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为了确定直肠地西泮凝胶(商品名Diastate)治疗急性癫痫反复发作的功效和安全性,将125例病人(年龄2~60岁)随机分为两组(分别接受地西泮0.2~0.5mg/kg和安慰剂)进行随机双盲平行安慰剂对照研究。儿童均用药两次,癫痫发作开始时1次,4h后再用1次;成人用药3次,开始1次,开始后的4h和12h再各用药1次。
In order to determine the efficacy and safety of rectal diazepam (trade name Diastate) in the treatment of recurrent acute epileptic seizures, 125 patients (age 2 to 60 years) were randomized to receive either 0.2-0.5 mg diazepam / kg and placebo) were randomized double-blind parallel placebo-controlled study. Children were treated twice, once at the onset of seizures, and once more after 4 hours; 3 times for adult use, once for 1 second and 4 hours and 12 hours after the start of treatment.