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1.
Molecules ; 26(9)2021 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-33946599
2.
Medicine (Baltimore) ; 100(15): e25417, 2021 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-33847640

RESUMO

BACKGROUND: 68Ga-PSMA-PET/CT (positron emission tomography/computed tomography) is a promising method for prostate cancer (PC) detection. However, the ability of 68Ga-PSMA-PET/CT to detect malignant bone lesions, and whether this method is superior to the existing bone imaging methods are still lack of systematic analysis. PURPOSE: To evaluate the value of 68Ga-PSMA-PET/CT and bone scan in clinical diagnosis of prostatic cancer from the perspective of evidence-based medicine. METHODS: PubMed, The Cochrane Library, EMBASE, Springer Link, Sinomed, CNKI, Wanfang database, and CQVIP database were searched to find the satisfactory studies that needed systematic review of trials and compared the value of 68Ga-PSMA-PET/CT and bone scan. All studies published from inception to March 31, 2020. According to the inclusion and exclusion criteria, 2 reviewers independently evaluated and extracted the literature. Review Manager 5.3 was applied to evaluate the included literature quality. The heterogeneity of the included literature was tested by Meta Disc 1.4, and the effect model was selected according to the heterogeneity test results, and the sensitivity (SEN), specificity (SPE), PLR, NLR and diagnostic odds ratio (DOR) were analyzed. After testing the heterogeneity results of literature by using the 95% confidence interval and the forest map. RESULTS: A total of 4 studies were eligible for inclusion in the meta-analysis, which included 318 patients, 120 cases with bone metastasis and 198 cases without bone metastasis. The results of summary evaluation for 68Ga-PSMA-PET/CT and bone scan in diagnosis of prostatic cancer as follow respectively: The SEN were 0.97 and 0.86; the SPE were 1.00 and 0.87; the DOR were 1468.33 and 36.23; PLR were 88.45 and 6.67; NLR were 0.05 and 0.19; and the area under curve (AUC) and 95% CI were 0.9973 (1.0000-0.9927) and 0.8838 (0.9584-0.8092). CONCLUSION: By comparing the diagnostic results of 68Ga-PSMA-PET/CT and bone scan imaging diagnosis methods, the 68Ga-PSMA-PET/CT has a higher SEN and SPE than bone scan, and it has a higher diagnostic efficiency for prostate cancer bone metastasis, which is worthy of clinical application.


Assuntos
Neoplasias Ósseas/secundário , Ácido Edético/análogos & derivados , Oligopeptídeos/administração & dosagem , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Neoplasias da Próstata/patologia , Compostos Radiofarmacêuticos/administração & dosagem , Tomografia Computadorizada por Raios X/métodos , Neoplasias Ósseas/diagnóstico por imagem , Combinação de Medicamentos , Ácido Edético/administração & dosagem , Humanos , Masculino , Nitratos , Fosfatos , Neoplasias da Próstata/diagnóstico por imagem , Sensibilidade e Especificidade
3.
Cochrane Database Syst Rev ; 1: CD011302, 2021 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-33461239

RESUMO

BACKGROUND: Anaemia is a condition where the number of red blood cells (and consequently their oxygen-carrying capacity) is insufficient to meet the body's physiological needs. Fortification of wheat flour is deemed a useful strategy to reduce anaemia in populations. OBJECTIVES: To determine the benefits and harms of wheat flour fortification with iron alone or with other vitamins and minerals on anaemia, iron status and health-related outcomes in populations over two years of age. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, 21 other databases and two trials registers up to 21 July 2020, together with contacting key organisations to identify additional studies. SELECTION CRITERIA: We included cluster- or individually-randomised controlled trials (RCTs) carried out among the general population from any country, aged two years and above. The interventions were fortification of wheat flour with iron alone or in combination with other micronutrients. We included trials comparing any type of food item prepared from flour fortified with iron of any variety of wheat DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results and assessed the eligibility of studies for inclusion, extracted data from included studies and assessed risks of bias. We followed Cochrane methods in this review. MAIN RESULTS: Our search identified 3538 records, after removing duplicates. We included 10 trials, involving 3319 participants, carried out in Bangladesh, Brazil, India, Kuwait, Philippines, South Africa and Sri Lanka. We identified two ongoing studies and one study is awaiting classification. The duration of interventions varied from 3 to 24 months. One study was carried out among adult women and one trial among both children and nonpregnant women. Most of the included trials were assessed as low or unclear risk of bias for key elements of selection, performance or reporting bias. Three trials used 41 mg to 60 mg iron/kg flour, three trials used less than 40 mg iron/kg and three trials used more than 60 mg iron/kg flour. One trial used various iron levels based on type of iron used: 80 mg/kg for electrolytic and reduced iron and 40 mg/kg for ferrous fumarate. All included studies contributed data for the meta-analyses. Iron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added Iron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added may reduce by 27% the risk of anaemia in populations (risk ratio (RR) 0.73, 95% confidence interval (CI) 0.55 to 0.97; 5 studies, 2315 participants; low-certainty evidence). It is uncertain whether iron-fortified wheat flour with or without other micronutrients reduces iron deficiency (RR 0.46, 95% CI 0.20 to 1.04; 3 studies, 748 participants; very low-certainty evidence) or increases haemoglobin concentrations (in g/L) (mean difference MD 2.75, 95% CI 0.71 to 4.80; 8 studies, 2831 participants; very low-certainty evidence). No trials reported data on adverse effects in children (including constipation, nausea, vomiting, heartburn or diarrhoea), except for risk of infection or inflammation at the individual level. The intervention probably makes little or no difference to the risk of Infection or inflammation at individual level as measured by C-reactive protein (CRP) (mean difference (MD) 0.04, 95% CI -0.02 to 0.11; 2 studies, 558 participants; moderate-certainty evidence). Iron-fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added) It is unclear whether wheat flour fortified with iron, in combination with other micronutrients decreases anaemia (RR 0.77, 95% CI 0.41 to 1.46; 2 studies, 317 participants; very low-certainty evidence). The intervention probably reduces the risk of iron deficiency (RR 0.73, 95% CI 0.54 to 0.99; 3 studies, 382 participants; moderate-certainty evidence) and it is unclear whether it increases average haemoglobin concentrations (MD 2.53, 95% CI -0.39 to 5.45; 4 studies, 532 participants; very low-certainty evidence). No trials reported data on adverse effects in children. Nine out of 10 trials reported sources of funding, with most having multiple sources. Funding source does not appear to have distorted the results in any of the assessed trials. AUTHORS' CONCLUSIONS: Fortification of wheat flour with iron (in comparison to unfortified flour, or where both groups received the same other micronutrients) may reduce anaemia in the general population above two years of age, but its effects on other outcomes are uncertain. Iron-fortified wheat flour in combination with other micronutrients, in comparison with unfortified flour, probably reduces iron deficiency, but its effects on other outcomes are uncertain. None of the included trials reported data on adverse side effects except for risk of infection or inflammation at the individual level. The effects of this intervention on other health outcomes are unclear. Future studies at low risk of bias should aim to measure all important outcomes, and to further investigate which variants of fortification, including the role of other micronutrients as well as types of iron fortification, are more effective, and for whom.


