Randomized, double-blind, placebo-controlled trial on symptomatic effects of coenzyme Q10 in Parkinson disease
Randomized, double-blind, placebo-controlled trial on symptomatic effects of coenzyme Q10 in Parkinson disease
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DOI：
10.1001/archneur.64.7.nct60005
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发表时间：
2007-07-01
影响因子：
--
通讯作者：
Reichmann, Heinz
中科院分区：
文献类型：
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作者：
Storch, Alexander;Jost, Wolfgang H.;Reichmann, Heinz
背景资料：帕金森病病理生理学的主要标志是细胞能量消耗和氧化应激，导致细胞功能障碍和死亡。辅酶Q（10）（CoQ（10））是一种电子受体桥接线粒体复合物I和II/III，是一种有效的抗氧化剂，可持续部分恢复多巴胺能神经元的功能。目的：确定纳米辅酶Q（10）是否安全，并在无运动波动的中期帕金森病患者中显示症状性效果。设计：多中心、随机、双盲、安慰剂对照、分层、平行组、单剂量试验。设置：学术和非学术运动障碍诊所。患者：131例帕金森病患者，无运动波动，接受稳定的抗帕金森病治疗。干预：随机分配到安慰剂或纳米辅酶Q（10）（100毫克，每天3次）治疗3个月。分层标准为左旋多巴治疗。主要结果测量：受试者在每月的每次访视时接受统一帕金森病评定量表（UMRS）的评估。主要结果变量是基线和3个月visit.Results之间的总评分的变化的WESTERS第二和第三部分：131例受试者随机根据协议。安慰剂组和辅酶Q（10）组的总的BPRS第II/III部分评分的平均变化分别为-3.69和-3.33（P= 0.82）。根据分层进行的统计分析未导致主要结局变量的显著变化。安慰剂组和辅酶Q（10）组之间没有次要结局指标显示显著变化。两个治疗组的不良事件的频率和质量相似。结论：Nanospecific辅酶Q（10）在300 mg/d的剂量是安全的，耐受性良好，并导致血浆水平类似于1200 mg/d的标准制剂。补充辅酶Q（10）在中期帕金森病中没有表现出症状效应。
Background: Major hallmarks in the pathophysiology of Parkinson disease are cellular energy depletion and oxidative stress leading to cellular dysfunction and death. Coenzyme Q(10) ( CoQ(10)) is an electron acceptor bridging mitochondrial complexes I and II/III and a potent antioxidant that consistently partially recovers the function of dopaminergic neurons.Objective: To determine whether nanoparticular CoQ(10) is safe and displays symptomatic effects in patients with midstage Parkinson disease without motor fluctuations.Design: Multicenter, randomized, double-blind, placebo-controlled, stratified, parallel-group, single-dose trial.Setting: Academic and nonacademic movement disorder clinics.Patients: One hundred thirty-one patients with Parkinson disease without motor fluctuations and a stable antiparkinsonian treatment.Intervention: Random assignment to placebo or nanoparticular CoQ(10) ( 100 mg 3 times a day) for a treatment period of 3 months. Stratification criterion was levodopa treatment.Main Outcome Measure: The subjects underwent evaluation with the Unified Parkinson's Disease Rating Scale ( UPDRS) at each visit on a monthly basis. The primary outcome variable was the change of the sum score of the UPDRS parts II and III between the baseline and 3-month visits.Results: One hundred thirty-one subjects were randomized according to the protocol. The mean changes of the sum UPDRS parts II/III score were -3.69 for the placebo group and -3.33 for the CoQ(10) group ( P=.82). Statistical analysis according to the stratification did not result in significant changes of the primary outcome variable. No secondary outcome measure showed a significant change between the placebo group and the CoQ(10) group. The frequency and quality of adverse events were similar in both treatment groups.Conclusions: Nanoparticular CoQ(10) at a dosage of 300 mg/d is safe and well tolerated and leads to plasma levels similar to 1200 mg/d of standard formulations. Add-on CoQ(10) does not display symptomatic effects in midstage Parkinson disease.