臨床薬理

The clinical efficacy of new benzodiazepine derivative, D-58SI (20mg), was compared with that of nitrazepam (10 mg) and placebo in insomniac patients by the double-blind and cross-over method. The subjects employed were 63 inpatients suffering from moderate to severe sleep disturbances with psychosomatic or internal diseases.
Global judgement revealed that D-58SI and nitrazepam showed a significantly greater effect (p<0.01) on sleep disturbance than did placebo. No significant difference was found between D-58SI and nitrazepam
Among the test items on the questionnaire, the onset and duration of sleep differed most significantly from those obtained with placebo . In every item, D-58SI showed no characteristic feature different from nitrazepam . The adverse effects with these drugs were not significantly different from those with placebo .
The “double-blind placebo” was found to be significantly more effective than either single-blind or washout placebo . When subjects were divided into neurotic and non-neuroic groups by the psychological test, both the drugs and placebo were less effective in the former group than in the latter.

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The antidiabetic effect of 1-(2-endo-hydroxy-3-endo-bornyl)-3- (p-toly sulfonyl) urea (Ro6-4563) was studied by means of the screening system designed by us.
The hypoglycemic effect of Ro6-4563 was evidenced by the tests in rats and rabbits, and the dose-response curves for the drug tested were found parallel with those for tolbutamide used as a standard preparation. Furthermore, the shift direction of the point on the e-^-k_x C coordinate in the single administration test for the intravenous glucose tolerance examination was to the left, this being similar with that for tolbutamide. On the other hand, the results obtained from the repeated aministration test for glucose tolerance examination and from the humping test in rabbits were found to differ further from those for tolbutamide, Ro6-4563 rather showing a resemble effect to some SH-inhibitors, the chelating agents and the polycarbonyls. The action-mechanism of Ro6-4563 on the glucose tolerance curve in rabbits was briefly discussed and it was suspected that these actions were based on the chelating ability which was induced between the hyd roxy radical on bolneol ring and N in urea.
The above mentioned results suggest that Ro6-4563 may have certain important actions on metal. This fact should not be disregarded when Ro6-4563 is clinically evaluated.

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