Eichhorn T E, Schrag A, Trenkwalder C, Selzer R, Kohnen R, Oertel W H, Poewe W
Neurologische Klinik, Klinikum Grosshadern, Universität München.
Nervenarzt. 1995 Dec;66(12):933-41.
In an open label study 63 patients with idiopathic Parkinson's disease suffering from end-of-dose akinesia were switched from a treatment with a L-DOPA standard formulation to a combined therapy of L-DOPA standard in the morning and L-DOPA slow release (levodopa, benserazide, Madopar Depot) at the remaining single doses. Substitution of L-DOPA standard by L-DOPA slow release took on average 2-4 weeks. Patients were subsequently treated for 6 months. Due to a lower bioavailability of the slow release formulation--the latter is based on the "hydrodynamically balanced system" (HBS)--, the patients remained initially on their time schedule of drug intake but received a higher dose of L-DOPA slow release compared to the preceding L-DOPA standard therapy. In 20 centers 37 men and 26 women were included into the study. 27 males and 20 females completed the 6 month treatment period. Before switching, the patients received 438 +/- 213 mg a day L-DOPA standard, after conversion, the average dose was 617 +/- 323 mg L-DOPA slow release and 107 +/- 95 mg L-DOPA standard a day. Fluctuations during the day and at night which were rated according to a newly developed clinical 5-point rating scale were significantly improved by the treatment regimen from 2.8 +/- 0.9 to 1.4 +/- 1.2. Additionally, parkinsonian symptoms were significantly reduced during the ON-phase as there was a significant decrease of the Webster rating score from 12.0 +/- 4.6 to 7.1 +/- 4.0. Quality of life as measured by subjective ratings of the patients improved. The tolerability of the new formulation of L-DOPA was rated to be good in 51.1% and very good in 48.9%. The results of this open label study suggest that the combination of L-DOPA standard in the morning and L-DOPA slow release formulation at the following time points can be an efficient therapy in parkinsonian patients who suffer form L-DOPA related end-of-dose motor akinesia.
在一项开放标签研究中，63例患有剂末运动不能的特发性帕金森病患者从左旋多巴标准制剂治疗转换为早晨服用左旋多巴标准制剂，其余单次剂量服用左旋多巴缓释制剂（左旋多巴、苄丝肼、美多芭长效片）。用左旋多巴缓释制剂替代左旋多巴标准制剂平均需要2 - 4周。随后患者接受了6个月的治疗。由于缓释制剂的生物利用度较低——后者基于“流体动力学平衡系统”（HBS）——患者最初保持其药物摄入时间表，但与之前的左旋多巴标准治疗相比，接受了更高剂量的左旋多巴缓释制剂。在20个中心，37名男性和26名女性被纳入研究。27名男性和20名女性完成了6个月的治疗期。转换前，患者每天服用438±213毫克左旋多巴标准制剂，转换后，平均剂量为每天617±323毫克左旋多巴缓释制剂和107±95毫克左旋多巴标准制剂。根据新制定的临床5分制评分量表对白天和夜间波动进行评分，治疗方案使波动情况从2.8±0.9显著改善至1.4±1.2。此外，在“开”期帕金森症状显著减轻，因为韦伯斯特评分从12.0±4.6显著降至7.1±4.0。通过患者主观评分衡量的生活质量得到改善。左旋多巴新制剂的耐受性被评为良好的占51.1%，非常好的占48.9%。这项开放标签研究的结果表明，早晨服用左旋多巴标准制剂并在随后时间点服用左旋多巴缓释制剂的联合疗法，对于患有左旋多巴相关剂末运动不能的帕金森病患者可能是一种有效的治疗方法。
