高压氧辅助治疗糖尿病足溃疡的系统评价
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摘要
目的系统评价高压氧辅助治疗糖尿病足溃疡的临床疗效和安全性。方法计算机检索h e Cochrane Library(2014年第1期)、Pub Med、EMbase、CBM、VIP、CNKI和Wan Fang Data数据库,纳入关于高压氧辅助治疗糖尿病足溃疡的随机对照试验(RCT),检索时限均截至2014年1月。由2位研究者独立按照纳入与排除标准筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.2软件进行Meta分析。结果共纳入14个RCT,合计910例患者。Meta分析结果显示:高压氧联合常规治疗在糖尿病足溃疡愈合率[RR=2.16,95%CI(1.43,3.26),P=0.000 3]、大截肢发生率[RR=0.20,95%CI(0.10,0.38),P<0.000 01]、溃疡面积减少[MD=1.73,95%CI(1.34,2.11),P<0.000 01]和经皮氧分压改善情况[MD=14.75,95%CI(2.01,27.48),P=0.02]等方面均优于常规治疗,但在小截肢发生率方面不优于常规治疗[RR=0.70,95%CI(0.24,2.11),P=0.53]。此外,高压氧联合常规治疗无严重治疗相关副作用及并发症发生。结论当前证据表明,高压氧辅助治疗糖尿病足溃疡可能促进溃疡愈合和减少大截肢发生率。
Objective To systematically review the clinical efficacy and safety of hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. Methods Such databases as the Cochrane Library(Issue 1,2014),Pub Med,EMbase,CBM,VIP,CNKI and Wan Fang Data were searched up to January 2014 for randomized controlled trials(RCTs) about hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. According to the inclusion and exclusion criteria,two reviewers independently screened literature,extracted data,and assessed methodological quality of included studies. Then,meta-analysis was performed using Rev Man 5.2 sot ware. Results Fourteen RCTs involving 910 patients were included. The results of metaanalysis showed that,hyperbaric oxygen therapy combined with routine therapy was superior to routine therapy alone regarding ulcer healing rates(RR=2.16,95%CI 1.43 to 3.26,P=0.000 3),incidence of major amputation(RR=0.20,95%CI 0.10 to 0.38,P<0.000 01),reduction of ulcer area(MD=1.73,95%CI 1.34 to 2.11,P<0.000 01),and improvement of transcutaneous oxygen tension(MD=14.75,95%CI 2.01 to 27.48,P=0.02). However,no significant dif erence was found between the two group in minor amputation rates(RR=0.70,95%CI 0.24 to 2.11,P=0.53). In addition,neither relevant serious adverse reaction nor complications were reported when using hyperbaric oxygen therapy as adjunctive treatment. Conclusion Current evidence shows that hyperbaric oxygen therapy as adjunctive treatment could improve ulcer healing and reduce incidence of major amputation.
Objective To systematically review the clinical efficacy and safety of hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. Methods Such databases as the Cochrane Library(Issue 1,2014),Pub Med,EMbase,CBM,VIP,CNKI and Wan Fang Data were searched up to January 2014 for randomized controlled trials(RCTs) about hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. According to the inclusion and exclusion criteria,two reviewers independently screened literature,extracted data,and assessed methodological quality of included studies. Then,meta-analysis was performed using Rev Man 5.2 sot ware. Results Fourteen RCTs involving 910 patients were included. The results of metaanalysis showed that,hyperbaric oxygen therapy combined with routine therapy was superior to routine therapy alone regarding ulcer healing rates(RR=2.16,95%CI 1.43 to 3.26,P=0.000 3),incidence of major amputation(RR=0.20,95%CI 0.10 to 0.38,P<0.000 01),reduction of ulcer area(MD=1.73,95%CI 1.34 to 2.11,P<0.000 01),and improvement of transcutaneous oxygen tension(MD=14.75,95%CI 2.01 to 27.48,P=0.02). However,no significant dif erence was found between the two group in minor amputation rates(RR=0.70,95%CI 0.24 to 2.11,P=0.53). In addition,neither relevant serious adverse reaction nor complications were reported when using hyperbaric oxygen therapy as adjunctive treatment. Conclusion Current evidence shows that hyperbaric oxygen therapy as adjunctive treatment could improve ulcer healing and reduce incidence of major amputation.
引文
1 Boulton AJM.h e diabetic foot:from art to science.Diabetologia,2004,47:1343-1353.
2 Levy MJ,Valabhji J.h e diabetic foot.Surgery(Oxford),2008,26(1):25-28.
3 Abbott CA,Carrington AL,Ashe H,et al.h e North West Diabetes Foot Care Study:incidence of,and risk factors for,new diabetic foot ulceration in a community-based cohort.Diabet Med,2002,19:377-384.
