RESUMEN
BACKGROUND: Educational outreach visits (EOVs) have been identified as an intervention that may improve the practice of healthcare professionals. This type of face-to-face visit has been referred to as university-based educational detailing, academic detailing, and educational visiting. OBJECTIVES: To assess the effects of EOVs on health professional practice or patient outcomes. SEARCH STRATEGY: For this update, we searched the Cochrane EPOC register to March 2007. In the original review, we searched multiple bibliographic databases including MEDLINE and CINAHL. SELECTION CRITERIA: Randomised trials of EOVs that reported an objective measure of professional performance or healthcare outcomes. An EOV was defined as a personal visit by a trained person to healthcare professionals in their own settings. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. We used bubble plots and box plots to visually inspect the data. We conducted both quantitative and qualitative analyses. We used meta-regression to examine potential sources of heterogeneity determined a priori. We hypothesised eight factors to explain variation across effect estimates. In our primary visual and statistical analyses, we included only studies with dichotomous outcomes, with baseline data and with low or moderate risk of bias, in which the intervention included an EOV and was compared to no intervention. MAIN RESULTS: We included 69 studies involving more than 15,000 health professionals. Twenty-eight studies (34 comparisons) contributed to the calculation of the median and interquartile range for the main comparison. The median adjusted risk difference (RD) in compliance with desired practice was 5.6% (interquartile range 3.0% to 9.0%). The adjusted RDs were highly consistent for prescribing (median 4.8%, interquartile range 3.0% to 6.5% for 17 comparisons), but varied for other types of professional performance (median 6.0%, interquartile range 3.6% to 16.0% for 17 comparisons). Meta-regression was limited by the large number of potential explanatory factors (eight) with only 31 comparisons, and did not provide any compelling explanations for the observed variation in adjusted RDs. There were 18 comparisons with continuous outcomes, with a median adjusted relative improvement of 21% (interquartile range 11% to 41%). There were eight trials (12 comparisons) in which the intervention included an EOV and was compared to another type of intervention, usually audit and feedback. Interventions that included EOVs appeared to be slightly superior to audit and feedback. Only six studies evaluated different types of visits in head-to-head comparisons. When individual visits were compared to group visits (three trials), the results were mixed. AUTHORS' CONCLUSIONS: EOVs alone or when combined with other interventions have effects on prescribing that are relatively consistent and small, but potentially important. Their effects on other types of professional performance vary from small to modest improvements, and it is not possible from this review to explain that variation.
Asunto(s)
Educación Médica Continua , Personal de Salud/educación , Evaluación de Resultado en la Atención de Salud , Práctica Profesional/normas , Humanos , Cooperación del Paciente , Pautas de la Práctica en MedicinaRESUMEN
BACKGROUND: Some people believe that patients who take part in randomised controlled trials (RCTs) face risks that they would not face if they opted for non-trial treatment. Others think that trial participation is beneficial and the best way to ensure access to the most up to date physicians and treatments. OBJECTIVES: To assess the effects of patient participation in RCTs ('trial effects') independent both of the effects of the clinical treatments being compared ('treatment effects') and any differences between patients who participated in RCTs and those who did not. SEARCH STRATEGY: In May 2001, we searched The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, The Cochrane Methodology Register, SciSearch and PsycINFO for potentially relevant studies. Our search yielded over 10,000 references. In addition, we reviewed the reference lists of relevant articles and wrote to over 250 investigators to try to obtain further information. SELECTION CRITERIA: Randomised studies and cohort studies with data on clinical outcomes of RCT participants and similar patients who received similar treatment outside of RCTs. DATA COLLECTION AND ANALYSIS: At least two reviewers independently assessed studies for inclusion, assessed study quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: We included five randomised studies (yielding 6 comparisons) and 50 non-randomised cohort studies (85 comparisons), with 31,140 patients treated in RCTs and 20,380 patients treated outside RCTs. In the randomised studies, patients were invited to participate in an RCT or not; these comparisons provided limited information because of small sample sizes (a total of 412 patients) and the nature of the questions they addressed. There was statistically significant heterogeneity (P < 0.002, I(2) = 36.2%) among the 73 dichotomous outcome comparisons; none of the potential explanatory factors we investigated helped to explain this heterogeneity. No statistically significant differences were found for 63 of the 73 comparisons. Eight comparisons reported statistically significant better outcomes for patients treated within RCTs, and two comparisons reported statistically significant worse outcomes for patients treated within RCTs. There were no statistically significant differences in heterogeneity (P = 0.53, I(2) = 0%) or in outcomes (SMD 0.01, 95% CI -0.10 to 0.12) of patients treated within and outside RCTs in the 18 comparisons which had used continuous outcomes. AUTHORS' CONCLUSIONS: This review indicates that participation in RCTs is not associated with greater risks than receiving the same treatment outside RCTs. These results challenge the assertion that the results of RCTs are not applicable to usual practice.
