氨甲环酸结合引流管夹闭减少全膝关节置换出血的Meta分析
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摘要
背景:目前临床上对在全膝关节置换过程中使用氨甲环酸结合引流管夹闭减少围置换期出血的有效性尚无定论。目的:系统评价在全膝关节置换过程中使用氨甲环酸结合引流管夹闭减少围术期出血的疗效。方法:计算机检索2008年1月至2018年6月PubMed、EMBASE、The Cochrane Library、中国知网(CNKI)、维普(VIP)和万方数据库(Wanfang Data),查找氨甲环酸结合引流管夹闭与其他疗法比较治疗全膝关节置换疗效的临床研究。由2位评价员依据纳入排除标准分别独立筛选文献、提取资料和评价纳入研究的方法学质量后,通过RevMan 5.3软件对治疗后各结局指标进行Meta分析,主要结局指标为输血人数,次要结局指标为总失血量、引流失血量、血红蛋白降低量和深静脉血栓形成人数。结果与结论:(1)最终纳入12个研究,共计1 220例患者;(2)Meta分析主要结局指标中,试验组输血人数显著少于对照组[RR=0.35,95%CI(0.23,0.52),Z=5.22,P <0.05];(3)Meta分析次要结局指标中,试验组总失血量显著低于对照组[MD=-325.45,95%CI(-445.12,-205.78),Z=5.33,P <0.05];试验组引流失血量显著低于对照组[MD=-269.85,95%CI(-334.78,-204.93),Z=8.15,P <0.05];试验组血红蛋白降低量显著低于对照组[MD=-0.91,95%CI(-1.23,-0.58),Z=5.46,P <0.05];试验组深静脉血栓形成人数少于对照组,但差异无显著性意义[RR=0.40,95%CI(0.08,2.05),Z=1.09,P> 0.05];(4)Meta分析结果表明,与对照组相比,氨甲环酸结合引流管夹闭能够显著减少全膝关节置换患者围手术期出血量。但由于纳入研究的数量和质量有限,未来仍需要更多高质量的随机对照试验来确定全膝关节置换患者给予氨甲环酸的最佳剂量和引流管夹闭的最佳持续时间。
BACKGROUND: Clinical effects of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty still remain uncertain.OBJECTIVE: To systematically review the clinical effects of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty.METHODS: PubMed, EMBASE, The Cochrane Library, CNKI, VIP and WanFang databases were searched for the clinical trials addressing tranexamic acid plus drain-clamping versus other methods in total knee arthroplasty from January 2008 to June 2018. Two authors independently screened the literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality. The primary measurement outcome was the number of patients with blood transfusion. The secondary outcomes were total blood loss,drainage volume, decrease in hemoglobin, and the incidence of deep venous thrombosis. Changes in these outcomes were analyzed by a meta-analysis on Rev Man 5.3 software.RESULTS AND CONCLUSION:(1) Twelve studies with 1 220 patients were included.(2) Meta-analysis results showed that the number of patients with blood transfusion in the trial group was significantly less than that in the control group [RR=0.35, 95%CI(0.23, 0.52), Z=5.22, P <0.05].(3) The total blood loss [MD=-325.45, 95%CI(-445.12,-205.78), Z=5.33, P < 0.05], drainage volume [MD=-269.85, 95%CI(-334.78,-204.93), Z=8.15, P < 0.05], and the decrease in hemoglobin [MD=-0.91, 95%CI(-1.23,-0.58), Z=5.46, P < 0.05] in the trial group were significantly lower than those in the control group. The incidence of deep venous thrombosis in the trial group was slightly lower than that in the control group [RR=0.40, 95%CI(0.08, 2.05), Z=1.09, P > 0.05].(4) These results show that compared with the control group, tranexamic acid plus drain-clamping can significantly reduce perioperative blood loss in total knee arthroplasty. The number and the quality of the included studies are far from perfect, so more high-quality randomized controlled trials are needed to identify the optimal dose of tranexamic acid and the clamping hours.
