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1.
JAMA Intern Med ; 180(2): 223-230, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31816007

RESUMO

Importance: Risk of nephrogenic systemic fibrosis (NSF) to individual patients with stage 4 or 5 chronic kidney disease (CKD; defined as estimated glomerular filtration rate of <30 mL/min/1.73 m2) who receive a group II gadolinium-based contrast agent (GBCA) is not well understood or summarized in the literature. Objective: To assess the pooled risk of NSF in patients with stage 4 or 5 CKD receiving a group II GBCA. Data Sources: A health sciences informationist searched the Ovid (MEDLINE and MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citation, and Daily and Versions), Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Open Grey databases from inception to January 29, 2019, yielding 2700 citations. Study Selection: Citations were screened for inclusion in a multistep process. Agreement for final cohort inclusion was determined by 2 blinded screeners using Cohen κ. Inclusion criteria consisted of stage 4 or 5 CKD with or without dialysis, administration of an unconfounded American College of Radiology classification group II GBCA (gadobenate dimeglumine, gadobutrol, gadoterate meglumine, or gadoteridol), and incident NSF as an outcome. Conference abstracts, retracted manuscripts, narrative reviews, editorials, case reports, and manuscripts not reporting total group II GBCA administrations were excluded. Data Extraction and Synthesis: Data extraction was performed for all studies by a single investigator, including publication details, study design and time frame, patient characteristics, group II GBCA(s) administered, total exposures for patients with stage 4 or stage 5 CKD, total cases of unconfounded NSF, reason for GBCA administration, follow-up duration, loss to follow-up, basis for NSF screening, and diagnosis. Main Outcomes and Measures: Pooled incidence of NSF and the associated upper bound of a 2-sided 95% CI (risk estimate) for the pooled data and each of the 4 group II GBCAs. Results: Sixteen unique studies with 4931 patients were included (κ = 0.68) in this systematic review and meta-analysis. The pooled incidence of NSF was 0 of 4931 (0%; upper bound of 95% CI, 0.07%). The upper bound varied owing to different sample sizes for gadobenate dimeglumine (0 of 3167; upper bound of 95% CI, 0.12%), gadoterate meglumine (0 of 1204; upper bound of 95% CI, 0.31%), gadobutrol (0 of 330; upper bound of 95% CI, 1.11%), and gadoteridol (0 of 230; upper bound of 95% CI, 1.59%). Conclusions and Relevance: This study's findings suggest that the risk of NSF from group II GBCA administration in stage 4 or 5 CKD is likely less than 0.07%. The potential diagnostic harms of withholding group II GBCA for indicated examinations may outweigh the risk of NSF in this population. Trial Registration: PROSPERO identifier: CRD42019123284.


Assuntos
Meios de Contraste/efeitos adversos , Dermopatia Fibrosante Nefrogênica/induzido quimicamente , Insuficiência Renal Crônica/metabolismo , Contraindicações de Medicamentos , Gadolínio/efeitos adversos , Taxa de Filtração Glomerular , Compostos Heterocíclicos/efeitos adversos , Humanos , Meglumina/efeitos adversos , Meglumina/análogos & derivados , Compostos Organometálicos/efeitos adversos , Guias de Prática Clínica como Assunto , Risco , Índice de Gravidade de Doença , Estados Unidos , United States Food and Drug Administration
2.
Acta Radiol ; 61(7): 910-920, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31739672

RESUMO

BACKGROUND: Magnetic resonance imaging (MRI) examinations with intravenous (IV) contrast are performed worldwide in routine daily practice. In order to detect and enumerate even rare adverse events (AE) and serious adverse events (SAE), and to relate them with patients' baseline characteristics and diagnostic effectiveness, high quantity sample size is necessary. PURPOSE: To assess safety, diagnostic effectiveness, and baseline characteristics of patients undergoing IV gadoteric acid (Dotarem®) MRI in routine practice. MATERIAL AND METHODS: Data from two observational post-marketing surveillance (PMS) databases compiled by 139 and 52 German centers in 2004-2011 and 2011-2013, respectively, were pooled, yielding data on a total of 148,489 patients examined over a 10-year period. Radiologists used a standardized questionnaire to report data including patient demographics, characteristics of MR examinations, and results in terms of diagnosis and patient safety. RESULTS: Overall, 712 AEs were reported in 467 (0.3%) patients, mainly nausea (n = 224, 0.2%), vomiting (n = 29, <0.1%), urticaria (n = 20, <0.1%), and feeling hot (n = 13, <0.1%). AEs were considered related to gadoteric acid in 362 (0.2%) patients. Higher frequencies of AEs were observed among patients with a previous reaction to a contrast agent (2.0%), liver dysfunction (0.7%), bronchial asthma (0.7%), and a history of allergies (0.6%). There were 49 SAEs in 18 (<0.1%) patients, including two children. No fatal SAE was reported. Examinations were diagnostic in 99.8% of all patients, and image quality was excellent or good in 97.7% of the patients. CONCLUSION: Gadoteric acid is a safe peri-examinational and effective contrast agent for MRI in routine practice.


