過活動膀胱患者におけるα1受容体遮断薬の併用は生活の質を向上しうるか? : 抗コリン剤(塩酸プロビベリン)単独群および抗コリン剤α1受容体遮断薬(ウラピジル)併用群間の多施設前向きランダム化試験  [in Japanese] DOES α_1-BLOCKER PROVIDE ADDITIONAL IMPROVEMENT OF QUALITY-OF-LIFE IN PATIENTS WITH OVERACTIVE BLADDER? : A MULTI-CENTER PROSPECTIVE RANDOMIZED TRIAL BETWEEN ANTI-CHOLINERGIC (PROPIVERINE CHLORIDE) WITH AND WITHOUT α_1-BLOCKER (URAPIDIL)  [in Japanese]

(目的)過活動膀胱(以下OAB)による排尿障害は患者の生活の質を低下させる.本研究の目的はOAB患者の治療に抗コリン剤とα1受容体遮断薬を併用した際の有用性を明らかにすることである.(対象,方法)合計100名(男性:43,女性:57,平均年齢71.3歳)の頻尿(一日8回以上)および尿意切迫(週3回以上)を主訴とする患者を2群(塩酸プロビベリン単独群[52例]および塩酸プロビベリン,ウラピジル併用群[48例])にランダム化した.一次評価項目として蓄尿症状(頻尿,尿意切迫の回数,切迫性尿失禁)の改善およびキング健康調査票日本語版(以下KHQ)をもちいた治療前,治療開始後2週目,6週目の生活の質(以下QOL)の改善を比較した.二次評価項目として両群の有害事象を比較した.(結果)頻尿および尿意切迫は治療開始後2週目の時点で治療前と比べ両群とも有意の改善を認めた(それぞれp<0.01, <0.05).しかし2群間に有意差をみとめなかった. QOLの改善に関しては全体の平均スコア,全般的健康感,生活への影響,睡眠・活力のドメインにおいて両群とも治療6週目において治療前と比べ有意の改善を認めた.有害事象に関しては両群とも有意差をみとめなかった. (結論)両群とも有意の蓄尿障害の改善と耐用性をみとめたがα1受容体遮断薬の併用効果は認められなかった.

(Aim) Storage/filling symptoms caused by overactive bladder (OAB) are bothersome to patients. The aim of this study is to clarify if α_1-blocker provides additional benefit in combination with anticholinergic treatment in patients with OAB. (Methods) In total, 100 patients (men/women: 43/57, mean age : 71.3 years) who had frequency (more than eight times a day) and urgency (more than three times a week) were prospectively randomized, and allocated to two groups (monotherapy group [n = 52] : propiverine alone or combination group [n = 48] : propiverine plus urapidil). The primary end point was to compare the improvement of storage symptoms (numbers of frequency, urgency, disappearance of urge incontinence) as well as patients' quality of life (QOL) assessed by King's Health Questionnaires (KHQ) at baseline, 2 weeks, and 6 weeks after the start of treatment in both groups. The second end point was to evaluate the safety of these agents. (Results) Statistically significant improvements in terms of urgency and frequency were observed in both groups at two-weeks after the start of treatment as compared with baseline (p< 0.01 and < 0.05, respectively), while no inter-group difference was observed between the two groups. Significant improvement of QOL was observed after six weeks treatment in overall mean score, general health perception, incontinence impact, sleep/energy domains in both groups as compared with baseline. No significant difference was observed in terms of toxic events between the two groups. (Conclusions) Although both groups showed identical improvement of storage symptoms and tolerability, no additional benefit of α_1-blocker was observed.