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【drug-news】【资讯翻译】拜耳和强生启动Xarelto (利伐沙班) 用于非瓣膜性房颤的IIIb期临床试验研究
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() Eye Wider Use for Xarelto With New TrialsBerlin, Germany, March 8, 2013 -Bayer HealthCare announced today the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto& (rivaroxaban) to investigate how best to treat patients with non-valvular atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) with stent placement.The PIONEER AF-PCI study will enroll approximately 2,100 patients worldwide. The trial will assess the safety of two rivaroxaban treatment strategies and a dose-adjusted vitamin K antagonist (VKA) treatment strategy. Patients will be treated for 12 months.&There are limited data available on how best to treat those patients with atrial fibrillation who require anticoagulant therapy for stroke prevention and also have a coronary stent implanted requiring dual antiplatelet therapy,& said C. Michael Gibson, M.S., M.D., Chairman of the PERFUSE Study Group, Harvard Medical School, and the Principal Investigator of the PIONEER AF-PCI study. &This study will help to address a clinically important question and provide physicians with information needed to make treatment decisions for this high-risk patient population.&&We heard the excitement from physicians when Xarelto was approved for use in patients with non-valvular atrial fibrillation and we also listened to the questions they asked us about what to do for patients with overlapping risk factors,& said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. &The PIONEER AF-PCI study is part of our ongoing commitment to improve patient outcomes across a broad range of venous and arterial thromboembolic conditions.&The PIONEER AF-PCI trial is part of the global clinical development program for rivaroxaban, which will- by the time of its completion - have involved more than 100,000 patients worldwide.About PIONEER AF-PCIThe PIONEER AF-PCI study (an open-label, randomized, controlled, multicentre study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in patients with atrial fibrillation who undergo percutaneous coronary intervention) will include approximately 2,100 patients worldwide. Patients with documented AF following PCI will be enrolled into the study. The primary endpoint is the composite of TIMI major bleeding, minor bleeding and bleeding requiring medical attention (known collectively as clinically significant bleeding). In the study, patients will be randomized into three arms:· Rivaroxaban 15 mg once daily and a P2Y12 inhibitor (such as clopidogrel 75 mg daily)· Rivaroxaban 2.5 mg twice daily, a P2Y12 inhibitor (such as clopidogrel 75 mg daily) and ASA 75-100 mg daily· Dose-adjusted VKA, a P2Y12 inhibitor (such as clopidogrel 75 mg daily) and ASA 75-100 mg dailyAbout Venous and Arterial Thromboembolism (VAT)Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous and Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.VAT is responsible for a number of serious and life threatening conditions:· Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary embolism (PE), an event which can be rapidly fatalArterial Thromboembolism (ATE) occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event that can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable anginaVAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.To learn more about VAT, please visit About Xarelto& (Rivaroxaban)Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto&. To date, Xarelto is approved for six distinct uses in the venous arterial thromboembolic (VAT) space:· The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors· The treatment of deep vein thrombosis (DVT) in adults· The treatment of pulmonary embolism (PE) in adults· The prevention of recurrent DVT and PE in adults· The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery· The prevention of venous thromboembolism (VTE) in adult patients undergoing elective knee replacement surgeryWhilst licences may differ from country to country, across all indications Xarelto is approved in more than 120 countries.Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.Responsible use of Xarelto is a high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.
