去纤苷副作用有什么？

Defibrotide (defiteli) was first developed by Gentium Pharmaceuticals in Italy as a DNA-derived anticoagulant for the treatment of hepatic veno-occlusive disease and hematopoietic stem cell transplantation in renal or pulmonary insufficiency. In 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 VOD with renal or pulmonary dysfunction after HSCT. 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 severe hepatic VOD who were not treated with defiteli was 21%-31%. So, what are the side effects of defibrotide (defiteli)? Let’s find out.

The most common side effects (incidence ≥10% and independent causal relationship) with defiteli are hypotension, diarrhea, vomiting, nausea, and epistaxis. The incidence rate of grade 3-4 reactions related to defibrotide (defiteli) was 7%, mainly hypotension, pulmonary and gastrointestinal bleeding, and abdominal cramps. Only 4% of patients stopped treatment due to side effects. In other words, the side effects of defibrotide (defiteli) are usually mild, and patients do not need to worry too much. 

A phase 3 randomized controlled trial of defibrotide (defiteli) for the prevention of hepatic VOD in pediatric transplant patients has also been completed. Defibrotide (defiteli) has been generally well tolerated; the most common side effects observed during premarketing use to treat hepatic VOD were bleeding, hypotension, and coagulopathy.

Patients should undergo regular physical examinations during the period of taking defibrotide (defiteli sodium, defiteli) to enhance the body's immunity, which will greatly reduce the chance of side effects. If serious side effects occur during the use of defibrotide, the drug should be discontinued and seek medical attention as soon as possible. Do not blindly change the dosage. If you have any other questions, please consult the medical companion passenger service.