RESUMEN
BACKGROUND: Whether the use of balanced multielectrolyte solution (BMES) in preference to 0.9% sodium chloride solution (saline) in critically ill patients reduces the risk of acute kidney injury or death is uncertain. METHODS: In a double-blind, randomized, controlled trial, we assigned critically ill patients to receive BMES (Plasma-Lyte 148) or saline as fluid therapy in the intensive care unit (ICU) for 90 days. The primary outcome was death from any cause within 90 days after randomization. Secondary outcomes were receipt of new renal-replacement therapy and the maximum increase in the creatinine level during ICU stay. RESULTS: A total of 5037 patients were recruited from 53 ICUs in Australia and New Zealand - 2515 patients were assigned to the BMES group and 2522 to the saline group. Death within 90 days after randomization occurred in 530 of 2433 patients (21.8%) in the BMES group and in 530 of 2413 patients (22.0%) in the saline group, for a difference of -0.15 percentage points (95% confidence interval [CI], -3.60 to 3.30; P = 0.90). New renal-replacement therapy was initiated in 306 of 2403 patients (12.7%) in the BMES group and in 310 of 2394 patients (12.9%) in the saline group, for a difference of -0.20 percentage points (95% CI, -2.96 to 2.56). The mean (±SD) maximum increase in serum creatinine level was 0.41±1.06 mg per deciliter (36.6±94.0 µmol per liter) in the BMES group and 0.41±1.02 mg per deciliter (36.1±90.0 µmol per liter) in the saline group, for a difference of 0.01 mg per deciliter (95% CI, -0.05 to 0.06) (0.5 µmol per liter [95% CI, -4.7 to 5.7]). The number of adverse and serious adverse events did not differ meaningfully between the groups. CONCLUSIONS: We found no evidence that the risk of death or acute kidney injury among critically ill adults in the ICU was lower with the use of BMES than with saline. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; PLUS ClinicalTrials.gov number, NCT02721654.).
Asunto(s)
Lesión Renal Aguda/prevención & control , Enfermedad Crítica/terapia , Solución Salina/uso terapéutico , Lesión Renal Aguda/etiología , Adulto , Anciano , Cuidados Críticos/métodos , Enfermedad Crítica/mortalidad , Método Doble Ciego , Femenino , Fluidoterapia , Gluconatos/efectos adversos , Gluconatos/uso terapéutico , Humanos , Unidades de Cuidados Intensivos , Cloruro de Magnesio/efectos adversos , Cloruro de Magnesio/uso terapéutico , Masculino , Persona de Mediana Edad , Cloruro de Potasio/efectos adversos , Cloruro de Potasio/uso terapéutico , Solución Salina/efectos adversos , Acetato de Sodio/efectos adversos , Acetato de Sodio/uso terapéutico , Cloruro de Sodio/efectos adversos , Cloruro de Sodio/uso terapéutico , Resultado del TratamientoRESUMEN
OBJECTIVES: Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concentration among patients undergoing major surgery. METHODS: We conducted a prospective, double-blinded cluster crossover trial comparing the effects of the two fluids on major surgery patients. The primary aim was to establish the pilot feasibility, safety and preliminary efficacy evidence base for a large interventional trial to establish whether saline or Plasma-Lyte is the preferred crystalloid fluid for managing major surgery patients. The primary efficacy outcome was the proportion of patients with changes in renal function as assessed by creatinine concentration during their index hospital admission. We used changes in creatinine to define acute kidney injury (AKI) according to the RIFLE criteria. RESULTS: The study was feasible with 100% patient and clinician acceptance. There were no deviations from the trial protocol. After screening, we allocated 602 patients to saline and 458 to Plasma-Lyte. The median (IQR) volume of intraoperative fluid received was 2000 mL (1000:2000) in both groups. Forty-nine saline patients (8.1%) and 49 Plasma-Lyte patients (10.7%) developed a postoperative AKI (adjusted incidence rate ratio [aIRR]: 1.34; 95% CI: 0.93-1.95; p = 0.120). No differences were observed in the development of postoperative complications (aIRR: 0.98; 95% CI: 0.89-1.08) or the severity of the worst complication (aIRR: 1.00; 95% CI: 0.78-1.30). The median (IQR) length of hospital stay was six days (3:11) for the saline group and five days (3:10) for the Plasma-Lyte group (aIRR: 0.85; 95% CI: 0.73-0.98). There were no serious adverse events relating to the trial fluids, nor were there fluid crossover or contamination events. CONCLUSIONS: The study design was feasible to support a future follow-up larger clinical trial. Patients treated with saline did not demonstrate an increased incidence of postoperative AKI (defined as changes in creatinine) compared to those treated with Plasma-Lyte. Our findings imply that clinicians can reasonably use either solution intraoperatively for adult patients undergoing major surgery. TRIAL REGISTRATION: Registry: Australian New Zealand Clinical Trials Registry; ACTRN12613001042730; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364988.
