Gaertner J, Radbruch L, Giesecke T, Gerbershagen H, Petzke F, Ostgathe C, Elsner F, Sabatowski R
Department of Palliative Care, University of Cologne, Cologne, Germany.
Acta Anaesthesiol Scand. 2006 Jul;50(6):664-72. doi: 10.1111/j.1399-6576.2006.01027.x.
The therapeutic use of opioids can be associated with altered cognition and impaired psychomotor function. Several studies have demonstrated the impact of opioid therapy on psychomotor performance and cognition, but no data exist about the effect of long-term treatment with controlled release oxycodone (CRO) on driving ability.
Thirty patients suffering from chronic non-cancer pain who had been treated with stable doses of CRO where included in a prospective trial and compared with 90 healthy volunteers (matched pairs). A computerized test battery that was developed to assess the driving ability of traffic delinquents in Germany was employed. Attention reaction, visual orientation, motor coordination and vigilance were evaluated. The data from a total of 11 parameters were assessed and for each test a relevant score was defined. As the primary endpoint the sum score of the three relevant scores was determined. A weaker statistical means to assess the patients' performance is to compare the test results with an age-independent control group. Individuals performing worse than the 16th percentile of this control group are considered to be unable to drive according to German legislation.
Significant non-inferiority could not be demonstrated for the primary endpoint. However, driving ability as defined as a result above the 16th percentile did not differ significantly between the patients receiving CRO and the age-independent control group.
The use of CRO does not prohibit driving, but individual assessment is necessary.
阿片类药物的治疗用途可能与认知改变和精神运动功能受损有关。多项研究已证明阿片类药物治疗对精神运动表现和认知的影响，但关于控释羟考酮（CRO）长期治疗对驾驶能力的影响尚无数据。
30名患有慢性非癌性疼痛且已接受稳定剂量CRO治疗的患者纳入一项前瞻性试验，并与90名健康志愿者（配对）进行比较。采用了一种为评估德国交通违法者驾驶能力而开发的计算机化测试组。评估了注意力反应、视觉定向、运动协调性和警觉性。评估了总共11个参数的数据，并为每个测试定义了一个相关分数。作为主要终点，确定了三个相关分数的总和。一种较弱的评估患者表现的统计方法是将测试结果与一个与年龄无关的对照组进行比较。根据德国法律，表现低于该对照组第16百分位数的个体被认为无法驾驶。
主要终点未显示出显著的非劣效性。然而，接受CRO治疗的患者与与年龄无关的对照组之间，以高于第16百分位数的结果定义的驾驶能力没有显著差异。
使用CRO并不禁止驾驶，但需要进行个体评估。
