Ｓｉｌｖｅｒ　ｓｕｌｆａｄｉａｚｉｎｅ（Ｔ１０７）のじょくそう，慢性皮膚かいように対する臨床評価　　二重盲検法によるｐｌａｃｅｂｏとの比較検討

• Published in: CHEMOTHERAPY Vol. 32; no. 4; pp. 208 - 222
• Main Author: YURA JIRO
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 1984; 公益社団法人 日本化学療法学会
• ISSN: 0009-3165; 1884-5894
• DOI: 10.11250/chemotherapy1953.32.208

We conducted the double blind clinical study with silver sulfadiazine (T 107) and placebo for the treatment of decubitus ulcer and chronic dermal ulcer with infection as cooperative study from 9 institutes in Central area of Japan.The period ranged from June 1982 to June 1983. Total analytical cases come up to 37 cases for T 107 group and 40 cases for placebo group (TP group).For qualitative data, we applied X2 test, FISHER exact probability test and U test. Judged by each physicians, efficacy rate (including excellent and good) was analysed as 64.7% for T 107 group and 27% for TP group with significant difference for T 107 group. In judgement by the committee, efficacy rate was significantly better for T 107 group as much as 87.8% in contrast to 24.3% for TP group. Each physicians did not admit any significant difference between the two groups with respect to improving state of wound, but significant difference was noted in overall judgement by each physicians as better for T 107 group as effective as 70.8% and as 32.4% for TP group. Side effects were only contact dermatitis observed in 1 case for T 107 group and 2 cases for TP group without any significant difference between the two. Both groups had no cases having abnormal changes in laboratory examination values attributable to the drug.We regarded T 107 to be safe and excellent in bactericidal and therapeuticsl effects to decubitus ulcer and chronic dermal ulcer from the above mentioned outcome. 中部地区9施設の協同研究により, 昭和57年6月から昭和58年6月までの期間に, 感染を伴った褥瘡, 慢性皮膚潰瘍を対象に, placeboを対照薬とする二重盲検法により, silver sulfadiazine (以下, T107) の臨床評価を行なった。解析対象例はT107群37例, placebo群 (以下, TP群) 40例であった。計数データにはX2検定, FISHERの直接確率法, U検定を用いた。解析の結果, 抗菌効果に関しては主治医判定でT107群で有効率 (著効, 有効を含む) は64.7%, TP群で27%と有意差をもってT107群が優れていた。また小委員会判定においても, Tl07群の有効率67.6%, TP群24.3%と有意差をもってT107群が優れていた。創の良化に関しては, 主治医判定では, T107およびTP群に有意差は認めなかったが, 総合判定を主治医判定でみると, T107群の有効率70.6%, TP群32.4%と有意差をもってT107群が優れていた。副作用に関しては接触皮膚炎をT107群で1例, TP群で2例を認めたのみで, 両群に有意差を認めなかった。また臨床検査値の変動においては, 両群とも本薬剤によると判定される異常変動は全例に認めなかった。以上の結果から, 褥瘡, 慢性皮膚潰瘍に対して, T1O7は優れた抗菌力と治療効果を有する安全な薬剤であることが認められた。