Heitmann J, Cassel W, Grote L, Bickel U, Hartlaub U, Penzel T, Peter J H
Department of Medicine, Marburg University, Germany.
Clin Pharmacol Ther. 1999 Mar;65(3):328-35. doi: 10.1016/S0009-9236(99)70112-8.
To investigate the effects of modafinil, a central nonamphetamine awakening substance, on blood pressure and heart rate in hypersomnolent patients with obstructive sleep apnea.
This double-blind, randomized, placebo-controlled crossover trial was performed over 2 days and 3 nights in a single-center study of hospitalized patients from a referred care center. Twenty-six otherwise healthy men (age range, 30 to 60 years) with mild to moderate obstructive sleep apnea were recruited by the outpatient department of the Marburg University Sleep Laboratory. Patients were given 200 mg oral modafinil in the morning and 100 mg at midday. Placebo was given in the same manner in a crossover design. Mean arterial (radial) blood pressure was monitored continuously during nocturnal sleep and during a series of standardized daytime physical and psychologic performance tests.
The difference in the main end point between the treatment with modafinil and placebo was 1.17+/-0.83 (mean +/- SE) mm Hg (95% confidence interval: -0.56 to 2.91 mm Hg). The maximal differences in blood pressure values occurred under loaded conditions (systolic blood pressure, ergometry: 5.62+/-1.13 mm Hg; mental stress test: 6.19+/-1.33 mm Hg).
Short-term administration of modafinil did not elicit a significant response with regard to the main end point. However, cardiovascular effects during mental and physical load were observed. Longterm studies that include subjects with hypertension are necessary to investigate the clinical relevance of the cardiovascular effects of modafinil.
研究中枢非苯丙胺类觉醒物质莫达非尼对阻塞性睡眠呼吸暂停低通气综合征患者血压和心率的影响。
本双盲、随机、安慰剂对照交叉试验在一家转诊护理中心对住院患者进行了为期2天3夜的单中心研究。马尔堡大学睡眠实验室门诊部招募了26名患有轻度至中度阻塞性睡眠呼吸暂停的健康男性（年龄范围30至60岁）。患者早晨口服200mg莫达非尼，中午口服100mg。采用交叉设计以相同方式给予安慰剂。在夜间睡眠期间以及一系列标准化的白天身体和心理性能测试期间持续监测平均动脉（桡动脉）血压。
莫达非尼治疗组与安慰剂组主要终点的差异为1.17±0.83（均值±标准误）mmHg（95%置信区间：-0.56至2.91mmHg）。血压值的最大差异出现在负荷条件下（收缩压，测力计测试：5.62±1.13mmHg；心理应激测试：6.19±1.33mmHg）。
短期服用莫达非尼在主要终点方面未引起显著反应。然而，观察到了精神和身体负荷期间的心血管效应。有必要开展纳入高血压患者的长期研究，以调查莫达非尼心血管效应的临床相关性。
