Evaluation of the Effects SK-P-9701 (Dextranomer paste) for the Treatment of Various Skin Ulcers
SK-P-9701 (Dextranomer paste) was given to 30 patients with various kinds of skin ulcers (decubitus, burn ulcer, leg ulcer, post-operation ulcer and the other ulcers) for 4 weeks to examine the efficacy, safety, usefulness and usability. In the efficacy evaluation, 13 patients revealed “markedly eff...
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| Published in | Skin research Vol. 42; no. 5; pp. 514 - 527 |
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| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
Meeting of Osaka Dermatological Association
2000
日本皮膚科学会大阪地方会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0018-1390 1884-541X |
| DOI | 10.11340/skinresearch1959.42.514 |
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| Abstract | SK-P-9701 (Dextranomer paste) was given to 30 patients with various kinds of skin ulcers (decubitus, burn ulcer, leg ulcer, post-operation ulcer and the other ulcers) for 4 weeks to examine the efficacy, safety, usefulness and usability. In the efficacy evaluation, 13 patients revealed “markedly effective”(54.2%), and 8 patients showed “effective”(33.3%), so that the effective rate was 87.5%. In the safety evaluation, SK-P-9701 was “safe”for the treatment of ulcers without any adverse reactions in 22 patients (88.0%). Two patients complained of pain in ulcers after topical application of the test material. Taken together, the usefulness evaluation was “markedly useful” in 9 patients (42.9%), and “useful” in 8 patients (38.1%), so that the useful rate was 81.0%(17/21). The usability of the paste on the ulcer surface was evaluated as “good” in 28 cases (93.3%). As a result, these findings indicate the efficacy and safety of SK-P-9701 in the management of various skin ulcers. |
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| AbstractList | SK-P-9701 (Dextranomer paste) was given to 30 patients with various kinds of skin ulcers (decubitus, burn ulcer, leg ulcer, post-operation ulcer and the other ulcers) for 4 weeks to examine the efficacy, safety, usefulness and usability. In the efficacy evaluation, 13 patients revealed “markedly effective”(54.2%), and 8 patients showed “effective”(33.3%), so that the effective rate was 87.5%. In the safety evaluation, SK-P-9701 was “safe”for the treatment of ulcers without any adverse reactions in 22 patients (88.0%). Two patients complained of pain in ulcers after topical application of the test material. Taken together, the usefulness evaluation was “markedly useful” in 9 patients (42.9%), and “useful” in 8 patients (38.1%), so that the useful rate was 81.0%(17/21). The usability of the paste on the ulcer surface was evaluated as “good” in 28 cases (93.3%). As a result, these findings indicate the efficacy and safety of SK-P-9701 in the management of various skin ulcers. SK-P-9701 (Dextranomer paste) was given to 30 patients with various kinds of skin ulcers (decubitus, burn ulcer, leg ulcer, post-operation ulcer and the other ulcers) for 4 weeks to examine the efficacy, safety, usefulness and usability.In the efficacy evaluation, 13 