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 inSkin research Vol. 42; no. 5; pp. 514 - 527
Main Authors Kawai, Shuzo, Suzuki, Kenji, Nishijima, Setsuko, Izeki, Hiromi, Soh, Hiroshi, Horio, Takeshi, Kondo, Masako, Kondo, Setsuko, Koumura, Jinro, Moriguchi, Takahiko, Inagawa, Kiichi
Format Journal Article
LanguageJapanese
Published Meeting of Osaka Dermatological Association 2000
日本皮膚科学会大阪地方会
Subjects
Online AccessGet full text
ISSN0018-1390
1884-541X
DOI10.11340/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.
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
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  fullname: 井関 宏美
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  fullname: 近藤 雅子
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  fullname: Kawai, Shuzo
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  fullname: Kondo, Setsuko
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  fullname: Inagawa, Kiichi
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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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Snippet 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...
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StartPage 514
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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