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[1]姜苗苗,譚勇海,金鑫,等.富血小板血漿聯(lián)合體外沖擊波治療骨不連的臨床研究[J].中醫(yī)正骨,2020,32(02):30-35.
　JIANG Miaomiao,TAN Yonghai,JIN Xin,et al.A clinical study of injection of platelet-rich plasma combined with extracorporeal shock wave therapy for treatment of nonunion of fractures[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(02):30-35.
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富血小板血漿聯(lián)合體外沖擊波治療骨不連的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期數(shù):
2020年02期
頁(yè)碼:
30-35
欄目:
臨床研究
出版日期:
2020-02-20

文章信息/Info

Title:
A clinical study of injection of platelet-rich plasma combined with extracorporeal shock wave therapy for treatment of nonunion of fractures
作者:
姜苗苗; 譚勇海; 金鑫; 鞠昌軍; 姜紅江
(山東省文登整骨醫(yī)院,山東 威海 264400)
Author(s):
JIANG Miaomiao; TAN Yonghai; JIN Xin; JU Changjun; JIANG Hongjiang
The Wendeng Osteopath Hospital,Weihai 264400,Shandong,China
關(guān)鍵詞:
骨折; 不愈合;  富血小板血漿;  高能量沖擊波;  臨床試驗(yàn)
Keywords:
fractures; ununited;  platelet-rich plasma;  high-energy shock waves;  clinical trial
摘要:
目的:探討富血小板血漿聯(lián)合體外沖擊波治療骨不連的臨床療效和安全性。方法:骨不連患者58例,男42例、女16例; 年齡20～45歲,中位數(shù)34.5歲。脛腓骨骨折24例,股骨干骨折15例,股骨頸骨折8例,尺橈骨骨折7例,其他部位骨折4例。均符合美國(guó)食品藥品監(jiān)督管理局制定的骨不連診斷標(biāo)準(zhǔn),且骨折端間隙<5 mm,骨痂間無(wú)骨小梁形成,無(wú)骨折端短縮、成角及移位。隨機(jī)分為聯(lián)合治療組和體外沖擊波組,每組29例。聯(lián)合治療組制備患者自體富血小板血漿,并檢測(cè)血漿中血管內(nèi)皮生長(zhǎng)因子(vascular endothelial growth factor,VEGF)和轉(zhuǎn)化生長(zhǎng)因子-β(transforming growth factor-β,TGF-β)的含量; 在C形臂X線機(jī)透視下定位骨折端,注入富血小板血漿,注射完畢后進(jìn)行沖擊波治療。體外沖擊波組單純進(jìn)行體外沖擊波治療。治療均由同一組醫(yī)師完成,每隔4 d治療1次,共治療3次。分別于治療前和治療結(jié)束后2個(gè)月、3個(gè)月、4個(gè)月、6個(gè)月、8個(gè)月,采用骨痂和骨折線影像學(xué)評(píng)分標(biāo)準(zhǔn)在X線片上評(píng)價(jià)骨折愈合情況。觀察并發(fā)癥發(fā)生情況。結(jié)果:①細(xì)胞生長(zhǎng)因子檢測(cè)結(jié)果。制備的患者自體富血小板血漿中,細(xì)胞生長(zhǎng)因子VEGF和TGF-β的含量分別為(583.87±23.51)pg·mL-1、(195.73±26.08)pg·mL-1。②療效和安全性評(píng)價(jià)結(jié)果。2組患者均獲隨訪,隨訪時(shí)間2～8個(gè)月,中位數(shù)4個(gè)月。治療前后不同時(shí)間點(diǎn),患者骨痂影像學(xué)評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=35.696,P=0.000); 2組患者骨痂影像學(xué)評(píng)分組間總體比較,差異無(wú)統(tǒng)計(jì)學(xué)意義,即不存在分組效應(yīng)(F=9.872,P=0.518); 時(shí)間因素和分組因素存在交互效應(yīng)(F=56.877,P=0.000)。治療前,2組患者骨痂影像學(xué)評(píng)分比較,差異無(wú)統(tǒng)計(jì)學(xué)意義[(1.77±0.63)分,(1.79±0.65)分; t=0.187,P=0.245]; 治療結(jié)束后2個(gè)月、3個(gè)月、4個(gè)月、6個(gè)月及8個(gè)月,聯(lián)合治療組骨痂影像學(xué)評(píng)分均高于體外沖擊波組[(2.45±0.67)分,(1.95±0.45)分,t=0.847,P=0.000;(3.27±0.55)分,(2.14±0.15)分,t=2.578,P=0.000;(7.83±0.88)分,(3.87±0.54)分,t=6.087,P=0.000;(5.87±0.38)分,(3.75±0.65)分,t=3.856,P=0.000;(4.67±0.85)分,(3.25±0.88)分,t=1.879,P=0.000]。治療前后不同時(shí)間點(diǎn),患者骨折線影像學(xué)評(píng)分比較,差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=42.876,P=0.000); 2組患者骨折線影像學(xué)評(píng)分組間總體比較,差異無(wú)統(tǒng)計(jì)學(xué)意義,即不存在分組效應(yīng)(F=12.631,P=0.678); 時(shí)間因素和分組因素存在交互效應(yīng)(F=67.541,P=0.000)。治療前,2組患者骨折線影像學(xué)評(píng)分的組間差異無(wú)統(tǒng)計(jì)學(xué)意義[(1.26±0.67)分,(1.28±0.68)分; t=1.587,P=0.342]; 治療結(jié)束后2個(gè)月、3個(gè)月、4個(gè)月、6個(gè)月及8個(gè)月,聯(lián)合治療組骨折線影像學(xué)評(píng)分均高于體外沖擊波組[(2.45±0.87)分,(1.98±0.78)分,t=2.876,P=0.000;(3.42±0.35)分,(2.12±0.57)分,t=5.687,P=0.000;(6.12±0.87)分,(3.45±0.64)分,t=9.864,P=0.000;(5.62±0.42)分,(3.12±0.85)分,t=6.874,P=0.000;(4.21±0.75)分,(2.85±0.64)分,t=3.587,P=0.000]。2組患者均無(wú)血管、神經(jīng)損傷等并發(fā)癥發(fā)生。結(jié)論:采用富血小板血漿聯(lián)合體外沖擊波治療骨不連,可促進(jìn)骨折愈合,并發(fā)癥少,療效優(yōu)于單純體外沖擊波治療。
Abstract:
Objective:To explore the clinical curative effects and safety of injection of platelet-rich plasma(PRP)combined with extracorporeal shock wave(ESW)therapy for treatment of nonunion of fractures.Methods:Fifty-eight patients with nonunion of fractures were enrolled in the study and they consisted of 42 males and 16 females and ranged in age from 20 to 45 years(Median=34.5 yrs).The fractures belonged to tibiofibular fractures(24),femoral shaft fractures(15),femoral neck fractures(8),ulna and radius fractures(7)and otherfractures(4).All patients met the diagnostic criteria of nonunion of fractures established by U.S. Food and Drug Administration.The interspace between broken ends of fractured bone was<5 mm and no bone trabeculas were found