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() Eye Wider Use for Xarelto With New Trials拜耳和强生公司进行新的实验着眼于利伐沙班的更广泛的用途Berlin, Germany, March 8, 2013 -Bayer HealthCare announced today the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto& (rivaroxaban) to investigate how best to treat patients with non-valvular atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) with stent placement.德国柏林的拜耳医药保健公司2013，3月8号宣布今天开始PIONEER AF-PCI研究，这项研究是关于口服抗凝血药（利伐沙班）在治疗皮冠状动脉介入（PCI）且有支架置入的非瓣膜房颤患者效果的IIIb期临床试验。The PIONEER AF-PCI study will enroll approximately 2,100 patients worldwide. The trial will assess the safety of two rivaroxaban treatment strategies and a dose-adjusted vitamin K antagonist (VKA) treatment strategy. Patients will be treated for 12 months.PIONEER AF-PCI实验将会全球招募大约2，100名患者。将会对两种利伐沙班治疗方案和调整剂量的维生素K拮抗剂（VKA）治疗方案的安全性进行评估。患者接受为期12周的治疗。&There are limited data available on how best to treat those patients with atrial fibrillation who require anticoagulant therapy for stroke prevention and also have a coronary stent implanted requiring dual antiplatelet therapy,& said C. Micrhael Gibson, M.S., M.D., Chairman of the PERFUSE Study Group, Havard Medical School, and the Principal Investigator of the PIONEER AF-PCI study. &This study will help to address a clinically important question and provide physicians with information needed to make treatment decisions for this high-risk patient population.&“有些房颤患者在为预防中风进行抗凝治疗同时因有冠状支架植入而进行双重抗血小板治疗，如何更好的治疗这类患者有用的数据很有限。”医学博士，PERFUSE研究小组的主席，PIONEER AF-PCI的主要研究者，哈佛医学院的C. Micrhael Gibson, M.S说。“这项研究有助于解决一个很重要的临床问题并给如何治疗这类高危病人提供内科医生需要的信息。”&We heard the excitement from physicians when Xarelto was approved for use in patients with non-valvular atrial fibrillation and we also listened to the questions they asked us about what to do for patients with overlapping risk factors,& said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. &The PIONEER AF-PCI study is part of our ongoing commitment to improve patient outcomes across a broad range of venous and arterial thromboembolic conditions.&“我们听说过当利伐沙班被批准用于非瓣膜性房颤患者时医生很兴奋，他们也询问我们当病人有重叠的危险因素时该如何去做。”拜耳医药保健执行委员会成员及全球发展总监Kemal Malik 说。“PIONEER AF-PCI是我们正在进行的旨在提高广泛静脉和动脉血栓栓塞情况患者预后的实验研究的一部分。”The PIONEER AF-PCI trial is part of the global clinical development program for rivaroxaban, which will- by the time of its completion - have involved more than 100,000 patients worldwide.PIONEER AF-PCI实验是利伐沙班全球临床发展项目的一部分，这项实验完成时，全球将会有100，000名患者参与实验。About PIONEER AF-PCI关于PIONEER AF-PCI
