帕金森病患者中罗匹尼罗到罗替高汀透皮贴剂的 overnight switch。

Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease.

机构信息

Department of Neurology and Movement Disorder Center, Parkinson Disease Study Group, and Neuroscience Research Institute, BK21, College of Medicine, Seoul National University Hospital, Seoul, Korea.

出版信息

BMC Neurol. 2011 Aug 10;11:100. doi: 10.1186/1471-2377-11-100.

DOI:10.1186/1471-2377-11-100

PMID:21831297

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3166898/

Abstract

BACKGROUND

A recent trial involving predominantly Caucasian subjects with Parkinson Disease (PD) showed switching overnight from an oral dopaminergic agonist to the rotigotine patch was well tolerated without loss of efficacy. However, no such data have been generated for Korean patients.

METHODS

This open-label multicenter trial investigated PD patients whose symptoms were not satisfactorily controlled by ropinirole, at a total daily dose of 3 mg to 12 mg, taken as monotherapy or as an adjunct to levodopa. Switching treatment from oral ropinirole to transdermal rotigotine was carried out overnight, with a dosage ratio of 1.5:1. After a 28-day treatment period, the safety and tolerability of switching was evaluated. Due to the exploratory nature of this trial, the effects of rotigotine on motor and nonmotor symptoms of PD were analyzed in a descriptive manner.

RESULTS

Of the 116 subjects who received at least one treatment, 99 (85%) completed the 28-day trial period. Dose adjustments were required for 11 subjects who completed the treatment period. A total of 76 treatment-emergent adverse events (AEs) occurred in 45 subjects. No subject experienced a serious AE. Thirteen subjects discontinued rotigotine prematurely due to AEs. Efficacy results suggested improvements in both motor and nonmotor symptoms and quality of life after switching. Fifty-two subjects (46%) agreed that they preferred using the patch over oral medications, while 31 (28%) disagreed.

CONCLUSIONS

Switching treatment overnight from oral ropinirole to transdermal rotigotine patch, using a dosage ratio of 1.5:1, was well tolerated in Korean patients with no loss of efficacy.

TRIAL REGISTRATION

This trial is registered with the ClincalTrails.gov Registry (NCT00593606).

摘要

背景

最近一项涉及主要为白种人帕金森病（PD）患者的试验表明，将口服多巴胺激动剂 overnight 切换为罗替高汀贴片，在不降低疗效的情况下，患者耐受性良好。然而，尚未为韩国患者生成此类数据。

方法

这项开放标签多中心试验纳入了症状不能通过罗匹尼罗（ropinirole）控制的 PD 患者，这些患者每天的总剂量为 3mg 至 12mg，单独使用或与左旋多巴联合使用。将口服罗匹尼罗转换为透皮罗替高汀 overnight 进行治疗，剂量比为 1.5:1。经过 28 天的治疗期后，评估转换治疗的安全性和耐受性。由于该试验的探索性质，以描述性方式分析了罗替高汀对 PD 的运动和非运动症状的影响。

结果

在至少接受一种治疗的 116 名受试者中，99 名（85%）完成了 28 天的试验期。11 名完成治疗期的受试者需要调整剂量。45 名受试者共发生 76 次治疗中出现的不良事件（AE）。无受试者发生严重 AE。13 名受试者因 AE 提前终止罗替高汀治疗。疗效结果表明，转换治疗后，运动和非运动症状以及生活质量均得到改善。52 名受试者（46%）认为他们更喜欢使用贴片而非口服药物，而 31 名受试者（28%）表示不喜欢。