Division of Pediatric Neurology, Chang Gung Memorial Hospitals in Keelung and Taoyuan, Chang Gung Children's Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Pediatr Neonatol. 2011 Feb;52(1):30-3. doi: 10.1016/j.pedneo.2010.12.009. Epub 2011 Feb 16.
Acute seizures are readily recognizable episodes requiring urgent treatment. This study was conducted to compare the efficacy and safety of suppository use of rectal diazepam solution [Stesolid rectal tube (SRT), Alpharma, Inc., Lierskogen, Norway] with those of intravenous diazepam (IVD), Li Ta Pharma Co, Ltd., Taichung, Taiwan for control of acute seizures in children with intractable epilepsy.
Subjects were patients, aged 1-18 years, with intractable epilepsy under at least three kinds of antiepileptic treatments. Caregivers were trained to rectally administer SRT or IVD (dosage varying from 0.2 to 0.5mg per kilogram of body weight) and to monitor respiration condition, seizure severity, and adverse drug effects.
Among the 24 subjects, 9 males and 15 females, treated for a period of 3 months, the ages ranged from 2 to 18 years, with a mean of 9.1 years. Seizure types were generalized tonic and/or clonic. Seizure frequency varied from once per week to 20 times per day. Twenty-one (87.5%) of them had mental retardation and/or developmental delay, and 103 of the 127 (81.1%) IVD administrations and 90 of the 103 (87.3%) SRT administrations resulted in rapid cessation of seizures within 10 minutes. Each first dose failed to control seizures in 24 and 13 episodes, respectively. A second dose of IVD achieved cessation of seizure in 21 of the 24 episodes and a second dose of SRT in 12 of the 13 episodes within another 10 minutes. Four episodes (3 with rectal IVD and 1 with SRT) of prolonged seizure beyond 20 minutes needed IVD injection at our emergency room. Sedation occurred in 17% of patients, which was attributed to IVD in 8% and SRT in 9% of patients. No respiratory depression was attributable to IVD or SRT. There was no significant statistical difference in efficacy and safety between these two forms of diazepam.
Rectal diazepam solution, administered by capable caregivers, is as effective and safe as rectal administration of IVD for children with intractable epilepsy.
急性发作是需要紧急治疗的易于识别的发作。本研究旨在比较直肠给予地西泮溶液栓剂（Stesolid 直肠管（SRT），Alpharma，Inc.，Lierskogen，挪威）与静脉给予地西泮（IVD）的疗效和安全性，以控制难治性癫痫儿童的急性发作。
研究对象为年龄在 1-18 岁的难治性癫痫患者，接受至少三种抗癫痫药物治疗。培训护理人员经直肠给予 SRT 或 IVD（剂量为 0.2 至 0.5mg/kg 体重），并监测呼吸状况、癫痫发作严重程度和药物不良反应。
24 名受试者中，9 名男性和 15 名女性，治疗期为 3 个月，年龄 2-18 岁，平均 9.1 岁。癫痫发作类型为全面强直阵挛发作和/或强直阵挛发作。发作频率从每周一次到每天 20 次不等。21 例（87.5%）存在智力低下和/或发育迟缓，103 次 IVD 给药和 90 次 SRT 给药中有 103 次（81.1%）和 90 次（87.3%）在 10 分钟内迅速停止发作。第一次剂量未能控制发作的分别有 24 次和 13 次。第二次 IVD 剂量在 24 次发作中有 21 次，第二次 SRT 剂量在 13 次发作中有 12 次在另外 10 分钟内停止发作。4 次发作（直肠 IVD 3 次，直肠 SRT 1 次）超过 20 分钟的发作需要在我们的急诊室注射 IVD。17%的患者出现镇静，其中 8%归因于 IVD，9%归因于 SRT。IVD 或 SRT 均未引起呼吸抑制。两种形式的地西泮在疗效和安全性方面无统计学差异。
有能力的护理人员直肠给予地西泮溶液，与直肠给予 IVD 治疗难治性癫痫儿童一样有效且安全。
