RESUMEN
Filgrastim alone and sequential sargramostim and filgrastim have been shown to be more effective than sargramostim alone in the mobilization of CD34(+) cells after myelosuppressive chemotherapy (MC). We sought to compare costs and resource use associated with these regimens. Data were collected prospectively alongside a multicenter, randomized trial of filgrastim, sargramostim, and sequential sargramostim and filgrastim. Direct medical costs were calculated for inpatient and outpatient visits and procedures, including administration of growth factors and MC. We followed 156 patients for 30 days or until initiation of high-dose chemotherapy. The main outcome measures were resource use and costs of inpatient and outpatient visits, platelet and red blood cell transfusions, antibiotic use, and apheresis procedures. Hospital admissions, red blood cell transfusions, and use of i.v. antibiotics were significantly more common in the sargramostim group than in the other treatment arms. In univariate and multivariable analyses, total costs were higher for patients receiving sargramostim alone than for patients in the other groups. Mean costs in multivariable analysis for the filgrastim and sequential sargramostim and filgrastim arms were not significantly different. Filgrastim alone and sequential sargramostim and filgrastim are less costly than sargramostim alone after MC, as well as therapeutically more beneficial.
Asunto(s)
Antineoplásicos/economía , Costos de los Medicamentos , Factor Estimulante de Colonias de Granulocitos/economía , Factor Estimulante de Colonias de Granulocitos y Macrófagos/economía , Adulto , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/terapia , Costos y Análisis de Costo , Costos de los Medicamentos/estadística & datos numéricos , Quimioterapia Combinada , Femenino , Filgrastim , Factor Estimulante de Colonias de Granulocitos/uso terapéutico , Factor Estimulante de Colonias de Granulocitos y Macrófagos/uso terapéutico , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Inmunosupresores/economía , Inmunosupresores/uso terapéutico , Linfoma/terapia , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Proteínas RecombinantesRESUMEN
PURPOSE: The purpose of this study was to compare the effects of filgrastim, sargramostim, or sequential sargramostim and filgrastim on CD34(+) cell yields and morbidity after myelosuppressive mobilization chemotherapy (MC). PATIENTS AND METHODS: One hundred fifty-six patients were randomized to receive filgrastim (n = 51), sargramostim (n = 52), or sargramostim for 5 days followed by filgrastim (n = 53) after MC with either cyclophosphamide and etoposide (n = 75) or paclitaxel and cyclophosphamide (n = 81). RESULTS: Compared with those who received sargramostim, patients who received filgrastim had faster recovery of an absolute neutrophil count of 0.5 x 10(9)/L or greater (a median of 11 v 14 days; P =. 0001), with fewer patients requiring RBC transfusions (P =.008), fewer patients with fever (18% v 52%; P = 0.001), fewer hospital admissions (20% v 42%; P =.013), and less intravenous antibiotic therapy (24% v 69%; P =.001). Patients who received filgrastim yielded more CD34(+) cells (median, 7.1 v 2.0 x 10(6)/kg/apheresis; P =.0001), and a higher fraction achieved 2.5 x 10(6) (94% v 78%; P =.021) and 5 x 10(6) (88% v 53%; P =.001) or more CD34(+) cells/kg with fewer aphereses (median, 2 v 3; P =.002) and fewer days of growth-factor treatment (median, 12 v 14; P =.0001). There were no major differences in outcomes between the filgrastim alone and the sequential regimens. After high-dose chemotherapy, patients who had peripheral-blood stem cells (PBSCs) mobilized with filgrastim or the sequential regimen received higher numbers of CD34(+) cells and had faster platelet recovery (P =.015), with fewer patients (P =.014) receiving fewer platelet transfusions (P =.001) than patients receiving sargramostim-mobilized PBSCs. CONCLUSION: It was concluded that filgrastim alone or sequential sargramostim and filgrastim were superior to sargramostim alone for the mobilization of CD34(+) cells and reduction of toxicities after MC.