BACKGROUND: Clinical effects of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty still remain uncertain.OBJECTIVE: To systematically review the clinical effects of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty.METHODS: PubMed, EMBASE, The Cochrane Library, CNKI, VIP and WanFang databases were searched for the clinical trials addressing tranexamic acid plus drain-clamping versus other methods in total knee arthroplasty from January 2008 to June 2018. Two authors independently screened the literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality. The primary measurement outcome was the number of patients with blood transfusion. The secondary outcomes were total blood loss,drainage volume, decrease in hemoglobin, and the incidence of deep venous thrombosis. Changes in these outcomes were analyzed by a meta-analysis on Rev Man 5.3 software.RESULTS AND CONCLUSION:(1) Twelve studies with 1 220 patients were included.(2) Meta-analysis results showed that the number of patients with blood transfusion in the trial group was significantly less than that in the control group [RR=0.35, 95%CI(0.23, 0.52), Z=5.22, P <0.05].(3) The total blood loss [MD=-325.45, 95%CI(-445.12,-205.78), Z=5.33, P < 0.05], drainage volume [MD=-269.85, 95%CI(-334.78,-204.93), Z=8.15, P < 0.05], and the decrease in hemoglobin [MD=-0.91, 95%CI(-1.23,-0.58), Z=5.46, P < 0.05] in the trial group were significantly lower than those in the control group. The incidence of deep venous thrombosis in the trial group was slightly lower than that in the control group [RR=0.40, 95%CI(0.08, 2.05), Z=1.09, P > 0.05].(4) These results show that compared with the control group, tranexamic acid plus drain-clamping can significantly reduce perioperative blood loss in total knee arthroplasty. The number and the quality of the included studies are far from perfect, so more high-quality randomized controlled trials are needed to identify the optimal dose of tranexamic acid and the clamping hours.
引文
[1]Schilling CG,Dowsey MM,Petrie DJ,et al.Predicting the long-term gains in health-related quality of life after total knee arthroplasty.JArthroplasty.2017;32(2):395-401.
[2]Kurtz S,Ong K,Lau E,et al.Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030.J Bone Joint Surg Am.2007;89(4):780-785.
[3]郭斌斌,张华.人工全膝关节表面置换术的临床应用浅析[J].甘肃医药,2017,36(11):913-916.
[4]Numkanisorn S,Chareancholvanich K,Pornrattanamaneewong C.Intravenous tranexamic acid before and after tourniquet use can reduce blood loss and blood transfusion after total knee arthroplasty.JMed Assoc Thai.2016;99(11):1220-1225.
[5]Good L,Peterson E,Lisander B.Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement.Br JAnaesth.2003;90(5):596-599.
[6]Li J,Li HB,Zhai XC,et al.Topical use of topical fibrin sealant can reduce the need for transfusion,total blood loss and the volume of drainage in total knee and hip arthroplasty:A systematic review and meta-analysis of 1489 patients.Int J Surg.2016;36:127-137.
[7]Li JF,Li H,Zhao H,et al.Combined use of intravenous and topical versus intravenous tranexamic acid in primary total knee and hip arthroplasty:a meta-analysis of randomised controlled trials.JOorthop Surg Res.2017;12(1):12-22.
[8]Li B,Liu ZT,Shen P,et al.Comparison of therapeutic effects between drainage blood reinfusion and temporary clamping drainage after total knee arthroplasty in patients with rheumatoid arthritis.Clinics.2015;70(3):202-206.
[9]Fillingham YA,Ramkumar DB,Jevsevar DS,et al.The efficacy of tranexamic acid in total knee arthroplasty:a network meta-analysis.JArthroplasty.2018;5(18):425-430.
[10]Gianakos AL,Hurley ET,Haring RS,et al.Reduction of blood loss by tranexamic acid following total hip and knee arthroplasty:a meta-analysis.JBJS Rev.2018;6(5):e1.
[11]Kiely N,Hockings M,Gambhir A.Does temporary clamping of drains following knee arthroplasty reduce blood loss?A randomised controlled trial.Knee.2001;8(4):325-327.
[12]Mccormick F,Cvetanovich GL,Kim JM,et al.An assessment of the quality of rotator cuff randomized controlled trials:utilizing the Jadad score and CONSORT criteria.J Shoulder Elbow Surg.2013;22(9):1180-1185.
