免疫调剂药物治疗多发性骨髓瘤发生深静脉血栓风险的系统评价和Meta分析
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摘要
目的:评价免疫调剂药物(IMiDs)治疗多发性骨髓瘤(MM)发生深静脉血栓(DVT)的风险。方法:计算机检索截止2017年12月31日发表在Pubmed,Web of Science,中国知网(CNKI),Cochrane图书馆,www.ClinicalTrials.gov网站有关IMiDs治疗MM患者发生DVT风险的研究,使用Stata 12.0统计软件进行Meta分析,并使用GRADE系统对证据进行评估分级。结果:共检索到11篇随机对照试验纳入分析。Meta分析结果显示,使用IMiDs治疗MM时DVT的发生率为7.0%。与常规化疗相比,IMiDs治疗MM发生DVT的风险更高,RR为3.58。亚组分析显示,接受IMiDs作为诱导治疗的MM患者,DVT发生的风险较常规化疗方案增加386%,RR为4.80,该证据级别为中等;与常规化疗方案相比,IMiDs作为维持治疗方案或者治疗复发难治性MM患者DVT发生风险差异无统计学意义,RR分别为2.40、2.20。结论:现有证据表明,IMiDs在治疗MM时发生DVT的风险较高。
Objective:We conducted a systematic review and meta-analysis to assess the possible impact of immunomodulatory drugs(IMiDs) on serious deep venous thrombosis(DVT) in patients with multiple myeloma(MM).Method:We searched Medline,Web of Science,CNKI,the Cochrane Central Register of Controlled Trials,and ClinicalTrials.gov to identify randomized controlled trials(RCTs) that addressed the effects of IMiDs on serious DVT in patients with MM.We combined data into meta-analysis using software Stata version 12.0.We also used the GRADE approach to rate the quality of evidence.Result:We identified 11 RCTs for review.The rate of DVT in patients with MM treated with IMiDs was 7.0%.Compared to conventional therapy,the use of IMiDs in MM patients significantly increased the risk of serious DVT(RR=3.58).Subgroup analysis showed that the risk of serious DVT in patients treated with IMiDs for induction therapy increased 386% with moderate quality evidence when compared with conventional therapy(RR=4.80).However,the risk for serious DVT in patients who received IMiDs for maintenance therapy or patients with relapsed and refractory MM did not increased significantly when compared with conventional therapy(RR=2.40,2.20).Conclusion:The current evidence suggests that patients with MM treated with IMiDs are at a high risk of serious DVT.
Objective:We conducted a systematic review and meta-analysis to assess the possible impact of immunomodulatory drugs(IMiDs) on serious deep venous thrombosis(DVT) in patients with multiple myeloma(MM).Method:We searched Medline,Web of Science,CNKI,the Cochrane Central Register of Controlled Trials,and ClinicalTrials.gov to identify randomized controlled trials(RCTs) that addressed the effects of IMiDs on serious DVT in patients with MM.We combined data into meta-analysis using software Stata version 12.0.We also used the GRADE approach to rate the quality of evidence.Result:We identified 11 RCTs for review.The rate of DVT in patients with MM treated with IMiDs was 7.0%.Compared to conventional therapy,the use of IMiDs in MM patients significantly increased the risk of serious DVT(RR=3.58).Subgroup analysis showed that the risk of serious DVT in patients treated with IMiDs for induction therapy increased 386% with moderate quality evidence when compared with conventional therapy(RR=4.80).However,the risk for serious DVT in patients who received IMiDs for maintenance therapy or patients with relapsed and refractory MM did not increased significantly when compared with conventional therapy(RR=2.40,2.20).Conclusion:The current evidence suggests that patients with MM treated with IMiDs are at a high risk of serious DVT.
引文
[1]崔玉山,房佰俊.多发性骨髓瘤药物治疗进展[J].临床血液学杂志,2017,30(7):572-576.
[2]高顺姬,孙艳花,李广伦,等.来那度胺联合地塞米松为主的方案治疗复发难治性多发性骨髓瘤的临床观察[J].临床血液学杂志,2016,29(11):905-907.
[3]Moher D,Liberati A,Tetzlaff J,et al.Preferred reporting items for systematic reviews and meta-analyses:the PRISMA statement[J].BMJ,2009,339:b2535.
[4]Clark HD,Wells GA,Hu3t C,et al.Assessing the quality of randomized trials:reliability of the Jadad scale[J].Control Clin Trials,1999,20:448-452.
[5]Caldwell DM,Ades AE,Dias S,et al.A threshold analysis assessed the credibility of conclusions from network meta-analysis[J].J Clin Epidemiol,2016,80:68-76.
[6]Sacchi S,Marcheselli R,Lazzaro A,et al.A randomized trial with melphalan and prednisone versus melphalan and prednisone plus thalidomide in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant[J].Leuk Lymphoma,2011,52:1942-1948.
