Mitler M M, Shafor R, Hajdukovich R, Timms R M, Browman C P
Sleep. 1986;9(1 Pt 2):260-4. doi: 10.1093/sleep/9.1.260.
Methylphenidate, pemoline, and protriptyline were studied for their treatment efficacy in narcolepsy. A low, intermediate, and high dose level of each drug was studied for 1 week. For methylphenidate the doses were 10, 30, or 60 mg/day; for pemoline, 18.75, 56.25, or 112.5 mg/day; and for protriptyline 10, 30, or 60 mg/day. The order of dose levels was random from subject to subject and the daily dose was divided into thirds and taken in identically appearing capsules morning, noon, and afternoon. Subjects were 6 narcoleptic patients studied on methylphenidate (5 women and 1 man; mean age 54.5 + 11.7 years), 7 narcoleptic patients studied on pemoline (5 women and 2 men; mean age 43.0 + 7.1 years), and 4 narcoleptic patients studied on protriptyline (2 women and 2 men; mean age 42.5 + 16.9 years). Testing consisted of day-long sessions occurring at the end of each dose level and involving a clinical status questionnaire as well as maintenance of wakefulness, Wilkinson addition, and Digit-Symbol Substitution tests. Results were compared with 9 control subjects with no sleep disorder (5 women and 4 men; mean age 39.2 + 8.4 years) who were given placebo that was purported to be a "stimulant drug" and tested in a similar manner. Results demonstrated profound differences in ability to stay awake and perform between narcoleptic patients and controls. Data also suggested that methylphenidate significantly improves ability to stay awake. Pemoline seems to improve ability to perform. Protriptyline does not significantly alter ability to stay awake or to perform.
对哌甲酯、匹莫林和普罗替林治疗发作性睡病的疗效进行了研究。每种药物设置了低、中、高三个剂量水平,研究周期为1周。哌甲酯的剂量分别为10、30或60毫克/天;匹莫林为18.75、56.25或112.5毫克/天;普罗替林为10、30或60毫克/天。剂量水平的顺序在受试者之间是随机的,每日剂量分为三等份,分别装入外观相同的胶囊,于上午、中午和下午服用。受试者为6名接受哌甲酯研究的发作性睡病患者(5名女性和1名男性;平均年龄54.5±11.7岁)、7名接受匹莫林研究的发作性睡病患者(5名女性和2名男性;平均年龄43.0±7.1岁)以及4名接受普罗替林研究的发作性睡病患者(2名女性和2名男性;平均年龄42.5±16.9岁)。测试包括在每个剂量水平结束时进行的为期一天的测试环节,涉及一份临床状况问卷以及清醒度维持测试、威尔金森加法测试和数字符号替换测试。将结果与9名无睡眠障碍的对照受试者(5名女性和4名男性;平均年龄39.2±8.4岁)进行比较,这些对照受试者服用了据称是“兴奋剂药物”的安慰剂,并以类似方式进行测试。结果表明,发作性睡病患者和对照受试者在保持清醒和执行任务的能力方面存在显著差异。数据还表明,哌甲酯能显著提高保持清醒的能力。匹莫林似乎能提高执行任务的能力。普罗替林对保持清醒或执行任务的能力没有显著影响。