[13]Oremus M,Oremus C,Hall GB,et al.Inter-rater and test-retest reliability of quality assessments by novice student raters using the Jadad and Newcastle-Ottawa Scales.BMJ Open.2012;2(4):136-138.
[14]罗杰,冷卫东.系统评价/Meta分析理论与实践[J].中国循证心血管医学杂志,2013,5(2):115.
[15]Chareancholvanich K,Siriwattanasakul P,Narkbunnam R,et al.Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty:a prospective randomized controlled trial.BMC Musculoskelet Disord.2012;13:124.
[16]Mutsuzaki H,Ikeda K.Intra-articular injection of tranexamic acid via a drain plus drain-clamping to reduce blood loss in cementless total knee arthroplasty.J Orthop Surg Res.2012;7:32.
[17]Onodera T,Majima T,Sawaguchi N,et al.Risk of deep venous thrombosis in drain clamping with tranexamic acid and carbazochrome sodium sulfonate hydrate in total knee arthroplasty.J Arthroplasty.2012;27(1):105-108.
[18]Sa-Ngasoongsong P,Channoom T,Kawinwonggowit V,et al.Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain:a prospective triple-blinded randomized controlled trial.Orthop Rev.2011;3(2):12.
[19]Sa-Ngasoongsong P,Wongsak S,Chanplakorn P,et al.Efficacy of low-dose intra-articular tranexamic acid in total knee replacement;a prospective triple-blinded randomized controlled trial.BMCMusculoskelet Disord.2013;14:340.
[20]Wang G,Wang D,Wang B,et al.Efficacy and safety evaluation of intra-articular injection of tranexamic acid in total knee arthroplasty operation with temporarily drainage close.Int J Clin Exp Med.2015;8(8):14328-14334.
[21]Wu Y,Yang T,Zeng Y,et al.Clamping drainage is unnecessary after minimally invasive total knee arthroplasty in patients with tranexamic acid:A randomized,controlled trial.Medicine.2017;96(7):5804.
[22]卞春喜,耿秋丽,马永成,等.氨甲环酸关节腔内灌注联合2小时引流管夹闭在初次单侧全膝关节置换术后失血量的临床研究[J].生物骨科材料与临床研究,2016,13(1):10-12.
[23]胡江琳.全膝关节置换术患者局部应用氨甲环酸以及引流管夹闭的护理及对患者出血量的影响[J].世界最新医学信息文摘,2018,18(37):250-251.
[24]陆志东,谭希鹏,李鹏,等.局部使用氨甲环酸联合夹闭引流管6 h减少人工全膝关节置换术后失血量[J].宁夏医学杂志,2017,39(9):778-781.
[25]吴翔,朱光勇,陈杰.局部使用氨甲环酸结合临时夹闭引流管减少全膝关节置换术后出血效果观察[J].浙江创伤外科,2016,21(2):355-356.
[26]张骏.静脉和局部联合应用氨甲环酸配合夹闭引流管在膝关节置换中的疗效分析[J].临床医药文献电子杂志,2016,3(31):6165-6166.
[27]Steinhaus ME,Christ AB,Cross MB.Total knee arthroplasty for knee osteoarthritis:support for a foregone conclusion?HSS J.2017;13(2):207-210.
[28]Carling MS,Jeppsson A,Eriksson BI,et al.Transfusions and blood loss in total hip and knee arthroplasty:a prospective observational study.J Orthop Surg Res.2015;10:48.
[29]Wang JW,Chen B,Lin PC,et al.The efficacy of combined use of rivaroxaban and tranexamic acid on blood conservation in minimally invasive total knee arthroplasty a double-blind randomized,controlled trial.J Arthroplasty.2017;32(3):801-806.
[30]Song EK,Seon JK,Prakash J,et al.Combined administration of iv and topical tranexamic acid is not superior to either individually in primary navigated tka.J Arthroplasty.2017;32(1):37-42.
[31]Zekcer A,Priori RD,Tieppo C,et al.Comparative study of topical vs.intravenous tranexamic acid regarding blood loss in total knee arthroplasty.Rev Bras Ortop.2017;52(5):589-595.
[32]Napolitano LM,Cohen MJ,Cotton BA,et al.Tranexamic acid in trauma:how should we use it?J Trauma Acute Care Surg.2013;74(6):1575-1586.
