爱尔兰爵士制药的去纤维钠在中国上市了吗？

Hepatic veno-occlusive disease (VOD), also known as sinus obstruction syndrome (SOS), is a fatal form of liver injury and chronic complication associated with HSCT. Within 21 days after HSCT, the sinusoidal endothelial cells of the liver were affected. Liver VOD occurs in 9%-14% of HSCT patients and is life-threatening in 30-50% of cases. Sir Irish Pharmaceuticals' drug is approved to treat hepatic veno-occlusive disease (VOD).

Results from three clinical studies (Phase 2, Phase 3, and Expanded Access Study) in patients with hepatic VOD and renal or pulmonary insufficiency. Subjects were treated with 6.25 mg/kg of defibrotide sodium every six hours, administered as a two-hour intravenous infusion. The phase 2 study included 75 adult and pediatric patients with multiple organ dysfunction of the liver (kidney or lung or both) who were treated with defibrotide for 14 days. The observed survival rate in the trial over 100 days after HSCT was 44%.

The phase 3 study enrolled 102 patients with liver VOD. The treatment group was given the drug for a minimum of 21 days, and patients in this group were not allowed to receive any concomitant drugs, such as heparin, warfarin or alteplase to avoid the risk of bleeding. The observed survival rate at +100 days after HSCT was 38%. In the expanded access study, which enrolled 351 patients with liver VOD with hepatorenal disease or pulmonary insufficiency, the survival rate at +100 days after HSCT was 45%.

Has Sir Irish Pharmaceuticals’ defibrinated sodium been launched in China?

Up to now, Sir Irish Pharmaceuticals has not been launched in China. For more drug information about defibrinated sodium, please consult the Medical Companion Travel Service.

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