A randomised clinical trial to evaluate the effects of Plantago ovata husk in Parkinson patients: changes in levodopa pharmacokinetics and biochemical parameters.

BACKGROUND: Plantago ovata husk therapy could be used in patients with Parkinson disease to reduce the symptoms of gastrointestinal disorders, but it is important to know whether this compound modifies levodopa pharmacokinetics. The maintenance of constant plasma concentrations of levodopa abolishes the clinical fluctuations in parkinsonian patients. The aim of this randomised clinical trial was to establish the influence of the fiber Plantago ovata husk in the pharmacokinetics of levodopa when administered to Parkinson patients well controlled by their oral medication. METHODS: To evaluate the effects of this fiber on several biochemical parameters. 18 volunteers participated in the study and received alternatively two treatments (Plantago ovata husk or placebo) with their usual levodopa/carbidopa oral dose. On days 0 (initial situation), 14 and 35 of the study, blood samples were taken to assess levodopa pharmacokinetics and to determine biochemical parameters. RESULTS: Levodopa Cmax was very similar in the initial situation (603.2 ng/ml) and after placebo administration (612.0 ng/ml), being slightly lower (547.8 ng/ml) when Plantago ovata husk was given. AUC was very similar in the three groups: initial situation.- 62.87 µg.min/ml, fiber treatment.- 64.47 µg.min/ml and placebo treatment.- 65.10 µg.min/ml. Fiber reduced significantly the number of peaks observed in the levodopa concentrations, maintaining concentrations more stable. No significant differences were found in total cholesterol, LDL-cholesterol and triglycerides with the administration of Plantago ovata husk. CONCLUSIONS: Plantago ovata husk administration caused a smoothing and homogenization of levodopa absorption, providing more stable concentrations and final higher levels, resulting in a great benefit for patients. TRIAL REGISTRATION: EudraCT2006-000491-33.

[Nutritional screening in hospitalized patients with vascular disease - The relationship of nutritional risk with clinical and economic outcomes in a surgery department]. / Cribado nutricional del paciente con patología vascular hospitalizado: relación del riesgo nutricional con los resultados clínicos y económicos en un servicio quirúrgico.

INTRODUCTION: Introduction: disease-related malnutrition has a negative impact on the outcome in surgical patients. Our objective was to assess the prevalence of nutritional risk in the field of vascular surgery, as well as its consequences on patient outcome and health expenditure. Patients and methods: this is a prospective, observational study conducted during 6 months in a vascular surgery ward at the University Hospital of León, Spain. The Malnutrition Universal Screening Tool was used to obtain data on admission and then every 7 days until hospital discharge. Clinical variables, surgical intervention performed, medical-surgical complications, hospital stay, healthcare costs, and early readmissions were studied. Results: a total of 104 patients, 84.6 % males, with a mean age of 69 (SD: 13) years were enrolled. Of these, 46.2 % were admitted due to peripheral arterial disease; 10.6 % had a positive MUST at the time of admission and 19.2 % at discharge; 100 % of malnourished patients at admission remained in the same situation at discharge. During hospitalization, in 29 patients (27.9 %) the nutritional situation worsened. In all, 81.25 % of patients who experienced worsening of their MUST score had been admitted urgently (p < 0.05). Patients who required urgent surgery significantly worsened in terms of their nutritional status (p < 0.001). Patients with worsening nutritional status obtained higher rates for: surgical reintervention (p < 0.05), pharmaceutical expense (p = 0.017), total hospital expense (€1,000/patient/admission), transfers to chronic care centers (p = 0.0002), and number of early readmissions (p = 0.017). Conclusion: patients with nutritional risk suffered an increase in medical-surgical complications, hospital stay, healthcare costs, and re-admission rates. Therefore, we consider that an implementation of screening procedures and the development of further studies in the vascular surgery setting are necessary.

