Clarke C E, Deane K H
Cochrane Database Syst Rev. 2001;2001(1):CD001518. doi: 10.1002/14651858.CD001518.
Long term levodopa therapy in Parkinson's disease is associated with the development of motor complications including abnormal involuntary movements and a shortening response to each dose (wearing off phenomenon). It is thought that dopamine agonists can reduce the duration of immobile off periods and the need for levodopa therapy whilst maintaining or improving motor impairments and only minimally increasing dopaminergic adverse events.
To compare the efficacy and safety of adjuvant cabergoline therapy versus placebo in patients with Parkinson's disease, already established on levodopa and suffering from motor complications.
Electronic searches of MEDLINE, EMBASE and the Cochrane Controlled Trials Register. Handsearching of the neurology literature as part of the Cochrane Movement Disorders Group's strategy. Examination of the reference lists of identified studies and other reviews. Contact with Pharmacia Upjohn Limited.
Randomised controlled trials of cabergoline versus placebo in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy.
Data was abstracted independently by the authors and differences settled by discussion. The outcome measures used included Parkinson's disease rating scales, levodopa dosage, off time measurements and the frequency of withdrawals and adverse events.
Cabergoline has been compared with placebo in two phase II (6 - 12 weeks) and one phase III randomised controlled trials (24 weeks). These were double-blind, parallel group, multicentre studies including 268 patients with Parkinson's disease and motor complications. The reduction of 1.14 hours (WMD; 95% CI -0.06, 2.33; p = 0.06) in off time in favour of cabergoline was not statistically significant. Inadequate data on dyskinesia was collected either on rating scales or as adverse event reporting to allow a conclusion to be drawn. A small but statistically significant advantage of cabergoline over placebo was seen in one study for UPDRS ADL (part II) score and UPDRS motor score. No such advantage was seen in one other study due to small numbers of patients and the comparatively low doses of cabergoline used. No significant differences in Schwab and England scale were seen in two studies. Levodopa dose reduction was significantly greater with cabergoline (WMD 149.6 mg/d; 95% CI 94.1, 205.1; p < 0.00001). There was a trend towards more dopaminergic adverse events with cabergoline but this did not reach statistical significance at the p < 0.01 level. However, there was a trend towards fewer withdrawals from cabergoline.
REVIEWER'S CONCLUSIONS: In the management of the motor complications seen in Parkinson's disease, cabergoline can be used to reduce levodopa dose and modestly improve motor impairment and disability with an acceptable adverse event profile. These conclusions are based on, at best, medium term evidence.
帕金森病患者长期使用左旋多巴治疗会出现运动并发症，包括异常不自主运动以及对每次剂量的反应时间缩短（剂末现象）。人们认为多巴胺激动剂可以减少静止期的时长以及左旋多巴治疗的需求，同时维持或改善运动障碍，且仅轻微增加多巴胺能不良反应。
比较卡麦角林辅助治疗与安慰剂对已接受左旋多巴治疗且患有运动并发症的帕金森病患者的疗效和安全性。
对MEDLINE、EMBASE和Cochrane对照试验注册库进行电子检索。作为Cochrane运动障碍小组策略的一部分，对手检神经学文献进行检索。查阅已识别研究及其他综述的参考文献列表。与法玛西亚普强有限公司联系。
卡麦角林与安慰剂对比治疗临床诊断为特发性帕金森病且有左旋多巴治疗长期并发症患者的随机对照试验。
作者独立提取数据，分歧通过讨论解决。所使用的结局指标包括帕金森病评定量表、左旋多巴剂量、静止期测量以及撤药频率和不良事件。
在两项II期（6 - 12周）和一项III期随机对照试验（24周）中对卡麦角林与安慰剂进行了比较。这些试验为双盲、平行组、多中心研究，包括268例患有帕金森病和运动并发症的患者。卡麦角林组静止期减少1.14小时（加权均数差；95%置信区间-0.06，2.33；p = 0.06）但未达到统计学显著性。在评定量表或不良事件报告中收集的异动症数据不足，无法得出结论。在一项研究中，卡麦角林在统一帕金森病评定量表日常生活活动部分（第二部分）评分和统一帕金森病评定量表运动评分方面比安慰剂有小但具有统计学显著性的优势。在另一项研究中，由于患者数量少且使用的卡麦角林剂量相对较低，未观察到这种优势。在两项研究中，施瓦布和英格兰量表无显著差异。卡麦角林组左旋多巴剂量减少显著更多（加权均数差149.6 mg/d；95%置信区间94.1，205.1；p < 0.00001）。卡麦角林组多巴胺能不良事件有增加趋势，但在p < 0.01水平未达到统计学显著性。然而，卡麦角林组撤药有减少趋势。
在帕金森病运动并发症的管理中，卡麦角林可用于减少左旋多巴剂量，并适度改善运动障碍和残疾状况，且不良事件可接受。这些结论最多基于中期证据。