Assuntos
Meios de Contraste/administração & dosagem , Meios de Contraste/efeitos adversos , Imagem por Ressonância Magnética , Meglumina/administração & dosagem , Meglumina/efeitos adversos , Compostos Organometálicos/administração & dosagem , Compostos Organometálicos/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Alemanha , Humanos , Lactente , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Inquéritos e Questionários
3.
AJNR Am J Neuroradiol ; 40(12): 2001-2009, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31727753

RESUMO

BACKGROUND AND PURPOSE: Contrast-enhanced MR imaging provides essential information for pediatric imaging applications. We evaluated gadobenate dimeglumine for contrast-enhanced MR imaging of infants younger than 2 years of age. MATERIALS AND METHODS: Ninety children younger than 2 years of age (including 55 children younger than 1 year) who underwent enhanced MR imaging of the CNS with gadobenate dimeglumine at 0.1 mmol/kg body weight ± 25% by volume were retrospectively enrolled at 2 imaging centers. Safety data were assessed for adverse events and, when available, vital signs and electrocardiogram and clinical laboratory values obtained from 48 hours before until 48 hours after the MR imaging examination. The efficacy of gadobenate dimeglumine-enhanced MR imaging was evaluated prospectively by 3 blinded, unaffiliated readers in terms of the accuracy of combined pre- and postcontrast images relative to precontrast images alone for differentiation of tumor from non-neoplastic disease and the correct diagnosis of specific disease. Differences were tested using the McNemar test. A possible effect of dose on diagnostic accuracy was assessed using the Fisher exact test. RESULTS: Nine nonserious adverse events were reported for 8 (8.8%) patients. Five adverse events occurred in patients 12 months of age or older. All events occurred at least 24 hours after gadobenate dimeglumine administration, and in each case, the investigating radiologist considered that there was no reasonable possibility of a relationship to gadobenate dimeglumine. No clinically meaningful changes in vital signs, electrocardiogram results, or laboratory parameters were reported. Accurate differentiation of tumor from non-neoplastic disease and exact matching of each specific MR imaging-determined diagnosis with the on-site final diagnosis were achieved in significantly more patients by each reader following evaluation of combined pre- and postcontrast images relative to precontrast images alone (91.0%-94.4% versus 75.3%-87.6%, P < .04, and 66.3%-73.0% versus 52.8%-58.4%, P < .02, respectively). No significant differences (P > .133) in diagnostic accuracy were noted between patients receiving ≤0.08 mmol/kg of gadobenate dimeglumine and patients receiving >0.08 mmol/kg of gadobenate dimeglumine. CONCLUSIONS: Gadobenate dimeglumine is safe and effective for pediatric MR imaging.


Assuntos
Encéfalo/diagnóstico por imagem , Meios de Contraste/efeitos adversos , Meios de Contraste/farmacologia , Imagem por Ressonância Magnética/métodos , Meglumina/análogos & derivados , Compostos Organometálicos/efeitos adversos , Compostos Organometálicos/farmacologia , Coluna Vertebral/diagnóstico por imagem , Neoplasias do Sistema Nervoso Central/diagnóstico por imagem , Relação Dose-Resposta a Droga , Eletrocardiografia , Feminino , Humanos , Aumento da Imagem , Lactente , Recém-Nascido , Masculino , Meglumina/efeitos adversos , Meglumina/farmacologia , Reprodutibilidade dos Testes , Estudos Retrospectivos
4.
Radiology ; 293(2): 317-326, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31549944

RESUMO

Background Gadoxetate disodium has been associated with various respiratory irregularities at arterial imaging MRI. Purpose To measure the relationship between gadolinium-based contrast agent administration and irregularities by comparing gadoxetate disodium and gadoterate meglumine at free breathing. Materials and Methods This prospective observational cohort study (January 2015 to May 2017) included consecutive abdominal MRI performed with either gadoxetate disodium or gadoterate meglumine enhancement. Participants underwent dynamic imaging by using the golden-angle radial sparse parallel sequence at free breathing. The quantitative assessment evaluated the aortic contrast enhancement, the respiratory hepatic translation, and the k-space-derived respiratory pattern. Analyses of variance compared hemodynamic metrics, respiratory-induced hepatic motion, and respiratory parameters before and after respiratory gating. Results A total of 497 abdominal MRI examinations were included. Of these, 338 participants were administered gadoxetate disodium (mean age, 59 years ± 15; 153 women) and 159 participants were administered gadoterate meglumine (mean age, 59 years ± 17; 85 women). The arterial bolus of gadoxetate disodium arrived later than gadoterate meglumine (19.7 vs 16.3 seconds, respectively; P < .001). Evaluation of the hepatic respiratory translation showed respiratory motion occurring in 70.7% (239 of 338) of participants who underwent gadoxetate-enhanced examinations and in 28.9% (46 of 159) of participants who underwent gadoterate-enhanced examinations (P < .001). The duration of motion irregularities was longer for gadoxetate than for gadoterate (19.2 seconds vs 17.2 seconds, respectively) and the motion irregularities were more severe (P < .001). Both the respiratory frequency and amplitude were shorter for participants administered gadoxetate from the prebolus phase to the late arterial phase compared with gadoterate (P < .001). Conclusion The administration of two different gadolinium-based contrast agents, gadoxetate and gadoterate, at free-breathing conditions potentially leads to respiratory irregularities with differing intensity and onset. © RSNA, 2019 Online supplemental material is available for this article.