patients revealed “markedly effective”(54.2%), and 8 patients showed “effective”(33.3%), so that the effective rate was 87.5%.In the safety evaluation, SK-P-9701 was “safe”for the treatment of ulcers without any adverse reactions in 22 patients (88.0%).Two patients complained of pain in ulcers after topical application of the test material. Taken together, the usefulness evaluation was “markedly useful” in 9 patients (42.9%), and “useful” in 8 patients (38.1%), so that the useful rate was 81.0%(17/21).The usability of the paste on the ulcer surface was evaluated as “good” in 28 cases (93.3%). As a result, these findings indicate the efficacy and safety of SK-P-9701 in the management of various skin ulcers. 30例の各種皮膚潰瘍患者 (褥瘡, 熱傷潰瘍, 下腿潰瘍, 術後潰瘍など) にSK-P-9701 (デキストラノマーペースト) を使用して, その有効性, 安全性, 有用性と使用機能性を検討した。最終全般改善度は「著明改善」: 13例 (54.2%), 「改善」: 8例 (33.3%) であり, 有効率は87.5%であった。安全性では「安全性に問題なし」が22例であり, 安全率は88.0%であった。なお, 不具合は2例 (8.0%) に局所の疼痛が認められた。これらの結果から勘案しての有用性は, 「極めて有用」: 9例 (42.9%), 「有用」: 8例 (38.1%) であり, 有用率は81.0%(17/21) であった。また, 患部への付着性を改良したペースト剤の使用機能性では, 良好の割合が93.3%(28/30) であった。以上の結果より, SK-P-9701は皮膚潰瘍治療材料として有用かつ安全な医療用具であると結論した。 |
| Author | Kondo, Setsuko Moriguchi, Takahiko Horio, Takeshi Kawai, Shuzo Kondo, Masako Koumura, Jinro Inagawa, Kiichi Suzuki, Kenji Izeki, Hiromi Nishijima, Setsuko Soh, Hiroshi |
| Author_FL | 森口 隆彦 西嶋 攝子 稲川 喜一 河合 修三 宗 弘 近藤 摂子 近藤 雅子 鈴木 健司 河村 甚郎 堀尾 武 井関 宏美 |
| Author_FL_xml | – sequence: 1 fullname: 河合 修三 – sequence: 2 fullname: 堀尾 武 – sequence: 3 fullname: 鈴木 健司 – sequence: 4 fullname: 井関 宏美 – sequence: 5 fullname: 近藤 雅子 – sequence: 6 fullname: 西嶋 攝子 – sequence: 7 fullname: 宗 弘 – sequence: 8 fullname: 近藤 摂子 – sequence: 9 fullname: 河村 甚郎 – sequence: 10 fullname: 稲川 喜一 – sequence: 11 fullname: 森口 隆彦 |
| Author_xml | – sequence: 1 fullname: Kawai, Shuzo organization: Department of Dermatology, Kansai Medical University – sequence: 1 fullname: Suzuki, Kenji organization: Department of Dermatology, Kansai Medical University Kouri Hospital – sequence: 1 fullname: Nishijima, Setsuko organization: Department of Dermatology, Kansai Medical University Kouri Hospital – sequence: 1 fullname: Izeki, Hiromi organization: Department of Dermatology, Kansai Medical University Kouri Hospital – sequence: 1 fullname: Soh, Hiroshi organization: Department of Dermatology, Kansai Medical University Rakusai-newtown Hospital – sequence: 1 fullname: Horio, Takeshi organization: Department of Dermatology, Kansai Medical University – sequence: 1 fullname: Kondo, Masako organization: Department of Dermatology, Kansai Medical University Kouri Hospital – sequence: 1 fullname: Kondo, Setsuko organization: Department of Dermatology, Tadukekoufukai Kitano Hospital – sequence: 1 fullname: Koumura, Jinro organization: Department of Dermatology, Tadukekoufukai Kitano Hospital – sequence: 1 fullname: Moriguchi, Takahiko organization: Department of Plastic and Reconstructive surgery, Kawasaki Medical School – sequence: 1 fullname: Inagawa, Kiichi organization: Department of Plastic and Reconstructive surgery, Kawasaki Medical School |