Assuntos
Anemia/dietoterapia , Farinha , Alimentos Fortificados , Ferro/administração & dosagem , Triticum , Adolescente , Adulto , Anemia/sangue , Criança , Pré-Escolar , Ácido Edético/administração & dosagem , Feminino , Compostos Férricos/administração & dosagem , Compostos Ferrosos/administração & dosagem , Fumaratos , Hemoglobina A/análise , Humanos , Lactente , Ferro/deficiência , Masculino , Micronutrientes/administração & dosagem , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
4.
Sci Rep ; 10(1): 22073, 2020 12 16.
Artigo em Inglês | MEDLINE | ID: mdl-33328515

RESUMO

The combination of ethylenediaminetetraacetic acid (EDTA) and sodium hypochlorite (NaOCl) has been advocated as an effective irrigation methodology to remove organic and inorganic matter in root canal therapy. Yet, it was suggested that both solutions might lead to structural changes of the dentinal wall surface, depending on the order of application which might affect sealer mechanical retention. This study aims to evaluate the effect of different irrigating protocols on dentin surface roughness using quantitative 3D surface texture analysis. Data stems from 150 human root dentin sections, divided into five groups, each prepared according to one of the following protocols: Negative control; 17% EDTA; 17% EDTA followed by 5.25% NaOCl; 5.25% NaOCl; and 5.25% NaOCl followed by 17% EDTA. Each dentin sample was examined for its three-dimensional surface texture using a high-resolution confocal disc-scanning measuring system. EDTA 17% and the combined EDTA 17% with NaOCl 5.25% showed considerably higher roughness properties compared to the control and to NaOCl 5.25% alone. However, the irrigation sequence did not affect the dentin roughness properties. Therefore, mechanical retention is probably not dependent upon the selection of irrigation protocol sequence.


Assuntos
Ácido Edético/administração & dosagem , Irrigantes do Canal Radicular/administração & dosagem , Tratamento do Canal Radicular , Hipoclorito de Sódio/administração & dosagem , Raiz Dentária , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
5.
Cochrane Database Syst Rev ; 7: CD011302, 2020 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-32677706

RESUMO

BACKGROUND: Anaemia is a condition where the number of red blood cells (and consequently their oxygen-carrying capacity) is insufficient to meet the body's physiologic needs. Fortification of wheat flour is deemed a useful strategy to reduce anaemia in populations. OBJECTIVES: To determine the benefits and harms of wheat flour fortification with iron alone or with other vitamins and minerals on anaemia, iron status and health-related outcomes in populations over two years of age. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, and other databases up to 4 September 2019. SELECTION CRITERIA: We included cluster- or individually randomised controlled trials (RCT) carried out among the general population from any country aged two years and above. The interventions were fortification of wheat flour with iron alone or in combination with other micronutrients. Trials comparing any type of food item prepared from flour fortified with iron of any variety of wheat were included. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results and assessed the eligibility of studies for inclusion, extracted data from included studies and assessed risk of bias. We followed Cochrane methods in this review. MAIN RESULTS: Our search identified 3048 records, after removing duplicates. We included nine trials, involving 3166 participants, carried out in Bangladesh, Brazil, India, Kuwait, Phillipines, Sri Lanka and South Africa. The duration of interventions varied from 3 to 24 months. One study was carried out among adult women and one trial among both children and nonpregnant women. Most of the included trials were assessed as low or unclear risk of bias for key elements of selection, performance or reporting bias. Three trials used 41 mg to 60 mg iron/kg flour, two trials used less than 40 mg iron/kg and three trials used more than 60 mg iron/kg flour. One trial employed various iron levels based on type of iron used: 80 mg/kg for electrolytic and reduced iron and 40 mg/kg for ferrous fumarate. All included studies contributed data for the meta-analyses. Seven studies compared wheat flour fortified with iron alone versus unfortified wheat flour, three studies compared wheat flour fortified with iron in combination with other micronutrients versus unfortified wheat flour and two studies compared wheat flour fortified with iron in combination with other micronutrients versus fortified wheat flour with the same micronutrients (but not iron). No studies included a 'no intervention' comparison arm. None of the included trials reported any other adverse side effects (including constipation, nausea, vomiting, heartburn or diarrhoea). Wheat flour fortified with iron alone versus unfortified wheat flour (no micronutrients added) Wheat flour fortification with iron alone may have little or no effect on anaemia (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.61 to 1.07; 5 studies; 2200 participants; low-certainty evidence). It probably makes little or no difference on iron deficiency (RR 0.43, 95% CI 0.17 to 1.07; 3 studies; 633 participants; moderate-certainty evidence) and we are uncertain about whether wheat flour fortified with iron increases haemoglobin concentrations by an average 3.30 (g/L) (95% CI 0.86 to 5.74; 7 studies; 2355 participants; very low-certainty evidence). No trials reported data on adverse effects in children, except for risk of infection or inflammation at the individual level. The intervention probably makes little or no difference to risk of Infection or inflammation at individual level as measured by C-reactive protein (CRP) (moderate-certainty evidence). Wheat flour fortified with iron in combination with other micronutrients versus unfortified wheat flour (no micronutrients added) Wheat flour fortified with iron, in combination with other micronutrients, may or may not decrease anaemia (RR 0.95, 95% CI 0.69 to 1.31; 2 studies; 322 participants; low-certainty evidence). It makes little or no difference to average risk of iron deficiency (RR 0.74, 95% CI 0.54 to 1.00; 3 studies; 387 participants; moderate-certainty evidence) and may or may not increase average haemoglobin concentrations (mean difference (MD) 3.29, 95% CI -0.78 to 7.36; 3 studies; 384 participants; low-certainty evidence). No trials reported data on adverse effects in children. Wheat flour fortified with iron in combination with other micronutrients versus fortified wheat flour with same micronutrients (but not iron) Given the very low certainty of the evidence, the review authors are uncertain about the effects of wheat flour fortified with iron in combination with other micronutrients versus fortified wheat flour with same micronutrients (but not iron) in reducing anaemia (RR 0.24, 95% CI 0.08 to 0.71; 1 study; 127 participants; very low-certainty evidence) and in reducing iron deficiency (RR 0.42, 95% CI 0.18 to 0.97; 1 study; 127 participants; very low-certainty evidence). The intervention may make little or no difference to the average haemoglobin concentration (MD 0.81, 95% CI -1.28 to 2.89; 2 studies; 488 participants; low-certainty evidence). No trials reported data on the adverse effects in children. Eight out of nine trials reported source of funding with most having multiple sources. Funding source does not appear to have distorted the results in any of the assessed trials. AUTHORS' CONCLUSIONS: Eating food items containing wheat flour fortified with iron alone may have little or no effect on anaemia and probably makes little or no difference in iron deficiency. We are uncertain on whether the intervention with wheat flour fortified with iron increases haemoglobin concentrations improve blood haemoglobin concentrations. Consuming food items prepared from wheat flour fortified with iron, in combination with other micronutrients, has little or no effect on anaemia, makes little or no difference to iron deficiency and may or may not improve haemoglobin concentrations. In comparison to fortified flour with micronutrients but no iron, wheat flour fortified with iron with other micronutrients, the effects on anaemia and iron deficiency are uncertain as certainty of the evidence has been assessed as very low. The intervention may make little or no difference to the average haemoglobin concentrations in the population. None of the included trials reported any other adverse side effects. The effects of this intervention on other health outcomes are unclear.