[33]Prasad N,Padmanabhan V,Mullaji A.Comparison between two methods of drain clamping after total knee arthroplasty.Arch Orthop Trauma Surg.2005;125(6):381-384.
[34]Keska R,Paradowski TP,Witonski D.Outcome in primary cemented total knee arthroplasty with or without drain:A prospective comparative study.Indian J Orthop.2014;48(4):404-409.
[35]Kim YH,Cho SH,Kim RS.Drainage verus no ndrainage in simultaneous bilateral total knee arthroplasty.Clin Orthop.1998;347:188-193.
[36]荆鑫,滕红林,吴海山,等.全关节置换术后关节腔引流问题的探讨[J].中国矫形外科杂志,2002,20(13):1295-1297.
[37]Huang Z,Ma J,Pei F,et al.Meta-analysis of temporary versus no clamping in TKA.Orthopedics.2013;36(7):543-550.
[2]Kurtz S,Ong K,Lau E,et al.Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030.J Bone Joint Surg Am.2007;89(4):780-785.
[3]郭斌斌,张华.人工全膝关节表面置换术的临床应用浅析[J].甘肃医药,2017,36(11):913-916.
[4]Numkanisorn S,Chareancholvanich K,Pornrattanamaneewong C.Intravenous tranexamic acid before and after tourniquet use can reduce blood loss and blood transfusion after total knee arthroplasty.JMed Assoc Thai.2016;99(11):1220-1225.
[5]Good L,Peterson E,Lisander B.Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement.Br JAnaesth.2003;90(5):596-599.
[6]Li J,Li HB,Zhai XC,et al.Topical use of topical fibrin sealant can reduce the need for transfusion,total blood loss and the volume of drainage in total knee and hip arthroplasty:A systematic review and meta-analysis of 1489 patients.Int J Surg.2016;36:127-137.
[7]Li JF,Li H,Zhao H,et al.Combined use of intravenous and topical versus intravenous tranexamic acid in primary total knee and hip arthroplasty:a meta-analysis of randomised controlled trials.JOorthop Surg Res.2017;12(1):12-22.
[8]Li B,Liu ZT,Shen P,et al.Comparison of therapeutic effects between drainage blood reinfusion and temporary clamping drainage after total knee arthroplasty in patients with rheumatoid arthritis.Clinics.2015;70(3):202-206.
[9]Fillingham YA,Ramkumar DB,Jevsevar DS,et al.The efficacy of tranexamic acid in total knee arthroplasty:a network meta-analysis.JArthroplasty.2018;5(18):425-430.
[10]Gianakos AL,Hurley ET,Haring RS,et al.Reduction of blood loss by tranexamic acid following total hip and knee arthroplasty:a meta-analysis.JBJS Rev.2018;6(5):e1.
[11]Kiely N,Hockings M,Gambhir A.Does temporary clamping of drains following knee arthroplasty reduce blood loss?A randomised controlled trial.Knee.2001;8(4):325-327.
[12]Mccormick F,Cvetanovich GL,Kim JM,et al.An assessment of the quality of rotator cuff randomized controlled trials:utilizing the Jadad score and CONSORT criteria.J Shoulder Elbow Surg.2013;22(9):1180-1185.
[13]Oremus M,Oremus C,Hall GB,et al.Inter-rater and test-retest reliability of quality assessments by novice student raters using the Jadad and Newcastle-Ottawa Scales.BMJ Open.2012;2(4):136-138.
[14]罗杰,冷卫东.系统评价/Meta分析理论与实践[J].中国循证心血管医学杂志,2013,5(2):115.
[15]Chareancholvanich K,Siriwattanasakul P,Narkbunnam R,et al.Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty:a prospective randomized controlled trial.BMC Musculoskelet Disord.2012;13:124.
[16]Mutsuzaki H,Ikeda K.Intra-articular injection of tranexamic acid via a drain plus drain-clamping to reduce blood loss in cementless total knee arthroplasty.J Orthop Surg Res.2012;7:32.
[17]Onodera T,Majima T,Sawaguchi N,et al.Risk of deep venous thrombosis in drain clamping with tranexamic acid and carbazochrome sodium sulfonate hydrate in total knee arthroplasty.J Arthroplasty.2012;27(1):105-108.