Asunto(s)
Factor Estimulante de Colonias de Granulocitos/uso terapéutico , Factor Estimulante de Colonias de Granulocitos y Macrófagos/uso terapéutico , Movilización de Célula Madre Hematopoyética/métodos , Recolección de Tejidos y Órganos/métodos , Adulto , Anciano , Antígenos CD34/sangre , Antígenos CD34/efectos de los fármacos , Quimioterapia Combinada , Femenino , Filgrastim , Recursos en Salud/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Proteínas Recombinantes , Estadísticas no ParamétricasRESUMEN
UNLABELLED: This investigation assessed the positive predictive value of matched ventilation/perfusion (V/Q) and chest radiographic defects (triple-matched defects) for the detection of acute pulmonary embolism (PE). METHODS: Data are from the Prospective investigation of Pulmonary Embolism Diagnosis (PIOPED). Only patients randomized for obligatory pulmonary angiography were included. Lungs were excluded if they showed any mismatched V/Q defect or any pleural effusion. RESULTS: Positive predictive values of triple-matched defects in the upper plus middle zones, 1 of 27 (4%), were less frequent than in the lower zones, 13 of 57 (23%) (p < 0.05). Triple-matched defects that involved 25-50% of a zone showed PE in 12 of 38 (32%) which was a higher positive predictive value than with smaller or larger triple-matched defects, 2 of 46 (4%) (p < 0.001). CONCLUSION: Refinement of the PIOPED data by elimination of nonrandomized patients, elimination of lungs with mismatched perfusion defects and elimination of lungs with a pleural effusion indicate that triple matches with PE (radiographic pulmonary infarcts) are infrequent in the upper and middle lung zones. When a triple match with PE occurs, it is most likely to be 25-50% of a zone.
Asunto(s)
Pulmón/diagnóstico por imagen , Embolia Pulmonar/diagnóstico por imagen , Enfermedad Aguda , Humanos , Valor Predictivo de las Pruebas , Arteria Pulmonar/diagnóstico por imagen , Radiografía , Cintigrafía , Relación Ventilacion-PerfusiónRESUMEN
PURPOSE: The purpose of this investigation was to determine the frequency of pulmonary embolism (PE) in a single lung that showed a normal ventilation/perfusion (V/Q) lung scan when the V/Q scan on the contralateral side was interpreted as non-high-probability for PE. METHODS: Data are from the national collaborative study Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED). PE was diagnosed or excluded in all lungs by pulmonary angiography. RESULTS: Single lungs with no V/Q abnormalities, when the V/Q scan on the contralateral side was interpreted as non-high-probability for PE, showed PE in 2 of 19 (11%) (95% confidence interval [CI], 1 to 33%). If PE was excluded by angiography on the side of the abnormal V/Q scan, then PE on the side of the normal V/Q scan was shown in only 1 of 19 (5%) (95% CI, 0 to 26%). CONCLUSION: A normal V/Q scan in a single lung, when the contralateral lung was interpreted as non-high-probability for PE, did not completely exclude PE on the apparently normal side. In such lungs, the probability of PE was in the range of low-probability interpretations. If the pulmonary angiogram showed no PE on the side of the abnormal V/Q scan, the probability of PE on the side of the normal V/Q scan satisfied the definition of very low probability for PE. This observation in patients undergoing pulmonary angiography may assist in determining whether the pulmonary angiogram should be bilateral.
Asunto(s)
Arteria Pulmonar/diagnóstico por imagen , Embolia Pulmonar/diagnóstico por imagen , Relación Ventilacion-Perfusión , Intervalos de Confianza , Humanos , Pulmón/diagnóstico por imagen , Probabilidad , Estudios Prospectivos , Embolia Pulmonar/fisiopatología , Radiografía , CintigrafíaRESUMEN
UNLABELLED: The purpose of this investigation was to identify characteristics or combinations of characteristics of the ventilation-perfusion (V/Q) scan in patients with suspected acute pulmonary embolism (PE) can be used for a "very low probability" interpretation ( < 10% positive predictive value). METHODS: Data were culled from individual lungs of 532 patients in the randomized arm of the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) study and 205 patients in the referred arm. All patients had a < 20% consensus probability estimate of PE based on V/Q scan results, and all underwent pulmonary angiography. RESULTS: Nonsegmental perfusion abnormalities, perfusion defects smaller than opacities on the chest radiograph, a combination of these types of perfusion abnormalities, and matched V/Q abnormalities in two or three zones of a single lung had a positive predictive value < 10%. These criteria can therefore be used for a very low probability interpretation. A matched V/Q defect in only one zone of the lung had a positive predictive value greater than 10% and is not a criterion for low probability. Perfusion defects associated with small pleural effusions (obliteration of the costophrenic angle) had a positive predictive value of 25%-33%, depending on the group studied, and are a criterion for intermediate probability. CONCLUSION: Criteria appropriate for a very low probability ( < 10% positive predictive value) interpretation of V/Q scans in patients with suspected acute PE have been identified.
