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Lovenox®

发布日期:2010-02-26 21:12:18  作者:  来源:互联网  浏览次数:0  文字大小:【】【】【
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 LOVENOX® Side Effects

LOVENOX®, like all medications, may have side effects. The most common include mild reactions or irritation, pain, bruising, and redness of the skin where you have the injection.

IT IS IMPORTANT TO NOTIFY YOUR HEALTHCARE PROFESSIONAL IF YOU NOTICE ANY OF THE FOLLOWING:

  • Bleeding or oozing from surgical wound
  • Any other bleeding episodes (for example, bleeding at the site of the injection, nosebleeds, blood in your urine, or if you cough or vomit blood)
  • Spontaneous bruising (a bruise not caused by a blow or any apparent reason)
  • Pain or swelling in any part of your leg, foot, or hip
  • Dizziness, numbness, or tingling
  • Rapid or unusual heartbeat
  • Chest pain or shortness of breath
  • Vomiting, nausea, or fever
  • Confusion

Be proactive about your own health

Sanofi-aventis, makers of LOVENOX®, cares about patient safety. We believe that the best defense against DVT blood clots is to stay informed and take a proactive role in managing your own healthcare. Have an ongoing dialogue with your hospital-based doctors and nurse specialists about any possible side effects.

LOVENOX® can help reduce the risk of developing DVT blood clots, which may lead to PE, in patients undergoing abdominal surgery, hip- or knee-replacement surgery, or in acutely ill medical patients with severely restricted mobility.

INDICATIONS

LOVENOX® is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism:

  • in patients undergoing abdominal surgery who are at risk for thromboembolic complications;
  • in patients undergoing hip-replacement surgery, during and following hospitalization;
  • in patients undergoing knee-replacement surgery;
  • in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.

LOVENOX® injection is indicated for:

  • the inpatient treatment of acute deep vein thrombosis, with or without pulmonary embolism, when administered in conjunction with warfarin sodium;
  • the outpatient treatment of acute deep vein thrombosis, without pulmonary embolism, when administered in conjunction with warfarin sodium.
Important Safety Information

Certain procedures, called "epidural/spinal anesthesia" and "spinal puncture," may be used as a normal part of hospitalization. Patients requiring these procedures while being treated with LOVENOX® or other low-molecular-weight heparins are at risk of developing a blood clot in or around the spine. This condition may result in long-term or permanent paralysis.

LOVENOX® is not the same as "unfractionated heparin" or other drugs called "low-molecular-weight heparins." Therefore, these drugs cannot be used interchangeably with LOVENOX®.

LOVENOX® can alter the blood’s ability to clot. Patients treated with LOVENOX®, who also have conditions affecting the clotting system, must be carefully monitored by their physician. Adjusting the dose of LOVENOX® may be necessary for patients who have certain forms of kidney disease. All patients receiving LOVENOX®, as well as other anticoagulants, should be carefully monitored for bleeding by their physician. Bleeding can occur at any site with LOVENOX® use.

Platelet drops, known as "thrombocytopenia," can occur with LOVENOX® use. Cases of a related condition called "heparin-induced thrombocytopenia" have been observed in clinical practice. If you have had this condition, you must notify your healthcare professional. Your physician may perform blood tests to monitor for the occurrence of any drop in platelet count.

The use of LOVENOX® has not been adequately studied in pregnant women with artificial (mechanical) heart valves.

LOVENOX® should not be used in patients with an allergy or sensitivity reaction to the active ingredient called enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding.

Common side effects include mild local reactions or irritation at the site of injection, pain, bruising, and redness of skin.

For specific questions about your health, you should always consult your physician or a qualified healthcare professional who is responsible for your care.

    Lovenox®与未分级肝素的安全有效性研究将在接受正规血管再通治疗的心脏病发作患者中展开
    目前,对STEMI患者的血管再通治疗往往采用溶栓剂与阿斯匹林和未分级肝素联合治疗.使用溶栓药物可以溶解导致STEMI的血管斑块.使用抗血栓药物可以血栓再次形成的危险.
 
    ExTRACT-TIMI 25 (Enoxaparin and ThrombolysisReperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction – Study 25)将比较Lovenox®与未分级肝素对接受溶栓治疗的STEMI患者的安全性和有效性.研究中将使用的溶栓剂包括链激酶, 阿太普酶,tenecteplase 或 reteplase.
  
    ExTRACT-TIMI 25是一项随机双盲研究.它将在美国及其他24各国家的1250个医学中心进行.这将是有关Lovenox®与溶栓剂联合使用效果的最大的心血管临床试验.研究的终点被设为随机分组30天后的死亡和非致死性的再次心肌梗塞的发生情况.其他的评估项目还包括与需急诊再通治疗的病例和中风相关的胸痛.  
   有关Lovenox®对STEMI的疗效已经在多项有关心脏病发作的患者的临床试验中证实.
  
     据ASSENT 3 (ASsessment of the Safety and Efficacy of New Thrombolytic regimens)研究报道,接受Lovenox®和全量的tenecteplase的心脏病患者,与接受未分级肝素和全量的tenecteplase的心脏病患者相比,起出现缺血性并发症的比例更少.这与在接受半量的tenecteplase与阿昔单抗和未分级肝素的患者中得到的结果相似.但是,前者比后者更有效.
  
     ENTIRE-TIMI 23研究发现,接受tenecteplase溶栓治疗的患者中, Lovenox(R)是未分级肝素的一个有效的替代品.无论是否同时使用糖蛋白IIb/IIIa受体拮抗剂.研究者进一步发现,使用Lovenox(R)的患者,其在30天时的死亡和再发病率都要更低.
 
     HART II (Heparins and Aspirin Reperfusion Therapy)研究显示,接受Lovenox®与rt-PA,或 alteplase治疗的患者,与接受未分级肝素与rt-PA的患者相比,其90分钟时动脉再通的效果是相同的.   
     AMI-SK (Acute Myocardial Infarction – StreptoKinase)研究发现, Lovenox®与链激酶合用可以改善正常冠状动脉的血流并改善急性心肌梗塞患者的预后.

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