Grosset Katherine, Grosset Donald, Lees Andrew
Institute of Neurological Sciences, Southern General Hospital, Glasgow, United Kingdom.
Mov Disord. 2005 Mar;20(3):363-6. doi: 10.1002/mds.20361.
The effect of pergolide 25 mug twice daily on levodopa initiation was assessed in a randomized, placebo-controlled, parallel group, double-blind multicenter trial in 106 untreated early Parkinson's disease patients. The primary endpoint of mean time until levodopa was 520 days (95% confidence interval [CI], 422-618 days) for pergolide versus 434 days (95% CI, 358-609 days) for placebo. However, this increase of 86 days for pergolide was not statistically significant. The wash-in effect of pergolide was significant at 6 weeks (change in mean Unified Parkinson's Disease Rating Scale [UPDRS] 2 and 3 was -0.1 [95% CI, -1.4 to 1.3] for pergolide vs. 2.2 [95% CI, 1.1-3.3] for placebo). At termination, the change from baseline in mean UPDRS 2 and 3 score was 11.4 (95% CI, 8.8-14) for pergolide and 14.6 (95% CI, 12-17.2) for placebo (P=0.08). There was no significant change in UPDRS 2 and 3 for the 83 patients achieving the planned 4-week washout at termination (pergolide 1.2 [95% CI, -0.8 to 3.2] vs. placebo 0.0 [95% CI, -1.6 to 1.6]. Adverse events were infrequent and occurred equally for pergolide and placebo. The study shows no evidence of a neuroprotective effect but indicates a mild symptomatic benefit from pergolide at a dose normally considered subtherapeutic.
在一项针对106例未经治疗的早期帕金森病患者的随机、安慰剂对照、平行组、双盲多中心试验中，评估了每日两次服用25微克培高利特对左旋多巴起始治疗的影响。培高利特组至开始使用左旋多巴的平均时间这一主要终点为520天（95%置信区间[CI]，422 - 618天），而安慰剂组为434天（95%CI，358 - 609天）。然而，培高利特组增加的这86天在统计学上并不显著。培高利特在6周时的导入期效应显著（统一帕金森病评定量表[UPDRS]2和3的平均变化，培高利特组为-0.1[95%CI，-1.4至1.3]，安慰剂组为2.2[95%CI，1.1 - 3.3]）。在试验结束时，培高利特组UPDRS 2和3评分相对于基线的变化为11.4（95%CI，8.8 - 14），安慰剂组为14.6（95%CI，12 - 17.2）（P = 0.08）。在试验结束时完成计划4周洗脱期的83例患者中，UPDRS 2和3没有显著变化（培高利特组为1.2[95%CI，-0.8至3.2]，安慰剂组为0.0[95%CI，-1.6至1.6]）。不良事件很少见，培高利特组和安慰剂组发生情况相同。该研究未显示神经保护作用的证据，但表明在通常认为低于治疗剂量的培高利特具有轻微的症状改善作用。
