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标准息宁与息宁控释片治疗轻至中度帕金森病患者的双盲对照研究

Double-blind comparison of standard Sinemet and Sinemet CR in patients with mild-to-moderate Parkinson's disease.

作者信息

Feldman R G, Mosbach P A, Kelly M R, Thomas C A, Saint Hilaire M H

机构信息

Ellen and Harold Wald Neurological Unit, University Hospital, Boston, MA.

出版信息

Neurology. 1989 Nov;39(11 Suppl 2):96-101; discussion 105.

PMID:2685655
Abstract

The combination of carbidopa and levodopa (Sinemet) is a highly effective treatment for the symptoms of Parkinson's disease. However, side effects, such as abnormal involuntary movements, fluctuations in motor performance, and "wearing off" phenomena limit its long-term usefulness in some patients. Open-label studies show that controlled-release Sinemet CR is effective in reducing motor fluctuations. This report discusses the results of a 14-week double-blind crossover study comparing the efficacy and tolerability of standard Sinemet with controlled-release Sinemet CR. Overall, there were no statistically significant differences in efficacy between Sinemet CR and standard Sinemet on any of the major efficacy measures, suggesting a clinical equivalence in terms of treating the symptoms of Parkinson's disease. The study also supports the tolerability of Sinemet CR. In summary, Sinemet CR holds the promise of reducing some disturbing side effects of long-term levodopa therapy, thus achieving optimal control of parkinsonian symptoms.

摘要

卡比多巴与左旋多巴的复方制剂(息宁)是治疗帕金森病症状的一种高效药物。然而,诸如异常不自主运动、运动功能波动以及“剂末”现象等副作用,在某些患者中限制了其长期应用价值。开放标签研究表明,控释息宁在减少运动波动方面有效。本报告讨论了一项为期14周的双盲交叉研究结果,该研究比较了标准息宁与控释息宁CR的疗效和耐受性。总体而言,在任何主要疗效指标上,息宁CR与标准息宁在疗效上均无统计学显著差异,这表明在治疗帕金森病症状方面具有临床等效性。该研究还支持了息宁CR的耐受性。总之,息宁CR有望减少长期左旋多巴治疗的一些令人困扰的副作用,从而实现对帕金森病症状的最佳控制。

相似文献

1
Double-blind comparison of standard Sinemet and Sinemet CR in patients with mild-to-moderate Parkinson's disease.标准息宁与息宁控释片治疗轻至中度帕金森病患者的双盲对照研究
Neurology. 1989 Nov;39(11 Suppl 2):96-101; discussion 105.
2
Controlled-release carbidopa/levodopa (Sinemet 50/200 CR4): clinical and pharmacokinetic studies.控释卡比多巴/左旋多巴(息宁50/200 CR4):临床和药代动力学研究。
Neurology. 1989 Nov;39(11 Suppl 2):45-53; discussion 59.
3
Comparison of Sinemet CR4 and standard Sinemet: double blind and long-term open trial in parkinsonian patients with fluctuations.息宁控释片4与标准息宁的比较:帕金森病症状波动患者的双盲和长期开放试验
Mov Disord. 1989;4(4):303-9. doi: 10.1002/mds.870040403.
4
Controlled-release carbidopa-levodopa (Sinemet) in combination with standard Sinemet in advanced Parkinson's disease.控释卡比多巴-左旋多巴(息宁)与标准息宁联合用于晚期帕金森病。
Ann Clin Lab Sci. 1989 Mar-Apr;19(2):101-6.
5
Controlled-release carbidopa/levodopa (CR) in parkinsonian patients with response fluctuations on standard levodopa treatment: clinical and pharmacokinetic observations.接受标准左旋多巴治疗出现反应波动的帕金森病患者使用控释卡比多巴/左旋多巴(CR):临床及药代动力学观察
Neurology. 1989 Nov;39(11 Suppl 2):88-92; discussion 95.
6
An open multicenter long-term treatment evaluation of Sinemet CR. Sinemet CR Multicenter Study Group.息宁控释片的开放性多中心长期治疗评估。息宁控释片多中心研究组。
Neurology. 1989 Nov;39(11 Suppl 2):101-4; discussion 105.
7
Long-term clinical efficacy of Sinemet CR in patients with Parkinson's disease.息宁控释片治疗帕金森病患者的长期临床疗效
Neurology. 1989 Nov;39(11 Suppl 2):92-5; discussion 95.
8
Multicenter controlled study of Sinemet CR vs Sinemet (25/100) in advanced Parkinson's disease.息宁控释片与息宁(25/100)治疗晚期帕金森病的多中心对照研究。
Neurology. 1989 Nov;39(11 Suppl 2):67-72; discussion 72-3.
9
Development and progression of motor fluctuations and side effects in Parkinson's disease: comparison of Sinemet CR versus carbidopa/levodopa.帕金森病中运动波动和副作用的发展与进展:息宁控释片与卡比多巴/左旋多巴的比较
Neurology. 1989 Nov;39(11 Suppl 2):63-6; discussion 72-3.
10
Treatment of early Parkinson's disease with controlled-release levodopa preparations.用控释左旋多巴制剂治疗早期帕金森病。
Neurology. 1989 Nov;39(11 Suppl 2):78-81; discussion 95.

引用本文的文献

1
Levodopa in Parkinson's Disease: Current Status and Future Developments.左旋多巴在帕金森病中的应用:现状与未来发展。
Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.
2
Application of Pharmacokinetics and Pharmacodynamics in Product Life Cycle Management. A Case Study with a Carbidopa-Levodopa Extended-Release Formulation.药代动力学和药效学在产品生命周期管理中的应用。以卡比多巴-左旋多巴缓释制剂为例的案例研究。
AAPS J. 2017 May;19(3):607-618. doi: 10.1208/s12248-016-0032-x. Epub 2017 Jan 24.
3
Soluble and controlled-release preparations of levodopa: do we really need them?
左旋多巴的可溶性和控释制剂:我们真的需要它们吗?
J Neurol. 2010 Nov;257(Suppl 2):S292-7. doi: 10.1007/s00415-010-5734-x.
4
International (NL-UK) double-blind study of Sinemet CR and standard Sinemet (25/100) in 170 patients with fluctuating Parkinson's disease.左旋多巴控释片与标准美多芭(25/100)治疗170例帕金森病症状波动患者的国际(荷兰-英国)双盲研究
J Neurol. 1996 Mar;243(3):235-40. doi: 10.1007/BF00868520.
5
New directions in the drug treatment of Parkinson's disease.帕金森病药物治疗的新方向。
Drugs Aging. 1996 Sep;9(3):169-84. doi: 10.2165/00002512-199609030-00003.
6
Concentration-effect relationship of levodopa in patients with Parkinson's disease.帕金森病患者左旋多巴的浓度-效应关系。
Clin Pharmacokinet. 1995 Oct;29(4):243-56. doi: 10.2165/00003088-199529040-00004.