過活動膀胱症状を有する前立腺肥大症に対するナフトピジルの有効性の検討 : 朝投与と夕投与の前向き無作為化比較試験

概要

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A total of 100 patients with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) symptoms (BPH/OAB), enrolled between June 2006 to March 2008, were randomly divided into 2 groups of morning medication (M) and evening medication (E) groups, then 50 mg of naftopidil was given once a day after breakfast or supper for 8 weeks. Data were available for efficacy analysis on 80 patients (M group ; 43, E group ; 37). Naftopidil significantly improved the overall international prostatic symptom score ; from 19.2±7.9 to 11.7±5.8 in the M group and from 19.4±6.4 to 12.3±6.8 in the E group (p＜0.0001), QOL score from 4.9±0.8 to 3.2±1.4 in the M group and from 5.0±0.8 to 3.6±1.3 in the E group (p＜0.0001), and OAB symptom score from 7.8±2.6 to 5.0±2.5 in the M group (p＜0.0001) and from 8.6±2.9 to 5.8± 3.3 in the E group (p＜0.0001). There was no significant difference in the incidence of adverse effects betwen the M group (6.1%) and E group (2.2%). These results suggest that naftopidil improves storage symptoms as well as voiding symptoms regardless of timing of administration.