Assuntos
Gadolínio DTPA/efeitos adversos , Meglumina/efeitos adversos , Compostos Organometálicos/efeitos adversos , Transtornos Respiratórios/induzido quimicamente , Adulto , Idoso , Idoso de 80 Anos ou mais , Meios de Contraste/administração & dosagem , Meios de Contraste/efeitos adversos , Meios de Contraste/farmacologia , Feminino , Gadolínio DTPA/administração & dosagem , Gadolínio DTPA/farmacologia , Hemodinâmica/efeitos dos fármacos , Humanos , Fígado/diagnóstico por imagem , Fígado/fisiopatologia , Imagem por Ressonância Magnética/métodos , Masculino , Meglumina/administração & dosagem , Meglumina/farmacologia , Pessoa de Meia-Idade , Movimento/fisiologia , Compostos Organometálicos/administração & dosagem , Compostos Organometálicos/farmacologia , Pletismografia/métodos , Estudos Prospectivos , Transtornos Respiratórios/diagnóstico por imagem , Adulto Jovem
5.
Radiology ; 292(3): 620-627, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31264948

RESUMO

Background Acute allergic-like and physiologic reactions occur following administration of gadolinium-based contrast agents (GBCAs) for MRI examinations. Because these reactions are uncommon, it is challenging to compare reaction rates between GBCAs and to determine risk factors. Purpose To compare reaction rates between the four GBCAs gadodiamide, gadobutrol, gadobenate dimeglumine, and gadoterate meglumine, and to determine potential risk factors for reactions. Materials and Methods This retrospective study identified all intravenous GBCA injections for MRI examinations performed at a single institution from June 1, 2009, to May 9, 2017. Reactions were identified by reviewing records from the MRI technologist, MRI nursing staff, radiologist, emergency department, and provider. Reactions were classified as allergic-like or physiologic and as mild, moderate, or severe by using American College of Radiology criteria. GBCA reaction rates and other potential risk factors were examined by using multivariable regression models with generalized estimating equations. Results Analysis included a total of 158 100 patients (median age, 55 years [interquartile range, 40-67 years], 51% women) who received a total of 281 945 GBCA injections (140 645 gadodiamide, 94 109 gadobutrol, 39 138 gadobenate, and 8053 gadoterate). At multivariate analysis, gadobenate or gadobutrol had higher rates of allergic-like reactions compared with gadodiamide (gadobenate: odds ratio [OR], 3.9 [95% confidence interval {CI}: 3.0, 5.1]; P < .001; gadobutrol: OR, 2.3 [95% CI: 1.8, 2.9]; P < .001) or gadoterate (gadobenate: OR, 4.8 [95% CI: 1.0, 23]; P = .049; gadobutrol: OR, 2.8 [95% CI: 0.6, 14]; P = .20). Physiologic reactions were more frequently observed with gadoterate (OR, 7.7 [95% CI: 2.3, 25; P = .001), gadobenate (OR, 1.8 [95% CI: 1.3, 2.5; P < .001), and gadobutrol (OR, 1.6 [95% CI: 1.3, 2.1; P < .001) administration compared with gadodiamide. Six severe allergic-like reactions (three gadobutrol, three gadobenate) occurred requiring hospitalization. Patient age (P values .025 to < .001), sex (P < .001), location (P = .006), and MRI type (P = .003 and P = .006) were associated with acute reactions. Conclusion Gadobenate and gadobutrol are associated with higher rates of allergic-like reactions compared with gadodiamide or gadoterate, and gadoterate, gadobenate, and gadobutrol are associated with higher rates of physiologic reactions compared with gadodiamide. Patient sex, age, location, and MRI type correlate with acute reaction rates. © RSNA, 2019 Online supplemental material is available for this article.


