背景:尽管及时治疗癫痫持续状态是治疗的标准,对癫痫患者群发性发作的抢救治疗时机的影响尚不清楚.癫痫发作是一种罕见但临床上很重要的疾病,和苯二氮卓类药物是治疗癫痫发作的基石。在地西泮鼻喷雾剂的安全性研究中,我们从治疗的癫痫发作簇的大数据集中表征了时间模式。
方法:本事后分析使用了护理伙伴和患者在1年安全性研究中记录的治疗后癫痫发作集群的时间数据。数据分析使用从癫痫发作开始到服用地西泮的时间。
结果:从4466个观察结果来看,3225的数据符合分析标准。总的来说,从癫痫发作开始到剂量给药的中位时间,给药至癫痫发作终止,总发作持续时间为2、3和7分钟,分别。在<5分钟(中位数1.0分钟)内治疗的癫痫发作群中,从剂量到癫痫发作终止的中位时间为2.0分钟,中位总发作持续时间为4.0min。在≥5分钟(中位数10.0分钟)内治疗的癫痫发作群中,癫痫发作终止的中位时间为10.0分钟,中位总发作持续时间为23.0min。以前发表的安全性结果报告说,平均参与1.5年,82.2%的患者出现≥1例治疗引起的不良事件(TEAE),与治疗无关。包括30.7%的严重TEAE;18.4%的TEAE被认为至少可能与研究药物有关,没有一个是严重的。没有心肺抑制事件。
结论:重申早期使用苯二氮卓类药物治疗癫痫持续状态的重要性,对难治性癫痫和频繁发作性癫痫患者进行的探索性分析发现,早期地西泮鼻喷雾剂治疗可使癫痫发作群内的癫痫发作得到更快的缓解.试用注册信息:ClinicalTrials.gov标识符NCT02721069(https://clinicaltrials.gov/ct2/show/NCT02721069)。
一些每天服用抗癫痫药物的癫痫患者可能仍然有癫痫发作。其中一些癫痫发作可能是紧急情况,可以用救援药物治疗。对于癫痫持续状态,一旦认识到这种癫痫发作紧急情况,就应给予抢救治疗。癫痫群很少见,也可能成为紧急情况,但到目前为止,还不清楚早期治疗是否会更好。地西泮鼻喷雾剂是一种被批准用于治疗癫痫发作的抢救药物。该报告使用了地西泮鼻喷雾剂在每年需要治疗≥6次的人群中安全性研究的数据。我们查看了癫痫发作群中癫痫发作开始到给予抢救治疗的时间。我们还研究了从接受抢救治疗到特定癫痫发作停止的时间。对于一些癫痫发作集群,在癫痫发作后<5分钟内给予抢救药物;平均而言,这些癫痫发作在抢救治疗后2分钟内停止。从癫痫发作集群中的癫痫发作开始到停止时的总时间为4分钟。相比之下,对于5分钟后治疗的癫痫发作簇,治疗后平均10分钟内癫痫发作停止。总的来说,这些癫痫发作持续了23分钟。总之,这项分析发现,当地西泮鼻用喷雾剂较早时,癫痫发作群中的癫痫发作结束得更快。这些发现表明,一旦识别出癫痫发作,选择患者和护理人员就不应该等待治疗。
BACKGROUND: Although prompt treatment of status epilepticus is standard of care, the effect of timing of rescue therapy administration for seizure clusters in epilepsy remains unknown. Seizure clusters are a rare but clinically important condition, and benzodiazepines are the cornerstone rescue therapy for seizure clusters in epilepsy. We characterized temporal patterns from a large dataset of treated seizure clusters in the safety study of diazepam nasal spray.
METHODS: This post hoc analysis used timing data of treated seizure clusters recorded by care partners and patients in seizure diaries during a 1-year safety study. Data analysis used time from seizure start to administration of diazepam.
RESULTS: From 4466 observations, 3225 had data meeting criteria for analysis. Overall, median times from seizure start to dose administration, dose administration to seizure termination, and total seizure duration were 2, 3, and 7 min, respectively. In seizure clusters treated in < 5 min (median 1.0 min), median time from dose to seizure termination was 2.0 min, and median total seizure duration was 4.0 min. Among seizure clusters treated in ≥ 5 min (median 10.0 min), median time to seizure termination was 10.0 min, and median total seizure duration was 23.0 min. Previously published safety results reported that over a mean participation of 1.5 years, 82.2% of patients had ≥ 1 treatment-emergent adverse events (TEAEs) irrespective of relationship to treatment, including 30.7% with serious TEAEs; 18.4% had TEAEs deemed at least possibly related to the study drug, none of which were serious. There were no events of cardiorespiratory depression.
CONCLUSIONS: Echoing the importance of early use of benzodiazepines in status epilepticus, the findings from this exploratory analysis of patients with refractory epilepsy and frequent seizure clusters identify a potential benefit of early diazepam nasal spray treatment leading to faster seizure resolution within the seizure cluster. Trial Registration Information: ClinicalTrials.gov identifier NCT02721069 ( https://clinicaltrials.gov/ct2/show/NCT02721069 ).
Some people with epilepsy who take daily antiseizure drugs might still have seizures. Some of these seizures may be emergencies that can be treated with rescue medicine. For status epilepticus, rescue treatment should be given as soon as this seizure emergency is recognized. Seizure clusters are rare and might also become emergencies, but until now it had not been clear if earlier treatment would be better. Diazepam nasal spray is a rescue medicine approved to treat seizure clusters. The report used data from a study of the safety of diazepam nasal spray in people needing treatment ≥ 6 times a year. We looked at the time the seizure in a seizure cluster started to the time rescue treatment was given. We also looked at the time from taking rescue treatment to the time when that specific seizure stopped. For some seizure clusters, rescue medicine was given in < 5 min after the seizure started; on average, these seizures stopped within 2 min after rescue treatment. The total time from the start of the seizure in the seizure cluster to when it stopped was 4 min. In contrast, for seizure clusters treated after 5 min, the seizures stopped in an average of 10 min after treatment. Overall, these seizures lasted 23 min. In conclusion, this analysis found that seizures in a seizure cluster ended more quickly when diazepam nasal spray was given sooner. These findings are suggestive that select patients and caregivers should not wait to treat a seizure cluster once it has been identified.