Pinter M M, Pogarell O, Oertel W H
Ludwig-Boltzmann-Institute for Restorative Neurology and Neuromodulation, Neurological Hospital Maria Theresien Schloessl, Vienna, Austria.
J Neurol Neurosurg Psychiatry. 1999 Apr;66(4):436-41. doi: 10.1136/jnnp.66.4.436.
Pramipexole, a non-ergot dopamine D2/D3 receptor agonist, was investigated as an add on drug in advanced parkinsonian patients with motor fluctuations to assess efficacy, safety, and tolerance.
Seventy eight patients of either sex with advanced Parkinson's disease and treatment complications such as motor fluctuations were enrolled into a double blind, placebo controlled, randomised, multicentre study (phase II) and assigned to add on treatment with pramipexole (n=34) versus placebo (n=44) to a previously stabilised antiparkinsonian medication (7 week dose titration interval, 4 week maintenance period). The primary end point of efficacy was the change from baseline in the total score of the unified Parkinson's disease rating scale (UPDRS) in the on "period" (2 hours after intake of study medication). Safety and tolerability were assessed on the basis of adverse events, vital signs, laboratory measurements, and ECG recordings.
There was a significant improvement of the pramipexole group in UPDRS total scores, subscores part II, III (activities of daily living and motor examination), and IV (complications of therapy). Mean UPDRS total score decreased by 37.3% under pramipexole compared with 12.2% under placebo (p<0.001). Patients under pramipexole reported an overall reduction in "off" periods of 12%--resulting in 1.7 more hours "on" time a day--compared with an increase in "off" periods of 2% under placebo. There were no unexpected safety results. The adverse event profile disclosed a high tolerability. The most important adverse events under pramipexole were fatigue, dyskinesia, and vivid dreams.
Pramipexole administration is an efficacious and well tolerated add on therapy in patients with advanced Parkinson's disease with an improvement in activities of daily living, motor function, and treatment associated complications.
普拉克索是一种非麦角类多巴胺D2/D3受体激动剂，作为附加药物用于治疗有运动波动的晚期帕金森病患者，以评估其疗效、安全性和耐受性。
78例患有晚期帕金森病且有运动波动等治疗并发症的患者被纳入一项双盲、安慰剂对照、随机、多中心研究（II期），并被分配接受普拉克索（n = 34）或安慰剂（n = 44）附加治疗，同时继续使用之前已稳定的抗帕金森病药物（剂量滴定间隔7周，维持期4周）。疗效的主要终点是在“开”期（服用研究药物2小时后）统一帕金森病评定量表（UPDRS）总分相对于基线的变化。根据不良事件、生命体征、实验室检查和心电图记录评估安全性和耐受性。
普拉克索组的UPDRS总分、II部分、III部分（日常生活活动和运动检查）及IV部分（治疗并发症）的子分数均有显著改善。与安慰剂组12.2%的降低相比，普拉克索组的UPDRS总分平均降低了37.3%（p < 0.001）。与安慰剂组“关”期增加2%相比，接受普拉克索治疗的患者报告“关”期总体减少了12%，即每天“开”的时间增加了1.7小时。未出现意外的安全性结果。不良事件表明其耐受性良好。普拉克索治疗下最重要的不良事件是疲劳、运动障碍和生动梦境。
对于晚期帕金森病患者，普拉克索给药是一种有效且耐受性良好的附加治疗方法，可改善日常生活活动、运动功能及与治疗相关的并发症。
