RESUMEN
PURPOSE: To determine whether cryopreserved solutions of the thrombolytic agent alteplase could be used as a safe, effective, and economically reasonable alternative to urokinase in patients presenting with occluded central venous access devices (CVADs). MATERIALS AND METHODS: Alteplase has been reported as an efficacious alternative to urokinase for treatment of occluded CVADs. However, the practicality of using alteplase as the thrombolytic of choice for this indication remained conjectural. To make this approach economically feasible, alteplase was diluted to 1 mg/mL and 2.5-mL aliquots were stored at -20 degrees C until use. A need to confirm that the cryopreserving and thawing of the reconstituted solution did not compromise the safety and efficacy reported from prior trials was recognized. A quality assessment initiative was undertaken to concurrently monitor the safety and efficacy of this approach. Patients presenting with occluded CVADs received a sufficient volume of the thawed alteplase solution to fill the occluded catheter(s). Data, including efficacy, adverse reactions, dwell time, and catheter type, were collected over a 5-month period. RESULTS: One hundred twenty-one patients accounting for 168 attempted clearances were assessable for safety and efficacy. One hundred thirty-six (81%) of the 168 catheter clearance attempts resulted in successful catheter clearance (95% confidence interval, 74% to 86%). No adverse events were reported. CONCLUSION: Cryopreserved 1-mg/mL aliquots of alteplase are safe and effective in the clearance of occluded CVADs when stored at -20 degrees C for 30 days. The ability to cryopreserve alteplase aliquots makes it an economically reasonable alternative to urokinase in the setting of CVAD occlusion.
Asunto(s)
Cateterismo Venoso Central/efectos adversos , Criopreservación/normas , Fibrinolíticos/economía , Fibrinolíticos/uso terapéutico , Activador de Tejido Plasminógeno/economía , Activador de Tejido Plasminógeno/uso terapéutico , Trombosis de la Vena/tratamiento farmacológico , Adolescente , Adulto , Anciano , Niño , Preescolar , Análisis Costo-Beneficio , Estudios de Factibilidad , Femenino , Fibrinolíticos/efectos adversos , Humanos , Lactante , Masculino , Persona de Mediana Edad , Control de Calidad , Activador de Tejido Plasminógeno/efectos adversos , Estados Unidos , Trombosis de la Vena/etiologíaRESUMEN
PURPOSE: This study determined gender differences in voluntary reporting of lower extremity musculoskeletal injuries among U.S, Marine Corps (USMC) recruits, and it examined the association between these differences and the higher injury rates typically found among women trainees. METHODS: Subjects were 176 male and 241 female enlisted USMC recruits who were followed prospectively through 11 wk (men) and 12 wk (women) of boot camp training. Reported injuries were measured by medical record reviews. Unreported injuries were determined by a questionnaire and a medical examination administered at the completion of training. RESULTS: Among female recruits the most commonly reported injuries were patellofemoral syndrome (10.0% of subjects), ankle sprain (9.1%), and iliotibial band syndrome (5.8%); the most common unreported injuries were patellofemoral syndrome (2.1%), metatarsalgia (1.7%), and unspecified knee pain (1.7%). Among male recruits iliotibial band syndrome (4.0% of subjects), ankle sprain (2.8%), and Achilles tendinitis/bursitis (2.8%) were the most frequently reported injuries; shin splints (4.6%), iliotibial band syndrome (4.0%), and ankle sprain (2.8%) were the most common unreported diagnoses. Female recruits were more likely to have a reported injury than male recruits (44.0% vs 25.6%, relative risk (RR) = 1.72, 95% confidence interval (CI) 1.29-2.30), but they were less likely to have an unreported injury (11.6% vs 23.9%, RR = 0.49, 95% CI 0.31-0.75). When both reported and unreported injuries were measured, total injury rates were high for both sexes (53.5% women, 45.5% men, RR = 1.18, 95% CI 0.96-1.44), but the difference between the rates was not statistically significant. CONCLUSIONS: Our results indicate that the higher injury rates often found in female military trainees may be explained by gender differences in symptom reporting.