Fourteen-year final report of the randomized PDRG-UK trial comparing three initial treatments in PD
Fourteen-year final report of the randomized PDRG-UK trial comparing three initial treatments in PD
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DOI：
10.1212/01.wnl.0000310812.43352.66
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发表时间：
2008-08-12
期刊：
影响因子：
9.9
通讯作者：
Lees, A. J.
中科院分区：
文献类型：
--
作者：
Katzenschlager, R.;Head, J.;Lees, A. J.
背景资料：英国帕金森病研究小组的试验的十年随访结果表明，与左旋多巴相比，在早期帕金森病（PD）中开始使用溴隐亭治疗没有长期优势。司来吉兰结合L-多巴的患者死亡率增加导致提前终止这一臂后6 years.Methods：在1985年和1990年之间，782例患者被招募到一个开放的务实的多中心试验，并被随机分配到L-多巴/脱羧酶抑制剂（DDCI），L-多巴/DDCI加司来吉兰，或溴隐亭。主要终点为死亡率、残疾和运动并发症。最后的后续行动，健康相关的生活质量和心理功能也assessed.Results：随访中位持续时间在最终评估为14年，在166（21%）幸存的参与者谁可以联系。校正基线特征后，左旋多巴组的残疾评分优于溴隐亭组（韦伯斯特：16.6 vs 19.8; p = 0.03;西北大学残疾：34.3 vs 30.0，p = 0.05）。在36项简明健康调查中，身体功能（差异20.8; 95% CI 10.0，31.6; p < 0.001）和身体总分（差异5.2; 95% CI 0.7，9.7; p = 0.03）也上级左旋多巴。运动障碍，运动波动和痴呆的死亡率和患病率的差异并没有显着difficult.Conclusion：多巴胺受体激动剂溴隐亭的初步治疗并没有降低死亡率或运动残疾和运动并发症的最初减少的频率并没有持续。我们没有发现初始多巴胺受体激动剂治疗的长期益处或临床相关疾病改善作用的证据。
Background: Ten-year follow-up results from the Parkinson's Disease Research Group of the United Kingdom trial demonstrated that there were no long-term advantages to initiating treatment with bromocriptine compared with L-dopa in early Parkinson disease (PD). Increased mortality in patients on selegiline combined with L-dopa led to premature termination of this arm after 6 years.Methods: Between 1985 and 1990, 782 patients were recruited into an open pragmatic multicenter trial and were randomized to L-dopa/decarboxylase inhibitor (DDCI), L-dopa/DDCI plus selegiline, or bromocriptine. The main endpoints were mortality, disability, and motor complications. For final follow-up, health-related quality of life and mental function were also assessed.Results: Median duration of follow-up at final assessment was 14 years in the 166 (21%) surviving participants who could be contacted. After adjustment for baseline characteristics, disability scores were better in the L-dopa than in the bromocriptine arm (Webster: 16.6 vs 19.8; p = 0.03; Northwestern University Disability: 34.3 vs 30.0, p = 0.05). Physical functioning (difference 20.8; 95% CI 10.0, 31.6; p < 0.001) and physical summary scores (difference 5.2; 95% CI 0.7, 9.7; p = 0.03) on the 36-item short-form health survey were also superior on L-dopa. Differences in mortality rates and prevalence of dyskinesias, motor fluctuations, and dementia were not significantly different.Conclusion: Initial treatment with the dopamine agonist bromocriptine did not reduce mortality or motor disability and the initially reduced frequency in motor complications was not sustained. We found no evidence of a long-term benefit or clinically relevant disease-modifying effect with initial dopamine agonist treatment.