替格瑞洛上市后的安全性风险
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摘要
通过对替格瑞洛安全性相关的文献报道、上市后安全性研究的状况进行分析,总结替格瑞洛上市后的安全性风险点,提出符合其本身特点的风险控制措施,为临床安全用药提供参考。
Through analyzing the safety-related literature of ticagrelor and post-marketing safety research, this paper summarized the safety risk points of ticagrelor of post-marketing, and proposed risk control measures in line with its own characteristics, so as to provide references for clinical safe administration.
Through analyzing the safety-related literature of ticagrelor and post-marketing safety research, this paper summarized the safety risk points of ticagrelor of post-marketing, and proposed risk control measures in line with its own characteristics, so as to provide references for clinical safe administration.
引文
[1] Hamm CW,Bassand JP,Agewall S,et al.ESC guidelines for the management of acute coronary syndromes in patients presenting wit-hout persistent ST-segment elevation:the task force for the mana-gement of acute coronary syndromes(ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology(ESC)[J].Eur Heart J,2011,32(23):2999-3054.
[2] Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology(ESC),Steg PG,James SK,et al.ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation[J].Eur Heart J,2012,33(20):2569-2619.
[3] Jneid H,Anderson JL,Wright RS,et al.2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction(updating the 2007 guideline and replacing the 2011 focused update):a report of the American College of Cardiology Foundation/American Heart Assoc-iation Task Force on practice guidelines[J].J Am Coll Cardiol,2012,60(7):645-681.
[4] O'Gara PT,Kushner FG,Ascheim DD,et al.2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction:a report of the American College of Cardiology Foundation/Amer-ican Heart Association Task Force on Practice Guidelines[J].Circulation,2013,127(4):e362-e425.
[5] 谢立,张文颖.我院替格瑞洛致不良反应108例分析[J].中国药房,2016,27(29):4085-4087.
[6] 王朋,胡勇.36例替格瑞洛片致出血不良反应报告分析[J].中国药事,2016,30(7):740-744.
[7] 孟凡刚,张沐华.替格瑞洛致呼吸困难1例临床分析[J].医学理论与实践,2017,30(20):3087.
[8] 叶振,罗富良,马双双,等.替格瑞洛致咯血[J].药物不良反应杂志,2017,19(5):387-388.
[9] 谢东君,刘伟,李博,等.替格瑞洛致药物性皮疹1例分析[J].基层医学论坛,2017,21(10):1288-1289.
[10] Storey RF,Becker RC,Harrington RA,et al.Pulmonary function in patients with acute coronary syndrome treated with ticagrelor or clo-pidogrel(from the Platelet Inhibition and Patient Outcomes[PLATO] pulmonary function substudy)[J].Am J Cardiol,2011,108(11):1542-1546.
[11] 边桂芝,钟燕,张志勇.替格瑞洛上市后出血不良反应信号检测与分析[J].中国医院药学杂志,2016,36(7):557-560.
[12] 蒲春华,周鹏,王沛坚.急性心肌梗死患者急诊PCI术前使用负荷剂量替格瑞洛的安全性及有效性[J].山东医药,2014,54(36):1-3,7.
[13] 苏子云,袁叶,田溪,等.替格瑞洛相关不良反应的研究进展[J].中国新药杂志,2016,25(8):878-882,892.
[14] 杨晓伟,张君毅,易甫,等.替格瑞洛对急性冠状动脉综合征择期介入治疗患者近中期疗效观察[J].中华临床医师杂志:电子版,2013,7(19):8696-8700.
[15] 许维忠,刘俊,陈金国,等.替格瑞洛治疗急性冠脉综合征的疗效和安全性观察[J].安徽医学,2015,36(1):40-44.
[16] Hiasa Y,Teng R,Emanuelsson H.Pharmacodynamics,pharm-acokinetics and safety of ticagrelor in Asian patients with stable coronary artery disease[J].Cardiovasc Interv Ther,2014,29(4):324-333.
[17] Teng R,Mitchell P,Butler K.Effect of age and gender on phar-macokinetics and pharmacodynamics of a single ticagrelor dose in healthy individuals[J].Eur J Clin Pharmacol,2012,68(8):1175-1182.
[18] Gurbel PA,Bliden KP,Butler K,et al.Response to ticagrelor in clopidogrel nonresponders and responders and effect of switching therapies:the RESPOND study[J].Circulation,2010,121(10):1188-1199.
[19] Scirica BM,Cannon CP,Emanuelsson H,et al.The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO(Platelet Inhibition and Patient Outcomes)trial:results of the continuous electrocardiographic assessment substudy[J].J Am Coll Cardiol,2011,57(19):1908-1916.
[20] Cheng JW.Ticagrelor.Oral reversible P2Y(12)receptor antagonist for the management of acute coronary syndromes[J].Clin Ther,2012,34(6):1209-1220.
[21] Goldberg A,Rosenfeld I,Nordkin I,et al.Life-threatening complete atrioventricular block associated with ticagrelortherapy[J].Int J Cardiol,2015,182:379-380.
[22] Butler K,Teng R.Evaluation and characterization of the effects of ticagrelor on serum and urinary uric acid in healthy volunteers[J].Clin Pharmacol Ther,2012,91(2):264-271.
[23] Teng R,Mitchell P,Butler K.Effect of rifampicin on the phar-macokinetics and pharmacodynamics of ticagrelorin healthy subjects[J].Eur J Clin Pharmacol,2013,69(4):877-883.