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Creatinina/sangre , Riñón/metabolismo , Complicaciones Posoperatorias/sangre , Solución Salina/administración & dosificación , Procedimientos Quirúrgicos Operativos/efectos adversos , Lesión Renal Aguda/sangre , Lesión Renal Aguda/etiología , Lesión Renal Aguda/prevención & control , Anciano , Australia , Estudios Cruzados , Método Doble Ciego , Femenino , Gluconatos/administración & dosificación , Gluconatos/efectos adversos , Humanos , Cloruro de Magnesio/administración & dosificación , Cloruro de Magnesio/efectos adversos , Masculino , Persona de Mediana Edad , Cloruro de Potasio/administración & dosificación , Cloruro de Potasio/efectos adversos , Estudios Prospectivos , Solución Salina/efectos adversos , Acetato de Sodio/administración & dosificación , Acetato de Sodio/efectos adversos , Cloruro de Sodio/administración & dosificación , Cloruro de Sodio/efectos adversosRESUMEN
BACKGROUND: Disulfiram and metals inactivate key oncoproteins resulting in anti-neoplastic activity. The goal of this study was to determine the maximum tolerated dose of copper when administered with disulfiram in patients with advanced solid tumors and liver involvement. METHODS: Disulfiram 250 mg was administered daily in 28-day cycles. Four doses of copper gluconate were tested (2, 4, 6, and 8 mg of elemental copper) in a standard 3 + 3 dose escalation design. Patients were evaluated for dose limiting toxicities and response. Protein S-glutathionylation was evaluated as a pharmacodynamic marker. RESULTS: Twenty-one patients were enrolled and 16 patients were evaluable for dose limiting toxicities. Among the 21 patients, there was a median of 4 lines of prior chemotherapy. Five Grade 3 toxicities were observed (anorexia, elevated aspartate aminotransferase or AST, elevated alkaline phosphatase, fever, and fatigue). Response data was available for 15 patients. Four patients had stable disease with the longest duration of disease control being 116 days. The median duration of treatment for evaluable patients was 55 days (range 28-124). Reasons for discontinuation included functional decline, disease progression, and disease-associated death. Increased S-glutathionylation of serum proteins was observed with treatment. CONCLUSION: Disulfiram 250 mg daily with copper gluconate (8 mg of elemental copper) was well-tolerated in patients with solid tumors involving the liver and was not associated with dose limiting toxicities. While temporary disease stabilization was noted in some patients, no objective responses were observed. Treatment was associated with an increase in S-glutathionylation suggesting that this combination could exert a suppressive effect on cellular growth and protein function. TRIAL REGISTRATION: NCT00742911 , first posted 28/08/2008.
