利伐沙班临床应用调查分析
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摘要
目的开展利伐沙班临床应用调查,分析其临床应用的合理性、有效性、安全性及药物相互作用,为规范其临床应用提供依据。方法汇总国内外临床应用专家指南或共识,形成利伐沙班合理性评价标准;回顾性调查某院2018年第一季度所有住院科室中使用利伐沙班病例,统计各科室使用率;通过纳排标准,将符合要求的病例进行合理性、疗效、不良反应、药物相互作用分析。结果 2018年第一季度,利伐沙班使用科室共计20个,使用人次共计1 117例;使用率最高的是骨外科病房,主要用于骨科术后血栓症的预防。利伐沙班临床应用时主要按照说明书适应证进行血栓栓塞症的预防或治疗。实际统计分析病例1 028份,病例不合理率为27.14%;以剂量不足、疗程不足、疗程过长为主要不合理原因,需要采取积极的干预措施。利伐沙班临床治疗及安全性较佳,无效率为1.17%(12/1 028),不良反应发生率为9.63%(99/1 028),其中74.58%(88/118)属于出血性不良反应。结论利伐沙班临床抗凝治疗与预防应用较广泛,其疗效良好,但仍然存在不合理用药情况,尤其在给药剂量方面,同时在使用期间要密切关注出血性相关不良反应。临床药师应积极关注药品临床应用指南更新,积极与医生沟通,共同促进利伐沙班合理使用。
OBJECTIVE To investigate the clinical application of rivaroxaban and analyze the rationality,effectiveness,safety and drug interactions of its clinical application,so as to provide a basis for regulating its clinical application. METHODS A summary of guidelines or consensus of clinical application experts at home and abroad was made to form a rationality evaluation standard for rivaroxaban. A retrospective survey was conducted on the use of rivaroxaban in all inpatient departments in a hospital in the first quarter of 2018,and the utilization rate of each department was calculated. Through the inclusion criteria,the cases that meet the requirements are analyzed for rationality,efficacy,adverse reactions and drug interactions. RESULTS In the first quarter of 2018,there were 20 wards and 1 117 cases use of rivaroxaban. The highest utilization rate was the osteological surgery ward,which was mainly used for the prevention of postoperative thrombosis in orthopedics. In the clinical application of rivaroxaban,the prophylaxis or treatment of thromboembolism is mainly performed according to the instructions. The case of irrational rate was 27. 14% all 1 028 cases of patients,with insufficient dose,lack of treatment,long course of treatment as the main reason for unreasonable,need to take active intervention measures. The clinical treatment and safety of rivaroxaban were better,with an ineffective rate of 1. 17%( 12/1 028) and an adverse reaction rate of 9. 63%( 99/1 028),of which 74. 58%( 88/118) belonged to hemorrhagic adverse reactions. CONCLUSION Rivaroxaban is widely used for clinical anticoagulant therapy or prevention,and has good curative effects,but there are irrational usage,especially in terms of dose. During using,it is necessary to pay close attention to hemorrhagic-related adverse reactions. Clinical pharmacists should pay active attention to the update of the clinical application guidelines for drugs and actively communicate with doctors to jointly promote the rational use of rivaroxaban.