Asunto(s)
Aceptación de la Atención de Salud , Evaluación de Procesos, Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto/efectos adversos , Negativa a Participar , Estudios de Cohortes , Humanos , Medición de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Audit and feedback continues to be widely used as a strategy to improve professional practice. It appears logical that healthcare professionals would be prompted to modify their practice if given feedback that their clinical practice was inconsistent with that of their peers or accepted guidelines. Yet, audit and feedback has not consistently been found to be effective. OBJECTIVES: To assess the effects of audit and feedback on the practice of healthcare professionals and patient outcomes. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group's register and pending file up to January 2004. SELECTION CRITERIA: Randomised trials of audit and feedback (defined as any summary of clinical performance over a specified period of time) that reported objectively measured professional practice in a healthcare setting or healthcare outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. Quantitative (meta-regression), visual and qualitative analyses were undertaken. For each comparison we calculated the risk difference (RD) and risk ratio (RR), adjusted for baseline compliance when possible, for dichotomous outcomes and the percentage and the percent change relative to the control group average after the intervention, adjusted for baseline performance when possible, for continuous outcomes. We investigated the following factors as possible explanations for the variation in the effectiveness of interventions across comparisons: the type of intervention (audit and feedback alone, audit and feedback with educational meetings, or multifaceted interventions that included audit and feedback), the intensity of the audit and feedback, the complexity of the targeted behaviour, the seriousness of the outcome, baseline compliance and study quality. MAIN RESULTS: Thirty new studies were added to this update, and a total of 118 studies are included. In the primary analysis 88 comparisons from 72 studies were included that compared any intervention in which audit and feedback is a component compared to no intervention. For dichotomous outcomes the adjusted risk difference of compliance with desired practice varied from - 0.16 (a 16 % absolute decrease in compliance) to 0.70 (a 70% increase in compliance) (median = 0.05, inter-quartile range = 0.03 to 0.11) and the adjusted risk ratio varied from 0.71 to 18.3 (median = 1.08, inter-quartile range = 0.99 to 1.30). For continuous outcomes the adjusted percent change relative to control varied from -0.10 (a 10 % absolute decrease in compliance) to 0.68 (a 68% increase in compliance) (median = 0.16, inter-quartile range = 0.05 to 0.37). Low baseline compliance with recommended practice and higher intensity of audit and feedback were associated with larger adjusted risk ratios (greater effectiveness) across studies. AUTHORS' CONCLUSIONS: Audit and feedback can be effective in improving professional practice. When it is effective, the effects are generally small to moderate. The relative effectiveness of audit and feedback is likely to be greater when baseline adherence to recommended practice is low and when feedback is delivered more intensively.
Asunto(s)
Retroalimentación Psicológica , Evaluación de Resultado en la Atención de Salud , Pautas de la Práctica en Medicina/normas , Práctica Profesional/normas , Educación Médica Continua , Personal de Salud/normas , Investigación sobre Servicios de Salud , Humanos , Auditoría MédicaRESUMEN
BACKGROUND: Audit and feedback continues to be widely used as a strategy to improve professional practice. It appears logical that healthcare professionals would be prompted to modify their practice if given feedback that their clinical practice was inconsistent with that of their peers or accepted guidelines. Yet, audit and feedback has not been found to be consistently effective. OBJECTIVES: To assess the effects of audit and feedback on the practice of healthcare professionals and patient outcomes. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group's register up to January 2001. This was supplemented with searches of MEDLINE and reference lists, which did not yield additional relevant studies. SELECTION CRITERIA: Randomised trials of audit and feedback (defined as any summary of clinical performance over a specified period of time) that reported objectively measured professional practice in a healthcare setting or healthcare outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. Quantitative (meta-regression), visual and qualitative analyses were undertaken. MAIN RESULTS: We included 85 studies, 48 of which have been added to the previous version of this review. There were 52 comparisons of dichotomous outcomes from 47 trials with over 3500 health professionals that compared audit and feedback to no intervention. The adjusted RDs of non-compliance with desired practice varied from 0.09 (a 9% absolute increase in non-compliance) to 0.71 (a 71% decrease in non-compliance) (median = 0.07, inter-quartile range = 0.02 to 0.11). The one factor that appeared to predict the effectiveness of audit and feedback across studies was baseline non-compliance with recommended practice. REVIEWER'S CONCLUSIONS: Audit and feedback can be effective in improving professional practice. When it is effective, the effects are generally small to moderate. The absolute effects of audit and feedback are more likely to be larger when baseline adherence to recommended practice is low.
