肝小静脉闭塞病患者注射去纤维钠治疗的效果

(Defitelio) is currently recognized as the most promising new drug for the treatment of hepatic veno-occlusive disease (HVOD) after hematopoietic stem cell transplantation (HSCT). It has the effects of anticoagulation, promoting fibrinolysis, and anti-inflammation, and its therapeutic effect is relatively significant.

A large series of prospective clinical studies included 305 patients with HVOD after HSCT, with a median age of 16 years (0.1-70 years), including 220 patients with sHVOD. The therapeutic dose of defibrotide sodium is 25 mg/kg per day by intravenous infusion. Preliminary results show that the CR rate is 30% and the OS rate 100 days after transplantation is 50%; the CR rate of sHVOD patients is 26% and the OS rate 100 days after transplantation is 45%; the CR rate of non-sHVOD patients is 39% and the OS rate 100 days after transplantation is 65%. The CR rates of pediatric and adult patients were 33% and 26%, respectively (P=0.187), and the OS rates 100 days after transplantation were 56% and 44%, respectively (P=0.0277). The CR rate of patients whose time from diagnosis of HVOD to the start of defibrination sodium application was >2 days was 20%, which was significantly lower than 34% of patients whose time of application of defibrination sodium was ≤2 days (P=0.0195).

In this clinical trial, 155 patients met the inclusion criteria for phase III clinical trials. Compared with historical controls who did not receive defibrotide treatment, the CR rates were 29% and 9% (P=0.0019), and the 100 dOS rates after transplantation were 49% and 25% (P=0.0016). This study not only strongly confirmed the effectiveness of defibrotide sodium in the treatment of post-transplantation HVOD, but also once again proved the superiority of defibrotide sodium in the treatment of HVOD in children and the importance of early treatment with defibrotide sodium.

In summary, (Defibroside) is effective in treating post-transplantation HVOD and is well tolerated, and can benefit HVOD patients. Children benefit more than adults. Once HVOD is diagnosed, treatment with defibrinated sodium as soon as possible will have better results.

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