Zhang Zhenxin, Wang Jian, Chen Shengdi, Liu Chunfeng, Zhang Baorong, Peng Rong, Sun Shenggang, Sun Xiangru, Zhao Gang, Qu Qiumin, Li Yansheng, Zhu Suiqiang, Pan Xiaoping, Shao Ming, Wang Yanping
1Peking Union Medical College Hospital, Beijing, China.
2Huashan Hospital, Fudan University, Shanghai, China.
Transl Neurodegener. 2018 Dec 6;7:32. doi: 10.1186/s40035-018-0137-5. eCollection 2018.
Rasagiline is a monoamine oxidase-B inhibitor used for Parkinson's disease (PD) treatment, but its effectiveness on Chinese patients is unclear. This study aimed to evaluate the efficacy and safety of rasagiline monotherapy in Chinese patients with early PD.
A 26-weeks, randomized, double-blind, placebo-controlled study has been performed at 15 sites in China and enrolled outpatients (≥35 years old) with idiopathic PD without a history of using any dopaminergic drugs. Participants were randomized 1:1 to receive rasagiline 1 mg once daily or placebo. The primary endpoint was the change of the Unified Parkinson's Disease Rating Scale (UPDRS) total score from baseline to 26 weeks treatment. Secondary endpoints included changes in UPDRS subscale scores from part I to III. Health status was assessed with the PD Questionnaire (PDQ)-39 and EuroQol-Five-Dimension (EQ-5D) questionnaire. Safety profile was collected until 30 weeks after randomization.
A total of 130 patients ( = 65/group) were recruited, and 127 (rasagiline, = 64; placebo, = 63) were included in the full analysis set. Baseline characteristics were comparable between the two groups. The decrease in the mean UPDRS total score was greater in the rasagiline group than in the placebo group (- 3.18 ± 0.95 vs. - 0.18 ± 0.98, = 0.025), and the mean UPDRS part I non-motor symptoms score (- 0.54 ± 0.15 vs. -0.08 ± 0.15, = 0.003) were significantly decreased in the rasagiline group compared with placebo treated patients. An improvement trend was observed in the active treatment group for the subscales evaluation with parts II and III, while the difference to placebo was not statistically significant. Life quality assessed by the EQ-5D visual analog scale improved in the rasagiline group but worsened in placebo treated patients. The overall incidence of treatment-emergent adverse events (AEs) was slightly lower in the rasagiline group (41.5%) than in the placebo group (46.2%).
Rasagiline is effective, safe, and well tolerated as monotherapy for the treatment of Chinese PD patients.
Clinicaltrials.gov: NCT01556165. Registered 13 Mar 2012.
雷沙吉兰是一种用于治疗帕金森病（PD）的单胺氧化酶B抑制剂，但其对中国患者的有效性尚不清楚。本研究旨在评估雷沙吉兰单药治疗中国早期PD患者的疗效和安全性。
在中国的15个地点进行了一项为期26周的随机、双盲、安慰剂对照研究，纳入无任何多巴胺能药物使用史的特发性PD门诊患者（≥35岁）。参与者按1:1随机分组，接受每日一次1mg雷沙吉兰或安慰剂治疗。主要终点是从基线到26周治疗期间统一帕金森病评定量表（UPDRS）总分的变化。次要终点包括UPDRS第一部分至第三部分各分量表得分的变化。使用帕金森病问卷（PDQ）-39和欧洲五维健康量表（EQ-5D）问卷评估健康状况。收集随机分组后30周内的安全性数据。
共招募了130例患者（每组=65例），127例（雷沙吉兰组=64例；安慰剂组=63例）纳入全分析集。两组的基线特征具有可比性。雷沙吉兰组UPDRS总分的平均降低幅度大于安慰剂组（-3.18±0.95 vs. -0.18±0.98，P=0.025），与安慰剂治疗的患者相比，雷沙吉兰组UPDRS第一部分非运动症状评分（-0.54±0.15 vs. -0.08±0.15，P=0.003）显著降低。在第二部分和第三部分的分量表评估中，活性治疗组观察到改善趋势，但与安慰剂组的差异无统计学意义。通过EQ-5D视觉模拟量表评估的生活质量在雷沙吉兰组有所改善，但在安慰剂治疗的患者中恶化。治疗中出现的不良事件（AE）的总体发生率在雷沙吉兰组（41.5%）略低于安慰剂组（46.2%）。
雷沙吉兰作为单药治疗中国PD患者有效、安全且耐受性良好。
Clinicaltrials.gov：NCT01556165。2012年3月13日注册。
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