Department of Neurology, City Hospital, Sandwell and West Birmingham NHS Trust, Dudley Road, Birmingham, United Kingdom.
Mov Disord. 2011 Jun;26(7):1187-93. doi: 10.1002/mds.23519. Epub 2011 Apr 14.
Evidence from clinical trials with monoamine oxidase type B inhibitors (TEMPO, ADAGIO and DATATOP) and levodopa (ELLDOPA) suggests that Parkinson's disease patients may benefit from treatment being commenced immediately on diagnosis rather than waiting for functional disability to develop, as is traditional clinical practice.
We performed a narrative literature review and meta-analysis of delayed-start design trials in Parkinson's disease.
There was inconsistency in the results of the two rasagiline delayed-start design trials, with early treatment with a 2 mg dose significantly superior in the TEMPO trial, but the 1 mg dose significantly better in the ADAGIO trial, making interpretation difficult. Further, the benefits of immediate treatment were small in terms of total unified Parkinson's disease rating scale scores, with a mean difference of 0.91 units (95% confidence interval 0.01, 1.80; P = 0.05) in a meta-analysis of the TEMPO and ADAGIO delayed-start design trials. Such small differences are unlikely to be of clinical relevance. There is also little information on whether immediate treatment has a beneficial effect on patient quality of life with an acceptable adverse reaction profile, and we have no data on whether immediate treatment is cost-effective.
Based on the evidence available, changing clinical practice to immediate therapy on diagnosis is not warranted and further trials are needed.
来自单胺氧化酶 B 抑制剂(TEMPO、ADAGIO 和 DATATOP)和左旋多巴(ELLDOPA)的临床试验证据表明,帕金森病患者可能受益于在诊断后立即开始治疗,而不是像传统临床实践那样等待功能障碍发展。
我们对帕金森病延迟启动设计试验进行了叙述性文献复习和荟萃分析。
两项雷沙吉兰延迟启动设计试验的结果不一致,TEMPO 试验中 2mg 剂量的早期治疗明显更好,但 ADAGIO 试验中 1mg 剂量明显更好,这使得解释变得困难。此外,就总统一帕金森病评定量表评分而言,立即治疗的益处较小,TEMPO 和 ADAGIO 延迟启动设计试验的荟萃分析显示,平均差异为 0.91 个单位(95%置信区间 0.01,1.80;P=0.05)。这种微小的差异不太可能具有临床相关性。关于立即治疗是否对患者生活质量有有益影响且不良反应谱可接受,我们也几乎没有信息,并且我们没有关于立即治疗是否具有成本效益的数据。
根据现有证据,改变临床实践,在诊断后立即进行治疗是没有依据的,需要进一步的试验。