Myllylä V V, Heinonen E H, Vuorinen J A, Kilkku O I, Sotaniemi K A
Department of Neurology, Oulu University Hospital, Finland.
Acta Neurol Scand. 1995 Mar;91(3):177-82. doi: 10.1111/j.1600-0404.1995.tb00429.x.
In an earlier report of our placebo-controlled selegiline trial on de novo parkinsonian patients, we have shown that the need to start additional levodopa therapy is significantly postponed by using selegiline monotherapy. Now we report the two-year interim results of the double-blind continuation of the trial in 44 patients after the introduction of levodopa to the earlier therapy with placebo or selegiline (21 and 23 patients, respectively). The clinical disability was assessed by three rating scales. The daily dose of levodopa needed to maintain an optimal condition had to be increased progressively up to a 52% higher level in the placebo group than in the selegiline group (543 +/- 150 and 358 +/- 117 mg, respectively, p < 0.001). The number of daily doses of levodopa was also statistically significantly higher in the placebo group during the 24 months' observation period (p < 0.01). The ratio of levodopa doses that was expected to stay the same contrarily significantly increased suggesting that selegiline would, besides having the levodopa potentiating effect, also have a beneficial influence on the progression of the basic cerebral dopamine deficiency. The combination of selegiline and levodopa was well tolerated, and the adverse event profiles did not differ from each other. In conclusion, early selegiline therapy allows a significant saving in the subsequent levodopa dosage. This saving seems to become even stronger along with the treatment time.
在我们之前关于初发帕金森病患者的司来吉兰安慰剂对照试验报告中,我们已经表明,使用司来吉兰单药治疗可显著推迟开始额外左旋多巴治疗的需求。现在我们报告在44例患者中,在早期使用安慰剂或司来吉兰治疗后引入左旋多巴,该试验双盲延续的两年中期结果(分别为21例和23例患者)。通过三种评定量表评估临床残疾情况。在安慰剂组中,维持最佳状态所需的左旋多巴日剂量必须逐渐增加,比司来吉兰组高出52%(分别为543±150和358±117毫克,p<0.001)。在24个月的观察期内,安慰剂组的左旋多巴每日剂量数在统计学上也显著更高(p<0.01)。预期保持不变的左旋多巴剂量比反而显著增加,这表明司来吉兰除了具有左旋多巴增效作用外,还对基础脑多巴胺缺乏的进展有有益影响。司来吉兰和左旋多巴的联合用药耐受性良好,不良事件谱彼此无差异。总之,早期司来吉兰治疗可显著节省后续左旋多巴剂量。随着治疗时间的延长,这种节省似乎会更加明显。