4 Apelqvist J,Bakker K,van Houtum WH,et al.International consensus and practical guidelines on the management and the prevention of the diabetic foot.Diabetes Metab Res Rev,2000,16(suppl 1):84-92.
5 Baroni G,Porro T,Faglia E,et al.Hyperbaric oxygen in diabetic gangrene treatment.Diabetes Care,1987,10:81-86.
6 Lipsky BA,Berendt AR.Hyperbaric Oxygen Therapy for Diabetic Foot Wounds Has hope hurdled hype?Diabetes Care,2010,33(5):1143-1145.
7 The Cochrane Collaboration.Cochrane Handbook for Systematic Reviews of Interventions.Version 5.1.0[updated March 2011].Available at:http://www.cochrane.org/.htm.
8 Leslie CA,Sapico FL,Ginunas VJ,et al.Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers.Diabetes Care,1988,11(2):111-115.
9 Doctor N,Pandya S,Supe A.Hyperbaric oxygen therapy in diabetic foot.J Postgrad Med,1992,38(3):112-114.
10 Faglia E,Favales F,Aldeghi A,et al.Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer:a randomized study.Diabetes Care,1996,19(12):1338-1343.
11 Abidia A,Laden G,Kuhan G,et al.h e role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers:a double-blind randomised-controlled trial.Eur J Vasc Endovasc Surg,2003,25(6):513-518.
12 Kessler L,Bilbault P,Ortéga F,et al.Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers:a prospective randomized study.Diabetes Care,2003,26(8):2378-2382.
13 Duzgun AP,Satir HZ,Ozozan O,et al.Ef ect of hyperbaric oxygen therapy on healing of diabetic foot ulcers.J Foot Ankle Surg,2008,47(6):515-519.
14 Lndahl M,Nilsson A,Katzman P,et al.Hyperbaric oxygen therapy as adjunctive treatment of chronic diabetic foot ulcers.Diabetes Care,2010,33(5):998-1003.
15 韦华,王民登,李凤玲,等.高压氧对糖尿病足溃疡临床效果及血浆纤溶系统的影响.重庆医学,2012,41(5):480-482.
16 熊雨,郑晓秋,陈代进.高压氧治疗糖尿病足的相关临床研究.医学信息,2011,8:3566-3567.
17 王华.高压氧治疗糖尿病的疗效研究.四川医学,2011,32(8):1232-1233.
18陆玉莲,钱心炜.高压氧治疗糖尿病的临床观察.中华临床医药与护理,2005,12:89-90.
19 王爱芳.高压氧治疗糖尿病足疗效观察.浙江中西医结合杂志,2007,17(11):674-675.
20 王灿良,郝建平.高压氧综合治疗糖尿病足疗效观察.河北医学,2007,13(7):844-846.
21 许立民.糖尿病足高压氧与非高压氧治疗的疗效对比.内科,2007,2(4):507-508.
22 Bakker K,Apelqvist J,Schaper NC,et al.Practical guidelines on the management and prevention of the diabetic foot 2011.Diabetes Metab Res Rev,2012,Suppl 1:225-231.
23 Kranke P,Benne RMH,Martyn St James M,et al.Hyperbaric oxygen therapy for chronic wounds.Cochrane Database Syst Rev,2012,(4):CD004123.
24 Sen CK.Wound healing essentials:let there be oxygen.Wound Repair Regen,2009,17(1):1-8.
25 Kui er DP.Hyperbaric oxygen therapy:an overview.J Wound Care,2010,19(2):77-79.
26 Bishop A.Role of oxygen in wound healing.J Wound Care,2008,17:399-409.
27 Rodriguez PG,Felix FN,Woodley DT,et al.h e role of oxygen in wound healing:a review ot he litemture.Dermatol Surg,2008,34(9):1159-1169.
28 高春锦,杨捷云,翟晓辉,主编.高压氧医学基础与临床.第1版.北京:人民卫生出版社,2008:105-109.
29 Liu R,Li L,Yang M,et al.Systematic Review of the Ef ectiveness of Hyperbaric Oxygenation Therapy in the Management of Chronic Diabetic Foot Ulcers.Mayo Clin Proc,2013,88(2):166-175.