OBJECTIVE To investigate the clinical application of rivaroxaban and analyze the rationality,effectiveness,safety and drug interactions of its clinical application,so as to provide a basis for regulating its clinical application. METHODS A summary of guidelines or consensus of clinical application experts at home and abroad was made to form a rationality evaluation standard for rivaroxaban. A retrospective survey was conducted on the use of rivaroxaban in all inpatient departments in a hospital in the first quarter of 2018,and the utilization rate of each department was calculated. Through the inclusion criteria,the cases that meet the requirements are analyzed for rationality,efficacy,adverse reactions and drug interactions. RESULTS In the first quarter of 2018,there were 20 wards and 1 117 cases use of rivaroxaban. The highest utilization rate was the osteological surgery ward,which was mainly used for the prevention of postoperative thrombosis in orthopedics. In the clinical application of rivaroxaban,the prophylaxis or treatment of thromboembolism is mainly performed according to the instructions. The case of irrational rate was 27. 14% all 1 028 cases of patients,with insufficient dose,lack of treatment,long course of treatment as the main reason for unreasonable,need to take active intervention measures. The clinical treatment and safety of rivaroxaban were better,with an ineffective rate of 1. 17%( 12/1 028) and an adverse reaction rate of 9. 63%( 99/1 028),of which 74. 58%( 88/118) belonged to hemorrhagic adverse reactions. CONCLUSION Rivaroxaban is widely used for clinical anticoagulant therapy or prevention,and has good curative effects,but there are irrational usage,especially in terms of dose. During using,it is necessary to pay close attention to hemorrhagic-related adverse reactions. Clinical pharmacists should pay active attention to the update of the clinical application guidelines for drugs and actively communicate with doctors to jointly promote the rational use of rivaroxaban.
引文
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[9]KINOV P,TANCHEV P P,ELLIS M,et al.Antithrombotic prophylaxis in major orthopaedic surgery:an historical overview and update of current recommendations[J].Inter Orthopae,2014,38(1):169-175.
[10]STEFFEL J,VERHAMME P,POTPARA T S,et al.The 2018European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation[J].Eur Heart J,2018,39(16):1330-1393.
[11]COMMITTEE P M O A W,DOHERTY J U,GLUCKMAN T J,et al.2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With No-nvalvular Atrial Fibrillation:A Report of the American College of Cardiology Clinical Expert Consensus Document Task Force[J].J Am College Cardiol,2017,69(7):871-898.
[12]KEARON C,AKL E A,ORNELAS J,et al.Antithrombotic therapy for VTE disease:CHEST guideline and expert panel report[J].Chest,2016,149(2):315-352.
[13]KHORANA A A,CARRIER M,GARCIA D A,et al.Guidance for the prevention and treatment of cancer-associated venous thromboembolism[J].J Thromb Thrombol,2016,41(1):81-91.
[14]PRINS M H,LENSING A W,BAUERSACHS R,et al.Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism:a pooled analysis of the EINSTEINDVT and PE randomized studies[J].Thromb J,2013,11(1):21.
[15]GLASSOCK R.Prophylactic anticoagulation in nephrotic syndrome:a clinical conundrum[J].J Am Soc Nephrol,2007,18(18):2221-2225.
[16]JEAN M,CONNORS M D.Prophylaxis against venous thromboembolism in ambulatory patients with cancer[J].New Engl J Med,2014,370(26):2515-2519.
[17]BARBAR S,NOVENTA F,ROSSETTO V,et al.A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism:the Padua Prediction Score[J].J Thromb Haem,2010,8(11):2450-2457.
[18]NEWALL F,BRANCHFORD B,MALE C.Anticoagulant prophylaxis and therapy in children:current challenges and emerging issues[J].J Thromb Haem,2018,16(2):196-208.
[19]GYAMLANI G,MOLNAR M Z,LU J L,et al.Association of serum albumin level and venous thromboembolic events in a large cohort of patients with nephrotic syndrome[J].Nephrol Dial Transplant,2017,32(1):157-164.
[20]GULSETH M P,MICHAUD J,NUTESCU E A.Rivaroxaban:an oral direct inhibitor of factor Xa[J].Am J Health Syst Pharm,2008,65(16):1520-1529.
[21]RADULESCU V C.Anticoagulation therapy in children[J].Semin Throm Hemost,2017,43(8):877-885.
[22]RADULESCU V.Management of venous thrombosis in the pediatric patient[J].Pediat Health Med Therap,2015,6:111-119.
[23]VAJNA E V,ALAM R,SO T Y.Current clinical trials on the use of direct oral anticoagulants in the pediatric population[J].Cardiol Ther,2016,5(1):19-41.
[24]BEYER WESTENDORF J,GEHRISCH S.Phamacokinetics of rivaroxaban in adolescents[J].Hmostaseologie,2014,34(1):85-87.
