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左旋多巴、左旋多巴与司来吉兰联用以及溴隐亭治疗早期轻度帕金森病患者的疗效比较:三年中期报告。英国帕金森病研究小组

Comparisons of therapeutic effects of levodopa, levodopa and selegiline, and bromocriptine in patients with early, mild Parkinson's disease: three year interim report. Parkinson's Disease Research Group in the United Kingdom.

出版信息

BMJ. 1993 Aug 21;307(6902):469-72. doi: 10.1136/bmj.307.6902.469.

Abstract

OBJECTIVE

To determine the optimum treatment for early Parkinson's disease.

DESIGN

An open, long term, prospective randomised trial conducted by the Parkinson's Disease Research Group of the United Kingdom.

SETTING

93 hospitals throughout the United Kingdom.

SUBJECTS

782 patients with early Parkinson's disease who were not receiving dopaminergic treatment.

INTERVENTIONS

Patients allocated to treatment with levodopa/dopa decarboxylase inhibitor alone (arm 1), levodopa/decarboxylase inhibitor/selegiline in combination (arm 2), or bromocriptine (arm 3).

MAIN OUTCOME MEASURES

Disability assessment as judged by improvement on Hoehn and Yahr, modified Webster, and North Western University disability scales. Adverse event profile and mortality ratios.

RESULTS

Interim results indicate that all three treatment regimens led to improvement in baseline disabilities after 12 months' treatment and that deterioration in control was apparent by three years. No significant differences were found between the results of treatment in arm 1 and arm 2, but both were significantly more effective than bromocriptine (arm 3) and had fewer early adverse reactions. The adjusted difference (95% confidence interval) in Webster rating for arm 3 v 1 was 0.93 points (0.27 to 1.50; p = 0.0058) and for arm 3 v 2 was 1.25 points (0.61 to 1.89; p = 0.0002). The incidence of dyskinesias and motor oscillations, however, was significantly lower in arm 3 (2% and 5%, respectively) than in arm 1 (27% and 33%, respectively) and arm 2 (34% and 35%, respectively).

CONCLUSIONS

As there were no marked differences in functional improvement between the three groups the choice of treatment in the early stages of Parkinson's disease may not be critical.

摘要

目的

确定早期帕金森病的最佳治疗方法。

设计

由英国帕金森病研究小组进行的一项开放性、长期、前瞻性随机试验。

地点

英国各地的93家医院。

研究对象

782例未接受多巴胺能治疗的早期帕金森病患者。

干预措施

患者被分配接受单独使用左旋多巴/多巴脱羧酶抑制剂治疗(第1组)、左旋多巴/脱羧酶抑制剂/司来吉兰联合治疗(第2组)或溴隐亭治疗(第3组)。

主要观察指标

根据霍恩和雅尔分级、改良韦伯斯特分级以及西北大学残疾评定量表的改善情况判断残疾程度。不良事件情况和死亡率。

结果

中期结果表明,所有三种治疗方案在治疗12个月后均使基线残疾状况得到改善,且在三年时病情控制出现恶化。第1组和第2组的治疗结果之间未发现显著差异,但两者均比溴隐亭(第3组)显著更有效,且早期不良反应更少。第3组与第1组相比,韦伯斯特评分的校正差异(95%置信区间)为0.93分(0.27至1.50;p = 0.0058),第3组与第2组相比为1.25分(0.61至1.89;p = 0.0002)。然而,异动症和运动波动的发生率在第3组(分别为2%和5%)显著低于第1组(分别为27%和33%)和第2组(分别为34%和35%)。

结论

由于三组在功能改善方面无明显差异,帕金森病早期的治疗选择可能并不关键。

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