去纤苷是哪个国家的药？

Hepatic veno-occlusive disease (HVOD), also known as sinusoidal obstruction syndrome, is a non-thrombotic obstruction of the hepatic circulation, accompanied by centrilobular sinusoidal fibrosis and fibrotic stenosis or occlusion of common hepatic venules. Clinical manifestations include liver enlargement, pain, ascites, etc., and more than half of the patients can recover. 20% of patients die of liver failure, and a few patients develop cirrhosis and portal hypertension.

On October 22, 2013, it was approved for marketing by the European Union as the first treatment for severe hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation. In which country is defibrotide a drug?

Manufacturer of defibrotide: developed by Gentium Pharmaceuticals in Italy

After Gentium Pharmaceuticals was acquired by American Jazz Pharmaceuticals, defibrotide was approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States on March 30, 2016.

Therapeutic effects of defibrotide:

Defibrotide (alias: defibrotide sodium) is a single-stranded oligonucleotide mixture with anti-thrombotic and fibrinolytic effects. In recent years, multiple research results have shown that defibrotide is safe and effective in preventing and treating HVOD.

In clinical trials, heparin was used to prevent diseases such as hepatic veno-occlusion while greatly increasing the risk of bleeding, while defibrinoside alone or in combination with heparin had a very low incidence of side effects and achieved good results in preventing HVOD.

In a phase III multi-center randomized clinical trial completed in Europe, a total of 356 stem cell transplant patients were recruited. The incidence of hepatic vein occlusion 30 days after transplantation was compared. It was found that 2 of 180 patients in the group developed hepatic vein occlusion, accounting for 12%; and 35 of 176 patients in the control group developed hepatic vein occlusion, accounting for 20%.

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