Assuntos
Anemia/dietoterapia , Farinha , Alimentos Fortificados , Ferro/administração & dosagem , Triticum , Adolescente , Adulto , Anemia/sangue , Criança , Pré-Escolar , Ácido Edético/administração & dosagem , Feminino , Compostos Férricos/administração & dosagem , Compostos Ferrosos/administração & dosagem , Fumaratos , Hemoglobina A/análise , Humanos , Lactente , Ferro/deficiência , Masculino , Micronutrientes/administração & dosagem , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
6.
Braz. j. otorhinolaryngol. (Impr.) ; 86(2): 222-227, March-Apr. 2020. graf
Artigo em Inglês | LILACS | ID: biblio-1132576

RESUMO

Abstract Introduction: The use of electron microscopy in the study of the inner ear has allowed us to observe minute details of the hair cells, especially in ototoxicity studies; however, the preparation of this material is a difficult and delicate task. In an attempt to simplify the handling of these materials, two agents, toluidine blue and ethylenediamine tetra-acetic acid were tested, in addition to the elimination of osmium tetroxide during the preparation of albino guinea pig cochleae. We also tested the applicability of these methodologies in an ototoxicity protocol. Objective: To verify the quality of the images obtained with and without the use of ethylenediamine tetra-acetic acid, toluidine blue and osmium tetroxide in the preparation of cochleae of albino guinea pigs for the scanning electron microscopy. Methods: Three groups of cochleae were used. In Group 1, 10 cochleae were prepared with the usual methodology, dissecting the optical capsule without decalcification and using osmium tetroxide as a post-fixative agent. In Group 2, we prepared 10 cochleae decalcified with ethylenediamine tetra-acetic acid, injecting toluidine blue in the endolymphatic space to facilitate the identification of the organ of Corti. In Group 3, we used 4 cochleae of guinea pigs that received 3 doses of cisplatin (7.5 mg/kg, D1-D5-D6), two prepared according to the methodology used in Group 1 and two with that used in Group 2. Scanning electron microscopy images were obtained from the organ of Corti region of the basal turn of each cochlea. Results: The organ of Corti was more easily identified with the use of toluidine blue. The dissection of the cochlea was more accurate in the decalcified cochleae. The quality of the images and the preservation of the organ of Corti obtained with the two methodologies were similar. Conclusion: The proposed modifications resulted in images of similar quality as those observed using the traditional methodology.


Resumo Introdução: O emprego da microscopia eletrônica no estudo da orelha interna permitiu observar detalhes minuciosos das células ciliadas especialmente em estudos de ototoxicidade. Entretanto, o preparo desse material é trabalhoso e delicado. Para simplificar a manipulação desses materiais, testou-se o uso de dois agentes, azul de toluidina e ácido etilenodiamino tetra-acético, além da retirada do tetróxido de ósmio na preparação de cócleas de cobaias albinas. Testamos também a aplicabilidade dessas metodologias em um protocolo de ototoxicidade. Objetivo: Verificar a qualidade das imagens obtidas com e sem o uso de ácido etilenodiamino tetra-acético, azul de toluidina e tetróxido de ósmio na preparação de cócleas de cobaias albinas para a microscopia eletrônica de varredura. Método: Foram utilizados três grupos de cócleas. No Grupo 1 preparou-se 10 cócleas com a metodologia usual, dissecando a cápsula ótica sem descalcificac¸ão e utilizando tetróxido de ósmio como pós-fixador. No Grupo 2 preparamos 10 cócleas descalcificadas com ácido etilenodiamino tetra-acético, injetando azul de toluidina no espac¸o endolinfático para facilitar a identificação do órgão de Corti. No Grupo 3 utilizamos 4 cócleas de cobaias que receberam 3 doses de cisplatina (7,5 mg/kg, D1-D5-D6), duas preparadas com a metodologia do Grupo 1 e duas com a do Grupo 2. Foram obtidas imagens da microscopia eletrônica de varredura da região do órgão de Corti do giro basal de cada cóclea. Resultados: O órgão de Corti foi mais facilmente identificado com o azul de touidina. A dissecção da cóclea foi mais precisa nas cócleas descalcificadas A qualidade das imagens e a preservac¸ão do órgão de Corti obtidas com as duas metodologias foi similar. Conclusão: As modificações propostas resultaram em imagens de qualidade similar as observadas com o uso da metodologia tradicional.


