In a double-blind study with randomly assigned topical solutions of 0%, 1%, 3%, or 5% minoxidil, the blood flow in balding scalps of 16 human volunteers was measured by the noninvasive techniques of both laser Doppler velocimetry (LDV) and photopulse plethysmography (PPG). On two consecutive days, an 0.25-ml volume of the assigned minoxidil formulation was spread uniformly over a 100-cm2 area of each side of the bald scalp and cutaneous blood flow was recorded for the following 4 h. Both measurement techniques showed that the 5% minoxidil solution stimulated the microcirculation of the bald scalp. Increased blood flow was greater with the 5% minoxidil solution than with the other treatments. Measured by LDV on day 1, the increase (p less than 0.0001) in blood flow occurred within 15 min of application of the 5% solution of minoxidil and was maintained at least through hour 1. On day 2, LDV showed blood flow stimulation with the 5% solution was 3-fold (p less than 0.0001) within 15 min of application and was so maintained for about 1 h. Measured by PPG, the only statistically significant (p less than 0.01) response occurred with the day 2 application of the 5% minoxidil solution. PPG is dependent on local blood volume and is only weakly correlated to cutaneous blood flow, which makes it unsuitable for this kind of study. Analysis of vital signs for days 1 and 2 revealed no systemic effect from treatment with minoxidil, suggesting that the blood flow stimulation was directly related to the topical application of minoxidil.
A randomized double-blind study with placebo control revealed that single large intravenous doses of methylprednisolone sodium succinate produced no serious systemic effects. The effects of a dose of 30 mg. per kilogram given over a 10 minute period were studied. A battery of tests given before, during, and after administration indicated that the physiologic changes are similar in kind and degree to those after oral administration. An ACTH stimulation test suggested that the ability of the adrenal gland to respond is preserved after the single large doses. On the basis of this study it was concluded that, when indicated, doses of up to 30 mg. per kilogram of methylprednisolone sodium succinate were safe for use.While there are many reports describing the use of pharmacologic doses of corticosteroids in shock and other medical emergencies/' 2, 4, 6, 7, 9 there is relatively little data on the tolerance to single large intravenous doses in normal healthy volunteers. In this study, we evaluated the effects of an mtravenous dose of 30 mg. per kilogram of methylprednisolone sodium succinate (Solu-Medrol), a water-soluble salt with somewhat greater anti-inflammatory potency than prednisolone and with little tendency to induce sodium and water retention.
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