高齢者における塩酸オキシブチニン(ポラキズ錠)の使用経験

Abstract

1)自覚的症状としての頻尿, 尿意切迫感および尿失禁いずれに関しても, ほぼ満足すべき改善率が得られた.2)疾患別, 診断名別の全般改善度では, 脳性疾患や前立腺疾患などによる神経因性膀胱および不安定膀胱に対して, その有効性が認められた.3)他覚的所見では, 最小尿意および最大膀胱容量とも本剤投与後に有意の増加がみられた.4) 1日投与量別改善度は6 mgと9 mg投与群で有意差はなかった.5)総合全般改善度は改善以上が43/75例, やや改善以上が67/75例と良好な結果が得られた.6)概括安全度は安全性に問題なしが73/75例で安全性の高い薬剤と考えられた.7)有用度は有用以上が44/75例, やや有用以上が61/75例であり, 本剤の有用性が認められた.8)副作用は73例中5例に口渇, 3例に排尿困難がみられた.また6 mg投与群は9 mg投与群に比べ副作用発現率が低かった.9)よって高齢者に対しては1日6 mg (2 mg×3回)投与が適していると考えられた

Oxybutynin hydrochloride (Pollakisu tablets) was administered at a daily dose of 6 or 9 mg to 75 elderly patients with urinary tract disorders, including neurogenic bladder and unstable bladder, with chief complaints of pollakisuria, urgency on urination and urinary incontinence. A post-marketing follow-up survey (phase IV study) was then performed to evaluate the efficacy safety and usefulness of Pollakisu tablets in these patients. The administration of Pollakisu tablets produced good results in the comprehensive assessment of overall improvement, being rated as "improved" or better in 57.5% of the patients and "slightly improved" or better in 89.0%. The assessment of general safety revealed that the drug caused almost no problems, with "no problem in safety" accounting for 97.3% of the responses. The assessment of the usefulness indicated that Pollakisu tablets are highly useful, being rated as "useful" or better in 58.9% and as "slightly useful" or better in 82.2%. Evaluation of the results according to daily dose indicated that a dose of 6 mg per day was appropriate for elderly patients from the viewpoint of drug efficacy and safety. With respect to adverse reactions, thirst was found in 5 and dysuria in 3 of the 73 patients. The overall incidence of adverse reactions was 11.0%. The above results indicate the efficacy, safety and usefulness of Pollakisu tablets in treating elderly patients with pollakisuria, urgency on urination and urinary incontinence.