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Who is it suitable for? On March 30, 2016, the FDA approved Defitelio for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT).

Hepatic veno-occlusive disease is one of the serious complications after hematopoietic stem cell transplantation (HSCT), and the mortality rate in patients with severe hepatic veno-occlusive disease can be as high as 100%. Defibrotide sodium is a mixture of single-stranded oligonucleotides with anti-thrombotic and fibrinolytic effects. In recent years, multiple clinical research results have shown that defibrination sodium is a safe and effective drug for the prevention and treatment of hepatic veno-occlusive disease after HSCT.

Defibrotide sodium is an adenosine receptor agonist with multiple effects. The adenosine A1/A2 receptors of endothelial cells are involved in the regulation of endothelial cells and the response of endothelial cells to injury. Defibrotide sodium can act on these receptors to produce a variety of downstream effects. Defibrinated sodium can also reduce the expression of cell adhesion molecules on the surface of endothelial cells, thereby reducing the adhesion of leukocytes to vascular endothelial cells and reducing the inflammatory damage of endothelial cells.

In addition, defibrinated sodium can also promote the release of prostaglandin I2 (PGI2) and prostaglandin E2 (PGE2), thereby causing blood vessel dilation, inhibiting platelet aggregation, and reducing ischemic damage. Studies have shown that defibrinated sodium can significantly increase the expression of thrombin regulatory protein (TM) and tissue factor pathway inhibitors to produce anticoagulant effects.

The recommended dose for adult and pediatric patients is 6.25 mg/kg given as a 2-hour intravenous infusion every 6 hours. Administer defibrinated sodium for a minimum of 21 days. If signs and symptoms of hepatic VOD have not resolved after 21 days, continue defibrination until resolution of VOD or up to a maximum of 60 days. Defibrotide must be diluted prior to infusion.

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