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吡贝地尔相对于普拉克索治疗早期帕金森病的疗效和安全性:系统文献评价和网络荟萃分析。

The Efficacy and Safety of Piribedil Relative to Pramipexole for the Treatment of Early Parkinson Disease: A Systematic Literature Review and Network Meta-Analysis.

机构信息

Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei City, Anhui Province, China.

MTEK Sciences, Vancouver, British Columbia, Canada.

出版信息

Clin Neuropharmacol. 2020 Jul/Aug;43(4):100-106. doi: 10.1097/WNF.0000000000000400.

DOI:10.1097/WNF.0000000000000400
PMID:32658035
Abstract

OBJECTIVES

Patients with early Parkinson disease (PD) frequently defer initiation of levodopa treatment to minimize long-term complications. Nonergoline dopamine agonists, such as pramipexole and piribedil, are frequent first-line therapies for early PD patients, yet limited head-to-head randomized controlled trial (RCT) evidence exists for dopamine agonists in this population. We therefore conducted a systematic literature review and network meta-analysis.

METHODS

MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched (until January 7, 2020), identifying RCTs assessing the efficacy of piribedil or pramipexole in early PD. Eligible trial data were incorporated into fixed- and random-effects Bayesian network meta-analyses.

RESULTS

No RCTs were identified directly comparing piribedil with pramipexole, but 6 trials provided data for pramipexole versus placebo and 2 compared piribedil versus placebo, facilitating indirect comparisons. Across all time points assessed, no significant differences were found between pramipexole and piribedil for change in the Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline. Piribedil and pramipexole demonstrated superiority relative to placebo for UPDRS II/III change at weeks 22 to 30. No significant differences were noted between the treatments at weeks 20 to 35 for anxiety, constipation, hypotension, nausea, and somnolence. Sensitivity analyses on adjustment for dose titration periods and baseline risk yielded the same pattern of results.

CONCLUSIONS

No significant differences were found for pramipexole versus piribedil in the UPDRS II/III scores from baseline in early PD, with similar safety profiles.

摘要

目的

患有早期帕金森病(PD)的患者常常推迟左旋多巴治疗的开始时间,以尽量减少长期并发症。非麦角类多巴胺激动剂,如普拉克索和吡贝地尔,是早期 PD 患者的常用一线治疗药物,但在该人群中,关于多巴胺激动剂的头对头随机对照试验(RCT)证据有限。因此,我们进行了系统的文献回顾和网络荟萃分析。

方法

系统检索了 MEDLINE、Embase 和 Cochrane 对照试验中心注册库(截至 2020 年 1 月 7 日),以确定评估吡贝地尔或普拉克索在早期 PD 中的疗效的 RCT。将符合条件的试验数据纳入固定效应和随机效应贝叶斯网络荟萃分析。

结果

没有 RCT 直接比较吡贝地尔与普拉克索,但有 6 项试验提供了普拉克索与安慰剂的比较数据,有 2 项试验比较了吡贝地尔与安慰剂,从而可以进行间接比较。在所有评估的时间点,普拉克索与吡贝地尔相比,从基线开始,统一帕金森病评定量表(UPDRS)评分的变化没有显著差异。吡贝地尔和普拉克索与安慰剂相比,在 22 至 30 周时 UPDRS II/III 的变化具有优势。在 20 至 35 周时,两种治疗方法在焦虑、便秘、低血压、恶心和嗜睡方面没有显著差异。对剂量滴定期和基线风险进行调整的敏感性分析得出了相同的结果模式。

结论

在早期 PD 中,普拉克索与吡贝地尔相比,在 UPDRS II/III 评分的基线方面没有显著差异,具有相似的安全性特征。

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