Asunto(s)
Disulfiram/administración & dosificación , Gluconatos/administración & dosificación , Glutatión/metabolismo , Neoplasias Hepáticas/secundario , Neoplasias/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Disulfiram/efectos adversos , Relación Dosis-Respuesta a Droga , Femenino , Gluconatos/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/metabolismoRESUMEN
OBJECTIVE: Iron deficiency anemia (IDA) in patients with heart disease is correlated with decreased exercise capacity and poor health-related quality of life, and predicts worse cardiovascular outcomes, especially for elderly patients. IDA can worsen cardiac function that can be monitored with Heart Rate Variability (HRV) analysis, providing important information about cardiac health. In a recent study we explored the effect and the tolerability of the administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) in "frailty" patients with secondary anemia and low kidney failure, by analysing the HRV frequency domain. The aim of the present study is the further confirmation of the safety of the already evaluated intervention, by analysing non-linear domain of HRV. PATIENTS AND METHODS: In this pilot study we enrolled 52 "frailty" elderly patients, with a recent diagnosis of secondary anemia due to iron deficiency, with Class II New York Heart Association (NYHA) hypertensive heart disease, low kidney failure, and atherosclerosis. The patients were divided in 2 groups: Group A (N=23 patients) received oral administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) 2 tabs/day, containing 60 mg of Fe3+, for 24 days; Group B (N=29 patients) received intravenous administration of ferrous gluconate 63 mg/day added to saline solution, while they were hospitalized (15±5 days). We evaluated laboratory values of hemoglobin (Hb) and sideremia levels. Furthermore, we measured ECG signals before and after treatment, using non-linear analysis techniques. RESULTS: Both intravenous and oral treatments evaluated in this study, were effective and safe about the cardiovascular risk in "frailty" elderly patients, as resulted from non-linear HRV analysis. Efficacy results showed that hemoglobin and sideremia levels after treatments are significantly increased. The HRV non-linear analysis showed that all parameters evaluated, except for the SD1 values in the Group A, were not affected by treatments, confirming the absence of cardiovascular risk of the therapy. CONCLUSIONS: Non-linear HRV evaluation confirmed that oral administration of Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) did not impact the cardiovascular risk, without causing adverse events typically reported with other iron supplementation therapies, both oral and intravenous.
Asunto(s)
Anemia Ferropénica/tratamiento farmacológico , Ácido Ascórbico/uso terapéutico , Compuestos Férricos/uso terapéutico , Ácido Fólico/uso terapéutico , Fragilidad/complicaciones , Gluconatos/uso terapéutico , Cardiopatías/complicaciones , Frecuencia Cardíaca/efectos de los fármacos , Quelantes del Hierro/uso terapéutico , Selenometionina/uso terapéutico , Anciano , Anciano de 80 o más Años , Anemia Ferropénica/sangre , Anemia Ferropénica/complicaciones , Anemia Ferropénica/diagnóstico , Ácido Ascórbico/efectos adversos , Combinación de Medicamentos , Ácido Edético/efectos adversos , Ácido Edético/uso terapéutico , Femenino , Compuestos Férricos/efectos adversos , Ácido Fólico/efectos adversos , Anciano Frágil , Fragilidad/diagnóstico , Fragilidad/fisiopatología , Gluconatos/efectos adversos , Factores de Riesgo de Enfermedad Cardiaca , Cardiopatías/diagnóstico , Cardiopatías/fisiopatología , Humanos , Quelantes del Hierro/efectos adversos , Masculino , Proyectos Piloto , Insuficiencia Renal/complicaciones , Insuficiencia Renal/diagnóstico , Insuficiencia Renal/fisiopatología , Medición de Riesgo , Selenometionina/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND AND AIM: Findings on the effects of zinc supplementation on the lipid profile in patients with type 2 diabetes mellitus (T2DM) are conflicting. The current comprehensive systematic review and meta-analysis aimed to summarize available evidence in this regard. METHODS AND RESULTS: After a systematic search in the online databases, we included the randomized controlled trials (RCTs) investigating the effect of zinc supplementation on lipid profile [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG)] in patients with T2DM. Altogether, 9 studies with a total sample size of 424 patients with T2DM were included in the analysis. Combining 9 effect sizes from 9 RCTs, we found a significant lowering effect of zinc supplementation on serum levels of TG (weighted mean difference (WMD): -17.08, 95% CI: -30.59, -3.58 mg/dL, P = 0.01) and TC (WMD: -26.16, 95% CI: -49.69, -2.62 mg/dL, P = 0.02). Although the overall effect of zinc supplementation on LDL-C levels was not significant, a beneficial effect was seen in studies that administered <100 mg/d zinc. Based on the non-linear dose-response analysis, a greater reduction in serum levels of TC and LDL-C following zinc supplementation was seen at <12 weeks' duration of intervention. Unlike the overall effect size, we found a significant increasing effect of zinc supplementation on serum HDL-C concentrations in most subgroups of RCTs according to the subgroup analyses. CONCLUSION: We found that zinc supplementation may beneficially influence lipid profile in patients with T2DM.