Assuntos
Animais , Feminino , Cisplatino/toxicidade , Cóclea/efeitos dos fármacos , Cóclea/ultraestrutura , Órgão Espiral/efeitos dos fármacos , Órgão Espiral/ultraestrutura , Tetróxido de Ósmio/administração & dosagem , Cloreto de Tolônio/administração & dosagem , Microscopia Eletrônica de Varredura , Ácido Edético/administração & dosagem , Cobaias , Células Ciliadas Auditivas/efeitos dos fármacos , Células Ciliadas Auditivas/ultraestrutura
7.
Chem Commun (Camb) ; 56(29): 4106-4109, 2020 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-32163087

RESUMO

Herein we report a pair of redox-responsive manganese complexes Mn(iii)/(ii)-N,N'-bis(2-hydroxy-4-trifluoromethylbenzyl)ethylenediamine-N,N'-diacetate (HTFBED, L1), which are water soluble and biologically interconvertible, as reversible redox-responsive probes in 1H/19F MRI for detecting and imaging biological redox species, offering a means to access valuable redox information associated with various diseases.


Assuntos
Complexos de Coordenação , Ácido Edético , Manganês , Sondas Moleculares , Acetilcisteína/análogos & derivados , Acetilcisteína/farmacologia , Antioxidantes/farmacologia , Ácido Ascórbico/farmacologia , Carbonil Cianeto m-Clorofenil Hidrazona/farmacologia , Complexos de Coordenação/administração & dosagem , Complexos de Coordenação/química , Ácido Edético/administração & dosagem , Ácido Edético/análogos & derivados , Ácido Edético/química , Células Hep G2 , Humanos , Imageamento por Ressonância Magnética , Manganês/administração & dosagem , Manganês/química , Sondas Moleculares/administração & dosagem , Sondas Moleculares/química , Oxirredução , Piocianina/farmacologia
8.
Acta Odontol Scand ; 78(5): 321-326, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31909679

RESUMO

Objective: The objective of this study is to evaluate the wall adaptation and apical microleakage values following the application of various irrigation protocols in primary teeth.Material and methods: For the two parts of the study, extracted upper incisor primary teeth were randomly included to the 1% sodium hypochlorite (NaOCl), 10% ethylenediaminetetraacetic acid (EDTA)+1% NaOCl, 6% citric acid (CA)+1% NaOCl and 0.9% physiological saline (PS) groups. Canal wall adaptation and apical microleakage were assessed by scanning electron microscopy (SEM) and stereomicroscope, respectively.Results: 6% CA + 1% NaOCl group was found to be the most successful irrigation protocol in providing strong canal wall adaptation and less apical microleakage, followed by 10% EDTA +1% NaOCl. 6% CA +1% NaOCl was significantly superior regarding apical microleakage (p < .05).Conclusions: Due to the ability to provide appropriate changes in the root canal walls to make a well-adapted and leak-proof canal filling, 6% CA + 1% NaOCl can be recommended as an irrigation protocol in primary teeth.


Assuntos
Infiltração Dentária , Ácido Edético/administração & dosagem , Microscopia Eletrônica de Varredura/métodos , Irrigantes do Canal Radicular/farmacologia , Preparo de Canal Radicular , Camada de Esfregaço , Hipoclorito de Sódio/administração & dosagem , Dente Decíduo/diagnóstico por imagem , Cavidade Pulpar/efeitos dos fármacos , Cavidade Pulpar/ultraestrutura , Humanos , Irrigantes do Canal Radicular/administração & dosagem , Fatores de Tempo
9.
Nucl Med Commun ; 41(1): 11-17, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31764593

RESUMO

OBJECTIVE: Drug quality in medical devices is not evaluated during the marketing authorization of radiopharmaceuticals. Therefore, the extemporaneous change of packaging made for preparation of patient unit doses in a syringe is the responsibility of radiopharmacists. The present study aimed to determine the impact of packaging and storage in a polypropylene syringe on the quality of hydrophilic drugs [Tc]Tc-EDDA/HYNIC-TOC (Tektrotyd) and [Ga]Ga-DOTA-TOC (Somakit-TOC). METHODS: Appearance, pH, radiochemical purity, sterility, and endotoxin tests were performed according the current European Pharmacopoeia. Subvisible and visible particles tests of the European Pharmacopoeia were adapted due to limited preparation volume (<25 ml). Sorption tests were performed according to the literature. RESULTS: After 2 h storage in a syringe, drug sorption of Tektrotyd and Somakit-TOC was of less than 2.5% and similar to other Tc-radiopharmaceuticals (range: from 1.1 ± 0.5% to 4.2 ± 0.6%). For Tektrotyd, this sorption phenomenon was positively influenced by the drug concentration and a short contact with the medical device (4.8 ± 0.2% up to 5 s vs. 2.3 ± 0.2%, n = 4; P < 0.001). For Somakit-TOC, the duration of contact with syringe had no impact (1.6 ± 0.2% up to 5 s vs. 1.7 ± 0.6%; P = 1.000). No drug radiolysis or alteration of microbiological aspects were observed. No impurity from a 3-piece-syringe was observed according to drug aspect, pH, and subvisible and visible particles, which remained within specification of the current European Pharmacopoeia. CONCLUSION: This study found that drug sorption to packaging was compatible with clinical use and absence of drug alteration of Tektrotyd and Somakit-TOC after repackaging in a syringe in polypropylene and prolonged storage during 2 h.


