1、慢性傷口臨床治療的循證研究Evidence-base Clinical Study of Chronic Wound蘭大一院蘭大一院 滕永軍滕永軍2010,09,202010,09,20CWs群體發(fā)病率在群體發(fā)病率在1-2%左右左右 DM發(fā)病專率發(fā)病專率5.6 15%DM出現(xiàn)出現(xiàn)DFU 10-14.5%DFU截肢截肢 截肢后月內(nèi)死亡截肢后月內(nèi)死亡10%CEs最低費(fèi)用達(dá)到6000美元;全球費(fèi)用負(fù)擔(dān)每年130-150億美元 臨床上比較常見的慢性傷口類型臨床上比較常見的慢性傷口類型 靜脈瘀滯性潰瘍靜脈瘀滯性潰瘍; ;動(dòng)脈潰瘍動(dòng)脈潰瘍; ;糖尿病足部潰瘍糖尿病足部潰瘍; ;壓力性潰瘍（壓瘡）壓力性潰瘍

2、（壓瘡）; ;燒傷后潰瘍；燒傷后潰瘍；脈管炎脈管炎; ;壞疽性膿皮癥壞疽性膿皮癥; ;放射性皮損放射性皮損臨床治療慢性傷口的原則臨床治療慢性傷口的原則 創(chuàng)面局部保持濕潤和傷口盡早封閉；創(chuàng)面局部保持濕潤和傷口盡早封閉；防止細(xì)菌滋生和局部感染；防止細(xì)菌滋生和局部感染；清創(chuàng)（傷口床準(zhǔn)備）；清創(chuàng)（傷口床準(zhǔn)備）；輔助治療輔助治療輔助治療輔助治療加壓加壓局部負(fù)壓裝置局部負(fù)壓裝置生長因子生長因子皮膚替代品皮膚替代品高壓氧治療高壓氧治療干細(xì)胞干細(xì)胞中藥中藥維維A A酸酸己酮可可堿己酮可可堿生長因子生長因子細(xì)胞細(xì)胞生長生長抑制抑制因子因子上上皮皮細(xì)細(xì)胞胞生生長長因因子子成成纖纖維維細(xì)細(xì)胞胞生生長長因因子子血血小

3、小板板衍衍生生生生長長因因子子轉(zhuǎn)轉(zhuǎn)化化生生長長因因子子胰胰島島素素樣樣生生長長因因子子白白介介素素臨床常用的包扎敷料 p紗布敷料（紗布敷料（GauzesGauzes）；）；p薄膜敷料（薄膜敷料（FilmsFilms）；）；p水凝膠敷料（水凝膠敷料（HydrogelsHydrogels）；）；p水膠體敷料（水膠體敷料（HydrocolloidsHydrocolloids）；）；p藻酸鹽敷料（藻酸鹽敷料（AlginatesAlginates）；）；p泡沫敷料（泡沫敷料（FoamsFoams）；）；p膠原蛋白敷料（膠原蛋白敷料（CollagensCollagens）；）；p殺菌劑（殺菌劑（Antim

4、icrobialsAntimicrobials） 第一部分組織工程皮膚治療糖尿病足潰瘍的Meta分析 目的：分析TES治療DFU的隨機(jī)對(duì)照試驗(yàn)，效果與效益。 方法：計(jì)算機(jī)檢索Cochrane圖書館、Pubmed、EMbase、CBMWeb、CNKI、VIP，手工檢索有關(guān)引用文獻(xiàn)，收集以TES為干預(yù)措施治療DFU的RCT，評(píng)價(jià)納入研究的方法學(xué)質(zhì)量并提取有效數(shù)據(jù)進(jìn)行Meta分析。 納入7個(gè)，共880名患者，多中心研究6個(gè)。 No. No. AuthorAuthorRandomizationRandomizationBlindingBlindingConcealmentConcealmentWith

