Peters Jurriaan M, Becker Danielle A, Misra Sunita N, Carrazana Enrique, Rabinowicz Adrian L
Department of Neurology, Harvard Medical School and Boston Children's Hospital, Boston, MA, USA.
Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Patient Prefer Adherence. 2024 Feb 7;18:383-389. doi: 10.2147/PPA.S447028. eCollection 2024.
In the US, 3 rescue treatment options are approved for patients with seizure clusters (ie, acute repetitive seizures), which are intermittent increases of seizure activity. This narrative PubMed review of these 3 treatments examines newer intranasal options that are well suited for adolescent and adult patients who may desire a transition from rectal treatment. Diazepam rectal gel is indicated for patients ≥2 years, diazepam nasal spray for those ≥6 years, and midazolam nasal spray for those ≥12 years. Approvals for diazepam rectal gel and midazolam nasal spray were based on safety and efficacy comparisons with placebo. Approval for diazepam nasal spray was based on results from long-term safety and tolerability studies in addition to its comparable bioavailability to diazepam rectal gel, while also showing less interpatient variability. The safety profiles of diazepam rectal gel and nasal spray are similar, and the medications share safety, warning, and precaution labeling. Thus, patients ≥6 years could be introduced to intranasal diazepam, allowing for continuity of familiar treatment while improving access and comfort. Intranasal midazolam also has a well-characterized safety profile. A proxy for effectiveness is the number of seizure clusters that were treated with a single dose, and these differed in separate, noncomparative studies. The safety and effectiveness of diazepam nasal spray have been examined in multiple subpopulations, whereas patient/caregiver experiences with both approved intranasal formulations have been characterized. Users may prefer nasal administration because it is noninvasive and effective, and provides social advantages, comfort, ease of use, and less variability compared with rectal gel. Nasal sprays are portable and convenient for use in the community (school, work, travel), and self-administration was reported in one study, with patients as young as 11 years old self-administering diazepam nasal spray. These newer, intranasal rescue treatments for seizure clusters provide an alternative to the rectal route.
在美国,3种急救治疗方案已被批准用于癫痫丛集发作(即急性重复性癫痫发作,为癫痫活动的间歇性增加)患者。本对这3种治疗方法的叙述性PubMed综述探讨了更适合可能希望从直肠给药过渡的青少年和成年患者的新型鼻内给药方案。地西泮直肠凝胶适用于≥2岁的患者,地西泮鼻喷雾剂适用于≥6岁的患者,咪达唑仑鼻喷雾剂适用于≥12岁的患者。地西泮直肠凝胶和咪达唑仑鼻喷雾剂的批准基于与安慰剂的安全性和有效性比较。地西泮鼻喷雾剂的批准基于长期安全性和耐受性研究的结果,以及其与地西泮直肠凝胶相当的生物利用度,同时还显示出较小的患者间变异性。地西泮直肠凝胶和鼻喷雾剂的安全性概况相似,两种药物的安全性、警示和预防标签相同。因此,≥6岁的患者可以使用鼻内地西泮,在改善给药途径和舒适度的同时,保持熟悉治疗的连续性。鼻内咪达唑仑也有明确的安全性概况。有效性的一个指标是单次给药治疗的癫痫丛集发作次数,在单独的非对照研究中这些次数有所不同。地西泮鼻喷雾剂的安全性和有效性已在多个亚组中进行了研究,而患者/护理人员对两种已批准的鼻内制剂的使用体验也已得到描述。使用者可能更喜欢鼻内给药,因为它无创且有效,并且与直肠凝胶相比具有社交优势、舒适度高、使用方便且变异性小。鼻喷雾剂便于携带,便于在社区(学校、工作场所、旅行)使用,一项研究报告了自我给药情况,年仅11岁的患者可自行使用地西泮鼻喷雾剂。这些用于癫痫丛集发作的新型鼻内急救治疗方法为直肠给药途径提供了一种替代方案。