Assuntos
Meios de Contraste/efeitos adversos , Hipersensibilidade a Drogas/epidemiologia , Doença Aguda , Adulto , Idoso , Meios de Contraste/administração & dosagem , Feminino , Gadolínio/administração & dosagem , Gadolínio/efeitos adversos , Gadolínio DTPA/administração & dosagem , Gadolínio DTPA/efeitos adversos , Compostos Heterocíclicos/administração & dosagem , Compostos Heterocíclicos/efeitos adversos , Humanos , Injeções Intravenosas , Imagem por Ressonância Magnética , Masculino , Meglumina/administração & dosagem , Meglumina/efeitos adversos , Meglumina/análogos & derivados , Pessoa de Meia-Idade , Compostos Organometálicos/administração & dosagem , Compostos Organometálicos/efeitos adversos , Estudos Retrospectivos , Fatores de Risco
8.
Transplantation ; 103(6): e159-e163, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30801544

RESUMO

BACKGROUND: Intravenous contrast-enhanced imaging is invaluable in diagnosing pathology following liver transplantation. Given the potential risk of contrast nephropathy associated with iodinated computed tomography contrast, alternate contrast modalities need to be examined, especially in the setting of renal insufficiency. The purpose of this study was to examine the renal safety of MRI with gadolinium following liver transplantation. METHODS: The study involved a retrospective analysis of 549 cases of abdominal MRI with low-dose gadobenate dimeglumine in liver transplant recipients at a single center. For each case, serum creatinine values before and after the MRI were compared. In addition, cases were analyzed for the development of nephrogenic systemic fibrosis. RESULTS: Pre-MRI creatinine values ranged from 0.32 to 6.57 mg/dL (median, 1.28 g/dL), with 191 cases having values ≥1.5 mg/dL (median, 1.86 g/dL). A comparison of the pre- and post-MRI creatinine values showed no significant difference, including those patients with pre-MRI values ≥1.5 mg/dL (mean change of -0.04 [95% confidence interval, -0.07 to -0.01; P = 0.004]). No cases of nephrogenic systemic fibrosis were noted. CONCLUSIONS: Our findings suggest that, irrespective of baseline renal function, MRI with gadobenate dimeglumine is a nonnephrotoxic imaging modality in liver transplant recipients. Importantly, this intravenous contrast-enhanced imaging modality can be considered in those posttransplant patients who have a contraindication to computed tomography contrast due to renal insufficiency.


Assuntos
Lesão Renal Aguda/induzido quimicamente , Meios de Contraste/efeitos adversos , Transplante de Fígado/efeitos adversos , Imagem por Ressonância Magnética/efeitos adversos , Meglumina/análogos & derivados , Dermopatia Fibrosante Nefrogênica/induzido quimicamente , Compostos Organometálicos/efeitos adversos , Complicações Pós-Operatórias/diagnóstico por imagem , Lesão Renal Aguda/diagnóstico , Lesão Renal Aguda/epidemiologia , Administração Intravenosa , Adulto , Idoso , Biomarcadores/sangue , Meios de Contraste/administração & dosagem , Creatinina/sangue , Feminino , Georgia/epidemiologia , Humanos , Incidência , Masculino , Meglumina/administração & dosagem , Meglumina/efeitos adversos , Pessoa de Meia-Idade , Dermopatia Fibrosante Nefrogênica/diagnóstico , Dermopatia Fibrosante Nefrogênica/epidemiologia , Compostos Organometálicos/administração & dosagem , Complicações Pós-Operatórias/epidemiologia , Insuficiência Renal/diagnóstico , Insuficiência Renal/epidemiologia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo
9.
Invest Radiol ; 54(5): 312-318, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30480553

RESUMO

INTRODUCTION: The potential adverse renal outcome among patients undergoing iodine-based contrast-enhanced computerized tomography (CT) has been questioned recently, given the caution undertaken in patients' selection, hydration protocols, and the low radiocontrast volume, used with advanced imaging equipment. MATERIALS AND METHODS: This study is a retrospective assessment of renal outcome in 12,580 hospitalized patients undergoing contrast-enhanced CT, compared with 754 patients subjected to gadolinium-based magnetic resonance imaging, with subsequent propensity matching for clinical characteristics and potential risk factors. RESULTS: The risk of postcontrast acute kidney injury (PC-AKI) was found to be negligible as compared with patients undergoing enhanced magnetic resonance imaging studies, before and after propensity matching (8% vs 7.3% rate of AKI in the nonmatched iodine-based contrast agents [IBCAs] and gadolinium-based contrast agents [GBCAs], respectively, P = 0.3, and 7% in the matched IBCA group, P = 0.9), including comparisons among subgroups with well-defined risk factors such as chronic renal failure, diabetes, older age, and hypertension. However, lower systolic blood pressure before imaging was associated with higher risk to develop PC-AKI after IBCA administration but not with GBCA (for systolic blood pressure lower than 110 mm Hg, odds ratio for AKI after IBCA was 1.49; 95% confidence interval, 1.16-1.88, and after GBCA; odds ratio, 0.12; 95% confidence interval, 0.003-0.73). CONCLUSIONS: With the current precautions undertaken, the real-life risk of PC-AKI among inpatients undergoing CT is insignificant. Possible reasons for the diverse impact of blood pressure on the propensity to develop acute kidney failure after iodine-based but not gadolinium-based enhancement imaging are discussed.