Asunto(s)
Evaluación de Resultado en la Atención de Salud , Pautas de la Práctica en Medicina/normas , Práctica Profesional/normas , Educación Médica Continua , Retroalimentación , Personal de Salud/normas , Investigación sobre Servicios de Salud , Humanos , Auditoría MédicaRESUMEN
PURPOSE: The safety and diagnostic efficacy of iodixanol (Visipaque) 270 mg I/ml was compared to that of iopamidol (Iopamiron) 300 mg I/ml in knee arthrography. MATERIAL AND METHODS: This trial was a bi-center double-blind trial including 128 patients (iodixanol/iopamidol 64/64 patients). Efficacy was evaluated by blinded grading of the diagnostic quality of the p.a. images taken 0, 12 and 25 min after contrast administration by the examining radiologist and later at a consensus evaluation by two experienced skeletal radiologists. Adverse events were recorded. RESULTS: No patient experienced any adverse event. The proportion of better images at both 12 and 25 min after injection was higher in the iodixanol group compared to the iopamidol group both by the examining radiologist and at the consensus evaluation. CONCLUSION: In the knee joint iodixanol is a safe contrast medium. The contrast effect of iodixanol lasted longer than that of iopamidol, which can be important when performing arthrography, especially CT arthrography, where the time between puncture and examination can be prolonged.
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Artrografía , Medios de Contraste/farmacocinética , Yopamidol/farmacocinética , Articulación de la Rodilla/diagnóstico por imagen , Ácidos Triyodobenzoicos/farmacocinética , Método Doble Ciego , Humanos , Aumento de la Imagen , Tasa de Depuración Metabólica/fisiología , Sensibilidad y EspecificidadRESUMEN
PURPOSE: To compare the diagnostic quality and adverse events of the water-soluble, non-ionic, iso-osmolar, dimeric contrast media iodixanol and iotrolan in hysterosalpingography (HSG). MATERIAL AND METHODS: One hundred and twenty patients participated in a double-blind randomized parallel-group phase-III study. Questionnaires and patient interviews were used. Diagnostic quality was assessed using a visual analogue scale and the quality in specific regions was rated using a categorical scale. RESULTS: Overall diagnostic quality was equal for the two groups. There was no statistically significant difference between the two groups in diagnostic quality in the specific regions of interest. No differences between the contrast media were found with regard to adverse events. CONCLUSION: Both contrast media provided images of high diagnostic quality in HSG.
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Medios de Contraste/administración & dosificación , Trompas Uterinas/patología , Histerosalpingografía , Infertilidad Femenina/diagnóstico por imagen , Ácidos Triyodobenzoicos , Útero/patología , Método Doble Ciego , Femenino , Humanos , Histerosalpingografía/métodos , Histerosalpingografía/normas , Inyecciones , Reproducibilidad de los Resultados , Seguridad , Encuestas y Cuestionarios , Ácidos Triyodobenzoicos/administración & dosificaciónRESUMEN
The purpose of this study was to evaluate and compare the radiographic efficacy and safety of iodixanol (Visipaque; 270 and 320 mg I/ml) and iohexol (Omnipaque; 300 mg I/ml) in myelography. The study was randomized, double-blind and comparative including 398 patients from five European university clinics. The radiographic visualisation was evaluated as poor, good or excellent. Adverse events were recorded by interviewing the patients after the myelography, and each patient was given a questionnaire to be returned after 1 week. In cervical myelography with cervical puncture more films with excellent quality was obtained after iodixanol 320 mgI/ml compared with iohexol 300 mgI/ml (p = 0.009). Also in lumbar myelography iodixanol 320 mgI/ml compared favourably with iohexol 300 mgI/ml (p = 0.006). The most frequent adverse event was headache, which occurred in 5-35 % of patients during the first 24 h and in 19-61 % within the first 7 days, depending on the centre. There was no difference in frequency and severity of the adverse effects between the contrast media.