The PIONEER AF-PCI study (an open-label, randomized, controlled, multicentre study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in patients with atrial fibrillation who undergo percutaneous coronary intervention) will include approximately 2,100 patients worldwide. Patients with documented AF following PCI will be enrolled into the study. The primary endpoint is the composite of TIMI major bleeding, minor bleeding and bleeding requiring medical attention (known collectively as clinically significant bleeding). In the study, patients will be randomized into three arms：PIONEER AF-PCI实验（一项外标签，随机，对照，多中心的研究，研究旨在探索对于已接受经皮冠状介入治疗的房颤患者，两种利伐沙班治疗方案及调整剂量的口服维生素K拮抗剂治疗方案的效果等）实验将会包括全球大约2，100名患者。有记录的房颤患者在进行PCI后将被纳入研究。首次终止点是TIMI大量出血，轻微出血和出血需要住院观察都有出现（叫做临床显著出血）。在这项研究中，病人将会随机分成三组：· Rivaroxaban 15 mg once daily and a P2Y12 inhibitor (such as clopidogrel 75 mg daily)利伐沙班15mg每天一次和一种P2Y12抑制剂（例如氯吡格雷 75mg每天） Rivaroxaban 2.5 mg twice daily, a P2Y12 inhibitor (such as clopidogrel 75 mg daily) and ASA 75-100 mg daily利伐沙班2.5mg每天两次，一种P2Y12抑制剂（例如氯吡格雷 75mg每天）和ASA 75-100mg每天Dose-adjusted VKA, a P2Y12 inhibitor (such as clopidogrel 75 mg daily) and ASA 75-100 mg daily调整剂量的VKA,一种P2Y12抑制剂（例如氯吡格雷 75mg每天）和ASA 75-100mg每天About Venous and Arterial Thromboembolism (VAT)关于静脉和动脉血栓栓塞（VAT） Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous and Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and .血栓形成是在血管内血凝块的形成，血凝块阻塞静脉（静脉血栓形成）或者动脉血管（动脉血栓形成）。静脉和动脉血栓栓塞（VAT）是由一些或者所有的血凝块在血管内流动直至阻塞小血管引起的。这会导致重要器官的损伤，因为阻塞血管下游的组织不能再得到营养和氧气。 AT is responsible for a number of serious and life threatening conditions:AT与很多严重的有生命危险的情况有关：· Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary embolism (PE), an event which can be rapidly fatal静脉血栓栓塞（VTE）发生在当血凝块在深静脉内形成时，例如在腿部（深静脉血栓形成，DVT）,这些血栓通过心脏到达肺部，会妨碍氧气的摄取。这也叫做肺栓塞（PE）,它能快速致命。Arterial Thromboembolism (ATE) occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event that can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable angina动脉栓塞(ATE)是当含氧血从心脏流到身体其他部分（通过动脉）时被血凝块中断。如果这种情况发生在向大脑供血的血管，可能导致中风，中风可是是严重的衰弱甚至是致命。如果发生在冠状动脉，能导致急性冠脉综合征（ACS），ACS是包括心肌梗死（心脏并发作）和不稳定性心绞痛的复合症状。VAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.VAT对发病率和死亡率有很重要的影响，需要积极的预防性治疗来避免潜在的严重或者致命的情况出现。To learn more about VAT, please visit 想了解更多有关VAT的信息，请登录About Xarelto& (Rivaroxaban)关于Xarelto&（利伐沙班）Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto&. To date, Xarelto is approved for six distinct uses in the venous arterial thromboembolic (VAT) space:利伐沙班是广泛运用的新型口服抗凝血药物，以商标名Xarelto&reg在市场上流通，迄今为止，利伐沙班已经批准用于六种不同情况的动静脉栓塞（VAT）:· The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors中风的预防和非瓣膜性房颤合并一项或更多危险因素的全身性栓塞成年患者的治疗。· The treatment of deep vein thrombosis (DVT) in adults成人深静脉血栓栓塞（DVT）的治疗· The treatment of pulmonary embolism (PE) in adults成人肺栓塞的治疗· The prevention of recurrent DVT and PE in adults预防成人DVT 和 PE 的复发· The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery接受选择性髋关节置换手术的成年患者预防静脉血栓栓塞（VTE）· The prevention of venous thromboembolism (VTE) in adult patients undergoing elective knee replacement surgery接受选择性全膝关节置换手术的成年患者预防静脉血栓栓塞（VTE）Whilst licences may differ from country to country, across all indications Xarelto is approved in more than 120 countries.在不同的国家批准运用的范围等也是不同的，针对这些适应症，利伐沙班在120多个国家被批准使用了。Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).利伐沙班是由拜耳公司发现的，和杨森研究发展有限公司共同开发的。利伐沙班在除美国外的其他国家由拜耳公司负责销售在美国则由杨森制药有限公司负责（强生公司）。Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.抗凝血药物是预防或治疗严重疾病和急救的有效治疗手段。在运用抗凝血药物治疗前，内科医生应该仔细针对每个病人评估治疗的益处和风险。Responsible use of Xarelto is a high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.拜耳高度重视如何正确地运用利伐沙班，公司开发出了一个针对内科医生的用药指南和针对病人的利伐沙班病人关爱卡以期达到最好效果。
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编译拜耳和强生公司进行新的实验着眼于利伐沙班的更广泛的用途德国柏林的拜耳医药保健公司2013，3月8号宣布今天开始PIONEER AF-PCI研究，这项研究是关于口服抗凝血药（利伐沙班）在治疗皮冠状动脉介入（PCI）且有支架置入的非瓣膜房颤患者效果的IIIb期临床试验。PIONEER AF-PCI实验将会全球招募大约2，100名患者。将会对两种利伐沙班治疗方案和调整剂量的维生素K拮抗剂（VKA）治疗方案的安全性进行评估。患者接受为期12周的治疗。“有些房颤患者在为预防中风进行抗凝治疗同时因有冠状支架植入而进行双重抗血小板治疗，如何更好的治疗这类患者有用的数据很有限。”医学博士，PERFUSE研究小组的主席，PIONEER AF-PCI的主要研究者，哈佛医学院的C. Micrhael Gibson, M.S说。“这项研究有助于解决一个很重要的临床问题并给如何治疗这类高危病人提供内科医生需要的信息。”“我们听说过当利伐沙班被批准用于非瓣膜性房颤患者时医生很兴奋，他们也询问我们当病人有重叠的危险因素时该如何去做。”拜耳医药保健执行委员会成员及全球发展总监Kemal Malik 说。“PIONEER AF-PCI是我们正在进行的旨在提高广泛静脉和动脉血栓栓塞情况患者预后的实验研究的一部分。”PIONEER AF-PCI实验是利伐沙班全球临床发展项目的一部分，这项实验完成时，全球将会有100，000名患者参与实验。关于PIONEER AF-PCI PIONEER AF-PCI实验（一项外标签，随机，对照，多中心的研究，研究旨在探索对于已接受经皮冠状介入治疗的房颤患者，两种利伐沙班治疗方案及调整剂量的口服维生素K拮抗剂治疗方案的效果等）实验将会包括全球大约2，100名患者。有记录的房颤患者在进行PCI后将被纳入研究。