Assuntos
Lesão Renal Aguda/epidemiologia , Meios de Contraste/efeitos adversos , Iohexol/efeitos adversos , Imagem por Ressonância Magnética , Meglumina/efeitos adversos , Compostos Organometálicos/efeitos adversos , Tomografia Computadorizada por Raios X , Lesão Renal Aguda/induzido quimicamente , Feminino , Gadolínio/efeitos adversos , Humanos , Pacientes Internados , Iodo , Israel/epidemiologia , Rim , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco
10.
Invest Radiol ; 54(4): 191-197, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30379729

RESUMO

OBJECTIVE: This study compares the incidence of new-onset symptoms within 24 hours after enhanced magnetic resonance imaging (eMRI) with intravenous administration of gadodiamide or gadoterate meglumine compared with a control group undergoing unenhanced MRI (uMRI). MATERIALS AND METHODS: A prospective cohort study (n = 1088 patients) was designed to assess the incidence of symptoms within 24 hours after administration of gadodiamide or gadoterate meglumine. The participants underwent a structured questionnaire by phone call before and 24 hours after the MRI scan to check for symptoms that were not present before the scan. The questionnaire included a list of active questions aimed to test the prevalence of symptoms that have been proposed in the debated definition of gadolinium deposition disease (GDD) and that we recorded in this study as GDD-like. In particular, the following symptoms and signs were tested: central torso pain, arm or leg pain, bone pain, headache, skin redness (any site of the body), fatigue, and mental confusion.Fisher exact test was used to test differences between groups with significance threshold set at P < 0.05. RESULTS: Within the 24 hours after the MRI scan, 8.3% of patients reported at least one new-onset symptom in the uMRI group versus 17.4% in the gadodiamide eMRI versus 17.8% in the gadoterate meglumine eMRI group. The difference between the eMRI and the uMRI group was statistically significant (P < 0.001 for gadodiamide and P < 0.001 for gadoterate meglumine). There was not a different incidence of symptoms between the gadodiamide and the gadoterate meglumine eMRI groups. For gadodiamide, fatigue (P < 0.05) and dizziness (P < 0.05) were symptoms significantly more frequent than uMRI group; for gadoterate meglumine, fatigue (P < 0.01), mental confusion (P < 0.01), and diarrhea (P < 0.01) were significantly more frequent than uMRI group. CONCLUSIONS: We found that the onset of new symptoms within 24 hours after exposure to gadolinium-based contrast agent was more frequent than after uMRI. Among GDD-like symptoms, fatigue and mental confusion were the most frequent symptoms reported after eMRI. The other GDD-like symptoms were not overreported after eMRI versus uMRI. Thus, these results are questioning the term GDD.


Assuntos
Meios de Contraste/efeitos adversos , Gadolínio DTPA/efeitos adversos , Aumento da Imagem/métodos , Meglumina/efeitos adversos , Compostos Organometálicos/efeitos adversos , Inquéritos e Questionários/estatística & dados numéricos , Administração Intravenosa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Meios de Contraste/administração & dosagem , Feminino , Gadolínio DTPA/administração & dosagem , Humanos , Incidência , Imagem por Ressonância Magnética/métodos , Masculino , Meglumina/administração & dosagem , Pessoa de Meia-Idade , Compostos Organometálicos/administração & dosagem , Estudos Prospectivos , Adulto Jovem
11.
Pediatr Radiol ; 48(12): 1724-1735, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30046901

RESUMO

BACKGROUND: Given the recent concerns about gadolinium-based contrast agent safety, dose reduction strategies are being investigated. OBJECTIVE: To compare half-dose and standard full-dose gadoterate meglumine at 3-tesla (T) MRI in paediatric bone and soft-tissue diseases. MATERIALS AND METHODS: We prospectively enrolled 45 children (age range 2.7 months to 17.5 years, median age 8.7 years, 49 total anatomical segments) with bone and soft-tissue diseases (neoplastic, inflammatory/infectious, ischaemic and vascular) imaged at 3-T MRI. Two consecutive half-doses of gadoterate meglumine (0.05 mmol/kg body weight) were administered. Two sets of post-contrast T1-weighted images were obtained, one after the first half dose and the other after the second half dose. For qualitative analysis, three radiologists, masked to the gadolinium dose, compared the diagnostic quality of the images. For quantitative analysis, we compared signal-to-noise ratio and contrast-to-noise ratio at half and full doses. RESULTS: Signal-to-noise ratio and contrast-to-noise ratio did not vary significantly between the two groups. Qualitative analysis yielded excellent image quality in both post-contrast image datasets (Cohen κ=0.8). CONCLUSION: In paediatric bone and soft-tissue 3-T MRI, it is feasible to halve the standard dose of gadoterate meglumine without losing image quality.


