sasaki, Junichi ; Shoji, Takahiro ; Terao, Satoshi ; Yamamoto, Ryo ; Katayama, Makoto ; Kikuo, Yo ; Kanazawa, Tokunori ; Kosugi, Kenzo ; Inaba, Makoto ; Ueno, Koichi ; Shimizu, Masayuki ; Kuranari, Yuki ; Wakahara, Sota ; Homma, Koichiro
Introduction:
Traumatic brain injury (TBI) often causes permanent neurological dysfunction. Although no medication has been validated yet to prevent secondary injury of brain tissue, recent animal studies have reported that perampanel, a glutamine receptor antagonist, could improve the neurological functions of animals with TBI by mitigating the abnormal calcium influx and cell death around the site of primary injury. The present study aims to elucidate the efficacy of perampanel administration in improving the neurological function of patients with TBI.
Methods and analysis:
The perampanel for alleviation of secondary injury in TBI trial is a multicentre, phase-II, open-label randomised controlled trial targeting patients with mild-to-moderate TBI. This trial will include adult TBI patients with a Glasgow Coma Scale score of 9–14 from five tertiary centres. Patients with epilepsy as a comorbidity, delayed presentation of symptoms (>24 hours after injury) or Injury Severity Score of ≥25 will be excluded. The study participants will be randomly assigned to either the perampanel group (2 mg/day) or the control group (fosphenytoin administered at a dose of 15–18 mg/kg/day, followed by 5–7.5 mg/kg/day of fosphenytoin). In both groups, the medication will be initiated within 12 hours of the TBI diagnosis and continued for 7 days. The antiepileptic drugs can be increased, changed or added as necessary if early post-traumatic seizures are observed. The primary outcome is favourable neurological outcome, defined as a Glasgow Outcome Scale Extended score of ≥5 at 90 days after the TBI diagnosis, which will then be compared between the groups through an intention-to-treat analysis.
Ethics and dissemination:
The present study has been approved by the Certified Review Board of Keio at the principal institution (approval number: N20240004). Written informed consent will be obtained from all participants or their legal representatives. The results will be disseminated via publications and presentations.
Trial registration number:
Japan Registry of Clinical Trials (jRCTs031250067).
2025-08-01EPILEPSY RESEARCH
Adequate and inadequate dosing of anti-seizure medications in status epilepticus
Article
作者: Smith, Melissa ; Schrader, Susan
BACKGROUND:
Status epilepticus (SE) is defined as five or more minutes of continuous seizures or two or more discrete seizures with incomplete recovery of consciousness.1 The incidence of SE in the United States ranges from 18.3 to 41 per 100,000 patients per year2. Reviews of SE clinical literature demonstrate that 70-75 % of patients did not receive an adequate dose of benzodiazepine according to clinical guidelines. Underdosing of benzodiazepines increases the risk of refractory SE and unfavorable outcomes.8-9 METHODS: This single center retrospective cohort study evaluated the dosing of benzodiazepines and other anti-seizure medications in adult patients with SE. The primary outcomes were incidence of breakthrough seizures in patients with appropriate dosing benzodiazepines compared to inappropriate dosing of benzodiazepines within 24 h of the first dose and incidence of breakthrough seizures in patients with appropriate loading dose of maintenance anti-seizure medication compared to inappropriate loading dose of anti-seizure medication within 24 h of the first dose.
RESULTS:
Thirty-eight patients received adequate benzodiazepine dosing compared to 155 with inadequate dosing. Eighty-seven percent of patients with adequate dosing of benzodiazepine experienced a breakthrough seizure compared to 84 % of patients with inadequate dosing (p = 0.62). Sixty-three percent of patients with adequate dosing of benzodiazepines required first non-benzodiazepine anti-seizure medication compared to 63 % of patients with inadequate dosing (p = 0.76). Breakthrough seizures within 24 h after the first load of non-benzodiazepine anti-seizure medication occurred in 21 % of patients in the adequate dosing group compared to 28 % in the inadequate dosing group (p = 0.73).
CONCLUSION:
While benzodiazepines and rescue anti-seizure medications are frequently underdosed in patients with status epilepticus, there was no difference in recurrent seizures comparted to those with adequate dosing.
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
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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 |
|---|---|---|---|---|
| 急性带状疱疹神经病 | 临床3期 | 日本 | 2022-08-05 | |
| 急性疼痛 | 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
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N/A | 15 | Intravenous fosphenytoin plus oral tapering of phenytoin | 鹹顧淵憲壓餘選淵鑰鏇(窪網繭醖製遞積選範衊) = 壓壓築顧鬱築網願醖壓 憲簾繭憲製夢壓鬱鏇衊 (餘壓鬱糧艱築壓築選簾 ) | 积极 | 2022-04-25 | ||
临床3期 | 癫痫持续状态 二线 | 462 | (children (aged <18 years)) | 網繭鏇製餘範製顧齋鹹(繭顧顧鹹獵構膚積窪願) = 觸觸齋鑰顧願鹹憲範範 壓糧遞窪衊糧製糧廠鑰 (鑰艱艱淵糧願積糧鏇艱, 41 ~ 62) | 积极 | 2020-04-11 | |
(adults) | 網繭鏇製餘範製顧齋鹹(繭顧顧鹹獵構膚積窪願) = 製襯築鹹餘鹽築鬱鹽膚 壓糧遞窪衊糧製糧廠鑰 (鑰艱艱淵糧願積糧鏇艱, 33 ~ 55) | ||||||
临床3期 | 478 | (Fosphenytoin (FOS)) | 廠壓窪製夢鹹鹽襯積壓 = 蓋鏇觸積醖鹹範繭簾憲 窪憲獵衊衊網築簾壓構 (鑰顧積繭糧鬱衊襯遞蓋, 壓膚蓋鏇膚膚積憲齋選 ~ 選簾壓廠鏇憲觸選築積) 更多 | - | 2020-02-28 | ||
(Valproic Acid) | 廠壓窪製夢鹹鹽襯積壓 = 餘廠齋構範製網構餘鏇 窪憲獵衊衊網築簾壓構 (鑰顧積繭糧鬱衊襯遞蓋, 築遞鬱膚鬱醖壓襯製齋 ~ 鑰鹽餘壓窪積鹹蓋獵憲) 更多 | ||||||
临床2期 | 74 | 夢鹹網襯廠觸簾鹽窪顧 = 鹹鏇製遞鑰糧襯襯鑰繭 壓蓋鏇鏇鑰蓋廠構鹽淵 (夢蓋夢醖憲膚夢蓋鏇壓, 鹹廠遞衊窪襯鑰窪壓築 ~ 齋顧糧憲獵糧醖醖構廠) 更多 | - | 2018-06-11 | |||
临床4期 | 158 | (Phenytoin/Fosphenytoin) | 餘醖壓顧膚淵艱鹽廠鏇 = 繭鏇憲淵鬱積淵窪觸齋 觸艱鑰窪網襯蓋遞廠壓 (齋鹹齋選築衊網簾醖範, 廠選衊窪鑰襯鹽鏇鏇網 ~ 觸襯顧憲壓鏇獵簾築觸) 更多 | - | 2013-08-05 | ||
(Levetiracetam) | 餘醖壓顧膚淵艱鹽廠鏇 = 網構顧觸繭糧鹽鑰餘選 觸艱鑰窪網襯蓋遞廠壓 (齋鹹齋選築衊網簾醖範, 繭齋鏇蓋膚餘觸獵窪襯 ~ 壓簾蓋積選選憲襯艱壓) 更多 |
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