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Medios de Contraste , Yohexol , Mielografía , Ácidos Triyodobenzoicos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Yohexol/efectos adversos , Masculino , Persona de Mediana Edad , Mielografía/efectos adversos , Ácidos Triyodobenzoicos/efectos adversosAsunto(s)
Enzimas/orina , Congelación , Proteinuria/orina , Manejo de Especímenes , Acetilglucosaminidasa/orina , Adulto , Anciano , Albúminas/análisis , Fosfatasa Alcalina/orina , Creatinina/orina , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valores de Referencia , Microglobulina beta-2/orinaRESUMEN
PURPOSE: To compare the diagnostic results following injection of (a) a high dose (0.3 mmol/kg b.w.) of gadodiamide injection and (b) the standard dose (0.1 mmol/kg b.w.) of Gd-DTPA, in patients with recurrent symptoms after surgery for lumbar disc herniation. MATERIAL AND METHODS: Twenty patients with recurrent or sustained symptoms after surgery for lumbar disc herniations were examined. MR imaging (0.3 T) was first performed before and after Gd-DTPA at 0.1 mmol/kg b.w., and then within one month (17 patients) or within 3 months (3 patients) before and after gadodiamide injection at 0.3 mmol/kg b.w. The examinations were first evaluated by 2 neuroradiologists blinded to dose but not to patient as the images were presented in pairs. Six months later the same investigators evaluated the examinations again, this time blinded to both dose and patient. RESULTS: At the evaluation in pairs (with the investigators blinded to dose only) the high-dose examinations were considered the most informative (p=0.05). However, at the later evaluation (with the investigators blinded both to dose and patient) no significant difference between high and standard dose was found regarding diagnosis or diagnostic certainty. CONCLUSION: In this study the high-dose contrast enhancement of MR imaging at 0.3 T did not increase the diagnostic information for differentiating between scar and recurrent hernia. The high-dose images were considered more informative when evaluated in pairs, but gave no additional or different information when evaluated separately. The study also indicated that comparisons in pairs should be interpreted with caution.
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Dolor de Espalda/etiología , Medios de Contraste/administración & dosificación , Gadolinio , Desplazamiento del Disco Intervertebral/diagnóstico , Vértebras Lumbares , Imagen por Resonancia Magnética , Complicaciones Posoperatorias/diagnóstico , Adulto , Anciano , Femenino , Gadolinio/administración & dosificación , Gadolinio DTPA , Humanos , Desplazamiento del Disco Intervertebral/cirugía , Vértebras Lumbares/patología , Masculino , Persona de Mediana Edad , Compuestos Organometálicos/administración & dosificación , Ácido Pentético/administración & dosificación , Ácido Pentético/análogos & derivados , RecurrenciaRESUMEN
A meta-analyses was performed to evaluate the safety of gadodiamide injection (OM-NISCAN) for magnetic resonance imaging in two different age groups (< 65 years; > or = 65 years). Data on vital signs, clinical laboratory parameters, and subjectively experienced adverse events were reviewed for 734 patients included in 19 European Phase II and III trials with gadodiamide injection (0.1 mmol/kg body weight or 0.3 mmol/kg body weight) used in magnetic resonance imaging. One hundred sixty-four patients were 65 years of age or older. No statistically significant differences were shown between this population and the population younger than 65 years of age with respect to vital signs or clinical laboratory parameters. A total of 48 adverse events, discomfort excluded, were reported, with no significant difference in frequency between the two age groups. Injection-associated discomfort was significantly (P = .0025) more frequent in the younger (9.2%) than in the older group (2.5%). Gadodiamide injection is in conclusion a safe contrast medium in older as well as in younger patients.