[25]MANTHA S,LAUBE E,MIAO Y,et al.Safe and effective use of rivaroxaban for treatment of cancer-associated venous thromboembolic disease:a prospective cohort study[J].J Thromb Thrombol,2017,43(2):1-6.
[26]RAVIKUMAR R,LIM C S,DAVIES A H.The role of new oral anticoagulants(NOACs)in cancer patients[J].Adv Exp Med Biol,2017,906:137-148.
[27]CHUGH K S,MALIK N,UBEROI H S,et al.Renal vein thrombosis in nephrotic syndrome--a prospective study and review[J].Postgr Med J,1981,57(671):566-570.
[28]LIONAKI S,DEREBAIL V K,HOGAN S L,et al.Venous thromboembolism in patients with membranous nephropathy[J].Clin J Am Soc Nephr Cjasn,2012,7(1):43-51.
[29]KUMAR S,CHAPAGAIN A,NITSCH D,et al.Proteinuria and hypoalbuminemia are risk factors for thromboembolic events in patients with idiopathic membranous nephropathy:an observational study[J].Bmc Nephrol,2012,13(1):1-8.
[30]SINGHAL R,BRIMBLE K S.Thromboembolic complications in the nephrotic syndrome:pathophysiology and clinical management[J].Thromb Res,2006,118(3):397-407.
[31]WEIRTHEIN J,SCOLNIK D,MILSHTEIN N Y,et al.Accidental rivaroxaban intoxication in a boy:some lessons in managing new oral anticoagulants in children[J].Ped Emerg Care,2018:1.
[2]WALENGA J,PRECHEL M W,HOPPENSTEADT D,et al.Rivaroxaban--an oral,direct factor Xa inhibitor--has potential for the management of patients with heparin-induced thrombocytopenia[J].Br J Haematol,2008,143(1):92-99.
[3]PATIO C E S,TABARES A H.Trombocitopenia inducida por heparina:nuevas opciones terapéuticas[J].Medicina,2016,76(4):230-234.
[4]PATEL MANESH R,MAHAFFEY KENNETH W,GARG JYOTSNA,et al.Rivaroxaban versus warfarin in nonvalvular atrial fibrillation[J].New England J Med,2011,365(10):883-891.
[5]LASSEN M,AGENO W,BORRIS L C,et al.Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty[J].N Engl J Med,2008,358(26):2776-2886.
[6]KUBITZA D,BECKA M,ZUEHLSDORF M,et al.Effect of food,an antacid,and the H2 antagonist ranitidine on the absorption of BAY 59-7939(rivaroxaban),an oral,direct factor Xa inhibitor,in healthy subjects[J].J Clin Pharmacol,2006,46(5):549-558.
[7]QASEEM A,CHOU R,HUMPHREY L L,et al.Venous thromboembolism prophylaxis in hospitalized patients:a clinical practice guideline from the American college of physicians[J].Annals Inter Med,2011,155(9):625-632.
[8]KAHN S R,LIM W,DUNN A S,et al.Prevention of VTE in orthopedic surgery patients:antithrombotic therapy and prevention of thrombosis,9th ed:American college of chest physicians evidence-based clinical practice guidelines[J].Chest,2012,141(2):e278S-325S.
[9]KINOV P,TANCHEV P P,ELLIS M,et al.Antithrombotic prophylaxis in major orthopaedic surgery:an historical overview and update of current recommendations[J].Inter Orthopae,2014,38(1):169-175.
[10]STEFFEL J,VERHAMME P,POTPARA T S,et al.The 2018European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation[J].Eur Heart J,2018,39(16):1330-1393.
[11]COMMITTEE P M O A W,DOHERTY J U,GLUCKMAN T J,et al.2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With No-nvalvular Atrial Fibrillation:A Report of the American College of Cardiology Clinical Expert Consensus Document Task Force[J].J Am College Cardiol,2017,69(7):871-898.