between bony calluses.Meanwhile,no shortening,angulation and displacement of broken ends of fractured bone were found.The patients were randomly divided into combination therapy group and ESW therapy group,29 cases in each group.The venous blood was drawn from patients in combination therapy group and was made into autologous PRP,and the contents of vascular endothelial growth factor(VEGF)and transforming growth factor-β(TGF-β)in autologous PRP were detected.The autologous PRP were injected into the broken ends of fractured bone which were fixed the position using C-arm X-ray machine and then ESW therapy was performed on patients in combination therapy group.The patients in ESW therapy group were merely treated with ESW therapy.The treatment were performed on patients in the 2 groups by the same group of surgeons for consecutive 3 times with a 4-day rest-insertion between times.The fracture healing was evaluated using X-ray films according to bony callus and fracture line imageological scoring standard before the treatment and at 2,3,4,6 and 8 months after the end of the treatment respectively,and the complication incidences were observed.Results:The contents of VEGF and TGF-β in pre-prepared autologous PRP were 583.87+/-23.51 and 195.73+/-26.08 pg/mL respectively.All patients in the 2 groups were followed up for 2-8 months with a median of 4 months.There was statistical difference in bony callus imageological scores between different timepoints before and after the treatment,in other words,there was time effect(F=35.696,P=0.000).There was no statistical difference in bony callus imageological scores between the 2 groups in general,in other words,there was no group effect(F=9.872,P=0.518).There was interaction between time factor and group factor(F=56.877,P=0.000).There was no statistical difference in bony callus imageological scores between the 2 groups before the treatment(1.77+/-0.63 vs 1.79+/-0.65 points,t=0.187,P=0.245).The bony callus imageological scores were higher in combination therapy group compared to ESW therapy group at 2,3,4,6 and 8 months after the end of the treatment respectively(2.45+/-0.67 vs 1.95+/-0.45 points,t=0.847,P=0.000; 3.27+/-0.55 vs 2.14+/-0.15 points,t=2.578,P=0.000; 7.83+/-0.88 vs 3.87+/-0.54 points,t=6.087,P=0.000; 5.87+/-0.38 vs 3.75+/-0.65 points,t=3.856,P=0.000; 4.67+/-0.85 vs 3.25+/-0.88 points,t=1.879,P=0.000).There was statistical difference in fracture line imageological scores between different timepoints before and after the treatment,in other words,there was time effect(F=42.876,P=0.000).There was no statistical difference in fracture line imageological scores between the 2 groups in general,in other words,there was no group effect(F=12.631,P=0.678).There was interaction between time factor and group factor(F=67.541,P=0.000).There was no statistical difference in fracture line imageological scores between the 2 groups before the treatment(1.26+/-0.67 vs 1.28+/-0.68 points,t=1.587,P=0.342).The fracture line imageological scores were higher in combination therapy group compared to ESW therapy group at 2,3,4,6 and 8 months after the end of the treatment respectively(2.45+/-0.87 vs 1.98+/-0.78 points,t=2.876,P=0.000; 3.42+/-0.35 vs 2.12+/-0.57 points,t=5.687,P=0.000; 6.12+/-0.87 vs 3.45+/-0.64 points,t=9.864,P=0.000; 5.62+/-0.42 vs 3.12+/-0.85 points,t=6.874,P=0.000; 4.21+/-0.75 vs 2.85+/-0.64 points,t=3.587,P=0.000).No complications such as blood vessel injuries and nerve injuries were found in both of the 2 groups.Conclusion:PRP combined with ESW therapy can promote fracture healing in treatment of nonunion of fractures,and it has less complications,moreover,it surpasses the monotherapy of ESW therapy in clinical curative effects.

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備注/Memo

備注/Memo:
(收稿日期:2019-07-08 本文編輯:楊雅)基金項(xiàng)目:國(guó)家中醫(yī)藥管理局全國(guó)名老中醫(yī)藥專家傳承工作室建設(shè)項(xiàng)目(國(guó)中醫(yī)藥人教函[2018]134號(hào)); 山東省科技發(fā)展計(jì)劃項(xiàng)目(2014GSF118042); 威海市科技發(fā)展計(jì)劃項(xiàng)目(2014GNS044、2017GNS013) 通訊作者:姜紅江 E-mail:[email protected]
更新日期/Last Update: 2020-02-15