Adjunct rasagiline to treat Parkinson’s disease with motor fluctuations:a randomized,double-blind study in China  

作　　者：Zhenxin Zhang Ming Shao Shengdi Chen Chunfeng Liu Rong Peng Yansheng Li Jian Wang Suiqiang Zhu Qiumin Qu Xiaoying Zhang Haibo Chen Xiangru Sun Yanping Wang Shenggang Sun Baorong Zhang Jimei Li Xiaoping Pan Gang Zhao 

机构地区：[1]Department of Neurology,Peking Union Medical College Hospital,53 Dongdan N St,Dongcheng,Beijing,China [2]Department of Neurology,The First Affiliated Hospital of Guangzhou Medical University,Guangzhou,China [3]Department of Neurology,Ruijin Hospital,Shanghai Jiaotong University School of Medicine,Shanghai,China [4]Department of Neurology,The Second Affiliated Hospital of Soochow University,Suzhou,China [5]Department of Neurology,West China Hospital,Sichuan University,Chengdu,China [6]Department of Neurology,Renji Hospital,Shanghai Jiaotong University School of Medicine,Shanghai,China [7]Department of Neurology,Huashan Hospital,Fudan University,Shanghai,China [8]Department of Neurology,Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China [9]Department of Neurology,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an,China [10]Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing,China [11]Department of Neurology,Beijing Hospital,Beijing,China [12]Department of Neurology,Peking University First Hospital,Beijing,China [13]Department of Neurology,The Second Affiliated Hospital of Guangzhou Medical University,Guangzhou,China [14]Department of Neurology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China [15]Department of Neurology,The Second Affiliated hospital of Zhejiang University School of Medicine,Zhejiang,Hangzhou,China [16]Department of Neurology,Beijing Friendship Hospital,Capital Medical University,Beijing,China [17]Department of Neurology,Guangzhou First People’s Hospital,Guangzhou,China [18]Department of Neurology,Xijing Hospital,The First Affiliated Hospital of The Fourth Military Medical University,Xi’an,China

出　　处：《Translational Neurodegeneration》2018年第1期127-137,共11页转化神经变性病（英文）

摘　　要：Background:The use of adjunct rasagiline in levodopa-treated patients with Parkinson’s disease and motor fluctuations is supported by findings from large-scale clinical studies.This study is to investigate the efficacy and safety of adjunct rasagiline in Chinese patients with Parkinson’s disease,as a product registration study.Methods:This 16-week,randomized,double-blind,parallel-group,multicenter,placebo-controlled study of rasagiline 1 mg/day included levodopa-treated patients with Parkinson’s disease and motor fluctuations.The primary efficacy endpoint was mean change from baseline in total daily OFF time over 16 weeks.Secondary endpoints were Clinical Global Impressions–Improvement(CGI-I),and change in Unified Parkinson’s Disease Rating Scale(UPDRS)Activities of daily living(ADL)and Motor scores.Patient well-being(EQ-5D),and the frequency of adverse events were also assessed.Results:In total,324 levodopa-treated patients were randomized to rasagiline 1 mg/day(n=165)or placebo(n=159).Over 16 weeks,rasagiline statistically significantly reduced the mean[95% confidence interval]total daily OFF time versus placebo(−0.5 h[−0.92,−0.07];p=0.023).There were also statistically significant improvements versus placebo in CGI-I(−0.4 points[−0.61,−0.22];p<0.001),UPDRS-ADL OFF(−1.0 points[−1.75,−0.27];p=0.008),and UPDRS-Motor ON(−1.6 points[−3.05,−0.14];p=0.032)scores,as well as the EQ-5D utility index(p<0.05).Rasagiline was safe and well tolerated.Conclusions:In levodopa-treated Chinese patients with Parkinson’s disease and motor fluctuations,adjunct rasagiline 1 mg/day statistically significantly reduced OFF time,and improved daily function and overall well-being,versus placebo.Consistent with findings in other countries,adjunct rasagiline was proven efficacious and well tolerated in Chinese patients.

关 键 词：Parkinson’s disease RASAGILINE ADJUNCT Motor fluctuations OFF time Quality of life China 

分 类 号：R74[医药卫生—神经病学与精神病学]