[12]KEARON C,AKL E A,ORNELAS J,et al.Antithrombotic therapy for VTE disease:CHEST guideline and expert panel report[J].Chest,2016,149(2):315-352.
[13]KHORANA A A,CARRIER M,GARCIA D A,et al.Guidance for the prevention and treatment of cancer-associated venous thromboembolism[J].J Thromb Thrombol,2016,41(1):81-91.
[14]PRINS M H,LENSING A W,BAUERSACHS R,et al.Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism:a pooled analysis of the EINSTEINDVT and PE randomized studies[J].Thromb J,2013,11(1):21.
[15]GLASSOCK R.Prophylactic anticoagulation in nephrotic syndrome:a clinical conundrum[J].J Am Soc Nephrol,2007,18(18):2221-2225.
[16]JEAN M,CONNORS M D.Prophylaxis against venous thromboembolism in ambulatory patients with cancer[J].New Engl J Med,2014,370(26):2515-2519.
[17]BARBAR S,NOVENTA F,ROSSETTO V,et al.A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism:the Padua Prediction Score[J].J Thromb Haem,2010,8(11):2450-2457.
[18]NEWALL F,BRANCHFORD B,MALE C.Anticoagulant prophylaxis and therapy in children:current challenges and emerging issues[J].J Thromb Haem,2018,16(2):196-208.
[19]GYAMLANI G,MOLNAR M Z,LU J L,et al.Association of serum albumin level and venous thromboembolic events in a large cohort of patients with nephrotic syndrome[J].Nephrol Dial Transplant,2017,32(1):157-164.
[20]GULSETH M P,MICHAUD J,NUTESCU E A.Rivaroxaban:an oral direct inhibitor of factor Xa[J].Am J Health Syst Pharm,2008,65(16):1520-1529.
[21]RADULESCU V C.Anticoagulation therapy in children[J].Semin Throm Hemost,2017,43(8):877-885.
[22]RADULESCU V.Management of venous thrombosis in the pediatric patient[J].Pediat Health Med Therap,2015,6:111-119.
[23]VAJNA E V,ALAM R,SO T Y.Current clinical trials on the use of direct oral anticoagulants in the pediatric population[J].Cardiol Ther,2016,5(1):19-41.
[24]BEYER WESTENDORF J,GEHRISCH S.Phamacokinetics of rivaroxaban in adolescents[J].Hmostaseologie,2014,34(1):85-87.
[25]MANTHA S,LAUBE E,MIAO Y,et al.Safe and effective use of rivaroxaban for treatment of cancer-associated venous thromboembolic disease:a prospective cohort study[J].J Thromb Thrombol,2017,43(2):1-6.
[26]RAVIKUMAR R,LIM C S,DAVIES A H.The role of new oral anticoagulants(NOACs)in cancer patients[J].Adv Exp Med Biol,2017,906:137-148.
[27]CHUGH K S,MALIK N,UBEROI H S,et al.Renal vein thrombosis in nephrotic syndrome--a prospective study and review[J].Postgr Med J,1981,57(671):566-570.
[28]LIONAKI S,DEREBAIL V K,HOGAN S L,et al.Venous thromboembolism in patients with membranous nephropathy[J].Clin J Am Soc Nephr Cjasn,2012,7(1):43-51.
[29]KUMAR S,CHAPAGAIN A,NITSCH D,et al.Proteinuria and hypoalbuminemia are risk factors for thromboembolic events in patients with idiopathic membranous nephropathy:an observational study[J].Bmc Nephrol,2012,13(1):1-8.
[30]SINGHAL R,BRIMBLE K S.Thromboembolic complications in the nephrotic syndrome:pathophysiology and clinical management[J].Thromb Res,2006,118(3):397-407.
[31]WEIRTHEIN J,SCOLNIK D,MILSHTEIN N Y,et al.Accidental rivaroxaban intoxication in a boy:some lessons in managing new oral anticoagulants in children[J].Ped Emerg Care,2018:1.