速愈樂TM愈傷敷料治療糖尿病足潰瘍的臨床研究_《中國修復重建外科雜志》

作者：

王芳 ¹ , 袁南兵 ^1# , 王玉珍 ² , 王椿 ¹ , 王愛紅 ² , 余婷婷 ¹ , 劉關鍵 ³ , 許樟榮 ² , 冉興無 ¹

1 四川大學華西醫院內分泌科糖尿病足診治中心（成都，610041）;;
2 解放軍第306醫院內分泌科全軍糖尿病診治中心;;
3 中國循證醫學中心;

關鍵詞：

速愈樂TM愈傷敷料清得佳水凝膠敷料糖尿病足潰瘍隨機對照試驗

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目的評價速愈樂TM愈傷敷料[Bismuth Subgallate/Borneol（SuileTM），BSB]治療糖尿病足（diabetic foot，DF）潰瘍的有效性和安全性。方法研究為兩個中心、隨機、陽性敷料[清得佳（Intrasite gel，IG）水凝膠]的開放性對照（2∶1）試驗。2005年9月－2006年11月，共納入Wagner 2～3級DF潰瘍患者35例，其中試驗組（BSB組）25例，對照組（IG組）10例。兩組患者基線資料差異無統計學意義（P gt; 0.05），具有可比性。兩組患者均在DF綜合治療基礎上加用相應敷料局部治療。觀察期間每周測量潰瘍面積，觀察創面出血情況，詢問患者接受程度，同時記錄不良事件至潰瘍愈合或第12周試驗結束。結果除BSB組3例和IG組2例敷料脫落外，其余患者均順利完成試驗。意向性治療分析顯示：BSB組患者潰瘍完全愈合19例（76%），顯效3例（12%），有效1例（4%），無效2例（8%）；IG組完全愈合8例（80%），有效1例（10%），無效1例（10%）。符合方案分析顯示：BSB組患者潰瘍完全愈合19例（86%），顯效3例（14%）；IG組8例均完全愈合（100%）。兩種分析結果兩組間比較差異均無統計學意義（P gt; 0.05）。治療期間兩組潰瘍面積變化趨勢一致，各時間點兩組間的止血作用無明顯差異（P gt; 0.05），患者更傾向于接受BSB敷料（P lt; 0.05）。未出現與兩種敷料有關的不良事件。結論BSB愈傷敷料治療DF潰瘍療效及安全性與IG敷料相當，可為DF局部治療提供新的選擇。

引用本文： 王芳,袁南兵,王玉珍,王椿,王愛紅,余婷婷,劉關鍵,許樟榮,冉興無. 速愈樂TM愈傷敷料治療糖尿病足潰瘍的臨床研究. 中國修復重建外科雜志, 2012, 26(8): 955-960. doi: 復制

1.	何利平, 冉興無. 糖尿病足的診治進展. 內科急危重癥雜志, 2008, 14(4): 171-173, 183.
2.	Bloomgarden ZT. The diabetic foot. Diabetes Care, 2008, 31(2): 372-376.
3.	Mai LM, Lin CY, Chen CY, et al. Synergistic effect of bismuth subgallate and borneol, the major components of Sulbogin, on the healing of skin wound. Biomaterials, 2003, 24(18): 3005-3012.
4.	Tramontina VA, Machado MA, Nogueira Filho Gda R, et al. Effect of bismuth subgallate (local hemostatic agent) on wound healing in rats: Histological and histometric findings. Braz Dent J, 2002, 13(1): 11-16.
5.	Fenton JE, Blayney AW, O’Dwyer TP, et al. Bismuth subgallate—its role in tonsillectomy. J Laryngol Otol, 1995, 109(3): 203-205.
6.	Callanan V, Curran AJ, Smyth DA, et al. The influence of bismuth subgallate and adrenaline paste upon operating time and operative blood loss in tonsillectomy. J Laryngol Otol, 1995, 109(3): 206-208.
7.	Scanlon L. Review: debridement using hydrogel appears to be more effective than standard wound care for healing diabetic foot ulcers. Evid Based Nurs, 2003, 6(3): 83.
8.	Ingle R, Levin J, Polinder K. Wound healing with honey—a randomised controlled trial. S Afr Med J, 2006, 96(9): 831-835.
9.	Rook JM, Hasan W, McCarson KE. Temporal effects of topical morphine application on cutaneous wound healing. Anesthesiology, 2008, 109(1): 130-136.
10.	王艷, 劉關鍵, 袁南兵, 等. 數碼照相結合Image J 醫學圖像分析軟件法與無菌薄膜勾邊法測量糖尿病皮膚潰瘍面積的可靠性比較. 中國修復重建外科雜志, 2008, 22(5): 563-566.
11.	姜小飛, 冉興無. 糖尿病足潰瘍面積及體積計算的方法學介紹. 華西醫學, 2008, 23(1): 114-115.
12.	袁南兵, 王椿, 王艷, 等. 自體富血小板凝膠在糖尿病難治性皮膚潰瘍中的初步應用. 四川大學學報: 醫學版, 2007, 38(5): 900-903.
13.	Dharmananda S. Borneol, artemisia, and moxa[EB/OL]. [1998-09-01]. http: //www. itmonline. org /arts/ borneol. htm.
14.	Serena T, Parnall LK, Knox C, et al. Bismuth subgallate/borneol (suile) is superior to bacitracin in the human forearm biopsy model for acute wound healing. Adv Skin Wound Care, 2007, 20(9 Pt 1): 485-492.
15.	Uchi H, Igarashi A, Urabe K, et al. Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer. Eur J Dermatol, 2009, 19(5): 461-468.
16.	Blozik E, Scherer M. Skin replacement therapies for diabetic foot ulcers: systematic review and meta-analysis. Diabetes Care, 2008, 31(4): 693-694.
17.	Langer A, Rogowski W. Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers. BMC Health Serv Res, 2009, 9: 115.
18.	Jeffcoate WJ, Price PE, Phillips CJ, et al. Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Health Technol Assess, 2009, 13(54): 1-86.
19.	Biswas A, Bharara M, Hurst C, et al. Use of sugar on the healing of diabetic ulcers: a review. J Diabetes Sci Technol, 2010, 4(5): 1139-1145.
20.	Eddy JJ, Gideonsen MD, Mack GP. Practical considerations of using topical honey for neuropathic diabetic foot ulcers: a review. WMJ, 2008, 107(4): 187-190.
21.	Viswanathan V, Kesavan R, Kavitha KV, et al. A pilot study on the effects of a polyherbal formulation cream on diabetic foot ulcers. Indian J Med Res, 2011, (134): 168-173.

