前立腺肥大症に対するエビプロスタット製剤の臨床的有用性の検討 : エビプロスタット錠とその2倍量製剤との比較

Abstract

前立腺肥大症患者を, エビプロット錠1日3回, 1回2錠内服の46例(男・平均65.8歳:A群)と, エビプロット錠の主成分を倍量含むEVI-F錠1回1錠内服の46例(男・平均63.6歳:B群)に封筒法により無作為に割付け, 効果を比較した。国際前立腺症状スコア(IPSS)の合計は投与開始時A群15.6, B群14.9, 投与後4週ではそれぞれ11.6, 11.2, 8週後では9.4, 8.8と有意に低下し, 両群間で有意差はなかった。スコア変化量, 症状改善度にも両群で有意差はなかった。またQOLスコアおよびIPPSの各サブスコアも同様に有意な改善を示し, 両群間で有意差はなかった。副作用はA群6例9件, B群3例3件に認めたが, ほとんどは軽度で臨床的に問題はなく, 発現率に両群間で有意差はなかった。治験後のアンケート調査で飲みやすいと回答したのはA群72.9%, B群95.7%であった。EVI-F錠はエビプロット錠と同等の有効性と安全性を有していることが確認され, 服薬状況を向上させる可能性も示唆された。

We compared the usefulness of Eviprostat tablet, a therapeutic agent for benign prostatic hyperplasia (BPH), and EVI-F tablet, a new formulation of Eviprostat containing two times more active ingredients (Chimaphila umbellata extract, Populus tremula extract, Pulsatilla pratensis extract, Equisetum arvense extract and purified wheat germ oil) and consequently designed to reduce the number of tablets per dose by half. In this study, patients with BPH were randomly assigned to either Eviprostat group (6 tabs/day) or EVI-F group (3 tabs/day) using the envelope method. The clinical efficacy of these two drugs were evaluated by the International Prostate Symptom Score (IPSS) and QOL score at the end of the treatment period, and their safety was evaluated by the incidence of side effects. Based on the clinical study guidelines for dysuria, the change in the IPSS total score and QOL score were comparable to the previously reported data for other treatment agents for BPH, and these indices showed gradual improvement with the treatment period. Both treatments were well tolerated. The clinical usefulness of the monotherapy with EVI-F tablet or Eviprostat tablet was reasonably demonstrated in this study. Furthermore, both treatments reduced nocturia, which has an impact on the QOL of patients with BPH.