常规方法联合导管内溶栓治疗急性下肢深静脉血栓形成的有效性及安全性的Meta分析
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摘要
目的系统评价常规治疗(conventional treatment,CT)联合导管内溶栓(catheter-directed thrombolysis,CDT)治疗与只进行常规治疗对急性下肢深静脉血栓形成(deep vein thrombosis,DVT)的有效性以及安全性。方法计算机检索The Cochrane Library、Pubmed、EMBASE.com、Medline、CNKI、WanFang Data、CBM、CSJD、CJFD等数据库及Google Scholar查找有关CT联合DVT治疗急性下肢深静脉血栓形成的随机对照试验(RCT),时限均为建库至2013年6月30日止。由两位研究者依据纳入与排除标准独立筛选文献、提供资料并评价文献质量。对纳入的研究以RevMan 5.1软件进行Meta分析。结果共入选2个RCT 3篇文献,224例患者。纳入的文献无发表偏倚(Begg检验,Z=1.02,P>0.05;Egger检验,t=0.98,P>0.05)。Meta分析结果显示:术后6个月CDT组髂股静脉通畅率高于CT组(OR=3.62,95%CI:1.51~8.64,P=0.004);术后6个月髂股静脉闭塞和(或)静脉反流率CDT组低于CT组(OR=0.24,95%CI:0.11~0.53,P=0.000);CDT组术后24个月下肢深静脉血栓后遗症(PTS)发生率要低于CT组(OR=0.55,95%CI:0.31~0.96,P=0.040);在其他严重并发症发生率上CDT组与CT组间差异无统计学意义(OR=1.34,95%CI:0.12~15.69,P=0.810);而CT组的其他次要并发症发生率以及手术后总并发症发生率较CDT组低,统计值分别为OR=13.67,95%CI:4.08~45.83,P<0.000 1和OR=11.67,95%CI:4.40~30.99,P<0.000 01。结论 CDT在治疗早期深静脉血栓形成对血管再通,防止血管再次闭塞、反流及PTS发生上具有较为肯定的疗效。受纳入研究质量和数量的限制,以上结论仍需要更多高质量的研究,特别是需要大样本、多中心的随机双盲对照试验来加以验证。腔内治疗的应用应根据患者的具体情况而定。
Objective To evaluate the effectiveness and safety of the additional catheter-directed thrombolysis(CDT) and conventional treatment(CT) for treatment primary deep vein thrombosis. Methods Databases such as CNKI, WanFang Data, Pubmed, EMBASE.com, Medline, CBM, CSJD, CJFD, and the Cochrane Library were electronically searched from the date of their establishment to 30 June, 2013, and the relevant literatures and conference proceedings were also manually searched to include randomized controlled trials(RCTs) on comparison of additional CDT versus CT for primary deep vein thrombosis. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data, and accessed the methodological quality of the included studies. Then the metaanalysis was performed by using RevMan 5.1 software. Publication bias was assessed by STATA software. A metaregression model was used to describe between study variability. Results Two RCTs including 3 literatures contain 224 patients reporting data on safety and effi cacy of CDT versus CT were included. There were no publication bias(Begg'Stest, Z=1.02. P > 0.05;Egger'S test, t=0.98, P > 0.05). The results of meta-analysis showed that: in 6 months after surgery iliofemoral vein patency rate of CDT group was higher than that of CT group(OR=3.62, 95% CI:1.51-8.64, P=0.004), in 6 months after surgery CDT group with a lower rate than CT group of the iliofemoral vein occlusion and(or)venous reflux rate(OR=0.24, 95% CI:0.11-0.53, P=0.000), and the incidence rate of PTS in 24 months after surgery in CTD group was less than that of CT group(OR=0.55, 95% CI:0.31-0.96, P=0.040). There were no statistically signifi cant of the major complications after surgery between CDT group and CT group(OR=1.34, 95% CI:0.12-15.69, P=0.810). But the incidence rates of minor complications and total complications after surgery in CT group were lower than those of CDT group(OR=13.67, 95% CI:4.08-45.83, P<0.00 01 and OR=11.67, 95% CI:4.40-30.99, P<0.000 01). Conclusions CDT is a effective and positive way to treat early deep venous thrombosis especially in terms of the patency of vascular and prevent the occlusion and PTS. Due to the limitation of the included studies, large sample size, multicenter, and high quality studies are needed to verify the above conclusion, such as the ATTRACT Study. The intracavitary therapy could be applied to clinic combining individual conditions of patients.