1. 何利平, 冉興無. 糖尿病足的診治進展. 內科急危重癥雜志, 2008, 14(4): 171-173, 183.
2. Bloomgarden ZT. The diabetic foot. Diabetes Care, 2008, 31(2): 372-376.
3. Mai LM, Lin CY, Chen CY, et al. Synergistic effect of bismuth subgallate and borneol, the major components of Sulbogin, on the healing of skin wound. Biomaterials, 2003, 24(18): 3005-3012.
4. Tramontina VA, Machado MA, Nogueira Filho Gda R, et al. Effect of bismuth subgallate (local hemostatic agent) on wound healing in rats: Histological and histometric findings. Braz Dent J, 2002, 13(1): 11-16.
5. Fenton JE, Blayney AW, O’Dwyer TP, et al. Bismuth subgallate—its role in tonsillectomy. J Laryngol Otol, 1995, 109(3): 203-205.
6. Callanan V, Curran AJ, Smyth DA, et al. The influence of bismuth subgallate and adrenaline paste upon operating time and operative blood loss in tonsillectomy. J Laryngol Otol, 1995, 109(3): 206-208.
7. Scanlon L. Review: debridement using hydrogel appears to be more effective than standard wound care for healing diabetic foot ulcers. Evid Based Nurs, 2003, 6(3): 83.
8. Ingle R, Levin J, Polinder K. Wound healing with honey—a randomised controlled trial. S Afr Med J, 2006, 96(9): 831-835.
9. Rook JM, Hasan W, McCarson KE. Temporal effects of topical morphine application on cutaneous wound healing. Anesthesiology, 2008, 109(1): 130-136.
10. 王艷, 劉關鍵, 袁南兵, 等. 數碼照相結合Image J 醫學圖像分析軟件法與無菌薄膜勾邊法測量糖尿病皮膚潰瘍面積的可靠性比較. 中國修復重建外科雜志, 2008, 22(5): 563-566.
11. 姜小飛, 冉興無. 糖尿病足潰瘍面積及體積計算的方法學介紹. 華西醫學, 2008, 23(1): 114-115.
12. 袁南兵, 王椿, 王艷, 等. 自體富血小板凝膠在糖尿病難治性皮膚潰瘍中的初步應用. 四川大學學報: 醫學版, 2007, 38(5): 900-903.
13. Dharmananda S. Borneol, artemisia, and moxa[EB/OL]. [1998-09-01]. http: //www. itmonline. org /arts/ borneol. htm.
14. Serena T, Parnall LK, Knox C, et al. Bismuth subgallate/borneol (suile) is superior to bacitracin in the human forearm biopsy model for acute wound healing. Adv Skin Wound Care, 2007, 20(9 Pt 1): 485-492.
15. Uchi H, Igarashi A, Urabe K, et al. Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer. Eur J Dermatol, 2009, 19(5): 461-468.
16. Blozik E, Scherer M. Skin replacement therapies for diabetic foot ulcers: systematic review and meta-analysis. Diabetes Care, 2008, 31(4): 693-694.
17. Langer A, Rogowski W. Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers. BMC Health Serv Res, 2009, 9: 115.
18. Jeffcoate WJ, Price PE, Phillips CJ, et al. Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Health Technol Assess, 2009, 13(54): 1-86.
19. Biswas A, Bharara M, Hurst C, et al. Use of sugar on the healing of diabetic ulcers: a review. J Diabetes Sci Technol, 2010, 4(5): 1139-1145.
20. Eddy JJ, Gideonsen MD, Mack GP. Practical considerations of using topical honey for neuropathic diabetic foot ulcers: a review. WMJ, 2008, 107(4): 187-190.
21. Viswanathan V, Kesavan R, Kavitha KV, et al. A pilot study on the effects of a polyherbal formulation cream on diabetic foot ulcers. Indian J Med Res, 2011, (134): 168-173.

《中國修復重建外科雜志》

速愈樂TM愈傷敷料治療糖尿病足潰瘍的臨床研究

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《中國修復重建外科雜志》

速愈樂TM愈傷敷料治療糖尿病足潰瘍的臨床研究

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

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