Assuntos
Meios de Contraste/administração & dosagem , Imagem por Ressonância Magnética/métodos , Meglumina/administração & dosagem , Doenças Musculoesqueléticas/diagnóstico por imagem , Compostos Organometálicos/administração & dosagem , Doenças Vasculares/diagnóstico por imagem , Adolescente , Criança , Pré-Escolar , Meios de Contraste/efeitos adversos , Feminino , Humanos , Lactente , Masculino , Meglumina/efeitos adversos , Compostos Organometálicos/efeitos adversos , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Razão Sinal-Ruído
12.
Mem Inst Oswaldo Cruz ; 113(9): e180200, 2018 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-29947651

RESUMO

BACKGROUND: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES: The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS: It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS: A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).


Assuntos
Antiprotozoários/administração & dosagem , Leishmaniose Cutânea/tratamento farmacológico , Meglumina/administração & dosagem , Compostos Organometálicos/administração & dosagem , Adolescente , Adulto , Idoso , Antiprotozoários/efeitos adversos , Brasil , Feminino , Humanos , Injeções Intralesionais , Leishmaniose Cutânea/fisiopatologia , Masculino , Meglumina/efeitos adversos , Antimoniato de Meglumina , Pessoa de Meia-Idade , Compostos Organometálicos/efeitos adversos , Resultado do Tratamento , Adulto Jovem
13.
World J Gastroenterol ; 24(13): 1486-1490, 2018 Apr 07.
Artigo em Inglês | MEDLINE | ID: mdl-29632429

RESUMO

This case highlights a patient with Gilbert syndrome who underwent endoscopic retrograde cholangiopancreatography (ERCP) with removal of bile duct stones, who then experienced an unexplained increase in bilirubin, with total bilirubin (TBIL) levels increasing from 159.5 µmol/L to 396.2 µmol/L and to a maximum of 502.8 µmol/L after 9 d. Following the decrease in the TBIL level, enhanced magnetic resonance cholangiopancreatography (MRCP) was performed to exclude any possible remaining choledocholithiasis. Nevertheless, the serum bilirubin level increased again, with TBIL levels rising from 455.7 µmol/L to 594.8 µmol/L and a maximum level of 660.3 µmol/L with no remaining bile duct stones. A liver biopsy showed severe bile duct cholestasis with no inflammation. Based on the exclusion of other potential causes of hyperbilirubinemia and the fact that both instances of increased bilirubin occurred after ERCP and MRCP, the contrast agents iopromide and gadoterate meglumine were suspected to be the causes of the hyperbilirubinemia. As of the writing of this report, the patient's bilirubin levels have spontaneously returned to baseline levels. In summary, ERCP and MRCP utilizing the contrast agents iopromide and gadoterate meglumine may possibly induce prolonged hyperbilirubinemia.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangiopancreatografia por Ressonância Magnética/efeitos adversos , Coledocolitíase/cirurgia , Meios de Contraste/efeitos adversos , Doença de Gilbert/sangue , Icterícia Obstrutiva/induzido quimicamente , Adulto , Bilirrubina/sangue , Biópsia , Colangiopancreatografia Retrógrada Endoscópica/métodos , Coledocolitíase/diagnóstico por imagem , Humanos , Iohexol/efeitos adversos , Iohexol/análogos & derivados , Icterícia Obstrutiva/sangue , Icterícia Obstrutiva/diagnóstico por imagem , Icterícia Obstrutiva/patologia , Fígado/diagnóstico por imagem , Fígado/patologia , Testes de Função Hepática , Masculino , Meglumina/efeitos adversos , Compostos Organometálicos/efeitos adversos , Remissão Espontânea
15.
AJR Am J Roentgenol ; 210(4): 715-719, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29412016

RESUMO

OBJECTIVE: The objective or our study was to assess the incidence rate and clinical characteristics of allergiclike reactions in patients who received both nonionic iodinated contrast medium (ICM) and gadolinium-based contrast medium (GBCM). MATERIALS AND METHODS: Acute allergiclike reactions in patients who received both ICM and GBCM to nonionic ICM or GBCM injections during a 5-year period were analyzed. Allergy preparation was not administered when patients received a different type of contrast material. Acute allergiclike reactions to both ICM and GBCM were evaluated. RESULTS: Of 302,858 contrast injections (155,234 ICM and 147,624 GBCM) during a 5-year period, 1006 (752 ICM and 254 GBCM) acute allergiclike contrast reactions were reported. The overall rate of reaction to ICM was 0.48% (95% CI, 0.45-0.52%), and the overall rate of reaction to GBCM was 0.17% (95% CI, 0.15-0.19%). A total of 19,237 patients received at least one ICM injection and one GBCM injection, with a total of 56,310 injections (19,237 initial injections and 37,073 subsequent injections). Nine patients had reactions to both ICM and GBCM with the primary reaction rate of 9/19,237 (incidence rate, 0.047%; 95% CI, 0.044-0.050%), and the secondary reaction rate of 9/37,073 (incidence rate, 0.024%; 95% CI, 0.023-0.026%). All secondary reactions in patients who had a reaction to both ICM and GBCM were mild. None of the patients required medication for the treatment of the secondary reaction. CONCLUSION: An allergiclike reaction to both nonionic ICM and GBCM was an extremely rare event that presented as a mild acute reaction without significant clinical consequences despite the fact that an allergy preparation was not administered.