Assuntos
Administração Intravenosa/instrumentação , Ácido Edético/análogos & derivados , Octreotida/análogos & derivados , Compostos Organometálicos/administração & dosagem , Compostos de Organotecnécio/administração & dosagem , Compostos de Organotecnécio/química , Contaminação de Medicamentos , Ácido Edético/administração & dosagem , Ácido Edético/química , Ácidos Nicotínicos/química , Octreotida/administração & dosagem , Controle de Qualidade , Seringas/microbiologia
11.
Braz J Otorhinolaryngol ; 86(2): 222-227, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-30797727

RESUMO

INTRODUCTION: The use of electron microscopy in the study of the inner ear has allowed us to observe minute details of the hair cells, especially in ototoxicity studies; however, the preparation of this material is a difficult and delicate task. In an attempt to simplify the handling of these materials, two agents, toluidine blue and ethylenediamine tetra-acetic acid were tested, in addition to the elimination of osmium tetroxide during the preparation of albino guinea pig cochleae. We also tested the applicability of these methodologies in an ototoxicity protocol. OBJECTIVE: To verify the quality of the images obtained with and without the use of ethylenediamine tetra-acetic acid, toluidine blue and osmium tetroxide in the preparation of cochleae of albino guinea pigs for the scanning electron microscopy. METHODS: Three groups of cochleae were used. In Group 1, 10 cochleae were prepared with the usual methodology, dissecting the optical capsule without decalcification and using osmium tetroxide as a post-fixative agent. In Group 2, we prepared 10 cochleae decalcified with ethylenediamine tetra-acetic acid, injecting toluidine blue in the endolymphatic space to facilitate the identification of the organ of Corti. In Group 3, we used 4 cochleae of guinea pigs that received 3 doses of cisplatin (7.5mg/kg, D1-D5-D6), two prepared according to the methodology used in Group 1 and two with that used in Group 2. Scanning electron microscopy images were obtained from the organ of Corti region of the basal turn of each cochlea. RESULTS: The organ of Corti was more easily identified with the use of toluidine blue. The dissection of the cochlea was more accurate in the decalcified cochleae. The quality of the images and the preservation of the organ of Corti obtained with the two methodologies were similar. CONCLUSION: The proposed modifications resulted in images of similar quality as those observed using the traditional methodology.


Assuntos
Cisplatino/toxicidade , Cóclea/efeitos dos fármacos , Cóclea/ultraestrutura , Animais , Ácido Edético/administração & dosagem , Feminino , Cobaias , Células Ciliadas Auditivas/efeitos dos fármacos , Células Ciliadas Auditivas/ultraestrutura , Microscopia Eletrônica de Varredura , Órgão Espiral/efeitos dos fármacos , Órgão Espiral/ultraestrutura , Tetróxido de Ósmio/administração & dosagem , Cloreto de Tolônio/administração & dosagem
12.
Clin Toxicol (Phila) ; 58(3): 190-200, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31389254

RESUMO

Background: Dicobalt edetate and hydroxocobalamin are widely used to treat hydrogen cyanide poisoning. However, comparative and quantitative efficacy data are lacking. Although post-exposure treatment is typical, it may be possible to administer these antidotes before exposure to first attenders entering a known site of cyanide release, as supplementary protection to their personal protective equipment.Methods: We established an anaesthetised Gottingen minipig model of lethal bolus potassium cyanide (KCN) injection to simulate high dose hydrogen cyanide inhalation. Doses were similar to human lethal doses of KCN. Dicobalt edetate and hydroxocobalamin were administered shortly before KCN and their effect on metabolic and cardiovascular variables and survival time were measured.Results: Increases in arterial lactate were similar after 0.08 and 0.12 mmol/kg KCN. KCN 0.08 mmol/kg was survived by 4/4 animals with moderate cardiovascular effects, while the 0.12 mmol/kg dose was lethal in 4/4 animals, with a mean time to euthanasia of 28.3 (SEM: 13.9) min. Administration of dicobalt edetate (0.021 mmol/kg, 8.6 mg/kg) or hydroxocobalamin (0.054 mmol/kg, 75 mg/kg) at clinically licenced doses had modest effect on lactate concentrations but increased survival after administration of KCN 0.12 mmol/kg (survival: dicobalt edetate 4/4, hydroxocobalamin 2/4) but not 0.15 mmol/kg (0/4 and 0/4, respectively). In a subsequent larger study, doubling the dose of hydroxocobalamin (0.108 mmol/kg, 150 mg/kg) was associated with a modest but inconsistent increased survival after 0.15 mmol/kg KCN (survival: control 0/8, 75 mg/kg 1/10, 150 mg/kg 3/10) likely due to variable pharmacokinetics.Conclusions: In this porcine study of cyanide exposure, with pre-exposure antidote administration, licenced doses of dicobalt edetate and hydroxocobalamin were effective at just lethal doses but ineffective at less than twice the estimated LD50. The efficacy of a rapidly-administered double-dose of hydroxocobalamin was limited by variable pharmacokinetics. In clinical poisoning scenarios, with delayed administration, the antidotes are likely to be even less effective. New antidotes are required for treatment of cyanide exposures appreciably above the minimum lethal dose.


Assuntos
Antídotos/uso terapêutico , Quelantes/uso terapêutico , Cianetos/envenenamento , Ácido Edético/uso terapêutico , Hidroxocobalamina/uso terapêutico , Animais , Cianetos/antagonistas & inibidores , Modelos Animais de Doenças , Relação Dose-Resposta a Droga , Ácido Edético/administração & dosagem , Hidroxocobalamina/administração & dosagem , Masculino , Profilaxia Pré-Exposição/métodos , Suínos , Porco Miniatura
13.
J Vet Intern Med ; 33(5): 2124-2132, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31386229