Objective To evaluate the effectiveness and safety of the additional catheter-directed thrombolysis(CDT) and conventional treatment(CT) for treatment primary deep vein thrombosis. Methods Databases such as CNKI, WanFang Data, Pubmed, EMBASE.com, Medline, CBM, CSJD, CJFD, and the Cochrane Library were electronically searched from the date of their establishment to 30 June, 2013, and the relevant literatures and conference proceedings were also manually searched to include randomized controlled trials(RCTs) on comparison of additional CDT versus CT for primary deep vein thrombosis. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data, and accessed the methodological quality of the included studies. Then the metaanalysis was performed by using RevMan 5.1 software. Publication bias was assessed by STATA software. A metaregression model was used to describe between study variability. Results Two RCTs including 3 literatures contain 224 patients reporting data on safety and effi cacy of CDT versus CT were included. There were no publication bias(Begg'Stest, Z=1.02. P > 0.05;Egger'S test, t=0.98, P > 0.05). The results of meta-analysis showed that: in 6 months after surgery iliofemoral vein patency rate of CDT group was higher than that of CT group(OR=3.62, 95% CI:1.51-8.64, P=0.004), in 6 months after surgery CDT group with a lower rate than CT group of the iliofemoral vein occlusion and(or)venous reflux rate(OR=0.24, 95% CI:0.11-0.53, P=0.000), and the incidence rate of PTS in 24 months after surgery in CTD group was less than that of CT group(OR=0.55, 95% CI:0.31-0.96, P=0.040). There were no statistically signifi cant of the major complications after surgery between CDT group and CT group(OR=1.34, 95% CI:0.12-15.69, P=0.810). But the incidence rates of minor complications and total complications after surgery in CT group were lower than those of CDT group(OR=13.67, 95% CI:4.08-45.83, P<0.00 01 and OR=11.67, 95% CI:4.40-30.99, P<0.000 01). Conclusions CDT is a effective and positive way to treat early deep venous thrombosis especially in terms of the patency of vascular and prevent the occlusion and PTS. Due to the limitation of the included studies, large sample size, multicenter, and high quality studies are needed to verify the above conclusion, such as the ATTRACT Study. The intracavitary therapy could be applied to clinic combining individual conditions of patients.
引文
[1]颜新,千英信,卫洪昌,等.下肢深静脉血栓形成的中医治疗进展[J].上海中医杂志,2006,37(3):58-60.
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[3]Harenberg J.Fixed-dose versus adjusted-dose low molecular weight heparin for the initial treatment of patients with deep venous thrombosis[J].Curr Opin Pulm Med,2002,8(5):383-388.
[4]Semba CP,Dake MD.Iliofemoral deep venous thrombosis:aggressive therapy with catheter-directed thrombolysis[J].Radiology,1994,191(2):467-494.
[5]Kearon C,Kahn SR,Agnelli G,et al.Antithrombotic therapy for venous thromboembolic disease:American College of Chest Physicians Evidence-Based Clinical Practice Guidelines(8th Edition)[J].Chest,2008,133(6 Supp1):454S-545S.
[6]Watson LI,Armon MP.Thrombolysis for acute deep vein thrombosis[J].Cochrane Database Syst Rev,2004,18(4):CD00-2783.
[7]刘关键,吴泰相,康德英.Meta-分析中统计学过程[J].中国临床康复,2003,7(4):538-539.
[8]吴泰相,刘关键,赵娜,等.观察性研究系统评价/Meta-分析的方法[J].中国循证医学杂志,2004,4(5):337-341.
[9]Higgins JPT,Green S.Cochrane Handbook for SystematicReviews of Interventions Version 5.0.1(updated September 2008)[EB/OL].The Cochrane Collaboration,2008.Available from www.cochranehandbook.org.
[10]Enden T,Kl?w NE,Sandvik L,et al.Catheter-directed thrombolysis vs.anticoagulant therapy alone in deep vein thrombosis:results of an open randomized,controlled trial reporting on shortterm patency[J].J Thromb Haemost,2009,7(8):1268-1275.