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Medios de Contraste/efectos adversos , Gadolinio DTPA , Compuestos Organometálicos/efectos adversos , Ácido Pentético/análogos & derivados , Adulto , Factores de Edad , Anciano , Medios de Contraste/administración & dosificación , Femenino , Humanos , Inyecciones Intravenosas , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Compuestos Organometálicos/administración & dosificación , Ácido Pentético/administración & dosificación , Ácido Pentético/efectos adversosRESUMEN
The aim was to compare the abilities of contrast-enhanced CT, non-contrast-enhanced MR imaging and contrast-enhanced MR imaging using standard (0.1 mmol/kg b.w.) and high (0.3 mmol/kg b.w.) doses of Gadodiamide injection to detect brain metastases (i.e. blood-brain barrier damage). Sixteen patients with at least 2 metastases found by CT were evaluated by MR imaging using non-contrast-enhanced spin-echo, T1-weighted, T2-weighted sequences, and contrast-enhanced spin-echo T1-weighted sequences at 2 dose levels. Gadodiamide injection was first given at the dose of 0.1 mmol/kg b.w. After imaging, another 0.2 mmol/kg b.w. was given, yielding a cumulative dose of 0.3 mmol/kg b.w. No contrast media-related adverse events were recorded. The images were evaluated openly by one and blindly by 2 investigators and the number of metastases, size, delineation (open study) and diagnostic certainty (blind study) of each individual metastasis noted. High-dose MR imaging showed significantly more and smaller metastases than any other examination, and gave a higher diagnostic certainty. All high-dose images were superior to those with the standard dose MR imaging when compared blindly in pairs. We conclude that spin-echo MR imaging with a high dose of Gadodiamide injection is an efficient way to improve the detection of brain metastases, in particular of small ones.
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Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/secundario , Medios de Contraste/administración & dosificación , Gadolinio DTPA , Gadolinio , Aumento de la Imagen , Imagen por Resonancia Magnética , Compuestos Organometálicos , Ácido Pentético/análogos & derivados , Intensificación de Imagen Radiográfica , Tomografía Computarizada por Rayos X , Adulto , Barrera Hematoencefálica , Neoplasias Encefálicas/diagnóstico por imagen , Medios de Contraste/efectos adversos , Femenino , Gadolinio/administración & dosificación , Gadolinio/efectos adversos , Humanos , Procesamiento de Imagen Asistido por Computador , Inyecciones Intravenosas , Imagen por Resonancia Magnética/métodos , Masculino , Variaciones Dependientes del Observador , Compuestos Organometálicos/administración & dosificación , Compuestos Organometálicos/efectos adversos , Dolor/etiología , Ácido Pentético/administración & dosificación , Ácido Pentético/efectos adversos , Método Simple CiegoRESUMEN
Forty-five patients with known or suspected musculoskeletal tumors were examined with static and dynamic MR imaging to evaluate the safety, tolerability and diagnostic utility of gadodiamide injection and to assess the diagnostic value of dynamic MR imaging and parametric "first-pass" (FP) images. The proportion of patients presenting more diagnostic information on the contrast-enhanced compared to the precontrast spin-echo examinations was determined. The dynamic enhancement characteristics were evaluated with time-intensity curves and parametric images of the FP enhancement rate. The tolerance of gadodiamide injection was good. Contrast enhancement was useful for delineating tumor from muscle, and differentiating viable from necrotic tissue and cystic from solid lesions. Malignant tumors showed a significantly higher slope value, earlier onset of enhancement, and higher maximum enhancement than benign lesions. However, slope values could not be used to predict the malignant potential of a lesion, due to overlap between highly vascular benign and low vascular malignant lesions. By displaying highly vascular areas, parametric FP images provided useful information on the most active part in a tumor before biopsy and for assessing the incorporation of bone-chip allografts. Static, dynamic and FP MR imaging using gadodiamide injection appears safe and provides useful information for diagnosis, biopsy and follow-up of musculoskeletal lesions.