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Suplementos Dietéticos , Dislipidemias/tratamiento farmacológico , Gluconatos/uso terapéutico , Lípidos/sangre , Sulfato de Zinc/uso terapéutico , Adulto , Anciano , Biomarcadores/sangre , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiología , Suplementos Dietéticos/efectos adversos , Dislipidemias/sangre , Dislipidemias/diagnóstico , Dislipidemias/epidemiología , Femenino , Gluconatos/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Sulfato de Zinc/efectos adversosRESUMEN
: The current study aimed to measure the effects of Plasma-Lyte 148 solution on the blood coagulation profile according to the hemodilution level using rotational thromboelastometry (ROTEM) tests. Venous blood was collected from 12 healthy volunteers and divided into four specimen bottles, which were diluted at different levels with Plasma-Lyte 148 (0, 20, 40, and 60%). Following this, ROTEM tests were performed on the study samples. We found that as the hemodilution level increased, the ROTEM values showed a hypocoagulable pattern. The change rate of the maximum clot firmness (MCF) of INTEM was greater in the 40 (Pâ=â0.015) and 60% (Pâ<â0.001) dilutions than it was in the 20% dilution. Greater lengthening of the clot formation time of EXTEM was observed in the 60% dilution than it was in the 20% dilution (Pâ<â0.001). The alpha-angle of EXTEM showed a greater decrease in the 60% dilution than it did in the 20% dilution (Pâ<â0.001). A larger change rate of the MCF of EXTEM was observed in the 40 (Pâ=â0.003) and 60% (Pâ<â0.001) dilutions than it was in the 20% dilution. A greater decrease in the MCF of FIBTEM was identified in the 40 (Pâ=â0.009) and 60% (Pâ<â0.001) dilutions than in the 20% dilution. All coagulation pathways exhibited hypocoagulable patterns as the hemodilution level increased. However, most of the mean values of ROTEM parameters were within the normal reference range, except for those of the 60% dilution.
Asunto(s)
Pruebas de Coagulación Sanguínea/métodos , Coagulación Sanguínea/efectos de los fármacos , Femenino , Gluconatos/efectos adversos , Humanos , Cloruro de Magnesio/efectos adversos , Masculino , Cloruro de Potasio/efectos adversos , Acetato de Sodio/efectos adversos , Cloruro de Sodio/efectos adversos , Tromboelastografía , VoluntariosRESUMEN
Acne vulgaris is a chronic disease of the pilosebaceous units presenting as inflammatory or noninflammatory lesions in individuals of all ages. The current standard of treatment includes topical formulations in the forms of washes, gels, lotions, and creams such as antibiotics, antibacterial agents, retinoids, and comedolytics. Additionally, systemic treatments are available for more severe or resistant forms of acne. Nevertheless, these treatments have shown to induce a wide array of adverse effects, including dryness, peeling, erythema, and even fetal defects and embolic events. Zinc is a promising alternative to other acne treatments owing to its low cost, efficacy, and lack of systemic side effects. In this literature review, we evaluate the effectiveness and side-effect profiles of various formulations of zinc used to treat acne.
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Acné Vulgar/tratamiento farmacológico , Fármacos Dermatológicos/administración & dosificación , Gluconatos/administración & dosificación , Piel/efectos de los fármacos , Acetato de Zinc/administración & dosificación , Sulfato de Zinc/administración & dosificación , Acné Vulgar/diagnóstico , Administración Cutánea , Administración Oral , Fármacos Dermatológicos/efectos adversos , Combinación de Medicamentos , Femenino , Gluconatos/efectos adversos , Humanos , Masculino , Piel/patología , Resultado del Tratamiento , Acetato de Zinc/efectos adversos , Óxido de Zinc/administración & dosificación , Sulfato de Zinc/efectos adversosAsunto(s)
Humanos , Masculino , Femenino , Anciano , Compuestos Férricos/efectos adversos , Sales de Hierro/efectos adversos , Óxido Ferrosoférrico/efectos adversos , Ácido Glucárico/efectos adversos , Gluconatos/efectos adversos , Anafilaxia/etiología , Complejo Hierro-Dextran/efectos adversos , Estados Unidos/epidemiología , Compuestos Férricos/administración & dosificación , Riesgo , Óxido Ferrosoférrico/administración & dosificación , Sacarato de Óxido Férrico , Ácido Glucárico/administración & dosificación , Gluconatos/administración & dosificación , Anafilaxia/epidemiología , Inyecciones Intravenosas , Complejo Hierro-Dextran/administración & dosificaciónRESUMEN