Asunto(s)
Pulmón/diagnóstico por imagen , Embolia Pulmonar/diagnóstico por imagen , Estudios de Evaluación como Asunto , Cardiopatías/epidemiología , Humanos , Valor Predictivo de las Pruebas , Probabilidad , Estudios Prospectivos , Arteria Pulmonar/diagnóstico por imagen , Embolia Pulmonar/epidemiología , Radiografía , Cintigrafía , Distribución Aleatoria , Relación Ventilacion-PerfusiónRESUMEN
PURPOSE: The purpose of this investigation was to evaluate the diagnostic accuracy of radionuclide scintigraphic lung scans and clinical assessment in critically ill patients with suspected acute pulmonary embolism. MATERIALS AND METHODS: Critically ill patients were defined as follows: (1) patients who were hypoxemic on room air, and not given ventilatory support (n = 89); (2) patients given ventilatory support (n = 46); and (3) patients in ICUs, but not given ventilatory support (n = 85), and hypotensive patients who were not hypoxemic or given ventilatory support (n = 3). Comparisons were made with patients who had none of these characteristics of critically ill patients (n = 627). Data are from the Prospective Investigation of Pulmonary Embolism Diagnosis. RESULTS: The sensitivities, specificities, and positive predictive values of high probability lungs scans among each of the four categories of critically ill patients were not statistically significantly lower than values in noncritically ill patients. The positive predictive values of the clinical assessments did not differ to a statistically significant extent from noncritically ill patients. Clinical assessment, when concordant with the lung scan interpretation, usually increased the positive predictive value for pulmonary embolism. CONCLUSION: Scintigraphic lung scans and clinical assessment retain their diagnostic value even in critically ill patients.
Asunto(s)
Pulmón/diagnóstico por imagen , Embolia Pulmonar/diagnóstico por imagen , Enfermedad Aguda , Angiografía , Enfermedad Crítica , Humanos , Hipoxia/fisiopatología , Valor Predictivo de las Pruebas , Embolia Pulmonar/fisiopatología , Embolia Pulmonar/terapia , Cintigrafía , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial , Sensibilidad y EspecificidadRESUMEN
PURPOSE: The purpose of this investigation was to determine the frequency of future pulmonary embolism (PE) among patients in whom PE was suspected and excluded by pulmonary angiography. METHODS: Data are from the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED). The present investigation includes 380 patients in whom PE was excluded by pulmonary angiography and who received no anticoagulant therapy while in the hospital or after discharge. Patients were followed 1 year after their normal pulmonary angiograms. RESULTS: Pulmonary embolism occurred within 1 year in 6 of 380 (1.6%)(95% confidence interval [CI] 0.3 to 2.9%) patients with suspected PE and normal pulmonary angiograms. Four of six (67%) PE were nonfatal. Three of six (50%) PE occurred in the first 8 days and four of six (67%) PE occurred within the first month. Among patients who subsequently showed PE, a history of thrombophlebitis or an objective test suggestive of deep venous thrombosis was present in five of six (83%). Symptoms, signs, and radiographic abnormalities were similar among patients who showed PE on follow-up and those who did not, although the pulmonary artery mean pressure was higher among those with subsequent PE (34 +/- 25 mm Hg vs 22 +/- 10 mm Hg) (p < 0.01). CONCLUSION: The frequency of PE on follow-up among patients with normal pulmonary angiograms is small. There is, however, a real and measureable rate of clinically important PE over the subsequent 12 months that is higher than reported in the general population of hospitalized patients. Patients with suspected PE, therefore, even if their angiogram is normal, might benefit from definitive studies of the lower extremities to exclude deep venous thrombosis. The cost benefit ratio of this, however, has not been evaluated.
