塩酸フェキソフェナジンの精神運動機能に及ぼす影響

健常成人におけるパソコンによるワープロ入力作業を指標にして

抄録

Objective: To confirm the hypothesis that fexofenadine hydrochloride (in the therapeutic dose range) does not impair the quality of life, we assessed the effects of fexofenadinehydrochloride (120 mg-higher than Japanese dose) by using an English word processor.
Methods: A double-blind, randomized, placebo-controlled, single dose, Latin square crossover study was conducted in 18 healthy volunteers, including 9 males and 9 females, who used word processors in their daily lives. The ratio of the total number of characters input after drug administration to the number input before drug administration was assessed for the following 4 parameters: number of total keyed-in characters, number of correctly keyed-in characters, number of wrongly keyed-in characters and number of revised characters. Subjective self-ratings (visual analogue scale) were also measured. d-Chlorpheniramine maleate (6 mg) was used as a positive control drug.
Results: For the total number of keyed-in characters and the total number of correctly keyed-in characters, the ratios were significantly lower for subjects with d-chlorpheniramine maleate than those for subjects with placebo (p<0.05, respectively). For the total number of wrongly keyed-in characters and the total number of revised characters, the ratios with d-chlorpheniramine maleate were significantly higher than those with placebo (p < 0.05, respectively). These results indicate that dchlorpheniramine maleate can be used as the active control drug. The ratios for both the total number of correctly keyed-in characters and the total number of keyed-in charac ters were significantly higher for subjects with fexofenadine hydrochloride than for subjects with d-chlorpheniramine maleate (p <0.05, respectively). The ratio for the total number of revised characters was significantly lower for subjects with fexofenadine hydrochloride than for subjects with d-chlorpheniramine maleate (p < 0.05). The ratio for the total number of wrongly keyed-in characters, however, did not differ significantly between subjects with fexofenadine hydrochloride and d-chlorpheniramine maleate (p=0.051). There were no significant differences between fexofenadine hydrochloride and placebo in all parameters.
One subject on fexofenadine experienced mild headache and drowsiness, which were considered likely to be drug related. Another subject experienced dizziness, which was probably an adverse event in the placebo treatment. There was no report of adverse events related to blood pressure, pulse rate, body temperature, electrocardiographic findings or clinical laboratory results.
Conclusion: The impairment of word processor performance caused by fexo fenadine hydrochloride was considerably less than that caused by d-chlorpheniramine maleate, and similar to placebo. These results suggest that fexofenadine does not impair quality of life domains related to activities of daily living. In contrast, dchlorpheniramine maleate significantly impaired performance, which may reflect impairment in the quality of life.