University Hospital Dresden, Dresden, Germany.
Drug Alcohol Depend. 2011 Sep 1;117(2-3):190-7. doi: 10.1016/j.drugalcdep.2011.01.017. Epub 2011 Feb 25.
Despite the fact that buprenorphine is effective, well tolerated and due to its pharmacological profile a very safe drug, the impact of long-term buprenorphine substitution therapy on complex psychomotor and cognitive function predicting driving ability is not yet clear. Therefore, a prospective comparison between patients receiving sublingual buprenorphine and a control group of untreated, healthy volunteers was performed.
Treated and untreated subjects were matched for age and sex, with three control subjects selected for every buprenorphine patient. Patients using unreported drugs were included in the intention-to-treat (ITT) analysis; the remaining patients were analysed as the per-protocol (PP) group. The test battery comprised the assessment of: performance during stress, visual orientation, concentration, attention, vigilance and reaction time. The primary endpoint was defined as the sum of the relevant scores of the tests after z-transformation of the individual scores.
30 patients with sublingual buprenorphine treatment (7.7±3.9 mg per day) were matched to 90 controls. 19 patients were excluded from the PP-analysis because of additional unreported drug intake. Significant non-inferiority could be demonstrated for the PP-group (p<0.05) as well as for the ITT-group (p<0.001).
Patients receiving a stable dose of sublingual buprenorphine showed no significant impairment of complex psychomotor or cognitive performance as compared to healthy controls. However intake of illicit drugs as well as the lack of social reliability are major problems in this specific patients group. Despite of the absence of a relevant impact of the drug on driving ability, those patients do not seem to be qualified for getting their driving license.
尽管丁丙诺啡有效、耐受性良好，且由于其药理学特性，是一种非常安全的药物，但长期丁丙诺啡替代治疗对复杂的精神运动和认知功能（预测驾驶能力）的影响尚不清楚。因此，我们对接受舌下丁丙诺啡治疗的患者与未经治疗的健康志愿者对照组进行了前瞻性比较。
治疗组和未治疗组按年龄和性别匹配，每例丁丙诺啡患者选择 3 名对照者。纳入接受未报告药物治疗的患者进行意向治疗（ITT）分析；其余患者按方案（PP）分析。测试组合包括：应激期间的表现、视觉定向、注意力、警觉性和反应时间的评估。主要终点定义为个体分数的 z 变换后的相关测试分数之和。
30 例接受舌下丁丙诺啡治疗的患者（每天 7.7±3.9mg）与 90 例对照者相匹配。19 例患者因额外的未报告药物摄入而被排除在 PP 分析之外。PP 组（p<0.05）和 ITT 组（p<0.001）均显示出显著的非劣效性。
与健康对照者相比，接受稳定剂量舌下丁丙诺啡治疗的患者复杂精神运动或认知功能没有明显受损。然而，非法药物的摄入以及社会可靠性的缺乏是该特定患者群体的主要问题。尽管该药物对驾驶能力没有显著影响，但这些患者似乎没有获得驾驶执照的资格。