[11]Enden T,Haig Y,Kl?w NE,et al.Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis(the CaVenT study):a randomised controlled trial[J].Lancet,2012,379(9810):31-38.
[12]Elsharawy M,Elzayat E.Early results of thrombolysis versus anticoagulation in iliofemoral venous thrombosis.A randomized clinical trial[J].Eur J Vase Endovasc Surg,2002,24(3):209-214.
[13]Mewissen MW,Seabrook GR,Meissner MH,et al.Catheter-directedthrombolysis for lower extremity deep venous thrombosis:report of a national multicenter registry[J].Radiology,1999,211(1):39-49.
[14]Semba CP,Razavi MK,Kee ST,et al.Thrombolysis for lower extremity deep venous thrombosis[J].Tech Vasc Interv Radiology,2004,7(2):68-78.
[15]Bjarnason H,Kruse JR,Asinger DA,et al.Iliofemoral deep venous thrombosis:safety and effi cacy outcome during 5 years of catheter-directed thrombolytic therapy[J].J Vasc Interv Radiol,1997,8(3):405-418.
[16]Ly B,Njaastad AM,Sandbaek G,et al.Catheter-directed thrombolysis of iliofemoral venous thrombosis[J].Tidsskr Nor Laegeforen,2004,124(4):478-480.
[17]Sillesen H,Just S,J?rgensen M,et al.Catheter-directed thrombolysis for treatment of iliofemoral deep venous thrombosis is durable,preserves venous valve function and may prevent chronicvenous insuffi ciency[J].Eur J Vasc Endovasc Surg,2005,30(5):556-562.
[18]Protack CD,Bakken AM,Pate N,et al.Long-term outcomes of catheter-directed thrombolysis for lower extremity deep venous thrombosis without prophylactic inferior vena cava fi lter placement[J].J Vasc Surg,2007,45(5):992-997.
[19]Meissner MH,Wakefield TW,Asher E,et al.Acute venous disease:venous thrombosis and venous trama[J].J Vasc Surg,2007,46 Suppl S:25S-53S.
[20]Kearon C.Natural history of venous thromboembolism[J].Circulation,2003,107(23 Suppl 1):I22-I30.
[21]Janssen MC,Wollersheim H,Schultze-Kool LJ,et al.Local and systemic thrombolytic therapy for acute venous thrombosis[J].Neth J Med,2005,63(3):81-90.
[22]Comerota AJ,Schmieder FA.Intraoperative lytic therapy:agents and methods of administration[J].Simin Vasc Surg,2001,14(2):132-142.
[23]Segal JB,Streiff MB,Hoffmann LV,et al.Management of venous thromboembolism:a systematic review for a practice guideline[J].Ann Intern Med,2007,146(3):211-222.
[24]Ogawa T,Hoshino S,Midorikawa H,et al.Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low-dose urokinase in patients with acute proximal venous thrombosis of the leg[J].J Vase Surg,2005,42(5):940-944.
[25]Kakkos SK,Daskalopoulou SS,Daskalopoulos ME,et al.Review on the value of graduated elastic compression stockings after deep vein thrombosis[J].Thromb Haemost,2006,96(4):441-445.
[26]Vedantham S,Goldhaber SZ,Kahn SR,et al.Rationale and design of the ATTRACT Study:a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis[J].Am Heart J,2013,165(4):523-530.
[2]陈孝平.外科学[M].北京:人民卫生出版社,2005:792-794.
[3]Harenberg J.Fixed-dose versus adjusted-dose low molecular weight heparin for the initial treatment of patients with deep venous thrombosis[J].Curr Opin Pulm Med,2002,8(5):383-388.
[4]Semba CP,Dake MD.Iliofemoral deep venous thrombosis:aggressive therapy with catheter-directed thrombolysis[J].Radiology,1994,191(2):467-494.
[5]Kearon C,Kahn SR,Agnelli G,et al.Antithrombotic therapy for venous thromboembolic disease:American College of Chest Physicians Evidence-Based Clinical Practice Guidelines(8th Edition)[J].Chest,2008,133(6 Supp1):454S-545S.
