Carmen Alemán1, José M Porcel2, José Alegre3, Eva Ruiz3, Silvia Bielsa2, Jordi Andreu4, Maria Deu5, Pilar Suñé6, Mireia Martínez-Sogués7, Iker López5, Esther Pallisa4, Joan Antoni Schoenenberger7, J Bruno Montoro6, Tomás Fernández de Sevilla3. 1. Department of Internal Medicine, University Hospital Vall d'Hebron, Universitat Autónoma de Barcelona, Barcelona, Spain. 29261cal@comb.cat. 2. Pleural Medicine Unit, Department of Internal Medicine, Arnau de Vilanova University Hospital, Biomedical Research Institute of Lleida, Lleida, Spain. 3. Department of Internal Medicine, University Hospital Vall d'Hebron, Universitat Autónoma de Barcelona, Barcelona, Spain. 4. Department of Radiology, University Hospital Vall d'Hebron, Universitat Autónoma de Barcelona, Barcelona, Spain. 5. Department of Thoracic Surgery, University Hospital Vall d'Hebron, Universitat Autónoma de Barcelona, Barcelona, Spain. 6. Department of Pharmacy, University Hospital Vall d'Hebron, Universitat Autónoma de Barcelona, Barcelona, Spain. 7. Department of Pharmacy, Arnau de Vilanova University Hospital, Biomedical Research Institute of Lleida, Lleida, Spain.
Abstract
BACKGROUND:Pleurofibrinolysis has been reported to be potentially beneficial in the management of complicated parapneumonic effusions (CPPE) and empyemas in the adult population. METHODS: Prospective, controlled, randomized, and double-blind study, to evaluate intrapleural alteplase 10 mg (initially 20 mg was considered but bleeding events forced dose reduction) versus 100,000 UI urokinase every 24 h for a maximum of 6 days in patients with CPPE or empyemas. The primary aim was to evaluate the success rate of each fibrinolytic agent at 3 and 6 days. Success of therapy was defined as the presence of both clinical and radiological improvement, making additional fibrinolytic doses unnecessary, and eventually leading to resolution. Secondary outcomes included the safety profile of intrapleural fibrinolytics, referral for surgery, length of hospital stay, and mortality. RESULTS:A total of 99 patients were included, of whom 51 received alteplase and 48 urokinase. Success rates for urokinase and alteplase at 3 and 6 days were not significantly different, but when only the subgroup of CPPE was considered, urokinase resulted in a high proportion of cures. There were no differences in mortality or surgical need (overall, 3 %). Five (28 %) patients receiving 20 mg of alteplase and 4 (12 %) receiving 10 mg presented serious bleeding events. CONCLUSIONS: If intrapleural fibrinolytics are intended to be used, urokinase may be more effective than alteplase in patients with non-purulent CPPE and have a lower rate of adverse events.
RCT Entities:
BACKGROUND: Pleurofibrinolysis has been reported to be potentially beneficial in the management of complicated parapneumonic effusions (CPPE) and empyemas in the adult population. METHODS: Prospective, controlled, randomized, and double-blind study, to evaluate intrapleural alteplase 10 mg (initially 20 mg was considered but bleeding events forced dose reduction) versus 100,000 UI urokinase every 24 h for a maximum of 6 days in patients with CPPE or empyemas. The primary aim was to evaluate the success rate of each fibrinolytic agent at 3 and 6 days. Success of therapy was defined as the presence of both clinical and radiological improvement, making additional fibrinolytic doses unnecessary, and eventually leading to resolution. Secondary outcomes included the safety profile of intrapleural fibrinolytics, referral for surgery, length of hospital stay, and mortality. RESULTS: A total of 99 patients were included, of whom 51 received alteplase and 48 urokinase. Success rates for urokinase and alteplase at 3 and 6 days were not significantly different, but when only the subgroup of CPPE was considered, urokinase resulted in a high proportion of cures. There were no differences in mortality or surgical need (overall, 3 %). Five (28 %) patients receiving 20 mg of alteplase and 4 (12 %) receiving 10 mg presented serious bleeding events. CONCLUSIONS: If intrapleural fibrinolytics are intended to be used, urokinase may be more effective than alteplase in patients with non-purulent CPPE and have a lower rate of adverse events.
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