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Enfermedades Óseas/diagnóstico , Medios de Contraste , Gadolinio DTPA , Imagen por Resonancia Magnética/métodos , Enfermedades Musculares/diagnóstico , Compuestos Organometálicos , Ácido Pentético/análogos & derivados , Neoplasias de los Tejidos Blandos/diagnóstico , Adulto , Neoplasias Óseas/diagnóstico , Femenino , Humanos , Inyecciones Intravenosas , Masculino , Estudios ProspectivosRESUMEN
Radiation induced normal tissue complication probability is calculated for three different organs: brain, liver and kidney. The model applied is a reliability model where the volume effect of the tissue is described by the structural parameter, k, which reflects the architecture of the functional subunits (p) and the irradiated volume fraction (n). For partial, homogeneous irradiation of the brain, a k-value close to unity was found, and the respective values for liver and kidney were 0.92 and 0.77. An extension of the reliability model to account for individual inactivation probability of the subunits allows calculation of complication probability for inhomogeneous dose distributions. For the brain, intercomparison of a three-field and a two-field technique demonstrated a small reduction in complication probability for the former at low total doses. At high total doses a minimum complication probability was achieved applying a three-field technique, being three times less than that associated with the two-field technique.
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Encéfalo/efectos de la radiación , Riñón/efectos de la radiación , Hígado/efectos de la radiación , Modelos Biológicos , Traumatismos por Radiación/etiología , Relación Dosis-Respuesta en la Radiación , Humanos , Probabilidad , Radioterapia/efectos adversos , Dosificación RadioterapéuticaRESUMEN
This study compared the safety and tolerability of gadodiamide injection at the standard dose (0.1 mmol/kg) and at a higher dose (0.3 mmol/kg) in 289 patients participating in a parallel group multiple independent trial program. All patients had a known or suspected central nervous system lesion necessitating investigation with contrast medium-enhanced magnetic resonance imaging. Safety assessments were made before and after injection of the contrast medium, and 1 day later. No adverse events were judged to be related to gadodiamide injection, and only 3.5% of the patients in each dose group reported adverse events that had an uncertain relationship to the contrast medium; both doses were therefore well tolerated. Headache was the most frequently reported event (2%). There were no significant injection-related changes in neurologic status, laboratory test results, or vital signs. The data obtained indicate that the higher dose of gadodiamide injection is as safe and well tolerated as the standard dose.
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Enfermedades del Sistema Nervioso Central/diagnóstico , Medios de Contraste/administración & dosificación , Gadolinio DTPA , Imagen por Resonancia Magnética/métodos , Compuestos Organometálicos , Ácido Pentético/análogos & derivados , Medios de Contraste/efectos adversos , Femenino , Cefalea/inducido químicamente , Humanos , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Compuestos Organometálicos/administración & dosificación , Compuestos Organometálicos/efectos adversos , Ácido Pentético/administración & dosificación , Ácido Pentético/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , SeguridadRESUMEN
Iodixanol is a new nonionic, dimeric contrast medium. With the addition of 18 mmol/l Na+ and 0.3 mmol/l Ca++ to iodixanol 320 mg I/ml a plasma-isotonic solution was obtained. The purpose was to evaluate the suitability of iodixanol for use in cardioangiography by determining the diagnostic efficacy, patient tolerability, and cardiac and renal side-effects. Initially, 14 patients with coronary artery disease were examined using iodixanol. A double-blind, randomized study was then performed in 72 patients, comparing iodixanol and iohexol. Serum and urine were sampled before the examination, and one and 2 days after. The diagnostic information was good and the number of adverse events low with iodixanol. The patients reported significantly less of a sensation of warmth following injection of iodixanol than iohexol. Our results also indicate that iodixanol 320 mg I/ml influences renal function to a lesser degree than does iohexol 350 mg I/ml. We therefore conclude that isotonic iodixanol is a safe contrast medium for use in cardioangiography.