RESUMO

BACKGROUND: Subcutaneous ureteral bypass (SUB) device placement is an increasingly popular treatment option for decompression of ureteral obstruction in cats. Mineralization occlusion of the device occurs in a minority of cases but is the most common complication. OBJECTIVE: To evaluate a 2% tetrasodium ethylenediaminetetraacetic acid (tEDTA) solution for treatment of mineralization occlusion in cats with SUBs. ANIMALS: Six client-owned cats (8 obstructed devices). METHODS: Case series. Each cat was found to have device occlusion based on a combination of ultrasound examination, SUB irrigation, and failure to identify another cause of device obstruction. Each SUB was drained, irrigated using sterile saline, and infused with 1-2 mL of 2% tEDTA solution. Success was defined as normalization of flow during subsequent ultrasound visualization while irrigating. The volume and frequency of tEDTA instillations, time to achieve device patency, follow-up biochemical and ultrasound findings, and future reobstruction events were recorded. RESULTS: Resolution of mineralization was documented in all 8 SUBs. Reobstruction events occurred in 2 cats, all of which resolved after additional tEDTA infusions, but 1 cat ultimately required device exchange at 356 days from the first tEDTA infusion. In 1 cat, a single infusion was prematurely discontinued because of persistent pelvic dilatation after 1.25 mL of tEDTA had been instilled. No complications were observed. CONCLUSIONS AND CLINICAL IMPORTANCE: Tetrasodium EDTA infusions can be safely considered as a treatment option for mineralized SUB devices in cats. This solution was easily infused, well tolerated, and avoided the need for SUB device exchange in the majority of cats in which it was used.


Assuntos
Doenças do Gato/terapia , Ácido Edético/administração & dosagem , Stents/veterinária , Procedimentos Cirúrgicos Urológicos/veterinária , Animais , Quelantes de Cálcio/administração & dosagem , Doenças do Gato/diagnóstico por imagem , Gatos , Feminino , Masculino , Ultrassonografia/veterinária , Obstrução Ureteral/terapia , Obstrução Ureteral/veterinária , Procedimentos Cirúrgicos Urológicos/instrumentação
14.
Lancet Oncol ; 20(9): 1286-1294, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31375469

RESUMO

BACKGROUND: National Comprehensive Cancer Network guidelines consider 18F-fluciclovine PET-CT for prostate cancer biochemical recurrence localisation after radical prostatectomy, whereas European Association of Urology guidelines recommend prostate-specific membrane antigen (PSMA) PET-CT. To the best of our knowledge, no prospective head-to-head comparison between these tests has been done so far. The aim of this study was to compare prospectively paired 18F-fluciclovine and PSMA PET-CT scans for localising biochemical recurrence of prostate cancer after radical prostatectomy in patients with low prostate-specific antigen (PSA) concentrations (<2·0 ng/mL). METHODS: This was a prospective, single-centre, open-label, single-arm comparative study done at University of California Los Angeles (Los Angeles, CA, USA). Patients older than 18 years of age with prostate cancer biochemical recurrence after radical prostatectomy and PSA levels ranging from 0·2 to 2·0 ng/mL without any prior salvage therapy and with a Karnofsky performance status of at least 50 were eligible. Patients underwent 18F-fluciclovine (reference test) and PSMA (index test) PET-CT scans within 15 days. Detection rate of biochemical recurrence at the patient level and by anatomical region was the primary endpoint. A statistical power analysis demonstrated that a sample size of 50 patients was needed to show a 22% difference in detection rates in favour of PSMA (test for superiority). Each PET scan was interpreted by three independent masked readers and a consensus majority interpretation was generated (two vs one) to determine positive findings. This study is registered with ClinicalTrials.gov, number NCT02940262, and is complete. FINDINGS: Between Feb 26, 2018, and Sept 20, 2018, 143 patients were screened for eligibility, of whom 50 patients were enrolled into the study. Median follow-up was 8 months (IQR 7-9). The primary endpoint was met; detection rates were significantly lower with 18F-fluciclovine PET-CT (13 [26%; 95% CI 15-40] of 50) than with PSMA PET-CT (28 [56%; 41-70] of 50), with an odds ratio (OR) of 4·8 (95% CI 1·6-19·2; p=0·0026) at the patient level; in the subanalysis of the pelvic nodes region (four [8%; 2-19] with 18F-fluciclovine vs 15 [30%; 18-45] with PSMA PET-CT; OR 12·0 [1·8-513·0], p=0·0034); and in the subanalysis of any extrapelvic lesions (none [0%; 0-6] vs eight [16%; 7-29]; OR non-estimable [95% CI non-estimable], p=0·0078). INTERPRETATION: With higher detection rates, PSMA should be the PET tracer of choice when PET-CT imaging is considered for subsequent treatment management decisions in patients with prostate cancer and biochemical recurrence after radical prostatectomy and low PSA concentrations (≤2·0 ng/mL). Further research is needed to investigate whether higher detection rates translate into improved oncological outcomes. FUNDING: None.


Assuntos
Ácidos Carboxílicos/administração & dosagem , Ciclobutanos/administração & dosagem , Ácido Edético/análogos & derivados , Recidiva Local de Neoplasia/diagnóstico por imagem , Oligopeptídeos/administração & dosagem , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Neoplasias da Próstata/diagnóstico por imagem , Idoso , Meios de Contraste/administração & dosagem , Ácido Edético/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/sangue , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/cirurgia , Estudos Prospectivos , Antígeno Prostático Específico/sangue , Prostatectomia/métodos , Neoplasias da Próstata/sangue , Neoplasias da Próstata/patologia , Neoplasias da Próstata/cirurgia
15.
World J Gastroenterol ; 25(26): 3370-3379, 2019 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-31341362

