薬理と治療

Abstract

Objectives The objective of this study was to assess the safety of administration of mucuna sheets which contains L-dopa, by conducting the pharmacokinetics（PK）and the open-label trial in healthy elderly subjects. Methods Twenty-one Japanese healthy subjects, who were older than 60 years old, were enrolled in the study. The pharmacokinetics parameter of L-dopa which is the content of mucuna sheets were examined in two groups following the administration of two or four sheets of mucuna. Mucuna sheets were made of roasting and powdering the mucuna by Kisyu Hosokawa coroporation. After performing the PK trial, all participants ingested 6 sheets of mucuna per day for 12 weeks. The safety of ingestion of mucuna was evaluated through physical examination, interview, blood chemistry analysis, electrocardiogram（ECG）, and questionnaires on sleep and fatigue at baseline and every 4 weeks of treatment. Results The maximum plasma concentration（Cmax）of L-dopa of the groups which received two sheets and four sheets of mucuna were 137.4±96.8 nM and 483.0±409.7 nM, respectively. The individual variability of plasma concentration is around eight fold. Subjects showed no adverse reactions except slight sleepiness. Although there were significant differences in renal function and blood glucose level during 12 weeks of mucuna treatment, they do not impose any clinically important meaning and they are also considered not to be related with ingestion of mucuna sheet. Conclusion According to our findings, we conclude that continuous long-term administration of mucuna sheets at evaluated dose in elderly people is safe.