Assuntos
Meios de Contraste/efeitos adversos , Hipersensibilidade a Drogas/epidemiologia , Gadolínio/efeitos adversos , Iodo/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Gadolínio DTPA/efeitos adversos , Humanos , Incidência , Masculino , Meglumina/efeitos adversos , Meglumina/análogos & derivados , Pessoa de Meia-Idade , Compostos Organometálicos/efeitos adversos , Estudos Retrospectivos , Fatores de Risco
16.
Invest Radiol ; 53(9): 551-554, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29470193

RESUMO

PURPOSE: The aim of this study was to determine the severity of breakthrough reactions to gadobenate dimeglumine in patients premedicated with a 13-hour premedication regimen. METHODS: Institutional review board approval was obtained and informed consent waived for this Health Insurance Portability and Accountability Act-compliant retrospective cohort study. All acute allergic-like reactions to gadobenate dimeglumine from 11/1/2008 to 1/31/2016 were identified. Of these, 19 allergic-like reactions followed 13-hour premedication: 150 mg prednisone and 50 mg diphenhydramine (ie, "breakthrough reactions"). Reasons for premedication, risk factors, index reaction characteristics, and breakthrough reaction characteristics were catalogued. Reaction severities were assigned using American College of Radiology guidelines. Severities of breakthrough (n = 19) and nonbreakthrough reactions (n = 97) were compared with the Cochran-Armitage test for trend. RESULTS: Premedication was most commonly given (63% [12/19]) for a previous allergic-like reaction to gadolinium-based contrast material (GBCM); in 37% (7/19), it was given for a different risk factor. In those premedicated for a previous allergic-like reaction to GBCM of known severity (n = 9), the breakthrough reaction severity was the same as index reaction severity in 56% (5/9), less severe in 11% (1/9), and of greater severity in 33% (3/9). Two severe breakthrough reactions occurred; both were in subjects premedicated for risk factors other than a previous GBCM reaction. No subjects died. Five subjects were reexposed to GBCM a total of 9 times; no repeat breakthrough reactions occurred. Breakthrough reactions were more severe than nonbreakthrough reactions (P = 0.046), but the level of significance was borderline. CONCLUSION: Premedication does not eliminate severe reactions to gadobenate dimeglumine. Breakthrough reactions to gadobenate dimeglumine can be of greater severity than index reactions.


Assuntos
Meios de Contraste/efeitos adversos , Hipersensibilidade a Drogas/epidemiologia , Meglumina/análogos & derivados , Compostos Organometálicos/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Meglumina/efeitos adversos , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença
17.
Invest Radiol ; 53(5): 313-318, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29337841

RESUMO

OBJECTIVES: The purpose of this study is to determine the frequency and severity of acute allergic-like reactions to gadolinium-based contrast media (GBCM) in children before, during, and after the transition from gadopentetate dimeglumine to gadoterate meglumine as our primary clinical GBCM. MATERIALS AND METHODS: Institutional review board approval was obtained for this Health Insurance Portability and Accountability Act-compliant retrospective investigation. Allergic-like reactions to GBCM in pediatric patients were retrospectively assessed from January 2009 to January 2017, which included a departmental change of GBCM from gadopentetate dimeglumine to gadoterate meglumine. Allergic-like reactions were identified from departmental and hospital databases. The number of doses of GBCM was obtained from billing data. Allergic-like reaction frequencies for each GBCM were calculated and compared using the chi-squared test. RESULTS: A total of 32,365 administrations of GBCM occurred during the study period (327 for gadofosveset trisodium; 672 for gadoxetate disodium; 12,012 for gadoterate meglumine; and 19,354 for gadopentetate dimeglumine). Allergic-like reactions occurred after 21 (0.06%) administrations. Reaction frequencies were not significantly different among the GBCM (0.3% gadofosveset trisodium; 0% gadoxetate disodium, 0.06% gadoterate meglumine, 0.08% gadopentetate dimeglumine; P > 0.05). Ten (47.6%) reactions were mild, 10 (47.6%) were moderate, and 1 (4.8%) was severe. The overall reaction frequency peaked during the 6-month transition period from gadopentetate dimeglumine to gadoterate meglumine (0.20%), compared with 0.07% pretransition (P = 0.048) and 0.04% posttransition (P = 0.0095). CONCLUSION: Allergic-like reactions to GBCM in children are rare. Gadoterate meglumine has a reaction frequency that does not significantly differ from other GBCMs. During the transition from gadopentetate dimeglumine to gadoterate meglumine, an increase in the frequency of reported allergic-like reactions was observed, likely reflective of the Weber effect.