首次终止点是TIMI大量出血，轻微出血和出血需要住院观察都有出现（叫做临床显著出血）。在这项研究中，病人将会随机分成三组：利伐沙班15mg每天一次和一种P2Y12抑制剂（例如氯吡格雷 75mg每天）利伐沙班2.5mg每天两次，一种P2Y12抑制剂（例如氯吡格雷 75mg每天）和ASA 75-100mg每天调整剂量的VKA,一种P2Y12抑制剂（例如氯吡格雷 75mg每天）和ASA 75-100mg每天关于静脉和动脉血栓栓塞（VAT）血栓形成是在血管内血凝块的形成，血凝块阻塞静脉（静脉血栓形成）或者动脉血管（动脉血栓形成）。静脉和动脉血栓栓塞（VAT）是由一些或者所有的血凝块在血管内流动直至阻塞小血管引起的。这会导致重要器官的损伤，因为阻塞血管下游的组织不能再得到营养和氧气。AT与很多严重的有生命危险的情况有关：静脉血栓栓塞（VTE）发生在当血凝块在深静脉内形成时，例如在腿部（深静脉血栓形成，DVT）,这些血栓通过心脏到达肺部，会妨碍氧气的摄取。这也叫做肺栓塞（PE）,它能快速致命。动脉栓塞(ATE)是当含氧血从心脏流到身体其他部分（通过动脉）时被血凝块中断。如果这种情况发生在向大脑供血的血管，可能导致中风，中风可是是严重的衰弱甚至是致命。如果发生在冠状动脉，能导致急性冠脉综合征（ACS），ACS是包括心肌梗死（心脏并发作）和不稳定性心绞痛的复合症状。VAT对发病率和死亡率有很重要的影响，需要积极的预防性治疗来避免潜在的严重或者致命的情况出现。想了解更多有关VAT的信息，请登录关于Xarelto&（利伐班沙）利伐沙班是广泛运用的新型口服抗凝血药物，以商标名Xarelto&reg在市场上流通，迄今为止，利伐沙班已经批准用于六种不同情况的动静脉栓塞（VAT）:中风的预防和非瓣膜性房颤合并一项或更多危险因素的全身性栓塞成年患者的治疗。成人深静脉血栓栓塞（DVT）的治疗成人肺栓塞的治疗预防成人DVT 和 PE 的复发接受选择性髋关节置换手术的成年患者预防静脉血栓栓塞（VTE）接受选择性全膝关节置换手术的成年患者预防静脉血栓栓塞（VTE）在不同的国家批准运用的范围等也是不同的，针对这些适应症，利伐沙班在120多个国家被批准使用了。利伐沙班是由拜耳公司发现的，和杨森研究发展有限公司共同开发的。利伐沙班在除美国外的其他国家由拜耳公司负责销售在美国则由杨森制药有限公司负责（强生公司）。抗凝血药物是预防或治疗严重疾病和急救的有效治疗手段。在运用抗凝血药物治疗前，内科医生应该仔细针对每个病人评估治疗的益处和风险。拜耳高度重视如何正确地运用利伐沙班，公司开发出了一个针对内科医生的用药指南和针对病人的利伐沙班病人关爱卡以期达到最好效果。字数：1561
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zhangnil Berlin, Germany, March 8, 2013【1】 -Bayer HealthCare announced today the initiation of the PIONEER AF-PCI study, 德国柏林的拜耳医药保健公司2013，3月8号宣布今天开始PIONEER AF-PCI研究，【1】此处为新闻报道的地点和时间，并不是指拜耳在德国柏林。The PIONEER AF-PCI trial is part of the global clinical development program for rivaroxaban, which will- by the time of its completion - have involved more than【2】 100,000 patients worldwide.PIONEER AF-PCI实验是利伐沙班全球临床发展项目的一部分，这项实验完成时，全球将会有100，000名患者参与实验。【2】漏译了。应该是10万多The PIONEER AF-PCI study (an open-label, randomized, controlled, multicentre study PIONEER AF-PCI实验（一项外标签【3】，随机，对照，多中心的研究，【3】open-label是开放标签，即开放性试验The primary endpoint is the composite of TIMI major bleeding, minor bleeding and bleeding requiring medical attention (known collectively as clinically significant bleeding). In the study, patients will be randomized into three arms：首次终止点是TIMI大量出血，轻微出血和出血需要住院观察都有出现（叫做临床显著出血）。【4】应该为主要终点About Xarelto& (Rivaroxaban)关于Xarelto&（利伐沙班）Rivaroxaban is the most broadly【5】 indicated new oral anticoagulant and is marketed under the brand name Xarelto&利伐沙班是广泛运用的新型口服抗凝血药物，以商标名Xarelto&reg在市场上流通，【5】这里强调它是该类的第一，应该是最广泛。· The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors中风的预防和非瓣膜性房颤合并一项或更多危险因素的全身性栓塞成年患者的治疗【6】。【6】中风与全身性栓塞是并列的，同为prevention预防的对象。Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a 【7】Johnson & Johnson Company).利伐沙班是由拜耳公司发现的，和杨森研究发展有限公司共同开发的。利伐沙班在除美国外的其他国家由拜耳公司负责销售在美国则由杨森制药有限公司负责（强生公司）。【7】这里应该是指强生的一家公司，即一家子公司
