Vecchi G P, Neri M, Cortelloni C, De Vreese L, Sirotti C, Cipolli C, Fabbri L, Zerbini O
Institute of Gerontology and Geriatrics, University of Modena, Italy.
Int J Clin Pharmacol Res. 1990;10(1-2):145-52.
A multicentre study was planned and executed to evaluate the effect of acetyl-L-carnitine in the treatment of cerebral aging. Using 42 health centres, whose comparability of methodology was ensured through a training seminar and an instructional booklet on the psychometric battery of tests employed, some 400 elderly patients aged 60-80 years were enrolled using strict selection criteria. Treatment was run in four phases over 150 days. The first phase, serving as the baseline evaluation, defined through a battery of tests, consisted of 30-day placebo treatment. In the second phase of 45 days, daily treatment with 1500 mg acetyl-L-carnitine was given followed by a psychometric evaluation. For the next 45 days the same drug therapy was employed with a complete psychometric evaluation on the final day. In the last phase of 30 days the placebo was again administered and a final assessment made of the residual benefits of the 90-day treatment with acetyl-L-carnitine. Using this plan made it possible to evaluate the placebo effects, perform cross-study comparisons and demonstrate the effectiveness of the drug treatment.
一项多中心研究被规划并实施，以评估乙酰左旋肉碱在治疗脑老化方面的效果。利用42个健康中心，通过一次培训研讨会以及一本关于所采用心理测量测试组的指导手册确保了方法的可比性，使用严格的筛选标准招募了约400名60至80岁的老年患者。治疗分四个阶段进行，为期150天。第一阶段作为基线评估，通过一系列测试来界定，包括30天的安慰剂治疗。在为期45天的第二阶段，给予每日1500毫克乙酰左旋肉碱治疗，随后进行心理测量评估。在接下来的45天里，采用相同的药物治疗，并在最后一天进行全面的心理测量评估。在为期30天的最后阶段，再次给予安慰剂，并对乙酰左旋肉碱90天治疗的残留益处进行最终评估。采用这个方案能够评估安慰剂效应、进行跨研究比较并证明药物治疗的有效性。