[6]Watson LI,Armon MP.Thrombolysis for acute deep vein thrombosis[J].Cochrane Database Syst Rev,2004,18(4):CD00-2783.
[7]刘关键,吴泰相,康德英.Meta-分析中统计学过程[J].中国临床康复,2003,7(4):538-539.
[8]吴泰相,刘关键,赵娜,等.观察性研究系统评价/Meta-分析的方法[J].中国循证医学杂志,2004,4(5):337-341.
[9]Higgins JPT,Green S.Cochrane Handbook for SystematicReviews of Interventions Version 5.0.1(updated September 2008)[EB/OL].The Cochrane Collaboration,2008.Available from www.cochranehandbook.org.
[10]Enden T,Kl?w NE,Sandvik L,et al.Catheter-directed thrombolysis vs.anticoagulant therapy alone in deep vein thrombosis:results of an open randomized,controlled trial reporting on shortterm patency[J].J Thromb Haemost,2009,7(8):1268-1275.
[11]Enden T,Haig Y,Kl?w NE,et al.Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis(the CaVenT study):a randomised controlled trial[J].Lancet,2012,379(9810):31-38.
[12]Elsharawy M,Elzayat E.Early results of thrombolysis versus anticoagulation in iliofemoral venous thrombosis.A randomized clinical trial[J].Eur J Vase Endovasc Surg,2002,24(3):209-214.
[13]Mewissen MW,Seabrook GR,Meissner MH,et al.Catheter-directedthrombolysis for lower extremity deep venous thrombosis:report of a national multicenter registry[J].Radiology,1999,211(1):39-49.
[14]Semba CP,Razavi MK,Kee ST,et al.Thrombolysis for lower extremity deep venous thrombosis[J].Tech Vasc Interv Radiology,2004,7(2):68-78.
[15]Bjarnason H,Kruse JR,Asinger DA,et al.Iliofemoral deep venous thrombosis:safety and effi cacy outcome during 5 years of catheter-directed thrombolytic therapy[J].J Vasc Interv Radiol,1997,8(3):405-418.
[16]Ly B,Njaastad AM,Sandbaek G,et al.Catheter-directed thrombolysis of iliofemoral venous thrombosis[J].Tidsskr Nor Laegeforen,2004,124(4):478-480.
[17]Sillesen H,Just S,J?rgensen M,et al.Catheter-directed thrombolysis for treatment of iliofemoral deep venous thrombosis is durable,preserves venous valve function and may prevent chronicvenous insuffi ciency[J].Eur J Vasc Endovasc Surg,2005,30(5):556-562.
[18]Protack CD,Bakken AM,Pate N,et al.Long-term outcomes of catheter-directed thrombolysis for lower extremity deep venous thrombosis without prophylactic inferior vena cava fi lter placement[J].J Vasc Surg,2007,45(5):992-997.
[19]Meissner MH,Wakefield TW,Asher E,et al.Acute venous disease:venous thrombosis and venous trama[J].J Vasc Surg,2007,46 Suppl S:25S-53S.
[20]Kearon C.Natural history of venous thromboembolism[J].Circulation,2003,107(23 Suppl 1):I22-I30.
[21]Janssen MC,Wollersheim H,Schultze-Kool LJ,et al.Local and systemic thrombolytic therapy for acute venous thrombosis[J].Neth J Med,2005,63(3):81-90.
[22]Comerota AJ,Schmieder FA.Intraoperative lytic therapy:agents and methods of administration[J].Simin Vasc Surg,2001,14(2):132-142.
[23]Segal JB,Streiff MB,Hoffmann LV,et al.Management of venous thromboembolism:a systematic review for a practice guideline[J].Ann Intern Med,2007,146(3):211-222.
[24]Ogawa T,Hoshino S,Midorikawa H,et al.Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low-dose urokinase in patients with acute proximal venous thrombosis of the leg[J].J Vase Surg,2005,42(5):940-944.
[25]Kakkos SK,Daskalopoulou SS,Daskalopoulos ME,et al.Review on the value of graduated elastic compression stockings after deep vein thrombosis[J].Thromb Haemost,2006,96(4):441-445.
[26]Vedantham S,Goldhaber SZ,Kahn SR,et al.Rationale and design of the ATTRACT Study:a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis[J].Am Heart J,2013,165(4):523-530.