[24] Teng R,Mitchell PD,Butler KA.Pharmacokinetic interaction studies of co-administration of ticagrelor and atorvastatin or simvastatin in healthy volunteers[J].Eur J Clin Pharmacol,2013,69(3):477-487.
[25] No authors listed.BrilintaTM(ticagrelor)Tablets:A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary synromes(ACS)[J].P T,2013,37(4 section 2):4-18.
[26] 杨昭毅,向倩,周颖,等.新型抗血小板药物替格瑞洛临床应用分析[J].中国新药杂志,2015,24(2):235-240.
[2] Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology(ESC),Steg PG,James SK,et al.ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation[J].Eur Heart J,2012,33(20):2569-2619.
[3] Jneid H,Anderson JL,Wright RS,et al.2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction(updating the 2007 guideline and replacing the 2011 focused update):a report of the American College of Cardiology Foundation/American Heart Assoc-iation Task Force on practice guidelines[J].J Am Coll Cardiol,2012,60(7):645-681.
[4] O'Gara PT,Kushner FG,Ascheim DD,et al.2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction:a report of the American College of Cardiology Foundation/Amer-ican Heart Association Task Force on Practice Guidelines[J].Circulation,2013,127(4):e362-e425.
[5] 谢立,张文颖.我院替格瑞洛致不良反应108例分析[J].中国药房,2016,27(29):4085-4087.
[6] 王朋,胡勇.36例替格瑞洛片致出血不良反应报告分析[J].中国药事,2016,30(7):740-744.
[7] 孟凡刚,张沐华.替格瑞洛致呼吸困难1例临床分析[J].医学理论与实践,2017,30(20):3087.
[8] 叶振,罗富良,马双双,等.替格瑞洛致咯血[J].药物不良反应杂志,2017,19(5):387-388.
[9] 谢东君,刘伟,李博,等.替格瑞洛致药物性皮疹1例分析[J].基层医学论坛,2017,21(10):1288-1289.
[10] Storey RF,Becker RC,Harrington RA,et al.Pulmonary function in patients with acute coronary syndrome treated with ticagrelor or clo-pidogrel(from the Platelet Inhibition and Patient Outcomes[PLATO] pulmonary function substudy)[J].Am J Cardiol,2011,108(11):1542-1546.
[11] 边桂芝,钟燕,张志勇.替格瑞洛上市后出血不良反应信号检测与分析[J].中国医院药学杂志,2016,36(7):557-560.
[12] 蒲春华,周鹏,王沛坚.急性心肌梗死患者急诊PCI术前使用负荷剂量替格瑞洛的安全性及有效性[J].山东医药,2014,54(36):1-3,7.
[13] 苏子云,袁叶,田溪,等.替格瑞洛相关不良反应的研究进展[J].中国新药杂志,2016,25(8):878-882,892.
[14] 杨晓伟,张君毅,易甫,等.替格瑞洛对急性冠状动脉综合征择期介入治疗患者近中期疗效观察[J].中华临床医师杂志:电子版,2013,7(19):8696-8700.
[15] 许维忠,刘俊,陈金国,等.替格瑞洛治疗急性冠脉综合征的疗效和安全性观察[J].安徽医学,2015,36(1):40-44.
[16] Hiasa Y,Teng R,Emanuelsson H.Pharmacodynamics,pharm-acokinetics and safety of ticagrelor in Asian patients with stable coronary artery disease[J].Cardiovasc Interv Ther,2014,29(4):324-333.
[17] Teng R,Mitchell P,Butler K.Effect of age and gender on phar-macokinetics and pharmacodynamics of a single ticagrelor dose in healthy individuals[J].Eur J Clin Pharmacol,2012,68(8):1175-1182.
[18] Gurbel PA,Bliden KP,Butler K,et al.Response to ticagrelor in clopidogrel nonresponders and responders and effect of switching therapies:the RESPOND study[J].Circulation,2010,121(10):1188-1199.
[19] Scirica BM,Cannon CP,Emanuelsson H,et al.The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO(Platelet Inhibition and Patient Outcomes)trial:results of the continuous electrocardiographic assessment substudy[J].J Am Coll Cardiol,2011,57(19):1908-1916.
[20] Cheng JW.Ticagrelor.Oral reversible P2Y(12)receptor antagonist for the management of acute coronary syndromes[J].Clin Ther,2012,34(6):1209-1220.
[21] Goldberg A,Rosenfeld I,Nordkin I,et al.Life-threatening complete atrioventricular block associated with ticagrelortherapy[J].Int J Cardiol,2015,182:379-380.
[22] Butler K,Teng R.Evaluation and characterization of the effects of ticagrelor on serum and urinary uric acid in healthy volunteers[J].Clin Pharmacol Ther,2012,91(2):264-271.
[23] Teng R,Mitchell P,Butler K.Effect of rifampicin on the phar-macokinetics and pharmacodynamics of ticagrelorin healthy subjects[J].Eur J Clin Pharmacol,2013,69(4):877-883.
[24] Teng R,Mitchell PD,Butler KA.Pharmacokinetic interaction studies of co-administration of ticagrelor and atorvastatin or simvastatin in healthy volunteers[J].Eur J Clin Pharmacol,2013,69(3):477-487.
[25] No authors listed.BrilintaTM(ticagrelor)Tablets:A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary synromes(ACS)[J].P T,2013,37(4 section 2):4-18.
[26] 杨昭毅,向倩,周颖,等.新型抗血小板药物替格瑞洛临床应用分析[J].中国新药杂志,2015,24(2):235-240.