Assuntos
Meios de Contraste/efeitos adversos , Hipersensibilidade a Drogas/epidemiologia , Gadolínio/efeitos adversos , Adolescente , Criança , Pré-Escolar , Meios de Contraste/administração & dosagem , Hipersensibilidade a Drogas/fisiopatologia , Feminino , Gadolínio/administração & dosagem , Gadolínio DTPA/administração & dosagem , Gadolínio DTPA/efeitos adversos , Humanos , Masculino , Meglumina/administração & dosagem , Meglumina/efeitos adversos , Ohio/epidemiologia , Compostos Organometálicos/administração & dosagem , Compostos Organometálicos/efeitos adversos , Estudos Retrospectivos , Índice de Gravidade de Doença
18.
World Neurosurg ; 111: 264-268, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29292188

RESUMO

BACKGROUND: Gadolinium-based contrast agents are relatively safe for use in magnetic resonance imaging (MRI) of nervous system pathology. Few reports have been reported regarding the severe adverse effects. These are mostly mild anaphylactoid reactions, especially in the vulnerable group. CASE DESCRIPTION: We report a case of an adverse effect of gadoteric acid concerning the misuse as intraventricular administration. To our knowledge, this is the first report related to intraventricular spillage and its results. A 38-year-old male patient with a complaint of headache and drowsiness was admitted to the hospital, after which cranial MRI revealed that he had a posterior fossa mass. An operation was performed with the catheterization of the lateral ventricule as a safety device at the beginning, and later mass was evacuated gross totally. Frozen pathology result showed the tumor was medulloblastoma. On the first postoperative day a control contrasted cranial and total spinal MRI was planned. He was observed to have a tonic-clonic generalized seizure soon after returning to the ward. After giving the acute management with antiepileptics, the patient was stabilized and it was recognized that the patient was administered contrast media by the intraventricular route. Symptomatic treatment and cerebrospinal fluid irrigation by external ventricular drainage helped the patient's improvement. After a week his symptoms were relieved and he had no complications during outpatient controls. CONCLUSIONS: In addition to formal basic supportive treatment, cerebrospinal fluid irrigation of the toxic contrast material is the best management method in case of such an unexpected misadministration of gadoteric acid.


Assuntos
Meios de Contraste/efeitos adversos , Imagem por Ressonância Magnética/métodos , Meglumina/efeitos adversos , Compostos Organometálicos/efeitos adversos , Adulto , Anafilaxia/induzido quimicamente , Neoplasias Cerebelares/patologia , Neoplasias Cerebelares/cirurgia , Meios de Contraste/administração & dosagem , Humanos , Infusões Intraventriculares , Masculino , Meduloblastoma/patologia , Meduloblastoma/cirurgia , Meglumina/administração & dosagem , Compostos Organometálicos/administração & dosagem
20.
AJNR Am J Neuroradiol ; 39(1): 24-30, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29146718

RESUMO

BACKGROUND AND PURPOSE: Intrinsic T1-hyperintense signal has recently been reported in the deep gray nuclei on brain MR imaging after multiple doses of gadolinium-based contrast agents. Most reports have included adult patients and excluded those undergoing radiation or chemotherapy. We investigated whether T1 shortening is also observed in children and tried to determine whether radiochemotherapy is a risk factor for this phenomenon. MATERIALS AND METHODS: In this single-center retrospective study, we reviewed clinical charts and images of all patients 18 years of age or younger with ≥4 gadobenate dimeglumine-enhanced MRIs for 6 years. Seventy-six children (mean age, 9.3 years; 60 unconfounded by treatment, 16 with radiochemotherapy) met the selection criteria (>4 MR imaging examinations; mean, 8). T1 signal intensity ratios for the dentate to pons and globus pallidus to thalamus were calculated and correlated with number of injections, time interval, and therapy. RESULTS: Among the 60 children without radiochemotherapy, only 2 had elevated T1 signal intensity ratios (n = 20 and 16 injections). Twelve of the 16 children with radiochemotherapy showed elevated signal intensity ratios. Statistical analysis demonstrated a significant signal intensity ratio change for the number of injections (P < .001) and amount of gadolinium (P = .008), but not for the interscan time interval (P = .35). There was a significant difference in the average signal intensity ratio change between those with and without radiochemotherapy (P < .001). Chart review revealed no new neurologic deficits in any patients, related to their underlying conditions and prior surgeries. CONCLUSIONS: Compared with published adult series, children show a similar pattern of T1 hyperintense signal changes of the dentate and globus pallidus after multiple gadobenate dimeglumine injections. The T1 signal changes in children may have a later onset but are accelerated by radiochemotherapy.


Assuntos
Encéfalo/efeitos dos fármacos , Meios de Contraste/efeitos adversos , Imagem por Ressonância Magnética/métodos , Meglumina/análogos & derivados , Compostos Organometálicos/efeitos adversos , Adolescente , Encéfalo/diagnóstico por imagem , Encéfalo/efeitos da radiação , Neoplasias Encefálicas/tratamento farmacológico , Neoplasias Encefálicas/radioterapia , Quimiorradioterapia , Criança , Feminino , Humanos , Masculino , Meglumina/efeitos adversos , Estudos Retrospectivos
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