5、drawalWithdrawalITTITTQuality levelQuality level1 1Gray DG 1996Gray DG 1996 1010AdequateAdequateSi- BlindSi- BlindAdequateAdequateDescribedDescribedYesYesA A2 2Richard AP Richard AP 19971997 11 11UnclearUnclearSi- BlindSi- BlindAdequateAdequateDescribedDescribedYesYesA A3 3Aristidis V 2001Aristidis

6、V 2001 1212AdequateAdequateNot useNot useUnclearUnclearDescribedDescribedYesYesB B4 4Jason RH 2002Jason RH 2002 1313AdequateAdequateSi- BlindSi- BlindAdequateAdequateNot- descriNot- descriYesYesA A5 5Hunter HSHunter HS 20022002 1414AdequateAdequateNot useNot useAdequateAdequateDescribedDescribedYesY

7、esA A6 6Carlo C 2003Carlo C 2003 15 15AdequateAdequateSi- BlindSi- BlindUnclearUnclearDescribedDescribedYesYesA A7 7William AM 2003William AM 2003 1616AdequateAdequateSi- BlindSi- BlindAdequateAdequateDescribedDescribedYesYesA ATES與CT治療DFU的療效分析 Study or SubgroupCaravaggi C 2003 21Gentzkow GD 1996 10

8、Jason R 2002 22Marston WA 2003 24Richard AP 1997 23Sams HH 2002 25Veves AF 2001 12Total (95% CI)Total eventsHeterogeneity: Chi = 5.32, df = 6 (P = 0.50); I = 0%Test for overall effect: Z = 4.28 (P 0.0001)Events2611153940563199Total4337241301099112464Events15162140436123Total361322115126896416Weight9

9、.5%1.5%3.5%23.0%34.7%2.8%25.0%100.0%M-H, Fixed, 95% CI2.14 0.87, 5.275.08 0.59, 43.954.44 1.27, 15.521.92 1.05, 3.511.25 0.73, 2.141.25 0.19, 8.442.14 1.23, 3.741.88 1.41, 2.51TESCTOdds RatioOdds RatioM-H, Fixed, 95% CI0.010.1110100Favours experimentalFavours control不同種類組織工程皮膚療效亞組分析 Study or Subgrou

10、p1.1.1 Dermagraft VS. CTGentzkow GD 1996 10Jason R 2002 22Marston WA 2003 24Richard AP 1997 23Subtotal (95% CI)Total eventsHeterogeneity: Chi = 5.11, df = 3 (P = 0.16); I = 41%Test for overall effect: Z = 3.09 (P = 0.002)1.1.2 Graftskin VS. CTSams HH 2002 25Veves AF 2001 12Subtotal (95% CI)Total eve

11、ntsHeterogeneity: Chi = 0.27, df = 1 (P = 0.60); I = 0%Test for overall effect: Z = 2.71 (P = 0.007)1.1.3 Hyalograft 3D VS. CTCaravaggi C 2003 21Subtotal (95% CI)Total eventsHeterogeneity: Not applicableTest for overall effect: Z = 1.69 (P = 0.09)Total (95% CI)Total eventsHeterogeneity: Chi = 6.08,

12、df = 6 (P = 0.41); I = 1%Test for overall effect: Z = 4.41 (P 0.0001)Test for subgroup differences: Not applicableEvents11153940105563682626199Total372413010930091121214343464Events16214068436401515123Total13221151262768961043636416Weight4.5%5.3%28.2%27.0%65.0%2.0%23.9%25.9%9.1%9.1%100.0%M-H, Fixed,

13、 95% CI0.22 0.01, 0.430.35 0.08, 0.620.12 0.01, 0.220.05 -0.07, 0.170.12 0.04, 0.190.06 -0.42, 0.530.19 0.05, 0.320.18 0.05, 0.310.19 -0.03, 0.410.19 -0.03, 0.410.14 0.08, 0.20TESCTRisk DifferenceRisk DifferenceM-H, Fixed, 95% CI-0.5-0.2500.250.5Favours experimentalFavours controlStudy or Subgroup1.

