Ahlskog J E, Wright K F, Muenter M D, Adler C H
Department of Neurology, Mayo Clinic, Rochester, Minnesota 55905, USA.
Clin Neuropharmacol. 1996 Jun;19(3):202-12. doi: 10.1097/00002826-199619030-00002.
Adjunctive cabergoline or placebo, in doses up to 5 mg daily, were administered to Parkinson's disease patients with short-duration levodopa responses in a 6-month double-blind trial. The 13 patients randomized to cabergoline and completing the study had significantly improved Unified Parkinson's Disease Rating Scale (UPDRS) motor scores and timed hand-tapping test scores. Serial measurements on test days documented improved scores: (a) before the first levodopa (and cabergoline) dose of the day, (b) at the time of the peak levodopa effect, and (c) at the end of the levodopa response cycle, 5 h after test doses. Continued testing verified that these therapeutic responses were sustained for at least 48 h after the last cabergoline dose. Patients randomized to placebo failed to improve on any of these measures. In a subsequent open-label dose-escalation phase, further improvement was documented as the dosage was gradually raised to 10 mg daily. As in the double-blind phase, levodopa reduction allowed the improvement to occur in the absence of significantly increased dyskinesias. Other side effects were more substantial with higher doses, however, including two of 11 patients with hallucinations and confusion. In summary, adjunctive single-daily-dose cabergoline therapy resulted in long-lasting, dose-related improvement in parkinsonism not seen in patients receiving placebo.
在一项为期6个月的双盲试验中，对左旋多巴反应持续时间短的帕金森病患者给予每日剂量高达5毫克的辅助卡麦角林或安慰剂。随机分配至卡麦角林组并完成研究的13名患者，其帕金森病统一评定量表（UPDRS）运动评分和定时手部敲击测试评分显著改善。在测试日进行的系列测量记录了评分的改善情况：（a）在当日首次服用左旋多巴（和卡麦角林）之前，（b）在左旋多巴效应达到峰值时，以及（c）在测试剂量后5小时，即左旋多巴反应周期结束时。持续测试证实，这些治疗反应在最后一剂卡麦角林后至少持续48小时。随机分配至安慰剂组的患者在这些测量指标上均未改善。在随后的开放标签剂量递增阶段，随着剂量逐渐增加至每日10毫克，记录到进一步的改善。与双盲阶段一样，减少左旋多巴剂量使得在不显著增加运动障碍的情况下出现改善。然而，高剂量时其他副作用更为明显，包括11名患者中有2名出现幻觉和精神错乱。总之，辅助每日单剂量卡麦角林治疗导致帕金森病出现持久的、与剂量相关的改善，而接受安慰剂的患者未出现这种情况。
