Reichmann Heinz, Brecht Michael H, Köster Jürgen, Kraus Peter H, Lemke Mathias R
Department of Neurology, Technical University of Dresden, Dresden, Germany.
CNS Drugs. 2003;17(13):965-73. doi: 10.2165/00023210-200317130-00003.
The mixed dopamine D2/D3 receptor agonist pramipexole is effective as monotherapy in early Parkinson's disease and as adjunctive therapy in advanced disease. Clinical trials suggest that the benefits of pramipexole may extend beyond the relief of motor symptoms (akinesia, rigidity and tremor at rest) to amelioration of depressive symptoms in Parkinson's disease. The aim of this study was to confirm the beneficial effects of pramipexole on the core symptoms of Parkinson's disease (with a focus on tremor), as well as to assess its antidepressant activity, during routine clinical practice. The study also aimed to demonstrate the practicability of the Snaith-Hamilton Pleasure Scale (SHAPS-D), the Tremor Impact Scale (TIS) and the Short Parkinson's Evaluation Scale (SPES) under conditions of routine clinical practice.
This was a prospective observational study.
Data for 657 outpatients with Parkinson's disease were collected from German hospitals and specialist practices. The majority of patients were in Hoehn & Yahr stage II or III and were receiving levodopa.
Pramipexole (Sifrol) was initiated at a dosage of 0.375 mg/day (using a three-times-daily schedule) and titrated upwards, as required, at weekly intervals over a 4-week period to a maximum dosage of 4.5 mg/day (three times daily). Clinical evaluation was performed at baseline, at the end of the titration phase and at the end of maintenance therapy. Patients were assessed via the German questionnaire versions of the physician-assessed SPES, the self-evaluated TIS and the SHAPS-D. Changes in scale scores were evaluated nonparametrically, using the Wilcoxon-matched pairs test. Cronbach's alpha was used as a measure for item consistency.
Pramipexole significantly improved SPES subscores for motor symptoms, complications of therapy, psychological status and activities of daily living. Pramipexole also reduced the detrimental effect of tremor on activities of daily living and social interactions, as assessed by patients via the TIS. As indicated by the results of the SHAPS-D questionnaire, pramipexole significantly reduced anhedonia in patients who had associated depression. Internal consistency of SPES subscales was found to be unaltered between the initial evaluation and follow-up. Likewise, internal consistency for TIS and SHAPS-D was demonstrated. Pramipexole was well tolerated and accepted by the vast majority of physicians and patients.
In addition to ameliorating the core symptoms of akinesia and rigidity in Parkinson's disease, pramipexole improves tremor and depressive symptoms in routine clinical practice. The SPES, TIS and SHAPS-D were found to be useful instruments with validity in this study.
混合性多巴胺D2/D3受体激动剂普拉克索在帕金森病早期作为单一疗法有效，在晚期疾病中作为辅助疗法有效。临床试验表明，普拉克索的益处可能不仅限于缓解运动症状（运动不能、僵硬和静止性震颤），还可改善帕金森病的抑郁症状。本研究的目的是在常规临床实践中确认普拉克索对帕金森病核心症状（重点为震颤）的有益作用，以及评估其抗抑郁活性。该研究还旨在证明斯奈斯-汉密尔顿愉悦量表（SHAPS-D）、震颤影响量表（TIS）和帕金森病简短评估量表（SPES）在常规临床实践条件下的实用性。
这是一项前瞻性观察性研究。
从德国医院和专科诊所收集了657例帕金森病门诊患者的数据。大多数患者处于 Hoehn & Yahr 分期的 II 期或 III 期，且正在接受左旋多巴治疗。
普拉克索（森福罗）起始剂量为0.375 mg/天（每日三次给药方案），并根据需要每周递增剂量，在4周内逐渐增至最大剂量4.5 mg/天（每日三次）。在基线、滴定阶段结束时和维持治疗结束时进行临床评估。通过医生评估的SPES、自我评估的TIS和SHAPS-D的德文问卷版本对患者进行评估。使用Wilcoxon配对检验对量表评分变化进行非参数评估。Cronbach's α用于衡量项目一致性。
普拉克索显著改善了SPES运动症状、治疗并发症、心理状态和日常生活活动方面的子评分。通过TIS评估，普拉克索还降低了震颤对日常生活活动和社交互动的不利影响。如SHAPS-D问卷结果所示，普拉克索显著降低了伴有抑郁症患者的快感缺失。发现SPES子量表在初始评估和随访之间的内部一致性未改变。同样，也证明了TIS和SHAPS-D的内部一致性。普拉克索耐受性良好，绝大多数医生和患者都能接受。
除了改善帕金森病的运动不能和僵硬等核心症状外，普拉克索在常规临床实践中还可改善震颤和抑郁症状。在本研究中，发现SPES、TIS和SHAPS-D是有效的有用工具。
