直肠用安定凝胶与安慰剂治疗急性重复性癫痫发作的比较。
A comparison of rectal diazepam gel and placebo for acute repetitive seizures.
作者信息
Dreifuss F E, Rosman N P, Cloyd J C, Pellock J M, Kuzniecky R I, Lo W D, Matsuo F, Sharp G B, Conry J A, Bergen D C, Bell W E
机构信息
Department of Neurology, University of Virginia, Charlottesville, USA.
出版信息
N Engl J Med. 1998 Jun 25;338(26):1869-75. doi: 10.1056/NEJM199806253382602.
BACKGROUND
Acute repetitive seizures are readily recognizable episodes involving increased seizure frequency. Urgent treatment is often required. Rectal diazepam gel is a promising therapy.
METHODS
We conducted a randomized, double-blind, parallel-group, placebo-controlled study of home-based treatment for acute repetitive seizures. Patients were randomly assigned to receive either rectal diazepam gel, at a dosage varying from 0.2 to 0.5 mg per kilogram of body weight on the basis of age, or placebo. Children received one dose at the onset of acute repetitive seizures and a second dose four hours later. Adults received three doses -- one dose at onset, and two more doses 4 and 12 hours after onset. Treatment was administered by a care giver, such as a parent, who had received special training. The number of seizures after the first dose was counted for 12 hours in children and for 24 hours in adults.
RESULTS
Of 125 study patients (64 assigned to diazepam and 61 to placebo) with a history of acute repetitive seizures, 91 (47 children and 44 adults) were treated for an exacerbation of seizures during the study period. Diazepam treatment was superior to placebo with regard to the outcome variables related to efficacy: reduced seizure frequency (P<0.001) and improved global assessment of treatment outcome by the care giver (frequency and severity of seizures and drug toxicity) (P<0.001). Post hoc analysis showed diazepam to be superior to placebo in reducing seizure frequency in both children (P<0.001) and adults (P=0.02), but only in children was it superior with regard to improvement in global outcome (P<0.001). The time to the first recurrence of seizures after initial treatment was longer for the patients receiving diazepam (P<0.001). Thirty-five patients reported at least one adverse effect of treatment; somnolence was the most frequent. Respiratory depression was not reported.
CONCLUSIONS
Rectal diazepam gel, administered at home by trained care givers, is an effective and well-tolerated treatment for acute repetitive seizures.
背景
急性重复性癫痫发作是癫痫发作频率增加的明显可识别发作。通常需要紧急治疗。直肠地西泮凝胶是一种有前景的治疗方法。
方法
我们进行了一项针对急性重复性癫痫发作家庭治疗的随机、双盲、平行组、安慰剂对照研究。患者根据年龄随机分配接受直肠地西泮凝胶，剂量为每公斤体重0.2至0.5毫克，或安慰剂。儿童在急性重复性癫痫发作开始时接受一剂，4小时后再接受一剂。成人接受三剂——发作时一剂，发作后4小时和12小时各一剂。治疗由经过特殊培训的护理人员（如家长）进行。在儿童中，首次给药后12小时内计数癫痫发作次数，在成人中则为24小时。
结果
在125例有急性重复性癫痫发作病史的研究患者中（64例分配接受地西泮治疗，61例接受安慰剂治疗），91例（47例儿童和44例成人）在研究期间因癫痫发作加重接受治疗。在地西泮治疗组中，与疗效相关的结果变量方面优于安慰剂组：癫痫发作频率降低（P<0.001），护理人员对治疗结果的总体评估改善（癫痫发作的频率和严重程度以及药物毒性）（P<）。事后分析显示，地西泮在降低儿童（P<0.001）和成人（P=0.02）癫痫发作频率方面优于安慰剂，但仅在儿童中，在总体结果改善方面更优（P<0.001）。接受地西泮治疗的患者在初始治疗后首次癫痫复发的时间更长（P<0.001）。35例患者报告了至少一种治疗不良反应；嗜睡是最常见的。未报告呼吸抑制。
结论
由经过培训的护理人员在家中给予直肠地西泮凝胶，是治疗急性重复性癫痫发作的一种有效且耐受性良好的方法。 001
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