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What diseases can be treated? Defibrotide sodium is a mixture of single-stranded oligonucleotides with anti-thrombotic and fibrinolysis-promoting effects, also called defibrinoside. It was first developed by Gentium Pharmaceuticals in Italy and was approved for marketing in the EU in October 2013. Its indication is the treatment of patients with hepatic veno-occlusive disease (VOD). It was approved for marketing in the United States by the U.S. Food and Drug Administration (FDA) on March 30, 2016. At present, defibrinated sodium is not yet available in my country.

Defibrotide sodium is administered by injection, based on body weight, and can be used by both adults and children. The recommended dose 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.

In clinical trials, it was found that the use of heparin to prevent diseases such as hepatic veno-occlusion greatly increases the risk of bleeding, while defibrotide sodium alone or in combination with heparin has a very low incidence of side effects and has achieved a good effect 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 defibrinated sodium group developed hepatic vein occlusion, accounting for 12%; 35 of 176 patients in the control group developed hepatic vein occlusion, accounting for 20%.

The most common adverse reactions (incidence ≥10% and independent causal relationship) are hypotension, diarrhea, vomiting, nausea, and epistaxis. NOTE: Concomitant use of defibrinated sodium and a systemic anticoagulant or fibrinolytic therapy (excluding use for routine maintenance or central venous line reopening) may increase the risk of bleeding. Discontinue anticoagulants and fibrinolytics before defibrination therapy, and consider delaying initiation of defibrination administration until the effects of the anticoagulant have lessened.

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