IMPORTANCE: All intravenous (IV) iron products are associated with anaphylaxis, but the comparative safety of each product has not been well established. OBJECTIVE: To compare the risk of anaphylaxis among marketed IV iron products. DESIGN, SETTING, AND PARTICIPANTS: Retrospective new user cohort study of IV iron recipients (n = 688,183) enrolled in the US fee-for-service Medicare program from January 2003 to December 2013. Analyses involving ferumoxytol were limited to the period January 2010 to December 2013. EXPOSURES: Administrations of IV iron dextran, gluconate, sucrose, or ferumoxytol as reported in outpatient Medicare claims data. MAIN OUTCOMES AND MEASURES: Anaphylaxis was identified using a prespecified and validated algorithm defined with standard diagnosis and procedure codes and applied to both inpatient and outpatient Medicare claims. The absolute and relative risks of anaphylaxis were estimated, adjusting for imbalances among treatment groups. RESULTS: A total of 274 anaphylaxis cases were identified at first exposure, with an additional 170 incident anaphylaxis cases identified during subsequent IV iron administrations. The risk for anaphylaxis at first exposure was 68 per 100,000 persons for iron dextran (95% CI, 57.8-78.7 per 100,000) and 24 per 100,000 persons for all nondextran IV iron products combined (iron sucrose, gluconate, and ferumoxytol) (95% CI, 20.0-29.5 per 100,000) , with an adjusted odds ratio (OR) of 2.6 (95% CI, 2.0-3.3; P < .001). At first exposure, when compared with iron sucrose, the adjusted OR of anaphylaxis for iron dextran was 3.6 (95% CI, 2.4-5.4); for iron gluconate, 2.0 (95% CI 1.2, 3.5); and for ferumoxytol, 2.2 (95% CI, 1.1-4.3). The estimated cumulative anaphylaxis risk following total iron repletion of 1000 mg administered within a 12-week period was highest with iron dextran (82 per 100,000 persons, 95% CI, 70.5- 93.1) and lowest with iron sucrose (21 per 100,000 persons, 95% CI, 15.3- 26.4). CONCLUSIONS AND RELEVANCE: Among patients in the US Medicare nondialysis population with first exposure to IV iron, the risk of anaphylaxis was highest for iron dextran and lowest for iron sucrose.
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Anafilaxia/etiología , Compuestos Férricos/efectos adversos , Óxido Ferrosoférrico/efectos adversos , Ácido Glucárico/efectos adversos , Gluconatos/efectos adversos , Complejo Hierro-Dextran/efectos adversos , Anciano , Anafilaxia/epidemiología , Femenino , Compuestos Férricos/administración & dosificación , Sacarato de Óxido Férrico , Óxido Ferrosoférrico/administración & dosificación , Ácido Glucárico/administración & dosificación , Gluconatos/administración & dosificación , Humanos , Incidencia , Inyecciones Intravenosas , Complejo Hierro-Dextran/administración & dosificación , Masculino , Medicare Part A/estadística & datos numéricos , Estudios Retrospectivos , Riesgo , Estados Unidos/epidemiologíaAsunto(s)
Resfriado Común/tratamiento farmacológico , Compuestos de Zinc/uso terapéutico , Resfriado Común/prevención & control , Formas de Dosificación , Gluconatos/efectos adversos , Gluconatos/uso terapéutico , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Zinc/efectos adversos , Zinc/uso terapéutico , Acetato de Zinc/efectos adversos , Acetato de Zinc/uso terapéutico , Compuestos de Zinc/efectos adversos , Sulfato de Zinc/efectos adversos , Sulfato de Zinc/uso terapéuticoRESUMEN
Intratesticular injection of EsterilSol (zinc gluconate neutralized with arginine) is a chemical sterilant for male dogs sometimes used in population control campaigns. Adverse reactions have been reported in 1% to 4% of treated dogs, but detailed histomorphologic descriptions are lacking. During a behavioral study conducted in the Chilean Patagonia in 2012, severe necrosuppurative orchitis and ulcerative dermatitis were observed in 2 of 36 (6%) dogs sterilized with EsterilSol according to the manufacturer's instructions. Reactions were noted on days 8 and 7 postinjection and required scrotal ablation on days 8 and 13, respectively; neither reaction was associated with the injection site. Although self-trauma following administration may have contributed, the cause of the adverse reactions is uncertain. EsterilSol is a relatively uncomplicated method to sterilize male dogs, but the occurrence of severe adverse reactions several days after administration emphasizes the need for the provision of long-term monitoring and veterinary care during sterilization campaigns using this product.
