複雑性尿路感染症に対するDL-8280の薬効評価 Pipemidic acidとの二重盲検比較試験

Abstract

複雑性尿路感染症に対するDL-8280の有効性, 安全性と有用性を客観的に評価するため, Pipemidic acid (PPA)を対照薬とし二重盲検法で比較検討した.DL-8280は1回200 mg, 1日3回, PPAは1回500 mg, 1日4回, を5日間連続経口投与した.総投与例数は311例で, 除外, 脱落を除く228例(DL-8280群115例, PPA群113例)に対し有効性を評価した.安全性の評価は306例(DL-8280群153例, PPA群153例), 有効性の評価は250例(DL-8280群124例, PPA群126例)につきおこなった.両群の背景因子には差はなかった.総合臨床効果は, DL-8280群で著効39.1%, 有効80.9%, PPA群それぞれ23.9, 57.5%と比較し有意に高かった.疾患病態群別には, 第2群(単独感染, 前立腺術後感染症)と第3群(単独感染, 上部尿路感染症)を除き, DL-8280群の総合臨床効果はPPA群に比し有意に優っていた.膿尿に対する効果は, 正常化率+改善率がDL-8280群で59.1%, PPA群で46.0%で, 前者が, 優る傾向をみた.細菌尿に対する効果では, DL-8280群の陰性化率は76.5%, PPA群は50.4%で, DL-8280群が有意に優っていた.細菌学的効果では, DL-8280群の分離菌の消失率89.0%に対し, PPA群は72.1%で, 有意差であった.グラム陰性桿菌, グラム陽性球菌についてもDL-8280群の消失率は有意に優っていた.主治医による臨床効果はDL-8280群が著効46.1%, 有効83.5%で, PPA群はそれぞれ26.5, 61, 1%で, 前者が有意に優っていた.有用性は, DL-8280群が"非常に満足", "満足"合わせて71.8%, PPA群が47.6%でDL-8280群が有意に優っていた.副作用はDL-8280群で11例, PPA群で12例に認め, 有意差はなく, 大部分は消化器症状で, 重篤なものはなかった.臨床検査値悪化もDL-8280群で10例, PPA群で9例にみ, 有意差はなかった

The clinical efficacy, safety and usefulness of DL-8280 for the treatment of complicated urinary tract infections were compared with those of pipemidic acid (PPA) by a double-blind method. DL-8280 and PPA were orally administered at a daily dose of 600 mg (t.i.d.) and 2.0 g (q.i.d.) for 5 days, respectively. Of the 311 patients who received DL-8280 or PPA, clinical efficacy, safety and usefulness were evaluated in 228 patients (DL-8280, 115; PPA, 113), 306 patients (DL-8280, 153; PPA, 153) and 250 patients (DL-8280, 124; PPA, 126), respectively. There was no significant difference in the background characteristics between the two groups. In the DL-8280 group the overall clinical efficacy was excellent in 39.1% and moderate in 41.7%, the effectiveness rate being 80.9%, whereas in the PPA group it was excellent in 23.9% and moderate in 33.6%, the effectiveness rate being 57.5%. The efficacy in the DL-8280 group was significantly higher than that in the PPA group (P less than 0.001). According to classification by the type of infection, the overall clinical efficacy of DL-8280 in groups except group 2 (monomicrobial infection, post prostatectomy) and group 3 (monomicrobial infection, upper urinary tract infection) was superior to that of PPA, the difference being significant. Pyuria was cleared or improved in 59.1% of the patients treated with DL-8280 and in 46.0% of the patients with PPA. The difference was not significant. Bacteriuria was eliminated in 76.5% in the DL-8280 group and in 50.4% in the PPA group. DL-8280 demonstrated a significantly higher response than PPA (P less than 0.001). Of the bacteria isolated from the DL-8280 group and PPA group 89.0% and 72.1%, respectively, were eradicated after the treatment, a significant difference being observed between the two groups (P less than 0.001). The clinical efficacy evaluated by the doctor in charge was excellent in 46.1% and good in 37.4% of the patients treated with DL-8280 and excellent in 26.5% and good in 34.5% of the patients treated with PPA, the intergroup difference in the efficacy being significant (P less than 0.001). The evaluation of usefulness of DL-8280 and PPA was "satisfactory" for 71.8% and 47.6%, respectively, the difference being significant (P less than 0.001). Side effects were observed in 11 patients (7.2%) in the DL-8280 group and in 12 patients (7.8%) in the PPA group, but none were serious.(ABSTRACT TRUNCATED AT 400 WORDS)