RESUMO

BACKGROUND: The treatment of difficult common bile duct stones (CBDS) remains a big challenge around the world. Biliary stenting is a widely accepted rescue method in patients with failed stone extraction under endoscopic retrograde cholangiopancreatography. Fully covered self-expanding metal stent (FCSEMS) has gained increasing attention in the management of difficult CBDS. AIM: To manufacture a drug-eluting FCSEMS, which can achieve controlled release of stone-dissolving agents and speed up the dissolution of CBDS. METHODS: Customized covered nitinol stents were adopted. Sodium cholate (SC) and disodium ethylene diamine tetraacetic acid (EDTA disodium, EDTA for short) were used as stone-dissolving agents. Three different types of drug-eluting stents were manufactured by dip coating (Stent I), coaxial electrospinning (Stent II), and dip coating combined with electrospinning (Stent III), respectively. The drug-release behavior and stone-dissolving efficacy of these stents were evaluated in vitro to sort out the best manufacturing method. And the selected stone-dissolving stents were further put into porcine CBD to evaluate their biosecurity. RESULTS: Stent I and Stent II had obvious burst release of drugs in the first 5 d while Stent III presented controlled and sustainable drug release for 30 d. In still buffer, the final stone mass-loss rate of each group was 5.19% ± 0.69% for naked FCSEMS, 20.37% ± 2.13% for Stent I, 24.57% ± 1.45% for Stent II, and 33.72% ± 0.67% for Stent III. In flowing bile, the final stone mass-loss rate of each group was 5.87% ± 0.25% for naked FCSEMS, 6.36% ± 0.48% for Stent I, 6.38% ± 0.37% for Stent II, and 8.15% ± 0.27% for Stent III. Stent III caused the most stone mass-loss no matter in still buffer or in flowing bile, which was significantly higher than those of other groups (P < 0.05). In vivo, Stent III made no difference from naked FCSEMS in serological analysis (P > 0.05) and histopathological examination (P > 0.05). CONCLUSION: The novel SC and EDTA-eluting FCSEMS is efficient in diminishing CBDS in vitro. When conventional endoscopic techniques fail to remove difficult CBDS, SC and EDTA-eluting FCSEMS implantation may be considered a promising alternative.


Assuntos
Stents Farmacológicos , Ácido Edético/administração & dosagem , Cálculos Biliares/terapia , Stents Metálicos Autoexpansíveis , Colato de Sódio/administração & dosagem , Ligas , Animais , Ducto Colédoco , Modelos Animais de Doenças , Portadores de Fármacos/química , Liberação Controlada de Fármacos , Ácido Edético/farmacocinética , Humanos , Masculino , Nanofibras , Poliésteres/química , Colato de Sódio/farmacocinética , Suínos , Porco Miniatura , Resultado do Tratamento
16.
Heart ; 105(22): 1695-1700, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31337670

RESUMO

Gadolinium-based contrast media are widely used in cardiovascular MRI to identify and to highlight the intravascular and extracellular space. After gadolinium, manganese has the second highest paramagnetic moment and was one of the first MRI contrast agents assessed in humans. Over the last 50 years, manganese-enhanced MRI (MEMRI) has emerged as a complementary approach enabling intracellular myocardial contrast imaging that can identify functional myocardium through its ability to act as a calcium analogue. Early progress was limited by its potential to cause myocardial depression. To overcome this problem, two clinical formulations of manganese were developed using either chelation (manganese dipyridoxyl diphosphate) or coadministration with a calcium compound (EVP1001-1, Eagle Vision Pharmaceuticals). Preclinical studies have demonstrated the efficacy of MEMRI in quantifying myocardial infarction and detecting myocardial viability as well as tracking altered contractility and calcium handling in cardiomyopathy. Recent clinical data suggest that MEMRI has exciting potential in the quantification of myocardial viability in ischaemic cardiomyopathy, the early detection of abnormalities in myocardial calcium handling, and ultimately, in the development of novel therapies for myocardial infarction or heart failure by actively quantifying viable myocardium. The stage is now set for wider clinical translational study of this novel and promising non-invasive imaging modality.


Assuntos
Cardiomiopatias/diagnóstico por imagem , Meios de Contraste/administração & dosagem , Ácido Edético/análogos & derivados , Imageamento por Ressonância Magnética , Manganês/administração & dosagem , Miocárdio/patologia , Fosfato de Piridoxal/análogos & derivados , Animais , Sinalização do Cálcio , Cardiomiopatias/metabolismo , Cardiomiopatias/patologia , Cardiomiopatias/fisiopatologia , Ácido Edético/administração & dosagem , Humanos , Miocárdio/metabolismo , Valor Preditivo dos Testes , Prognóstico , Fosfato de Piridoxal/administração & dosagem , Sobrevivência de Tecidos
17.
Int J Mol Sci ; 20(12)2019 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-31234286

RESUMO

Silk fiber has become a research focus because of its comprehensive mechanical properties. Metal ions can influence the conformational transition of silk fibroin. Current research is mainly focused on the role of a single ion, rather than the whole metal ion environment. Here, we report the effects of the overall metal ion environment on the secondary structure and mechanical properties of silk fibers after direct injection and feeding of silkworms with EDTA. The metal composition of the hemolymph, silk gland, and silk fiber changed significantly post EDTA treatment. Synchrotron FTIR analysis indicated that the secondary structure of silk fiber after EDTA treatment changed dramatically; particularly, the ß-sheets decreased and the ß-turns increased. Post EDTA treatment, the silk fiber had significantly decreased strength, Young's modulus, and toughness as compared with the control groups, while the strain exhibited no obvious change. These changes can be attributed to the change in the metal ion environment in the silk fibroin and sericin in the silk gland. Our investigation provides a new theoretical basis for the natural silk spinning process, and our findings could help develop a method to modify the mechanical properties of silk fiber using metal ions.


Assuntos
Bombyx/metabolismo , Ácido Edético/metabolismo , Metais/metabolismo , Seda/química , Ração Animal/análise , Animais , Fenômenos Biomecânicos , Bombyx/química , Ácido Edético/administração & dosagem , Módulo de Elasticidade , Metais/análise , Conformação Proteica em Folha beta , Seda/metabolismo , Espectroscopia de Infravermelho com Transformada de Fourier , Estresse Mecânico
18.
Saudi J Kidney Dis Transpl ; 30(3): 587-596, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31249222

RESUMO

Estimation of glomerular filtration rate (GFR) in renal transplant patients is often assessed by application of creatinine-based equations. The aim was to correlate the estimated GFR (eGFR) using creatinine-based equations [Cockroft-Gault, Modification of Diet in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Nankivell] with gold standard 51Cr-EDTA in kidney transplant patients in the Asian population. This is a single-center, cross-sectional study involving adult renal transplant patients. Background demographic data, medications, office blood pressure, and baseline investigations were taken. Correlations between measured GFR and eGFR were analyzed and Pearson's correlation coefficients, bias, and accuracy were assessed. Thirty-seven renal transplant patients with a mean age of 46 ± 13 years were recruited. Majority were Chinese (68%), Malay (24%), and Indian (8%). The median duration of the transplant was 84 (interquartile range 60,132) months. The mean measured GFR was 71 ± 21 mL/min/1.73 m2. Cockroft-Gault and CKD-EPI has the best correlation with 51Cr-EDTA with Pearson correlation coefficients of 0.733 (P <0.001) and 0.711 (P < 0.001), respectively. All formulae showed >80% accuracy with eGFR lies between 30% of the measured value. CKD-EPI and MDRD had the greatest accuracy with 89.2% each. Clinician may use any of these three serum creatinine-based equations to estimate GFR in kidney transplant recipients.