[7]Palumbo A,Hajek R,Delforge M,et al.Continuous lenalidomide treatment for newly diagnosed multiple myeloma[J].N Engl J Med,2012,366:1759-1769.
[8]Rajkumar SV,Rosinol L,Hussein M,et al.Multicenter,randomized,double-blind,placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma[J].J Clin Oncol,2008,26:2171-2177.
[9]Palumbo A,Bringhen S,Caravita T,et al.Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma:randomized controlled trial[J].Lancet,2006,367:825-831.
[10]Rajkumar SV,Blood E,Vesole D,et al.Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma:a clinical trial coordinated by the Eastern Cooperative Oncology Group[J].J Clin Oncol,2006,24:431-436.
[11]Ludwig H,Hajek R,TóthováE,et al.Thalidomidedexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma[J].Blood,2009,113:3435-3442.
[12]Attal M,Lauwers-Cances V,Marit G,et al.Lenalidomide maintenance after stem-cell transplantation for multiple myeloma[J].N Engl J Med,2012,366:1782-1791.
[13]Mateos MV,Hernández MT,Giraldo P,et al.Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma[J].N Engl J Med,2013,369:438-447.
[14]Offidani M,Corvatta L,Polloni C,et al.Thalidomidedexamethasone versus interferon-alpha-dexamethasone as maintenance treatment after ThaDD induction for multiple myeloma:aprospective,multicentre,randomised study[J].Br J Haematol,2009,144:653-659.
[15]Weber DM,Chen C,Niesvizky R,et al.Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America[J].N Engl J Med,2007,357:2133-2142.
[16]Dimopoulos M,Spencer A,Attal M,et al.Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma[J].N Engl J Med,2007,357:2123-2132.
[17]Nomura S,Ito T,Yoshimura H,et al.Evaluation of thrombosis-related biomarkers before and after therapy in patients with multiple myeloma[J].J Blood Med,2018,9:1-7.
[2]高顺姬,孙艳花,李广伦,等.来那度胺联合地塞米松为主的方案治疗复发难治性多发性骨髓瘤的临床观察[J].临床血液学杂志,2016,29(11):905-907.
[3]Moher D,Liberati A,Tetzlaff J,et al.Preferred reporting items for systematic reviews and meta-analyses:the PRISMA statement[J].BMJ,2009,339:b2535.
[4]Clark HD,Wells GA,Hu3t C,et al.Assessing the quality of randomized trials:reliability of the Jadad scale[J].Control Clin Trials,1999,20:448-452.
[5]Caldwell DM,Ades AE,Dias S,et al.A threshold analysis assessed the credibility of conclusions from network meta-analysis[J].J Clin Epidemiol,2016,80:68-76.
[6]Sacchi S,Marcheselli R,Lazzaro A,et al.A randomized trial with melphalan and prednisone versus melphalan and prednisone plus thalidomide in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant[J].Leuk Lymphoma,2011,52:1942-1948.
[7]Palumbo A,Hajek R,Delforge M,et al.Continuous lenalidomide treatment for newly diagnosed multiple myeloma[J].N Engl J Med,2012,366:1759-1769.
[8]Rajkumar SV,Rosinol L,Hussein M,et al.Multicenter,randomized,double-blind,placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma[J].J Clin Oncol,2008,26:2171-2177.
[9]Palumbo A,Bringhen S,Caravita T,et al.Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma:randomized controlled trial[J].Lancet,2006,367:825-831.
[10]Rajkumar SV,Blood E,Vesole D,et al.Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma:a clinical trial coordinated by the Eastern Cooperative Oncology Group[J].J Clin Oncol,2006,24:431-436.
[11]Ludwig H,Hajek R,TóthováE,et al.Thalidomidedexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma[J].Blood,2009,113:3435-3442.
[12]Attal M,Lauwers-Cances V,Marit G,et al.Lenalidomide maintenance after stem-cell transplantation for multiple myeloma[J].N Engl J Med,2012,366:1782-1791.
[13]Mateos MV,Hernández MT,Giraldo P,et al.Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma[J].N Engl J Med,2013,369:438-447.
[14]Offidani M,Corvatta L,Polloni C,et al.Thalidomidedexamethasone versus interferon-alpha-dexamethasone as maintenance treatment after ThaDD induction for multiple myeloma:aprospective,multicentre,randomised study[J].Br J Haematol,2009,144:653-659.
[15]Weber DM,Chen C,Niesvizky R,et al.Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America[J].N Engl J Med,2007,357:2133-2142.
[16]Dimopoulos M,Spencer A,Attal M,et al.Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma[J].N Engl J Med,2007,357:2123-2132.
[17]Nomura S,Ito T,Yoshimura H,et al.Evaluation of thrombosis-related biomarkers before and after therapy in patients with multiple myeloma[J].J Blood Med,2018,9:1-7.
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