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| References | 3. 渡辺博信, 石川英之, 有村博文: デブリサンの効力試験-In Vitroにおける細菌学的研究-, 基礎と臨床, 13: 1607-1615, 1979 12. 山村学, 大原敬太郎, 三宅彰他: 肉芽創治癒におよぼすDebrisanの効果, 新薬と臨床, 28, 1627-1638, 1979 15. 若松勝雄, 大久保正己, 吉江治彦他: デブリサンの使用経験, 皮膚, 22, 149-153, 1980 7. 日本化学療法学会副作用判定基準検討委員会: 抗菌薬による治験症例における副作用, 臨床検査値異常の判定基準, 日本化学療法学会雑誌, 40: 296, 1992 6. Pharmacia & Upjohn AB社内資料 9. Sven Ljungberg: Dextranomer for treatment of venous leg ulcers: Paste versus bead formulation, Curr Ther Res, 59: 498-502, 1998 1. S. Jacobsson, U. Rothma, G. Arturson et al: A New Principle for The Cleansing of Infected Wounds, Scand J Plast Reconstr Surg, 10: 65-72, 1976 13. 濱田稔夫, 石井正光, 泉谷一裕他: 難治性皮膚潰瘍などにおけるデキストラン・ポリマー小粒子 (Debrisan®) の治療効果の検討, 皮膚, 21, 65-73, 1979 4. 菊川章人, 榎本浩, 鍵谷昌男: デブリサンの効力試験-創傷面からのプロスタグランディンの除去-, 基礎と臨床, 13: 2015-2018, 1979 2. 榎本浩, 菊川章人, 小山守他: Dextranomer (Debrisan®) の創傷面からの滲出物吸収作用, 医薬品研究, 11: 114-121, 1980 5. 鍵谷昌男, 榎本浩, 菊川章人: Dextranomaer (Debrisan®) の実験的創傷面からのAlkalinephosphatase及Leucine aminopeptidaseの除去効果, 医薬品研究, 11: 122-124, 1980 11. 山本政勝: 外科, 皮膚科領域におけるデブリサンの臨床試験成績, 臨床医薬, 1: 169-204, 1985 14. 大塚秀人, 伊藤祐哉, 徳田安章: デブリサンの使用経験, 皮膚, 22, 143-148, 1980 8. 今村貞夫, 大河原章, 田上八朗他: SM-10902 (ピミルプロスト) 軟膏の褥瘡・皮膚潰瘍に対する前期第II相試験, 基礎と臨床, 31: 1851-1873, 1997 10. Sven Ljungberg: Comparison of dextranomer paste and saline dressings for management of decubital ulcers, Clinical Therapeutics, 20: 737-743, 1998 |
| References_xml | – reference: 3. 渡辺博信, 石川英之, 有村博文: デブリサンの効力試験-In Vitroにおける細菌学的研究-, 基礎と臨床, 13: 1607-1615, 1979 – reference: 2. 榎本浩, 菊川章人, 小山守他: Dextranomer (Debrisan®) の創傷面からの滲出物吸収作用, 医薬品研究, 11: 114-121, 1980 – reference: 4. 菊川章人, 榎本浩, 鍵谷昌男: デブリサンの効力試験-創傷面からのプロスタグランディンの除去-, 基礎と臨床, 13: 2015-2018, 1979 – reference: 13. 濱田稔夫, 石井正光, 泉谷一裕他: 難治性皮膚潰瘍などにおけるデキストラン・ポリマー小粒子 (Debrisan®) の治療効果の検討, 皮膚, 21, 65-73, 1979 – reference: 9. Sven Ljungberg: Dextranomer for treatment of venous leg ulcers: Paste versus bead formulation, Curr Ther Res, 59: 498-502, 1998 – reference: 6. Pharmacia & Upjohn AB社内資料 – reference: 1. S. Jacobsson, U. Rothma, G. Arturson et al: A New Principle for The Cleansing of Infected Wounds, Scand J Plast Reconstr Surg, 10: 65-72, 1976 – reference: 8. 今村貞夫, 大河原章, 田上八朗他: SM-10902 (ピミルプロスト) 軟膏の褥瘡・皮膚潰瘍に対する前期第II相試験, 基礎と臨床, 31: 1851-1873, 1997 – reference: 12. 山村学, 大原敬太郎, 三宅彰他: 肉芽創治癒におよぼすDebrisanの効果, 新薬と臨床, 28, 1627-1638, 1979 – reference: 11. 山本政勝: 外科, 皮膚科領域におけるデブリサンの臨床試験成績, 臨床医薬, 1: 169-204, 1985 – reference: 14. 大塚秀人, 伊藤祐哉, 徳田安章: デブリサンの使用経験, 皮膚, 22, 143-148, 1980 – reference: 10. Sven Ljungberg: Comparison of dextranomer paste and saline dressings for management of decubital ulcers, Clinical Therapeutics, 20: 737-743, 1998 – reference: 7. 日本化学療法学会副作用判定基準検討委員会: 抗菌薬による治験症例における副作用, 臨床検査値異常の判定基準, 日本化学療法学会雑誌, 40: 296, 1992 – reference: 5. 鍵谷昌男, 榎本浩, 菊川章人: Dextranomaer (Debrisan®) の実験的創傷面からのAlkalinephosphatase及Leucine aminopeptidaseの除去効果, 医薬品研究, 11: 122-124, 1980 – reference: 15. 若松勝雄, 大久保正己, 吉江治彦他: デブリサンの使用経験, 皮膚, 22, 149-153, 1980 |
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| SubjectTerms | clinical study dextranomer paste medical device SK-P-9701 skin ulcer デキストラノマーペースト 医療用具 皮膚潰瘍 臨床試験 |
| Title | Evaluation of the Effects SK-P-9701 (Dextranomer paste) for the Treatment of Various Skin Ulcers |
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