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对随机接受罗匹尼罗或左旋多巴初始治疗的帕金森病患者进行的十年随访。

Ten-year follow-up of Parkinson's disease patients randomized to initial therapy with ropinirole or levodopa.

作者信息

Hauser Robert A, Rascol Olivier, Korczyn Amos D, Jon Stoessl A, Watts Ray L, Poewe Werner, De Deyn Peter P, Lang Anthony E

机构信息

Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida 33606, USA.

出版信息

Mov Disord. 2007 Dec;22(16):2409-17. doi: 10.1002/mds.21743.

Abstract

In a 5-year, double-blind study, subjects with Parkinson's disease (PD) who were randomized to initial treatment with ropinirole had a significantly lower incidence of dyskinesia compared with subjects randomized to levodopa, although Unified Parkinson's Disease Rating Scale (UPDRS) motor scores were significantly more improved in the levodopa group. Subjects who completed the original study were eligible to participate in a long-term extension study conducted according to an open, naturalistic design and were evaluated approximately every 6 months until they had been followed for a total of 10 years. Comparing subjects randomized to initial treatment with ropinirole (n = 42) and levodopa (n = 27), the incidence of dyskinesia was significantly lower in the ropinirole group (adjusted odds ratio [OR] = 0.3; 95% confidence interval [CI]: 0.1, 1.0; P = 0.046) and the median time to dyskinesia was significantly longer (adjusted hazard ratio = 0.4; 95% CI: 0.2, 0.8; P = 0.007). The incidence of at least moderate wearing off ("off" time >/=26% of the awake day) was also significantly lower in the ropinirole group (adjusted OR = 0.3; 95% CI: 0.09, 0.03; P = 0.03). There were no significant differences in change in UPDRS activities of daily living or motor scores, or scores for the 39-item PD questionnaire, Clinical Global Impression, or the Epworth Sleepiness Scale. Early treatment decisions for individual patients depend largely on the anticipated risk of side effects and long-term complications. Both ropinirole and levodopa are viable treatment options in early PD.

摘要

在一项为期5年的双盲研究中,与随机接受左旋多巴初始治疗的帕金森病(PD)患者相比,随机接受罗匹尼罗初始治疗的患者运动障碍发生率显著更低,尽管左旋多巴组的统一帕金森病评定量表(UPDRS)运动评分改善更为显著。完成原研究的受试者有资格参与一项按照开放、自然主义设计进行的长期扩展研究,并每6个月左右接受一次评估,直至随访满10年。比较随机接受罗匹尼罗初始治疗(n = 42)和左旋多巴初始治疗(n = 27)的受试者,罗匹尼罗组运动障碍发生率显著更低(调整后的优势比[OR] = 0.3;95%置信区间[CI]:0.1,1.0;P = 0.046),运动障碍的中位发生时间显著更长(调整后的风险比 = 0.4;95% CI:0.2,0.8;P = 0.007)。罗匹尼罗组至少中度剂末现象(“关”期时间≥清醒时间的26%)的发生率也显著更低(调整后的OR = 0.3;95% CI:0.09,0.3;P = 0.03)。在UPDRS日常生活活动或运动评分、39项PD问卷评分、临床总体印象评分或爱泼华嗜睡量表评分的变化方面,两组之间无显著差异。针对个体患者的早期治疗决策在很大程度上取决于预期的副作用风险和长期并发症。罗匹尼罗和左旋多巴都是早期PD的可行治疗选择。

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