Shults Clifford W, Oakes David, Kieburtz Karl, Beal M Flint, Haas Richard, Plumb Sandy, Juncos Jorge L, Nutt John, Shoulson Ira, Carter Julie, Kompoliti Katie, Perlmutter Joel S, Reich Stephen, Stern Matthew, Watts Ray L, Kurlan Roger, Molho Eric, Harrison Madaline, Lew Mark
Department of Neurosciences, Mail Code 0662, University of California-San Diego, 9500 Gilman Dr, La Jolla, CA 92093-0662, USA.
Arch Neurol. 2002 Oct;59(10):1541-50. doi: 10.1001/archneur.59.10.1541.
Parkinson disease (PD) is a degenerative neurological disorder for which no treatment has been shown to slow the progression.
To determine whether a range of dosages of coenzyme Q10 is safe and well tolerated and could slow the functional decline in PD.
Multicenter, randomized, parallel-group, placebo-controlled, double-blind, dosage-ranging trial.
Academic movement disorders clinics.
Eighty subjects with early PD who did not require treatment for their disability.
Random assignment to placebo or coenzyme Q10 at dosages of 300, 600, or 1200 mg/d.
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.
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).
Coenzyme Q10 was safe and well tolerated at dosages of up to 1200 mg/d. Less disability developed in subjects assigned to coenzyme Q10 than in those assigned to placebo, and the benefit was greatest in subjects receiving the highest dosage. Coenzyme Q10 appears to slow the progressive deterioration of function in PD, but these results need to be confirmed in a larger study.
帕金森病（PD）是一种退行性神经疾病，尚无治疗方法被证明能减缓其进展。
确定一系列剂量的辅酶Q10是否安全且耐受性良好，以及是否能减缓帕金森病的功能衰退。
多中心、随机、平行组、安慰剂对照、双盲、剂量范围试验。
学术性运动障碍诊所。
80例早期帕金森病患者，其残疾状况无需治疗。
随机分配至安慰剂组或每日剂量为300、600或1200毫克的辅酶Q10组。
受试者在筛查、基线以及第1、4、8、12和16个月访视时接受统一帕金森病评定量表（UPDRS）评估。随访16个月或直至出现需要左旋多巴治疗的残疾状况。主要反应变量是UPDRS总分从基线到最后一次访视的变化。
安慰剂组调整后的UPDRS总分平均变化为+11.99，300毫克/日组为+8.81，600毫克/日组为+10.82，1200毫克/日组为+6.69。主要分析的P值，即剂量与UPDRS总分平均变化之间线性趋势的检验值为0.09，符合我们预先设定的试验阳性趋势标准。一项预先设定的次要分析是各治疗组与安慰剂组的比较，1200毫克/日组与安慰剂组之间的差异具有统计学意义（P = 0.04）。
每日剂量高达1200毫克时，辅酶Q10安全且耐受性良好。分配至辅酶Q10组的受试者比分配至安慰剂组的受试者残疾进展更少，且在接受最高剂量的受试者中获益最大。辅酶Q10似乎能减缓帕金森病功能的渐进性恶化，但这些结果需要在更大规模的研究中得到证实。