Asunto(s)
Embolia Pulmonar/epidemiología , Tromboflebitis/diagnóstico , Adulto , Angiografía , Femenino , Humanos , Pulmón/irrigación sanguínea , Pulmón/diagnóstico por imagen , Persona de Mediana Edad , Estudios Prospectivos , Embolia Pulmonar/etiología , Tromboembolia/diagnóstico , Tromboembolia/etiología , Tromboflebitis/complicacionesRESUMEN
PURPOSE: The purpose of this investigation was to evaluate measured asymmetry of the calves in the assessment of patients with suspected pulmonary embolism (PE). METHODS: Patients randomized for pulmonary angiography in the collaborative study of the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) were evaluated. Only patients in whom the circumference of the calves was measured were included in this evaluation of PIOPED data. Among these, 232 had angiographically diagnosed PE and 446 had no PE by angiography. For purposes of comparison, measurements of the calves also were made in a nonrandomized current cohort of 101 healthy subjects. All calf measurements were made 10 cm below the tibial tuberosity. RESULTS: Asymmetry in the circumference of the calves of 1 cm or more was measured in 101 of 232 or 44% (95% confidence interval [CI], 37 to 51%) with PE, 176 of 446 or 39% (95% CI, 34 to 44%) without PE, and in 6 of 101 or 6% (95% CI, 1 to 11%) control subjects (PE vs control subjects, p < 0.001; subjects without PE vs control subjects, p < 0.001; PE vs no PE, p = NS). Among patients with PE, the addition of calf asymmetry of 1 cm or more to qualitative signs of deep venous thrombosis increased the prevalence of a detectable abnormality of the lower extremities from 62 of 232 or 27% (95% CI, 21 to 33%) to 129 of 232 or 56% (95% CI, 49 to 63% [p < 0.001]). CONCLUSION: Asymmetry of the calves of 1 cm or more is abnormal. Such asymmetry of the calves did not distinguish between patients with PE and those with no PE. When considered in proper perspective with other nonspecific signs and symptoms in patients with suspected acute PE, however, subtle calf asymmetry may call attention to the possibility of thromboembolic disease. The observation of subtle asymmetry may indicate a need for noninvasive diagnostic tests of the lower extremities to determine whether deep venous thrombosis is present.
Asunto(s)
Pierna/fisiopatología , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/fisiopatología , Enfermedad Aguda , Adulto , Anciano , Humanos , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Tromboembolia/diagnósticoRESUMEN
PURPOSE: The purpose of this investigation was to evaluate the clinical characteristics of acute pulmonary embolism (PE) among patients with PE who did not receive treatment to assess how the natural course of untreated PE relates to its severity. METHODS: Data are from the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED). Among patients with PE diagnosed either by pulmonary angiography or at autopsy, 376 received treatment and 24 escaped treatment in the hospital and were not prescribed anticoagulant therapy at the time of hospital discharge. Among these untreated patients, however, four received anticoagulant therapy during the first 3 months of follow-up. We report the 3-month course of PE in the remaining 20 untreated patients. RESULTS: Among untreated patients, 1 of 20 (5.0%) died from the effects of the original PE and possibly some contribution from recurrent PE. Nonfatal recurrent PE occurred in 1 of 20 (5.0%). All untreated patients, 20 of 20 (100%), had less than three mismatched segmental perfusion defects compared with 227 of 376 (60%) treated patients (p < 0.001). Pulmonary arteries showed thromboemboli in segmental or smaller arteries in 16 of 19 (84%) untreated patients compared with 132 of 362 (36%) treated patients (p < 0.001). Untreated and treated patients, when grouped according to the size of the ventilation/perfusion lung scan defect or size of vessels involved on the pulmonary angiogram, showed no statistically significant difference in the frequency of fatal PE or nonfatal recurrent PE. CONCLUSION: Mild untreated PE carries a lower immediate mortality and lower mortality from recurrent PE than overt PE described in prior decades.
Asunto(s)
Embolia Pulmonar/fisiopatología , Enfermedad Aguda , Adulto , Anciano , Anticoagulantes/uso terapéutico , Hemodinámica , Humanos , Persona de Mediana Edad , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/mortalidad , Recurrencia , Tasa de SupervivenciaRESUMEN
A decision tree based on the common clinical indicators seen in acute and chronic cholecystitis is presented. The use of such a decision tree aids in the selective, rather than the routine, use of intraoperative cholangiography. In this series, the number of intraoperative cholangiograms could have been decreased from 275 to 101 by using the decision tree. At the same time, the number of negative explorations could have been reduced from 13 to 7, while the number of positive explorations would remain the same. The decision tree provides a systematic approach to the use of intraoperative cholangiography, thereby saving operating time and cost. By using this approach, the surgeon can not only select those patients in whom intraoperative cholangiogram will be useful in determining the need for exploration of the common duct and finding the unexpected common duct stone, but also eliminate [corrected] its use in those patients who have no clinical indications.