Cereghino J J, Mitchell W G, Murphy J, Kriel R L, Rosenfeld W E, Trevathan E
Oregon Health Sciences University, Portland 97201-3098, USA.
Neurology. 1998 Nov;51(5):1274-82. doi: 10.1212/wnl.51.5.1274.
To evaluate the effectiveness and safety of a single-dose treatment for acute repetitive seizure (ARS) episodes (e.g., clusters) administered in a nonmedical setting by caregivers.
Patients with epilepsy may experience ARS episodes despite optimal anticonvulsant treatment. Such episodes require rapid treatment as medical emergencies. Typically, the patient is treated in an emergency medical setting with i.v. medication by trained medical personnel.
The authors undertook a multicenter, randomized, parallel, double-blind study of a single administration of Diastat (diazepam rectal gel) for treating episodes of ARS. ARS episodes and treatment criteria were defined for each patient at the start of the study. Caregivers were taught to determine ARS episode onset, administer a predetermined dose of study medication, monitor outcome, count respirations, and record seizures and adverse events.
A total of 29 centers enrolled 158 patients, of whom 114 patients had a treated ARS episode (Diastat, n = 56; placebo, n = 58). Diastat treatment reduced median seizure frequency (p = 0.029). More Diastat patients were seizure free post-treatment (Diastat, 55%; placebo, 34%; p = 0.031). Kaplan-Meier analysis of the time to the next seizure favored Diastat treatment (p < 0.007). The most common adverse event was somnolence.
Administration of a single rectal dose of Diastat was significantly more effective than placebo in reducing the number of seizures following an episode of ARS. Caregivers could administer treatment safely and effectively in a nonmedical setting.
评估护理人员在非医疗环境中给予单剂量治疗急性重复性癫痫发作（ARS，如癫痫丛集发作）的有效性和安全性。
尽管接受了最佳抗惊厥治疗，癫痫患者仍可能经历ARS发作。此类发作作为医疗紧急情况需要迅速治疗。通常，患者在急诊医疗环境中由训练有素的医务人员通过静脉用药进行治疗。
作者进行了一项多中心、随机、平行、双盲研究，单次给予地西泮直肠凝胶（Diastat）治疗ARS发作。在研究开始时为每位患者定义了ARS发作及治疗标准。教导护理人员确定ARS发作的开始、给予预定剂量的研究药物、监测结果、计数呼吸以及记录癫痫发作和不良事件。
共有29个中心纳入了158例患者，其中114例患者有经治疗的ARS发作（地西泮直肠凝胶组，n = 56；安慰剂组，n = 58）。地西泮直肠凝胶治疗降低了癫痫发作频率的中位数（p = 0.029）。更多接受地西泮直肠凝胶治疗的患者治疗后无癫痫发作（地西泮直肠凝胶组，55%；安慰剂组，34%；p = 0.031）。对下次癫痫发作时间的Kaplan-Meier分析显示地西泮直肠凝胶治疗更具优势（p < 0.007）。最常见的不良事件是嗜睡。
单次直肠给予地西泮直肠凝胶在减少ARS发作后的癫痫发作次数方面显著优于安慰剂。护理人员可在非医疗环境中安全有效地进行治疗。