30 Broussanl CL.Hyperbaric oxygenation and wound healing.J Vasc Nurs,2004,22(2):42-48.
2 Levy MJ,Valabhji J.h e diabetic foot.Surgery(Oxford),2008,26(1):25-28.
3 Abbott CA,Carrington AL,Ashe H,et al.h e North West Diabetes Foot Care Study:incidence of,and risk factors for,new diabetic foot ulceration in a community-based cohort.Diabet Med,2002,19:377-384.
4 Apelqvist J,Bakker K,van Houtum WH,et al.International consensus and practical guidelines on the management and the prevention of the diabetic foot.Diabetes Metab Res Rev,2000,16(suppl 1):84-92.
5 Baroni G,Porro T,Faglia E,et al.Hyperbaric oxygen in diabetic gangrene treatment.Diabetes Care,1987,10:81-86.
6 Lipsky BA,Berendt AR.Hyperbaric Oxygen Therapy for Diabetic Foot Wounds Has hope hurdled hype?Diabetes Care,2010,33(5):1143-1145.
7 The Cochrane Collaboration.Cochrane Handbook for Systematic Reviews of Interventions.Version 5.1.0[updated March 2011].Available at:http://www.cochrane.org/.htm.
8 Leslie CA,Sapico FL,Ginunas VJ,et al.Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers.Diabetes Care,1988,11(2):111-115.
9 Doctor N,Pandya S,Supe A.Hyperbaric oxygen therapy in diabetic foot.J Postgrad Med,1992,38(3):112-114.
10 Faglia E,Favales F,Aldeghi A,et al.Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer:a randomized study.Diabetes Care,1996,19(12):1338-1343.
11 Abidia A,Laden G,Kuhan G,et al.h e role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers:a double-blind randomised-controlled trial.Eur J Vasc Endovasc Surg,2003,25(6):513-518.
12 Kessler L,Bilbault P,Ortéga F,et al.Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers:a prospective randomized study.Diabetes Care,2003,26(8):2378-2382.
13 Duzgun AP,Satir HZ,Ozozan O,et al.Ef ect of hyperbaric oxygen therapy on healing of diabetic foot ulcers.J Foot Ankle Surg,2008,47(6):515-519.
14 Lndahl M,Nilsson A,Katzman P,et al.Hyperbaric oxygen therapy as adjunctive treatment of chronic diabetic foot ulcers.Diabetes Care,2010,33(5):998-1003.
15 韦华,王民登,李凤玲,等.高压氧对糖尿病足溃疡临床效果及血浆纤溶系统的影响.重庆医学,2012,41(5):480-482.
16 熊雨,郑晓秋,陈代进.高压氧治疗糖尿病足的相关临床研究.医学信息,2011,8:3566-3567.
17 王华.高压氧治疗糖尿病的疗效研究.四川医学,2011,32(8):1232-1233.
18陆玉莲,钱心炜.高压氧治疗糖尿病的临床观察.中华临床医药与护理,2005,12:89-90.
19 王爱芳.高压氧治疗糖尿病足疗效观察.浙江中西医结合杂志,2007,17(11):674-675.
20 王灿良,郝建平.高压氧综合治疗糖尿病足疗效观察.河北医学,2007,13(7):844-846.
21 许立民.糖尿病足高压氧与非高压氧治疗的疗效对比.内科,2007,2(4):507-508.
22 Bakker K,Apelqvist J,Schaper NC,et al.Practical guidelines on the management and prevention of the diabetic foot 2011.Diabetes Metab Res Rev,2012,Suppl 1:225-231.
23 Kranke P,Benne RMH,Martyn St James M,et al.Hyperbaric oxygen therapy for chronic wounds.Cochrane Database Syst Rev,2012,(4):CD004123.
24 Sen CK.Wound healing essentials:let there be oxygen.Wound Repair Regen,2009,17(1):1-8.
25 Kui er DP.Hyperbaric oxygen therapy:an overview.J Wound Care,2010,19(2):77-79.
26 Bishop A.Role of oxygen in wound healing.J Wound Care,2008,17:399-409.
27 Rodriguez PG,Felix FN,Woodley DT,et al.h e role of oxygen in wound healing:a review ot he litemture.Dermatol Surg,2008,34(9):1159-1169.
28 高春锦,杨捷云,翟晓辉,主编.高压氧医学基础与临床.第1版.北京:人民卫生出版社,2008:105-109.
29 Liu R,Li L,Yang M,et al.Systematic Review of the Ef ectiveness of Hyperbaric Oxygenation Therapy in the Management of Chronic Diabetic Foot Ulcers.Mayo Clin Proc,2013,88(2):166-175.
30 Broussanl CL.Hyperbaric oxygenation and wound healing.J Vasc Nurs,2004,22(2):42-48.