爱尔兰爵士制药的去纤维钠效果怎样？

It is a mixture of single-stranded oligonucleotides with anti-thrombotic and fibrinolytic effects. In recent years, multiple clinical research results have shown that defibrotide sodium is a safe and effective drug for preventing and treating hepatic veno-occlusive disease (HVOD). Jazz Pharmaceuticals Public Limited Company (NASDAQ: JAZZ) was founded in 2003 and is headquartered in Dublin, Ireland. It has 1,620 full-time employees. It is a commercial-stage biopharmaceutical company engaged in the identification, development and commercialization of pharmaceutical products. So, how effective is Sir Irish Pharmaceuticals’ defibrinated sodium?

In clinical trials, heparin was used to prevent diseases such as hepatic venous occlusion while greatly increasing the risk of bleeding. However, 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%. Defibrotide sodium is the first drug approved by the FDA for the treatment of severe hepatic venule occlusion, a rare and fatal liver disease. The approval was based on a Phase 2 trial of 75 patients, a Phase 3 trial of 102 patients, and an expansion trial of an additional 351 patients. All patients in the trial were diagnosed with hepatic veno-occlusive disease and associated renal or pulmonary dysfunction after HSCT (hematopoietic stem cell transplantation). In the phase 2 trial, 44% of patients survived 100 days after transplantation, compared with 38% in the phase 3 trial and 45% in the expanded trial, and the FDA noted in a report that the expected 100-day survival rate for patients with untreated severe veno-occlusive disease was 21%-31%.

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