[18]Sa-Ngasoongsong P,Channoom T,Kawinwonggowit V,et al.Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain:a prospective triple-blinded randomized controlled trial.Orthop Rev.2011;3(2):12.
[19]Sa-Ngasoongsong P,Wongsak S,Chanplakorn P,et al.Efficacy of low-dose intra-articular tranexamic acid in total knee replacement;a prospective triple-blinded randomized controlled trial.BMCMusculoskelet Disord.2013;14:340.
[20]Wang G,Wang D,Wang B,et al.Efficacy and safety evaluation of intra-articular injection of tranexamic acid in total knee arthroplasty operation with temporarily drainage close.Int J Clin Exp Med.2015;8(8):14328-14334.
[21]Wu Y,Yang T,Zeng Y,et al.Clamping drainage is unnecessary after minimally invasive total knee arthroplasty in patients with tranexamic acid:A randomized,controlled trial.Medicine.2017;96(7):5804.
[22]卞春喜,耿秋丽,马永成,等.氨甲环酸关节腔内灌注联合2小时引流管夹闭在初次单侧全膝关节置换术后失血量的临床研究[J].生物骨科材料与临床研究,2016,13(1):10-12.
[23]胡江琳.全膝关节置换术患者局部应用氨甲环酸以及引流管夹闭的护理及对患者出血量的影响[J].世界最新医学信息文摘,2018,18(37):250-251.
[24]陆志东,谭希鹏,李鹏,等.局部使用氨甲环酸联合夹闭引流管6 h减少人工全膝关节置换术后失血量[J].宁夏医学杂志,2017,39(9):778-781.
[25]吴翔,朱光勇,陈杰.局部使用氨甲环酸结合临时夹闭引流管减少全膝关节置换术后出血效果观察[J].浙江创伤外科,2016,21(2):355-356.
[26]张骏.静脉和局部联合应用氨甲环酸配合夹闭引流管在膝关节置换中的疗效分析[J].临床医药文献电子杂志,2016,3(31):6165-6166.
[27]Steinhaus ME,Christ AB,Cross MB.Total knee arthroplasty for knee osteoarthritis:support for a foregone conclusion?HSS J.2017;13(2):207-210.
[28]Carling MS,Jeppsson A,Eriksson BI,et al.Transfusions and blood loss in total hip and knee arthroplasty:a prospective observational study.J Orthop Surg Res.2015;10:48.
[29]Wang JW,Chen B,Lin PC,et al.The efficacy of combined use of rivaroxaban and tranexamic acid on blood conservation in minimally invasive total knee arthroplasty a double-blind randomized,controlled trial.J Arthroplasty.2017;32(3):801-806.
[30]Song EK,Seon JK,Prakash J,et al.Combined administration of iv and topical tranexamic acid is not superior to either individually in primary navigated tka.J Arthroplasty.2017;32(1):37-42.
[31]Zekcer A,Priori RD,Tieppo C,et al.Comparative study of topical vs.intravenous tranexamic acid regarding blood loss in total knee arthroplasty.Rev Bras Ortop.2017;52(5):589-595.
[32]Napolitano LM,Cohen MJ,Cotton BA,et al.Tranexamic acid in trauma:how should we use it?J Trauma Acute Care Surg.2013;74(6):1575-1586.
[33]Prasad N,Padmanabhan V,Mullaji A.Comparison between two methods of drain clamping after total knee arthroplasty.Arch Orthop Trauma Surg.2005;125(6):381-384.
[34]Keska R,Paradowski TP,Witonski D.Outcome in primary cemented total knee arthroplasty with or without drain:A prospective comparative study.Indian J Orthop.2014;48(4):404-409.
[35]Kim YH,Cho SH,Kim RS.Drainage verus no ndrainage in simultaneous bilateral total knee arthroplasty.Clin Orthop.1998;347:188-193.
[36]荆鑫,滕红林,吴海山,等.全关节置换术后关节腔引流问题的探讨[J].中国矫形外科杂志,2002,20(13):1295-1297.
[37]Huang Z,Ma J,Pei F,et al.Meta-analysis of temporary versus no clamping in TKA.Orthopedics.2013;36(7):543-550.