Asunto(s)
Medios de Contraste , Enfermedad Coronaria/diagnóstico por imagen , Yohexol , Ácidos Triyodobenzoicos , Adulto , Anciano , Medios de Contraste/efectos adversos , Angiografía Coronaria , Método Doble Ciego , Hemodinámica/efectos de los fármacos , Humanos , Yohexol/efectos adversos , Riñón/efectos de los fármacos , Persona de Mediana Edad , Ácidos Triyodobenzoicos/efectos adversosRESUMEN
The low osmolar, non-ionic X-ray contrast media have shown a lower frequency of adverse events than the older ionic ones. In this study changes in routine clinical-chemical parameters in blood and urine, vital signs and adverse events were recorded in six groups of 10 healthy male volunteers receiving either iodixanol, a new non-ionic, dimeric X-ray contrast medium for general vascular use, or one of the two non-ionic, monomeric contrast media iopentol and iopamidol. Minor decreases were observed in the values for haemoglobin, haematocrit and erythrocytes 5 min and 3 days after injection of iodixanol. A minor increase was seen in platelets and total protein after 3 days. A transient increase in serum osmolality was seen 5 min after the injections of iopentol and iopamidol. This was not seen in any iodixanol group. The level of thyrotropin showed an increase in all groups at 3 days. It was back to normal within 21 days. No changes of clinical importance were seen regarding blood pressure, heart rate or ECG in any volunteer. No severe adverse events were reported. All events were of short duration, and of mild or moderate intensity. The results, however, may indicate a lower frequency of adverse events/discomfort after the administration of the dimeric iodixanol than the 2 monomeric contrast media iopentol and iopamidol.
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Angiografía , Medios de Contraste , Ácidos Triyodobenzoicos , Adulto , Medios de Contraste/efectos adversos , Método Doble Ciego , Tolerancia a Medicamentos , Humanos , Yopamidol/efectos adversos , Masculino , Persona de Mediana Edad , Concentración Osmolar , Estudios Retrospectivos , Ácidos Triyodobenzoicos/efectos adversosRESUMEN
A new nonionic dimeric contrast medium (CM), iodixanol, was intravenously administered to 40 healthy male volunteers in doses of 0.3-1.2 g of iodine per kilogram of body weight, nonionic monomeric iopamidol and iopentol were administered to 20 others, and the renal effects were studied up to 120 hours after administration. Computed tomography of the kidneys was performed up to 80 hours after injection. Creatinine clearance as an index of the glomerular filtration rate was unchanged with all CM. Urine volume and osmolar clearance increased most with the monomeric CM. The proximal tubular brush border enzyme alkaline phosphatase increased with all CM. The lysosomal enzyme N-acetyl-beta-glucosaminidase increased more with the monomeric CM than with iodixanol. A persistent increased attenuation in the region of the cortex was observed with all CM. Attenuation returned to baseline within 80 hours, with the slowest decline with iodixanol. This delayed cortical enhancement did not correlate with the effects of the CM on the tubular enzyme excretion.
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Medios de Contraste/farmacología , Pruebas de Función Renal , Riñón/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Acetilglucosaminidasa/orina , Adulto , Fosfatasa Alcalina/orina , Creatinina/orina , Diuresis/efectos de los fármacos , Humanos , Yopamidol/farmacología , Riñón/efectos de los fármacos , Masculino , Concentración Osmolar , Valores de Referencia , Ácidos Triyodobenzoicos/farmacología , Microglobulina beta-2/orinaRESUMEN
The objective of the present study was to investigate the quality of clinical trial publications on X-ray contrast media by use of a simple criteria list with 11 items. The publication quality in the 1960s, 1970s and 1980s and in five radiological journals was compared. One hundred and three articles retrieved from the literature and published in Br J Radiol (British), Acta Radiol (Scandinavian), Radiology (American), RöFo (German) and in Ann Radiol (French) were finally included. The adapted method seemed to be suitable for roughly assessing the quality of contrast medium publications. The present reporting standard has increased considerably since the 1960s, however a higher standard is still needed. Although the limited material gathered in our investigation does not allow unequivocal statements, the results indicate that the reporting standard of the 1980s in the selected American, British and Scandinavian radiological journals was somewhat better than in the German journal and better than in the French journal. Use of the present or other assessment methods is one tool to improve the reporting standard.
Asunto(s)
Ensayos Clínicos como Asunto , Escritura , Medios de Contraste , Humanos , Publicaciones Periódicas como AsuntoRESUMEN
In 39 patients the bioavailability of methotrexate from the two tablets Emthexat 2.5 mg and Methotrexate 2.5 mg was assessed in a double-blind study after a single oral dose of 30 mg/m2 Methotrexate. There was a considerable inter-individual variation of the serum pharmacokinetics in regard to Cmax and tmax, independent on the MTX formulation. Emthexat 2.5 mg tablets and Methotrexate 2.5 mg tablets were bioequivalent according to the definition (AUCE greater than or equal to AUCM X 80%).