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Dermatitis/veterinaria , Enfermedades de los Perros/inducido químicamente , Enfermedades de los Perros/patología , Gluconatos/efectos adversos , Necrosis/veterinaria , Orquitis/veterinaria , Escroto/patología , Animales , Castración/efectos adversos , Castración/veterinaria , Dermatitis/patología , Perros , Gluconatos/metabolismo , Técnicas Histológicas/veterinaria , Masculino , Necrosis/inducido químicamente , Necrosis/patología , Orquitis/inducido químicamente , Orquitis/patología , Testículo/metabolismoRESUMEN
Male sterilization by chemical agents is a nonsurgical contraceptive approach designed to induce azoospermia and, therefore, infertility. Intratesticular injection of zinc gluconate for sterilization of dogs has been described, but its use in cats remains limited. The objective of the present study was to evaluate, by light and transmission electron microscopy, the efficacy of a single intratesticular injection of a zinc gluconate solution (Testoblock) as a sterilant for male cats. Twelve sexually mature mixed breed cats were allocated at random into two groups (control = 6; treated = 6) and given a single injection into each testis of either isotonic saline or zinc gluconate, respectively. Histopathologic and ultrastructural evaluation was assessed at 120 days postinjection. Histopathologic changes were not detected in the testes from the control group. However, histologic evaluation of the treated group revealed atrophic and dilated seminiferous tubules, a decrease in the number of germ cells, and incomplete spermatogenesis. Sertoli cells had various degrees of cytoplasmic vacuolization. Intertubular tissue revealed active fibroblasts, collagen deposition, and inflammatory cells. The diameter of seminiferous tubules, epithelial height and tubular area were reduced (P < 0.05) in the treated group compared with controls. Azoospermia occurred in 8 of the 11 treated cats (73%). Ultrastructural evaluation of Leydig cells revealed loss of nuclear chromatin, increased smooth endoplasmatic reticulum, and mitochondria degeneration. Intratesticular injection of zinc gluconate solution impaired spermatogenesis in cats and has great potential as a permanent sterilant in this species.
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Castración/veterinaria , Gatos/fisiología , Anticoncepción/veterinaria , Anticonceptivos Masculinos/uso terapéutico , Gluconatos/uso terapéutico , Espermatogénesis/efectos de los fármacos , Testículo/efectos de los fármacos , Animales , Castración/métodos , Anticoncepción/métodos , Anticonceptivos Masculinos/efectos adversos , Gluconatos/efectos adversos , Masculino , Microscopía Electrónica de Transmisión , Testículo/ultraestructura , Testosterona/sangreRESUMEN
BACKGROUND: The common cold is one of the most widespread illnesses and is a leading cause of visits to the doctor and absenteeism from school and work. Trials conducted in high-income countries since 1984 investigating the role of zinc for the common cold symptoms have had mixed results. Inadequate treatment masking and reduced bioavailability of zinc from some formulations have been cited as influencing results. OBJECTIVES: To assess whether zinc (irrespective of the zinc salt or formulation used) is efficacious in reducing the incidence, severity and duration of common cold symptoms. In addition, we aimed to identify potential sources of heterogeneity in results obtained and to assess their clinical significance. SEARCH METHODS: In this updated review, we searched CENTRAL (2012, Issue 12), MEDLINE (1966 to January week 2, 2013), EMBASE (1974 to January 2013), CINAHL (1981 to January 2013), Web of Science (1985 to January 2013), LILACS (1982 to January 2013), WHO ICTRP and clinicaltrials.gov. SELECTION CRITERIA: Randomised, double-blind, placebo-controlled trials using zinc for at least five consecutive days to treat, or for at least five months to prevent the common cold. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trial quality. MAIN RESULTS: Five trials were identified in the updated searches in January 2013 and two of them did not meet our inclusion criteria. We included 16 therapeutic trials (1387 participants) and two preventive trials (394 participants). Intake of zinc was associated with a significant reduction in the duration (days) (mean difference (MD) -1.03, 95% confidence interval (CI) -1.72 to -0.34) (P = 0.003) (I(2) statistic = 89%) but not the severity of common cold symptoms (MD -1.06, 95% CI -2.36 to 0.23) (P = 0.11) (I(2) statistic = 84%). The proportion of participants who were symptomatic after seven days of treatment was significantly smaller (odds ratio (OR) 0.45, 95% CI 0.20 to 1.00) (P = 0.05) than those in the control, (I(2 )statistic = 75%). The incidence rate ratio (IRR) of developing a cold (IRR 0.64, 95% CI 0.47 to 0.88) (P = 0.006) (I(2) statistic = 88%), school absence (P = 0.0003) and prescription of antibiotics (P < 0.00001) was lower in the zinc group. Overall adverse events (OR 1.58, 95% CI 1.19 to 2.09) (P = 0.002), bad taste (OR 2.31, 95% CI 1.71 to 3.11) (P < 0.00001) and nausea (OR 2.15, 95% CI 1.44 to 3.23) (P = 0.002) were higher in the zinc group. The very high heterogeneity means that the averaged estimates must be viewed with caution. AUTHORS' CONCLUSIONS: Zinc administered within 24 hours of onset of symptoms reduces the duration of common cold symptoms in healthy people but some caution is needed due to the heterogeneity of the data. As the zinc lozenges formulation has been widely studied and there is a significant reduction in the duration of cold at a dose of ≥ 75 mg/day, for those considering using zinc it would be best to use it at this dose throughout the cold. Regarding prophylactic zinc supplementation, currently no firm recommendation can be made because of insufficient data. When using zinc lozenges (not as syrup or tablets) the likely benefit has to be balanced against side effects, notably a bad taste and nausea.
Asunto(s)
Resfriado Común/tratamiento farmacológico , Compuestos de Zinc/uso terapéutico , Resfriado Común/prevención & control , Formas de Dosificación , Gluconatos/efectos adversos , Gluconatos/uso terapéutico , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Zinc/efectos adversos , Zinc/uso terapéutico , Acetato de Zinc/efectos adversos , Acetato de Zinc/uso terapéutico , Compuestos de Zinc/efectos adversos , Sulfato de Zinc/efectos adversos , Sulfato de Zinc/uso terapéuticoRESUMEN
BACKGROUND: In an incidental finding, during a study of plasma chemistry after crystalloid infusion, participants reported subjective cognitive changes, particularly slower thinking, after saline but not Hartmann's (Ringer's lactate) solution. The authors tested the hypothesis that saline infusion would produce greater adverse cognitive changes than Plasmalyte infusion. METHODS: The authors conducted a randomized, cross-over, multiple blinded study of healthy adult volunteers. On separate days, participants received 30 ml/kg over 1 h of either 0.9% saline or Plasmalyte with the order randomly allocated. Plasma chemistry was tested on venous samples. As part of a battery of cognitive tests our primary endpoint was the reaction time index after infusion. RESULTS: The authors studied 25 participants. Plasma chloride was greater after saline than after Plasmalyte: mean difference 5.4 mM (95% CI, 4.1-6.6 mM; P < 0.001). Saline was also associated with greater metabolic acidosis: base-excess 2.5 mM more negative (95% CI, 1.9-3.0 mM more negative; P < 0.001). There was no evidence of a difference in the reaction time index between the two interventions: mean reaction time index 394 ms (SD, 72) after saline versus 385 ms (SD, 55) after Plasmalyte. Difference: saline 9 ms slower (95% CI, 30 ms slower to 12 ms faster; P = 0.39). There were minimal differences in the other cognitive and mood tests. CONCLUSIONS: Despite expected differences in plasma chemistry, the authors found that measures of cognition did not differ after infusions of Plasmalyte or saline.
