Zonisamide improves motor function in Parkinson disease - A randomized, double-blind study
Zonisamide improves motor function in Parkinson disease - A randomized, double-blind study
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DOI：
10.1212/01.wnl.0000250236.75053.16
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发表时间：
2007-01-02
期刊：
影响因子：
9.9
通讯作者：
Kanazawa, Ichiro
中科院分区：
文献类型：
--
作者：
Murata, Miho;Hasegawa, Kazuko;Kanazawa, Ichiro
目的：评价佐尼沙胺(ZNS)每日25、50、100 mg作为帕金森病(PD)辅助治疗的有效性、安全性和耐受性。方法：我们在日本进行了一项多中心、随机、双盲、平行治疗、安慰剂对照研究。对左旋多巴治疗无效的帕金森病患者给予安慰剂2周，然后在左旋多巴的基础上，每天服用25、50或100毫克的锌或安慰剂治疗12周，然后进行2周的减量治疗。主要终点是最终评估点统一帕金森病评定量表(UPDRS)第三部分总分与基线的变化。次要终点包括与基线相比的变化：每日总的“关”时间；UPDRS第I、II和IV部分的总分；以及改良的Hoehn和Yahr量表得分。安全性分析基于不良事件的发生率。结果：与安慰剂相比，25毫克组和50毫克组的主要终点有显著改善。与安慰剂相比，50毫克组和100毫克组的“关闭”时间显著缩短。ZNS组运动障碍未见增加。25毫克组、50毫克组和安慰剂组的不良反应发生率相似，但100毫克组的不良反应发生率更高。结论：唑尼沙胺作为帕金森病患者的辅助治疗，每天25~100 mg是安全、有效和耐受性良好的。
Objective: To evaluate the efficacy, safety and tolerability of daily doses of 25, 50, and 100 mg of zonisamide (ZNS) administered as adjunctive treatment in patients with Parkinson disease (PD). Methods: We conducted a multicenter, randomized, double-blind, parallel-treatment, placebo-controlled study in Japan. Patients with PD who showed insufficient response to levodopa treatment were given placebo for 2 weeks and then treated for 12 weeks with 25, 50, or 100 mg/day of ZNS or placebo, in addition to levodopa, followed by a 2-week dose-reduction period. The primary endpoint was change from baseline in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III at the final assessment point. Secondary endpoints included changes from baseline in total daily "off" time; total scores of UPDRS Parts I, II, and IV; and Modified Hoehn and Yahr Scale score. Safety analysis was based on the incidence of adverse events. Results: There was significant improvement in the primary endpoint in the 25-mg and 50-mg groups vs placebo. The duration of "off" time was significantly reduced in the 50-mg and 100-mg groups vs placebo. Dyskinesia was not increased in ZNS groups. The incidence of adverse effects was similar between the 25-mg, 50-mg, and placebo groups but higher in the 100-mg group. Conclusions: Zonisamide is safe, effective and well tolerated at 25 to 100 mg/day as an adjunctive treatment in patients with Parkinson disease.