Treatment Of Acute Deep Vein Thrombosis Of The Lower Ext
Treatment Of Acute Deep Vein Thrombosis Of The Lower Ext
批准号:
6844424
负责人:
Richard T Chang
金额:
$0.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
cardiovascular disorder chemotherapy clinical trials dosage drug adverse effect drug screening /evaluation embolism human subject human therapy evaluation limbs lung imaging /visualization /scanning patient oriented research plasminogen activator protein structure function pulmonary circulation obstruction recombinant proteins venous thrombosis
中文摘要
本研究旨在评价重组组织型纤溶酶原激活剂(RtPA)溶栓治疗急性深静脉血栓形成(DVT)的疗效。虽然单纯的抗凝治疗在预防危及生命的肺栓塞方面非常有效,但它不能保护患侧的静脉功能,通常会导致随后几年的静脉炎综合征。这项研究旨在评估这种形式的治疗在恢复下肢静脉功能方面的有效性、安全性和成本。自研究开始以来,已有17名患者接受了治疗。除1例患者外,其余患者均有明显改善。5名患者在开始治疗前的肺部扫描中也有肺栓塞的证据,而只有2名患者在接受该方案的所有患者的通风灌注肺扫描中发现了在治疗过程中形成的小的无症状肺血栓的证据。这些患者都没有临床症状。一名患者发生了无生命危险的二头肌血肿,可能是在rtPA治疗期间自动血压监测引起的。没有患者需要输血,也没有其他并发症发生。在3个月至5年的随访期内,我们的患者中没有一例出现复发的深静脉血栓形成或进展为静脉炎后综合征。我们患者的药代动力学研究为提高我们对溶栓治疗的理解和开发安全、负担得起和有效的方案做出了重大贡献,这些方案将保持DVT患者的生活质量。
英文摘要
The objective of the study is to evaluate thrombolytic therapy using recombinant tissue plasminogen activator (rtPA) for treatment of acute deep vein thrombosis (DVT) of the lower extremity. While the conventional therapy, anticoagulation alone, is highly effective in prevention of life threatening pulmonary embolism, it does not preserve venous function in the affected leg, often leading to postphlebitic syndromes in subsequent years. The study is designed to evaluate efficacy, safety, and cost of this form of treatment for restoration of venous function in the lower extremity. Since start of the study, 17 patients have been treated. All except one patient had significant improvement. Five patients also had evidence of pulmonary embolism by lung scans prior to start of their treatment whereas only two patients have had evidence of small asymptomatic pulmonary emboli that developed during treatment, detected on ventilation perfusion lung scans that are obtained in all patients accepted into the protocol. None of these patients were clinically symptomatic. One patient developed a non-life-threatening biceps hematoma probably induced by automatic blood pressure monitoring during the rtPA treatment. No patients have required blood transfusions and no other complications have occurred. Over a followup period that ranges from 3 months to 5 years, none of our patients have developed either recurrent deep vein thrombosis or progression to postphlebitic syndromes.Pharmacokinetic studies in our patients have made major contributions to improving our understanding of thrombolytic therapy and toward development of safe, affordable, and effective regimens that will preserve the quality of life for victims of DVT.
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