Assuntos
Taxa de Filtração Glomerular , Nefropatias/diagnóstico , Transplante de Rim , Rim/fisiopatologia , Modelos Biológicos , Adulto , Grupo com Ancestrais do Continente Asiático , Biomarcadores/sangue , Radioisótopos de Cromo/administração & dosagem , Creatinina/sangue , Estudos Transversais , Ácido Edético/administração & dosagem , Feminino , Humanos , Rim/diagnóstico por imagem , Rim/cirurgia , Nefropatias/etnologia , Nefropatias/fisiopatologia , Transplante de Rim/efeitos adversos , Malásia/epidemiologia , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Compostos Radiofarmacêuticos/administração & dosagem , Reprodutibilidade dos Testes , Resultado do Tratamento
19.
Photobiomodul Photomed Laser Surg ; 37(4): 248-253, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31050955

RESUMO

Objective: The aim of this randomized clinical study was to evaluate the effect of laser-activated irrigation using a photon-induced photoacoustic streaming (PIPS) technique on postoperative pain following completion of root canal obturation. Methods: Fifty-six patients were enrolled in this randomized clinical trial. Fifty-six healthy premolars or molars with asymptomatic irreversible pulpitis, symptomatic irreversible pulpitis, or symptomatic pulpal necrosis, with or without apical periodontitis, were mechanically prepared for endodontic treatment and divided into two groups. Patients were randomly allocated to treatment groups. In the positive control group G1, the final irrigation with 2 cc of 5.25% sodium hypochlorite (NaOCl) was achieved using a 27G needle, introduced into the canal to a distance of 5 mm from the predetermined working length. In the experimental group G2, the root canals were irrigated with 17% ethyldiamine tetric acid (EDTA) and 5.25% NaOCl following the PIPS protocol, using an Er:YAG 2940 nm laser (LightWalker ATS®; Fotona, Slovenia) with a 600 µm diameter tip and operating parameters of 20 mJ per pulse, 15 Hz frequency, 0.3 W average power, and a 50-µs pulse duration. Postoperatively, the patients were advised to take a minor analgesic (ibuprofen 400 mg) in the event of pain perception. Postoperative pain levels were assessed after 24, 48, and 72 h and 7 days through the use of a Visual Analogue Scale questionnaire, completed by each patient. Data were analyzed using Kolmogorov-Smirnov, Fisher Exact, Chi square, Mann-Whitney test, and Friedman's test. The level of significance was set at α = 0.05. Results: There was no significant difference between the laser-irradiated group and the control group (p < 0.5). Laser activation of irrigating solutions did not increase postoperative pain. Conclusions: The outcome of this investigation indicated that PIPS was as effective as conventional irrigation in relation to postoperative pain, making this activation technique interesting to use for supplementary root canal disinfection.


Assuntos
Lasers de Estado Sólido/uso terapêutico , Pulpite/terapia , Qualidade de Vida , Tratamento do Canal Radicular/métodos , Irrigação Terapêutica/métodos , Adulto , Idoso , Ácido Edético/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Dor Pós-Operatória , Irrigantes do Canal Radicular/administração & dosagem , Preparo de Canal Radicular/métodos , Hipoclorito de Sódio/administração & dosagem
20.
J Diabetes Complications ; 33(7): 490-494, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31101487

RESUMO

OBJECTIVE: Approximately 1 in 7 US adults have diabetes; and over 60% of deaths in patients with diabetes have cardiac disease as a principal or contributing cause. Both coronary and peripheral artery disease (PAD) identify high-risk cohorts among patients with diabetes. We have previously demonstrated improved cardiovascular outcomes with edetate disodium-based chelation in post-MI patients with diabetes, enrolled in the Trial to Assess Chelation Therapy (TACT). In these analyses we further studied the effect size of patients with diabetes and severe disease in 2 vascular beds; coronaries, and lower extremity arteries. We questioned whether greater atherosclerotic burden would attenuate the observed beneficial effect of edetate disodium infusions. RESEARCH DESIGN AND METHODS: The multicenter TACT used a double blind, placebo controlled, 2 × 2 factorial design with 1708 participants, randomly assigned to receive edetate disodium-based chelation, or placebo and high dose oral vitamins or placebo. There were 162 (9.5% of 1708) post-MI patients with a diagnosis of diabetes mellitus and PAD for this post hoc analysis. Patients received up to 40 double-blind intravenous infusions of edetate disodium-based chelation, or placebo. The composite primary endpoint of TACT consisted of death from any cause, myocardial infarction, stroke, coronary revascularization and hospitalization for angina. RESULTS: The median age was 66 years, 15% female, 5% non-Caucasian, and BMI was 31. Insulin was used by 32% of patients. Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint. There was a marked reduction in total mortality from 24% to 11%, although of borderline significance (P = 0.052). CONCLUSION: Atherosclerotic disease in multiple vascular beds did not attenuate the beneficial effect of edetate disodium infusions in post MI patients with diabetes. Studies now in progress will prospectively test this post hoc finding.


Assuntos
Terapia por Quelação , Diabetes Mellitus/tratamento farmacológico , Angiopatias Diabéticas/tratamento farmacológico , Ácido Edético/uso terapêutico , Doença Arterial Periférica/tratamento farmacológico , Idoso , Quelantes/administração & dosagem , Quelantes/uso terapêutico , Terapia por Quelação/métodos , Diabetes Mellitus/epidemiologia , Angiopatias Diabéticas/epidemiologia , Método Duplo-Cego , Quimioterapia Combinada , Ácido Edético/administração & dosagem , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/epidemiologia , Doença Arterial Periférica/complicações , Doença Arterial Periférica/epidemiologia , Placebos , Resultado do Tratamento
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