雑性尿路感染症に対するS6472 (Cefaclor持続性製剤) とCefaclor通常製剤の二重盲検比較試験 A DOUBLE-BLIND COMPARATIVE STUDY ON S 6472 (A LONG ACTING CEFACLOR) VERSUS CONVENTIONAL CEFACLOR PREPARATION IN COMPLICATED URINARY TRACT INFECTIONS

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カテーテル非留置の複雑性尿路感染症に対するS6472 (Cefaclor持続性製剤) の有効性, 安全性及び有用性を客観的に検討する目的でCefaclor通常製剤 (以下CCL) を対照薬として二重盲検比較試験を行った。<BR>S6472は1回750mgを1日2回, CCLは1回500mgを1日3回で5日間経口投与した。臨床効果の判定はUTI薬効評価基準 (第3版) に従い行つた。その結果以下の成績を得た。<BR>1.S6472投与群とCCL投与群の背景因子の分布に有意な偏りは認あられなかった。<BR>2.総合臨床効果はS6472投与群で76.2%, CCL投与群で75.5%の有効率であり, 両群間に有意差は認められなかった。UTI群別にみた効果についても, 2, 3, 4, 6群のいずれにおいても両群間に有意差を認めなかった<BR>3.主治医により判定された臨床効果において, 両群間に有意差は認められなかった。<BR>4.細菌学的効果はS6472投与群で81.2%, CCL投与群で78.3%の菌消失率を示し, 両群間に有意差は認められなかった。<BR>5.副作用の発生率はS6472投与群で2.9% (4例/139例), CCL投与群で0.7% (1例/141例) であり, 両群間に有意差は認あられなかった。臨床検査値異常変動はS6472投与群で94例中3例4件, CCL投与群で100例中5例5件が認められたが, 両群間に有意差を認めなかった。なお, 副作用及び臨床検査値異常変動はいずれも軽度且つ一過性であつた。又, 副作用と臨床検査値異常変動を考慮して主治医が判定した概括安全度においても, 両群間に有意差は認められなかった。<BR>6.有効性及び安全性を勘案して主治医により判定された有用性において両群間に有意差は認められなかった。<BR>以上の成績から, カテーテル非留置の複雑性尿路感染症に対してS6472は有効性, 安全性, 有用性においてCCL通常製剤と同等の優れた成績を示し, 1日2回投与という便利性を有する点から有用度の高い薬剤と考えられる。

For an objective evaluation of the clinical efficacy, safety and usefulness of S 6472 (a long acting cefaclor) in non-catheterized patients with complicated urinary tract infections, a double-blind comparative study was performed using conventional cefaclor preparation (hereafter, CCL) as the control drug.<BR>S 6472 was administered orally at a single dose of 750 mg twice daily, and CCL at a single dose of 500 mg 3 time daily. The duration of the treatment was 5 days for either drug. Clinical efficacies were evaluated according to the criteria for evaluation of drug efficacy by the Japanese UTI Committee (3rd edition), and the following results were obtained.<BR>1. The initial distribution of the patients' background characteristics was not significantly different between the S 6472 and CCL groups.<BR>2. The overall clinical efficacy rates were 76.2% in the S 6472 group and 75.5% in the CCL group, indicating no significant difference between the 2 groups. When clinical efficacies evaluated according to different types of infections (UTI groups), the differences between the 2 drug groups were not significant in any of desease groups 2, 3, 4, and 6.<BR>3. Clinical efficacy rates as evaluated by attending physicians were not significantly different between the 2 groups, either.<BR>4. Bacteriological responses were evaluated as eradicated in 81.2% in the S 6472 group and 78.3% in the CCL group, suggesting no statistically significant difference.<BR>5. The incidences of side effects were 2.9% (4/139) in the S 6472 group and 0.7% (1/141) in the CCL group, thus no significant differences existed between the 2 groups. On laboratory examination, 4 and 5 abnormal test values, respectively, were detected in 3/94 patients in the S 6472 group and 5/100 patients in the CCL group, but the difference wes not significant between the 2 groups, either. All of these side effect symptoms and abnormal laboratory test values were mild in severity and transient. The results of the overall safety rating which was based on the evaluations of the side effects and laboratory test values indicated no significant difference between the 2 groups.<BR>6. According to judgement by the attending doctors, the clinical usefulness rates evaluated based on the results of the efficacy and safety ratings were not significantly different between the S 6472 and CCL groups. These findings suggest that S 6472 produces excellent therapeutic results in complicated noncatheter-indwelt UTI patients and its clinical efficacy, safety, and usefulness are equal to those of the conventional CCL.<BR>Taking into account the advantage of twice-daily dosing for S 6472 instead of 3 times dosing, S 6472 is considered to be a highly useful antibiotics for complicated UTIs.

収録刊行物

  • The Japanese Journal of Antibiotics

    The Japanese Journal of Antibiotics 43(11), 1873-1892, 1990

    公益財団法人 日本感染症医薬品協会

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