关于拉沙吉林或普拉克索治疗早期帕金森病的疗效和安全性的系统回顾和荟萃分析

IF 2.1 4区 医学 Q3 CLINICAL NEUROLOGY Parkinson's Disease Pub Date : 2024-01-16 DOI:10.1155/2024/8448584
Pauli Seppänen, Markus M. Forsberg, Miia Tiihonen, Heikki Laitinen, Selena Beal, David C. Dorman
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引用次数: 0

摘要

背景。有人建议使用拉沙吉林或普拉克索单药治疗早期帕金森病(PD)。本研究旨在系统回顾拉沙吉林或普拉克索治疗早期帕金森病(病程≤5年,Hoehn和Yahr分期≤3期)的临床疗效和安全性。研究方法检索截至2021年9月发表的拉沙吉林或普拉克索治疗早期帕金森病的随机对照试验(RCT)。研究结果包括统一帕金森病评分量表(UPDRS)第二部分和第三部分的变化以及不良事件的发生率。计算了标准化平均差 (SMD)、比值比 (OR) 和 95% 置信区间 (CI),并通过 I2 检验测量了异质性。研究结果共纳入了九项拉沙吉林和十一项普拉克索的 RCT 研究。还纳入了对一项拉沙吉林研究的事后分析。每种药物均有五项研究被纳入UPDRS评分的荟萃分析。拉沙吉林的荟萃分析主要针对每天服用1毫克的患者。与安慰剂相比,拉沙吉林和普拉克索能明显改善UPDRS第二部分和第三部分的评分。研究之间存在明显的异质性(I2 >70%)。与安慰剂相比,拉沙吉林和普拉克索均未增加任何不良事件、严重不良事件或导致停药的不良事件的相对风险。结论应用建议、评估、发展和评价分级法(GRADE)对证据进行总结,我们发现拉沙吉林或普拉克索对早期帕金森病疗效的证据可信度为中等,这表明仍需进一步开展设计良好的多中心对比性RCT研究。
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A Systematic Review and Meta-Analysis of the Efficacy and Safety of Rasagiline or Pramipexole in the Treatment of Early Parkinson’s Disease
Background. Rasagiline or pramipexole monotherapy has been suggested for the management of early Parkinson’s disease (PD). The aim of this research was to systematically review the clinical efficacy and safety of rasagiline or pramipexole in early PD (defined as disease duration ≤5 years and Hoehn and Yahr stage of ≤3). Methods. Randomized controlled trials (RCTs) of rasagiline or pramipexole for early PD published up to September 2021 were retrieved. Outcomes of interest included changes in the Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II and III and the incidence of adverse events. Standardized mean difference (SMD), odds ratio (OR), and 95% confidence interval (CI) were calculated, and heterogeneity was measured with the I2 test. Results. Nine rasagiline and eleven pramipexole RCTs were included. One post hoc analysis of one rasagiline study was included. Five studies for each drug were included in meta-analyses of the UPDRS scores. The rasagiline meta-analysis focused on patients receiving 1 mg/day. Rasagiline and pramipexole significantly improved UPDRS Part II and III scores when compared to placebo. Significant heterogeneity among the studies was present (I2 > 70%). Neither rasagiline nor pramipexole increased the relative risk for any adverse events, serious adverse events, or adverse events leading to withdrawal when compared with placebo. Conclusion. Applying a Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to summarize the evidence, we found moderate confidence in the body of evidence for the efficacy of rasagiline or pramipexole in early PD, suggesting further well-designed, multicenter comparative RCTs remain needed.
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来源期刊
Parkinson's Disease
Parkinson's Disease CLINICAL NEUROLOGY-
CiteScore
5.80
自引率
3.10%
发文量
0
审稿时长
18 weeks
期刊介绍: Parkinson’s Disease is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to the epidemiology, etiology, pathogenesis, genetics, cellular, molecular and neurophysiology, as well as the diagnosis and treatment of Parkinson’s disease.
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