フケ症に対する0.75%硝酸ミコナゾール配合シャンプーの有用性の検討―シャンプー基剤を対照とした二重盲検比較試験:シャンプー基剤を対照とした二重盲検比較試験 Study on the Usefulness of Shampoo Containing 0.75% Miconazole Nitrate for Treatment of Dandruff-A Double-Blind, Comparative Study.:A Double-Blind, Comparative Study

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フケ症を対象に,0.75%硝酸ミコナゾールシャンプー(MZS)の有用性を,シャンプー基剤(BSS)を対照として8施設による二重盲検比較試験により検討を行った.また,フケおよびかゆみに対する症状の改善と<i>Malassezia furfur</i>の菌数の減少,すなわち真菌学的効果との関係についても併せて検討した.<br>その結果,総症例数134例中,安全性解析対象症例は130例,有効性および有用性解析対象症例は108例であった.有用率はMZS群58例中34例(58.6%),BSS群50例中19例(38.0%)であり,MZS群がBSS群に比し有意に優れる成績であった(p=0.020).フケの改善率では,MZS群58例中42例(72.4%),BSS群50例中26例(52.0%)であり,MZS群がBSS群に比し有意に優れる成績であった(p=0.017).<br><i>M.furfur</i>に対する真菌学的効果とフケに対する有効性に関して,効果の発現がみられた症例においては,菌数の有意な減少が認められた(p=0.0001).これに対し,無効の症例では試験開始前と終了後の菌数の変化に有意差を認めなかった.また,試験開始時の菌数による有効性の層別解析では,菌数が比較的多い症例において,MZS群がBSS群に比し有意に優れていた(p=0.038).副作用は130例全例において全く認められなかった.<br>以上より,MZSはフケ症に対して有効であり,フケの改善と<i>M.furfur</i>菌数の減少とも比較的一致する極めて有用なシャンプー剤であると考えられた.

A double-blind, comparative study on the usefulness of shampoo containing 0.75% miconazole nitrate (MZS) for the treatment of dandruff was conducted at 8 institutions, using the shampoo vehicle (BSS) without the reagent as the control. The relationship between improvement in clinical symptoms, such as dandruff and itching, and the decrease in the count of <i>Malassezia furfur</i>, that is, mycological response, was also studied.<br>Of a total of 134 subjects studied, 58 were shampooed with MZS, and 50 with BSS. One hundred thirty of these were included in a safety analysis, and 108 in an efficacy and usefulness analysis. MZS was evaluated as useful in 34 (58.6%) of the 58, and BSS in 19 (38.0%) of the 50 subjects, thus MZS was significantly more useful than BSS (p=0.020). Dandruff improved in 42 (72.4% ) of the 58 with MZS, and in 26 (52.0%) of the 50 subjects with BSS, MZS significantly reduced the dandruff and thus was more effective than BSS (p=0.017).<br>With regard to the relationship between the mycological response of <i>M. furfur</i> and the efficacy of shampooing against dandruff, the count of <i>M. furfur</i> decreased significantly in the subjects for whom the shampooing was evaluated as effective (p=0.0001), whereas there was no significant difference between the baseline and posttreatment counts in those for whom the shampooing was evaluated as ineffective. Stratification of results of efficacy evaluation according to the baseline count revealed that MZS was more effective than BSS in subjects with relatively high counts of <i>M. furfur</i> (p=0.038). No adverse reactions to either shampoo were observed in any of the 130 subjects.<br>The above results suggested that MZS is effective against dandruff, and further, that the usefulness of this shampoo shows a relatively close correlation between the improvement in dandruff and decrease in the count of <i>M. furfur</i>.

収録刊行物

  • 日本医真菌学会雑誌

    日本医真菌学会雑誌 38(1), 87-97, 1997

    The Japanese Society for Medical Mycology

各種コード

  • NII論文ID(NAID)
    130003671887
  • 本文言語コード
    JPN
  • ISSN
    0916-4804
  • データ提供元
    J-STAGE 
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