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透皮罗替戈汀对帕金森病非运动症状的影响:一项多中心、观察性、回顾性上市后研究。

The effects of transdermal rotigotine on non-motor symptoms of Parkinson's disease: a multicentre, observational, retrospective, post-marketing study.

作者信息

Valldeoriola Francesc, Salvador Antonio, Gómez-Arguelles José Maria, Marey José, Moya Miguel, Ayuga Ángel, Ramírez Francisco

机构信息

a Neurology Department , Hospital Clínico De Barcelona , Barcelona , Spain.

b Neurology Department , Hospital Clínico Universitario de Valencia , Valencia , Spain.

出版信息

Int J Neurosci. 2018 Apr;128(4):369-375. doi: 10.1080/00207454.2017.1387111. Epub 2017 Dec 17.

Abstract

AIM

This study evaluated the effect of ≥6 months of transdermal rotigotine on non-motor and motor symptoms of patients with advanced Parkinson's disease.

MATERIALS AND METHODS

The study was conducted in Spain between September 2011 and December 2012 (ClinicalTrials.gov: NCT01504529). The primary efficacy variable was the change from baseline in non-motor symptoms, as assessed by changes in Parkinson's Disease Non-Motor Symptoms Questionnaire total scores at 6 months. Secondary endpoints included the assessment of motor symptoms by Unified Parkinson's Disease Rating Scale III scores.

RESULTS

Data from 378 patients (mean age: 70.2 years; 56.9% male) with Parkinson's disease receiving rotigotine from were collected. Mean disease duration was 6.1 years, and mean rotigotine treatment duration was 45.6 months. Rotigotine reduced non-motor symptoms by 14.6% (mean change from baseline in Parkinson's Disease Non-Motor Symptoms Questionnaire: -1.5 ± 3.4; p < 0.0001). The majority of patients (58.2%) had improved non-motor symptoms at 6 months. Comparing the baseline versus study end, fewer patients experienced events in the urinary (78.6% vs. 73.3%; p = 0.0066), sleep (82.8% vs. 72.8%; p < 0.0001) and mood/cognition (77.3% vs. 66.4%; p < 0.0001) domains of the Parkinson's Disease Non-Motor Symptoms Questionnaire. Mean motor symptoms were reduced from baseline by 8.0% (mean change from baseline in Unified Parkinson's Disease Rating Scale III: -2.6 ± 8.0; p < 0.0001).

CONCLUSIONS

In clinical practice in Spain, rotigotine may be an effective treatment to reduce the non-motor and motor symptoms in patients with advanced Parkinson's disease.

摘要

目的

本研究评估了透皮罗替戈汀治疗≥6个月对晚期帕金森病患者非运动症状和运动症状的影响。

材料与方法

该研究于2011年9月至2012年12月在西班牙进行(ClinicalTrials.gov:NCT01504529)。主要疗效变量为非运动症状相对于基线的变化,通过帕金森病非运动症状问卷总分在6个月时的变化进行评估。次要终点包括通过统一帕金森病评定量表III评分评估运动症状。

结果

收集了378例接受罗替戈汀治疗的帕金森病患者的数据(平均年龄:70.2岁;56.9%为男性)。平均病程为6.1年,平均罗替戈汀治疗时长为45.6个月。罗替戈汀使非运动症状减少了14.6%(帕金森病非运动症状问卷相对于基线的平均变化:-1.5±3.4;p<0.0001)。大多数患者(58.2%)在6个月时非运动症状得到改善。比较基线与研究结束时,帕金森病非运动症状问卷中泌尿(78.6%对73.3%;p = 0.0066)、睡眠(82.8%对72.8%;p<0.0001)和情绪/认知(77.3%对66.4%;p<0.0001)领域出现相关情况的患者减少。运动症状平均值相对于基线降低了8.0%(统一帕金森病评定量表III相对于基线的平均变化:-2.6±8.0;p<0.0001)。

结论

在西班牙的临床实践中,罗替戈汀可能是减轻晚期帕金森病患者非运动症状和运动症状的有效治疗方法。

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