14、2.1 Wound InfectionCaravaggi C 2003Gentzkow G.D 1996Jason R 2002Marston W.A 2003Richard A. P 1997Veves A 2001Subtotal (95% CI)Total eventsHeterogeneity: Chi = 1.42, df = 5 (P = 0.92); I = 0%Test for overall effect: Z = 2.06 (P = 0.04)1.2.2 OsteomyelitisJason R 2002Marston W.A 2003Veves A 2001Subtota

15、l (95% CI)Total eventsHeterogeneity: Chi = 3.93, df = 2 (P = 0.14); I = 49%Test for overall effect: Z = 1.74 (P = 0.08)1.2.3 CellulitisJason R 2002Marston W.A 2003Sams H.H 2002Veves A 2001Subtotal (95% CI)Total eventsHeterogeneity: Chi = 5.62, df = 3 (P = 0.13); I = 47%Test for overall effect: Z = 0

16、.69 (P = 0.49)Total (95% CI)Total eventsHeterogeneity: Chi = 12.34, df = 12 (P = 0.42); I = 3%Test for overall effect: Z = 2.67 (P = 0.008)Test for subgroup differences: Not applicableEvents3911723126511431811221025108Total433724163109112488241631122992416391123081095Events63227301381413102751408271

17、35Total36132215112696444221519626922151896277990Weight3.8%1.9%2.2%15.2%11.3%10.0%44.4%2.2%15.2%10.0%27.4%2.2%15.2%0.8%10.0%28.2%100.0%M-H, Fixed, 95% CI-0.10 -0.24, 0.050.01 -0.26, 0.28-0.05 -0.19, 0.10-0.07 -0.15, 0.00-0.03 -0.13, 0.08-0.03 -0.12, 0.06-0.05 -0.10, -0.00-0.14 -0.32, 0.04-0.00 -0.06,

18、 0.06-0.08 -0.15, -0.01-0.04 -0.08, 0.01-0.19 -0.38, 0.01-0.02 -0.08, 0.040.22 -0.09, 0.530.01 -0.07, 0.08-0.02 -0.06, 0.03-0.04 -0.06, -0.01TESCTRisk DifferenceRisk DifferenceM-H, Fixed, 95% CI-0.5-0.2500.250.5Favours TESFavours CTTES與CT治療DFU的復(fù)發(fā)對(duì)比分析 Study or SubgroupSams H.H 2002Caravaggi C 2003Gen

19、tzkow G.D 1996Richard A. P 1997Veves A 2001Total (95% CI)Total eventsHeterogeneity: Chi = 1.16, df = 4 (P = 0.88); I = 0%Test for overall effect: Z = 0.47 (P = 0.64)Events00027330Total9433710951249Events00032436Total8361312631214Weight3.8%17.6%8.7%52.6%17.3%100.0%M-H, Fixed, 95% CI0.00 -0.20, 0.200.

20、00 -0.05, 0.050.00 -0.10, 0.10-0.01 -0.12, 0.10-0.07 -0.20, 0.06-0.02 -0.08, 0.05TESCTRisk DifferenceRisk DifferenceM-H, Fixed, 95% CI-100-50050100Favours experimental Favours controlTES與CT比較7個(gè)研究的漏斗圖 SubgroupsDermagraft VS. CTGraftskin VS. CTHyalograft 3D VS. CT-0.5-0.2500.250.500.10.20.30.40.5RDSE(

21、RD)第二部分銀離子敷料聯(lián)合水凝膠局部治療糖尿病足創(chuàng)面 目的：通過臨床半隨機(jī)對(duì)照試驗(yàn)，評(píng)價(jià)銀離子敷目的：通過臨床半隨機(jī)對(duì)照試驗(yàn)，評(píng)價(jià)銀離子敷料料+ +水凝膠治療糖尿病足創(chuàng)面的臨床療效。水凝膠治療糖尿病足創(chuàng)面的臨床療效。 方法：選擇方法：選擇20072007年年2 2月月-2008-2008年年6 6月入住糖尿病足部月入住糖尿病足部潰瘍潰瘍、級(jí)級(jí)4343例患者，病史例患者，病史5-205-20年、臨床年、臨床確診的糖尿病足，傷口不愈超過確診的糖尿病足，傷口不愈超過2 2個(gè)月，區(qū)組隨機(jī)個(gè)月，區(qū)組隨機(jī)分組，分別給予銀離子敷料分組，分別給予銀離子敷料+ +水凝膠治療（干預(yù)組）水凝膠治療（干預(yù)組）和傳統(tǒng)

