Effects of coenzyme Q10 in early Parkinson disease -: Evidence of slowing of the functional decline
Effects of coenzyme Q10 in early Parkinson disease -: Evidence of slowing of the functional decline
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DOI：
10.1001/archneur.59.10.1541
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发表时间：
2002-10-01
影响因子：
--
通讯作者：
Lew, M
中科院分区：
文献类型：
--
作者：
Shults, CW;Oakes, D;Lew, M
背景资料：帕金森病（PD）是一种退行性神经系统疾病，目前尚无治疗方法能减缓其进展。目的：确定一定剂量的辅酶Q（10）是否安全、耐受性良好，并能减缓PD患者的功能下降。设计：多中心、随机、平行组、安慰剂对照、双盲、剂量范围试验。设置：学术运动障碍诊所。患者：80例早期PD患者，他们不需要治疗残疾。干预措施：随机分配安慰剂或辅酶Q（10），剂量为300，600或1200 mg/d。主要结果测量：受试者在筛选、基线和1个月、4个月、8个月、12个月和16个月访视时使用统一帕金森病评定量表（UMRS）进行评估。他们被随访了16个月或直到需要左旋多巴治疗的残疾发展。主要反应变量是从基线到最后一次访视时的总评分变化。结果：安慰剂组的校正平均总评分变化为+11.99，300 mg/d组为+8.81，600 mg/d组为+10.82，1200 mg/d组为+6.69。主要分析的P值是0.09，这符合我们预先设定的试验阳性趋势的标准。主要分析是对剂量和总CRYSTRS评分平均变化之间线性趋势的检验。预先规定的次要分析是比较每个治疗组与安慰剂组，1200 mg/d和安慰剂组之间的差异是显着的（P= 0.04）。结论：辅酶Q（10）是安全的，耐受性良好，剂量高达1200 mg/d。服用辅酶Q（10）的受试者比服用安慰剂的受试者更少发生残疾，并且在接受最高剂量的受试者中获益最大。辅酶Q（10）似乎可以减缓PD功能的进行性恶化，但这些结果需要在更大规模的研究中得到证实。
Background: Parkinson disease (PD) is a degenerative neurological disorder for which no treatment has been shown to slow the progression.Objective: To determine whether a range of dosages of coenzyme Q(10) is safe and well tolerated and could slow the functional decline in PD.Design: Multicenter, randomized, parallel-group, placebo-controlled, double-blind, dosage-ranging trial.Setting: Academic movement disorders clinics.Patients: Eighty subjects with early PD who did not require treatment for their disability.Interventions: Random assignment to placebo or coenzyme Q(10) at dosages of 300, 600, or 1200 mg/d.Main Outcome Measure: The subjects underwent evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) at the screening, baseline, and 1-, 4-, 8-, 12-, and 16-month visits. They were followed up for 16 months or until disability requiring treatment with levodopa had developed. The primary response variable was the change in the total score on the UPDRS from baseline to the last visit.Results: The adjusted mean total UPDRS changes were +11.99 for the placebo group, +8.81 for the 300-mg/d group, +10.82 for the 600-mg/d group, and +6.69 for the 1200-mg/d group. The P value for the primary analysis, a test for a linear trend between the dosage and the mean change in the total UPDRS score, was .09, which met our prespecified criteria for a positive trend for the trial. A prespecified, secondary analysis was the comparison of each treatment group with the placebo group, and the difference between the 1200-mg/d and placebo groups was significant (P=.04).Conclusions: Coenzyme Q(10) was safe and well tolerated at dosages of up to 1200 mg/d. Less disability developed in subjects assigned to coenzyme Q(10) than in those assigned to placebo, and the benefit was greatest in subjects receiving the highest dosage. Coenzyme Q(10) appears to slow the progressive deterioration of function in PD, but these results need to be confirmed in a larger study.