前立腺肥大症に伴う排尿障害に対する塩酸テラゾシンの有用性の検討 ―1日1回投与と1日2回投与の多施設共同比較試験―

Abstract

前立腺肥大症による排尿障害に対する塩酸テラゾシン1日1回投与法の有効性と安全性について1日2回投与法との比較検討を多施設共同で行った.封筒法により1日1回投与21例, 1日2回投与21例にランダマイズされた前立腺肥大症42例を対象とした.投与開始から2週間は1日1mg, 3～4週にかけては2mgを投与し, 投与41週目迄の有用性を判定した.IPSS・QOLスコア, 最大尿流量率, 平均尿流量率において, 1日1回投与群, 1日2回投与群共に有意な改善を認め, かつ2群間では差を認めなかった.副作用はいずれも軽度であった.よって2群間の有用性に差はないものと考え, 塩酸テラゾシン1日1回投与法は薬剤コンブライアンスの点から推奨できる有用な治療法と考えた

We compared the efficacy of once a day administration of terazosin hydrochloride with that of twice a day administration for benign prostatic hyperplasia (BPH) patients. Forty-two patients with BPH were randomly assigned to receive a maximum dose of 2 mg terazosin either once (n = 21) or twice (n = 21) a day. International prostate symptom score (IPSS), uroflowmetry and side effect profile were determined before and 4 weeks after randomization. Both groups were similar with respect to patient age, baseline IPSS and prostate volume. After 4 weeks of treatment with terazosin, significant improvement in IPSS, maximum flow rate and mean flow rate were observed in both groups. However, these improvements did not differ significantly between them. In addition, there were no differences in side effects between the groups. In conclusion, once a day administration of terazosin hydrochloride is as effective and safe as twice a day administration in patients with BPH.