22、敷料換藥治療和傳統(tǒng)敷料換藥治療( (對(duì)照組對(duì)照組) )，動(dòng)態(tài)觀察創(chuàng)面閉，動(dòng)態(tài)觀察創(chuàng)面閉合及感染狀況。合及感染狀況。 兩組分期處理與治療方案兩組分期處理與治療方案分期分期干預(yù)組干預(yù)組對(duì)照組對(duì)照組黑期黑期水凝膠水凝膠+ +手術(shù)清創(chuàng)手術(shù)清創(chuàng)鹽水紗布、凡士林紗布鹽水紗布、凡士林紗布+ +手術(shù)清創(chuàng)手術(shù)清創(chuàng)黃期黃期水凝膠水凝膠+ +手術(shù)清創(chuàng)手術(shù)清創(chuàng)+ +銀離子敷料銀離子敷料手術(shù)清創(chuàng)、鹽水紗布、凡士林紗布手術(shù)清創(chuàng)、鹽水紗布、凡士林紗布+ +皮維碘紗皮維碘紗紅期紅期水凝膠水凝膠+ +銀離子敷料，手術(shù)修復(fù)銀離子敷料，手術(shù)修復(fù)皮維碘紗、鹽水紗布、凡士林紗布或手術(shù)修復(fù)皮維碘紗、鹽水紗布、凡士林紗布或手術(shù)修復(fù)粉期粉期

23、水凝膠水凝膠鹽水紗布、凡士林紗布或手術(shù)修復(fù)鹽水紗布、凡士林紗布或手術(shù)修復(fù)注：手術(shù)清創(chuàng)采用逐次適度清創(chuàng)；手術(shù)修復(fù)根據(jù)創(chuàng)面情況采取減張縫合、自體薄中厚皮注：手術(shù)清創(chuàng)采用逐次適度清創(chuàng)；手術(shù)修復(fù)根據(jù)創(chuàng)面情況采取減張縫合、自體薄中厚皮片游離植皮術(shù)、鄰近皮瓣轉(zhuǎn)移術(shù)等。片游離植皮術(shù)、鄰近皮瓣轉(zhuǎn)移術(shù)等。 銀離子敷料銀離子敷料+ +水凝膠治療組糖尿病足創(chuàng)面的水凝膠治療組糖尿病足創(chuàng)面的平均痊愈時(shí)間平均痊愈時(shí)間53.1853.189.499.49天，明顯短于傳天，明顯短于傳統(tǒng)敷料治療組統(tǒng)敷料治療組66.8666.867.907.90天天(P0.05)(P0.05)； 干預(yù)組創(chuàng)面細(xì)菌控制明顯優(yōu)于對(duì)照組干預(yù)組創(chuàng)面細(xì)菌控制明顯優(yōu)于對(duì)照組（2=20.299, P=0.0002=20.299, P=0.000）。）。 第三部分滲透壓在慢性傷口愈合機(jī)制中作用的相關(guān)性研究 目的：采用橫斷面的描述性研究，分析滲透壓與目的：采用橫斷面的描述性研究，分析滲透壓與其他生化數(shù)據(jù)的關(guān)系，以探討滲透壓與慢性傷口其他生化數(shù)據(jù)的關(guān)系，以探討滲透壓與慢性傷口治療等基礎(chǔ)研究的可能與方向。治療等基礎(chǔ)研究的可能與方向。 方法：方法：20072007年年1010月月-2010-2