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Treatment of severe veno-occlusive disease with defibrotide: compassionate use results in response without significant toxicity in a high-risk population Richardson PG; Elias AD; Krishnan A; Wheeler C; Nath R; Hoppensteadt D; Kinchla NM; Neuberg D; Waller EK; Antin JH; Soiffer R; Vredenburgh J; Lill M; Woolfrey AE; Bearman SI; Iacobelli M; Fareed J; Guinan ECBlood 1998[Aug]; 92 (3): 737-44Hepatic veno-occlusive disease (VOD) is the most common of the regimen-related toxicities accompanying stem cell transplantation (SCT). Despite aggressive therapies, including the combination of tissue plasminogen activator (t-PA) and heparin, severe VOD is almost uniformly fatal. Defibrotide (DF) is a polydeoxyribonucleotide with activity in several vascular disorders and, unlike t-PA and heparin, produces no systemic anticoagulant effects. Nineteen patients who developed severe VOD after SCT were treated with DF on a compassionate-use basis. Patients had clinically established VOD and met risk criteria predicting progression and fatality. At the initiation of DF, all 19 patients had evidence of multiorgan dysfunction; median bilirubin was 22.3 mg/dL, 12 patients had renal insufficiency (5 dialysis dependent), 14 required oxygen supplementation, and encephalopathy was present in 8 patients. Beginning a median of 6 days after diagnosis of VOD, DF was administered intravenously in doses ranging from 5 to 60 mg/kg/d for a planned minimum course of 14 days. In no case was DF discontinued for attributable toxicity. No severe hemorrhage related to DF administration was observed. Resolution of VOD (bilirubin <2 mg/dL with improvement in other symptoms and signs) was seen in 8 patients (42%). Six of 8 responders survived past day +100, contrasted with the 2% predicted survival reported in comparable patients. The observed response rate, survival to day +100, and absence of significant DF treatment-associated toxicity are compelling and warrant further evaluation.|Adolescent[MESH]|Adult[MESH]|Bilirubin/blood[MESH]|Child[MESH]|Child, Preschool[MESH]|Drug Evaluation[MESH]|Feasibility Studies[MESH]|Female[MESH]|Fibrinolytic Agents/adverse effects/*therapeutic use[MESH]|Hematopoietic Stem Cell Transplantation/*adverse effects[MESH]|Hemorrhage/chemically induced[MESH]|Heparin/therapeutic use[MESH]|Hepatic Veno-Occlusive Disease/*drug therapy/mortality[MESH]|Humans[MESH]|Male[MESH]|Multiple Organ Failure/prevention & control[MESH]|Neoplasms/mortality/therapy[MESH]|Palliative Care[MESH]|Polydeoxyribonucleotides/adverse effects/*therapeutic use[MESH]|Receptors, Purinergic P1/drug effects[MESH]|Retrospective Studies[MESH]|Risk[MESH]|Thalassemia/therapy[MESH]|Tissue Plasminogen Activator/therapeutic use[MESH]|Treatment Outcome[MESH] |