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前辈，我已修改如下编译拜耳和强生公司进行新的实验着眼于利伐沙班的更广泛的用途拜耳医药保健公司号在德国柏林宣布今天开始PIONEER AF-PCI研究，这项研究是关于口服抗凝血药（利伐沙班）在治疗皮冠状动脉介入（PCI）且有支架置入的非瓣膜房颤患者效果的IIIb期临床试验。PIONEER AF-PCI实验将会全球招募大约2，100名患者。将会对两种利伐沙班治疗方案和调整剂量的维生素K拮抗剂（VKA）治疗方案的安全性进行评估。患者接受为期12周的治疗。“有些房颤患者在为预防中风进行抗凝治疗同时因有冠状支架植入而进行双重抗血小板治疗，如何更好的治疗这类患者有用的数据很有限。”医学博士，PERFUSE研究小组的主席，PIONEER AF-PCI的主要研究者，哈佛医学院的C. Micrhael Gibson, M.S说。“这项研究有助于解决一个很重要的临床问题并给如何治疗这类高危病人提供内科医生需要的信息。”“我们听说过当利伐沙班被批准用于非瓣膜性房颤患者时医生很兴奋，他们也询问我们当病人有重叠的危险因素时该如何去做。”拜耳医药保健执行委员会成员及全球发展总监Kemal Malik 说。“PIONEER AF-PCI是我们正在进行的旨在提高广泛静脉和动脉血栓栓塞情况患者预后的实验研究的一部分。”PIONEER AF-PCI实验是利伐沙班全球临床发展项目的一部分，这项实验完成时，全球将会有10万多名患者参与实验。关于PIONEER AF-PCI PIONEER AF-PCI实验（开放性标签，随机，对照，多中心的研究，研究旨在探索对于已接受经皮冠状介入治疗的房颤患者，两种利伐沙班治疗方案及调整剂量的口服维生素K拮抗剂治疗方案的效果等）实验将会包括全球大约2，100名患者。有记录的房颤患者在进行PCI后将被纳入研究。主要终止点是TIMI大量出血，轻微出血和出血需要住院观察都有出现（叫做临床显著出血）。在这项研究中，病人将会随机分成三组：利伐沙班15mg每天一次和一种P2Y12抑制剂（例如氯吡格雷 75mg每天）利伐沙班2.5mg每天两次，一种P2Y12抑制剂（例如氯吡格雷 75mg每天）和ASA 75-100mg每天调整剂量的VKA,一种P2Y12抑制剂（例如氯吡格雷 75mg每天）和ASA 75-100mg每天关于静脉和动脉血栓栓塞（VAT）血栓形成是在血管内血凝块的形成，血凝块阻塞静脉（静脉血栓形成）或者动脉血管（动脉血栓形成）。静脉和动脉血栓栓塞（VAT）是由一些或者所有的血凝块在血管内流动直至阻塞小血管引起的。这会导致重要器官的损伤，因为阻塞血管下游的组织不能再得到营养和气。AT与很多严重的有生命危险的情况有关：静脉血栓栓塞（VTE）发生在当血凝块在深静脉内形成时，例如在腿部（深静脉血栓形成，DVT）,这些血栓通过心脏到达肺部，会妨碍氧气的摄取。这也叫做肺栓塞（PE）,它能快速致命。动脉栓塞(ATE)是当含氧血从心脏流到身体其他部分（通过动脉）时被血凝块中断。如果这种情况发生在向大脑供血的血管，可能导致中风，中风可是是严重的衰弱甚至是致命。如果发生在冠状动脉，能导致急性冠脉综合征（ACS），ACS是包括心肌梗死（心脏并发作）和不稳定性心绞痛的复合症状。VAT对发病率和死亡率有很重要的影响，需要积极的预防性治疗来避免潜在的严重或者致命的情况出现。想了解更多有关VAT的信息，请登录关于Xarelto&（利伐班沙）利伐沙班是最广泛运用的新型口服抗凝血药物，以商标名Xarelto&reg在市场上流通，迄今为止，利伐沙班已经批准用于六种不同情况的动静脉栓塞（VAT）:非瓣膜性房颤合并一项或更多危险因素患者中风和全身性栓塞的预防。成人深静脉血栓栓塞（DVT）的治疗成人肺栓塞的治疗预防成人DVT 和 PE 的复发接受选择性髋关节置换手术的成年患者预防静脉血栓栓塞（VTE）接受选择性全膝关节置换手术的成年患者预防静脉血栓栓塞（VTE）在不同的国家批准运用的范围等也是不同的，针对这些适应症，利伐沙班在120多个国家被批准使用了。利伐沙班是由拜耳公司发现的，和杨森研究发展有限公司共同开发的。利伐沙班在除美国外的其他国家由拜耳公司负责销售在美国则由杨森制药有限公司负责（强生子公司）。抗凝血药物是预防或治疗严重疾病和急救的有效治疗手段。在运用抗凝血药物治疗前，内科医生应该仔细针对每个病人评估治疗的益处和风险。拜耳高度重视如何正确地运用利伐沙班，公司开发出了一个针对内科医生的用药指南和针对病人的利伐沙班病人关爱卡以期达到最好效果。字数：1561
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