Asunto(s)
Cognición/efectos de los fármacos , Cloruro de Sodio/efectos adversos , Acidosis/inducido químicamente , Adulto , Estudios Cruzados , Femenino , Gluconatos/efectos adversos , Humanos , Cloruro de Magnesio/efectos adversos , Masculino , Persona de Mediana Edad , Cloruro de Potasio/efectos adversos , Tiempo de Reacción/efectos de los fármacos , Acetato de Sodio/efectos adversosRESUMEN
OBJECTIVE: To assess the association of 0.9% saline use versus a calcium-free physiologically balanced crystalloid solution with major morbidity and clinical resource use after abdominal surgery. BACKGROUND: 0.9% saline, which results in a hyperchloremic acidosis after infusion, is frequently used to replace volume losses after major surgery. METHODS: An observational study using the Premier Perspective Comparative Database was performed to evaluate adult patients undergoing major open abdominal surgery who received either 0.9% saline (30,994 patients) or a balanced crystalloid solution (926 patients) on the day of surgery. The primary outcome was major morbidity and secondary outcomes included minor complications and acidosis-related interventions. Outcomes were evaluated using multivariable logistic regression and propensity scoring models. RESULTS: For the entire cohort, the in-hospital mortality was 5.6% in the saline group and 2.9% in the balanced group (P < 0.001). One or more major complications occurred in 33.7% of the saline group and 23% of the balanced group (P < 0.001). In the 3:1 propensity-matched sample, treatment with balanced fluid was associated with fewer complications (odds ratio 0.79; 95% confidence interval 0.66-0.97). Postoperative infection (P = 0.006), renal failure requiring dialysis (P < 0.001), blood transfusion (P < 0.001), electrolyte disturbance (P = 0.046), acidosis investigation (P < 0.001), and intervention (P = 0.02) were all more frequent in patients receiving 0.9% saline. CONCLUSIONS: Among hospitals in the Premier Perspective Database, the use of a calcium-free balanced crystalloid for replacement of fluid losses on the day of major surgery was associated with less postoperative morbidity than 0.9% saline.
Asunto(s)
Soluciones Cardiopléjicas/efectos adversos , Procedimientos Quirúrgicos del Sistema Digestivo , Cloruro de Sodio/efectos adversos , Abdomen/cirugía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Comorbilidad , Servicios Médicos de Urgencia , Gluconatos/efectos adversos , Mortalidad Hospitalaria , Humanos , Modelos Logísticos , Cloruro de Magnesio/efectos adversos , Persona de Mediana Edad , Análisis Multivariante , Cloruro de Potasio/efectos adversos , Puntaje de Propensión , Estudios Retrospectivos , Acetato de Sodio/efectos adversos , Equilibrio Hidroelectrolítico , Adulto JovenAsunto(s)
Resfriado Común/tratamiento farmacológico , Mucosa Bucal , Absorción Cutánea , Compuestos de Zinc/administración & dosificación , Compuestos de Zinc/efectos adversos , Administración Oral , Esquema de Medicación , Gluconatos/administración & dosificación , Gluconatos/efectos adversos , Humanos , Guías de Práctica Clínica como Asunto , Acetato de Zinc/administración & dosificaciónRESUMEN
PURPOSE: The purpose of the study was to determine the effects of Plasma-Lyte 148 (PL) vs 0.9% saline (NS) fluid resuscitation in diabetic ketoacidosis (DKA). METHODS: A multicenter retrospective analysis of adults admitted for DKA to the intensive care unit, who received almost exclusively PL or NS infusion up until 12 hours, was performed. RESULTS: Nine patients with PL and 14 patients with NS were studied. Median serum bicarbonate correction was higher in the PL vs NS groups at 4 to 6 hours (8.4 vs 1.7 mEq/L) and 6 to 12 hours (12.8 vs 6.2 mEq/L) from baseline (P < .05). Median standard base excess improved by 10.5 vs 4.2 mEq/L at 4 to 6 hours and by 16.0 vs 9.1 mEq/L at 6 to 12 hours in the PL and NS groups, respectively (P < .05). Chloride levels increased significantly in the NS vs PL groups over 24 hours. Potassium levels were lower at 6 to 12 hours in the PL group. Mean arterial blood pressure was higher at 2 to 4 hours in the PL group, whereas cumulative urine output was lower at 4 to 6 hours in the NS group. There were no differences in glycemic control or duration of intensive care unit stay. CONCLUSION: Patients with DKA resuscitated with PL instead of NS had faster initial resolution of metabolic acidosis and less hyperchloremia, with a transiently improved blood pressure profile and urine output.