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司来吉兰单药治疗早期帕金森病的随机双盲安慰剂对照III期试验

A Randomized Double-Blind Placebo-Controlled Phase III Trial of Selegiline Monotherapy for Early Parkinson Disease.

作者信息

Mizuno Yoshikuni, Hattori Nobutaka, Kondo Tomoyoshi, Nomoto Masahiro, Origasa Hideki, Takahashi Ryosuke, Yamamoto Mitsutoshi, Yanagisawa Nobuo

机构信息

*Department of Neurology, Juntendo University School of Medicine, Tokyo; †Rehabilitation Hananoie Hospital, Tochigi; ‡Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Ehime; §Department of Biostatistics and Clinical Epidemiology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama; ∥Department of Neurology, Kyoto University Graduate School of Medicine, Kyoto; ¶Takamatsu Neurology Clinic, Takamatsu; and #All Japan Labor Welfare Foundation, Tokyo, Japan.

出版信息

Clin Neuropharmacol. 2017 Sep/Oct;40(5):201-207. doi: 10.1097/WNF.0000000000000239.

DOI:10.1097/WNF.0000000000000239
PMID:28857772
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5610558/
Abstract

BACKGROUND

In Japan, selegiline has been approved for combination therapy with levodopa for Parkinson disease (PD). We conducted a trial of selegiline monotherapy for early PD.

METHODS

In this 12-week controlled phase III trial, a total of 292 subjects were randomized to receive placebo (n = 146) (full analysis set 140) or selegiline (n = 146) (full analysis set 139). The primary outcome measure was the change in the Unified Parkinson Disease Rating Scale part I + II + III total score from baseline to the final visit. Other secondary measures and a safety profile were evaluated.

RESULTS

Selegiline monotherapy reduced the primary outcome measure by -6.26 ± 7.86 compared with the placebo -3.14 ± 6.98 (mean ± SD, P = 0.0005 by analysis of covariance). There was no significant difference in the number of adverse events between the 2 groups (P > 0.05).

CONCLUSIONS

Selegiline monotherapy reduced the total Unified Parkinson Disease Rating Scale part I + II + III score and was well tolerated in Japanese patients with early PD.

摘要

背景

在日本，司来吉兰已被批准用于与左旋多巴联合治疗帕金森病（PD）。我们开展了一项司来吉兰单药治疗早期PD的试验。

方法

在这项为期12周的III期对照试验中，共有292名受试者被随机分组，分别接受安慰剂（n = 146）（全分析集140例）或司来吉兰（n = 146）（全分析集139例）治疗。主要结局指标是从基线至末次访视时帕金森病统一评分量表第一部分+第二部分+第三部分总分的变化。对其他次要指标和安全性进行了评估。

结果

与安慰剂组（-3.14±6.98，均值±标准差）相比，司来吉兰单药治疗使主要结局指标降低了-6.26±7.86（经协方差分析，P = 0.0005）。两组间不良事件数量无显著差异（P>0.05）。

结论

司来吉兰单药治疗可降低帕金森病统一评分量表第一部分+第二部分+第三部分的总分，且在日本早期PD患者中耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/317bece42a57/wnf-40-201-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/71f03d980578/wnf-40-201-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/6d9e5a33b9bb/wnf-40-201-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/927e68575c74/wnf-40-201-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/317bece42a57/wnf-40-201-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/71f03d980578/wnf-40-201-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/6d9e5a33b9bb/wnf-40-201-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/927e68575c74/wnf-40-201-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/797b/5610558/317bece42a57/wnf-40-201-g005.jpg

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