INTRODUCCIÓN: Introducción y objetivos: la desnutrición relacionada con la enfermedad produce un impacto negativo en la evolución del paciente quirúrgico. Nuestro objetivo es valorar la prevalencia del riesgo nutricional en el ámbito de la cirugía vascular y sus consecuencias en la evolución del paciente y el gasto sanitario. Pacientes y métodos: estudio observacional prospectivo realizado durante 6 meses en la planta de cirugía vascular del Hospital Universitario de León. Se utilizó la herramienta Malnutrition Universal Screening Tool (MUST) para recoger datos al ingreso y cada 7 días hasta el alta hospitalaria. Se estudiaron las variables clínicas, la intervención quirúrgica realizada, las complicaciones médico-quirúrgicas, la estancia hospitalaria, los costes sanitarios y los reingresos precoces. Resultados: el estudio contó con 104 pacientes, de los que el 84,6 % eran varones, cuya media de edad era de 69 años (DE: 13). El 46,2 % habían ingresado por enfermedad arterial periférica. El 10,6 % presentaban un MUST positivo al ingreso y el 19,2 % lo presentaban al alta; el 100 % de los pacientes desnutridos al ingreso permanecían en la misma situación al alta. Durante la hospitalización, en 29 pacientes (27,9 %) empeoró la situación nutricional. El 81,25 % de los pacientes que sufrieron empeoramiento del MUST habían ingresado de forma urgente (p < 0,05). Los pacientes que habían precisado una cirugía urgente empeoraron significativamente en términos de su estado nutricional (p < 0,001). Los pacientes con empeoramiento del estado nutricional obtuvieron mayores porcentajes de: reintervención quirúrgica (p < 0,05), gasto farmacéutico (p = 0,017), gasto hospitalario total (1000 €/paciente/ingreso), traslados a centros de cuidados crónicos (p = 0,0002) y número de reingresos precoces (p = 0,017). Conclusiones: los pacientes en riesgo nutricional se asociaron a un incremento de las complicaciones médico-quirúrgicas, de la estancia hospitalaria, del coste sanitario y de la tasa de reingresos, por lo que consideramos necesaria la implantación de cribados y el desarrollo de estudios en el ámbito de la cirugía vascular.

Bone metabolism and fracture risk after Biliopancreatic Diversion.

BACKGROUND: Bariatric surgery (BS) is an effective treatment. However, there have been concerns regarding the negative effect on the bone. The aim of this study was to assess changes in bone metabolism and the risk of fracture after biliopancreatic diversion (BPD). MATERIAL AND METHODS: A retrospective analysis of obese patients undergoing BPD between 1998 and 2017 was conducted, and patients with at least 1 year of follow-up were included. The incidence of fracture and of changes in bone metabolism was studied. RESULTS: In total, 216 patients were included (78.2% female), with a mean age of 42.5(10.6) years. The median follow-up was 6.8(IQR 10.2-3.2) years. The mean body mass index (BMI) was 49.7(6.3) kg/m2. 13.2% (n=29) suffered a bone fracture after surgery; the time until the first fracture was 7.9(3.8) years (55.2% secondary to a casual fall). The rate of fracture incidence was 19.6 per 1000 person-years (95%CI: 1.3-2.7), prevalence was 13.4% (95%CI: 8.9-18.0). The risk of bone fractures seems to increase with longer postoperative evolution time. PTH (pg/ml) levels were significantly higher in patients with fractures (1 year, 98.1 vs. 77.8; 5 years, 162.5 vs. 110.3 p<0.05, adjusted HR 1.10; 95%CI 1.01-1.11). Subjects with a higher %EWL had less risk of fractures after surgery (adjusted HR 0.97; 95%CI 0.94-0.99). Moreover, 25(OH)D levels were lower, and osteocalcin and ß-Crosslaps levels were slightly higher (not significant) in patients with fractures. CONCLUSION: BPD is related to important changes in bone metabolism, which can lead to an increased risk of bone fractures. Assessing the risk of fractures should be part of BS patient care.

Bone metabolism and fracture risk after Biliopancreatic Diversion.

BACKGROUND: Bariatric surgery (BS) is an effective treatment. However, there have been concerns regarding the negative effect on the bone. The aim of this study was to assess changes in bone metabolism and the risk of fracture after biliopancreatic diversion (BPD). MATERIAL AND METHODS: A retrospective analysis of obese patients undergoing BPD between 1998 and 2017 was conducted, and patients with at least 1 year of follow-up were included. The incidence of fracture and of changes in bone metabolism was studied. RESULTS: In total, 216 patients were included (78.2% female), with a mean age of 42.5(10.6) years. The median follow-up was 6.8(IQR 10.2-3.2) years. The mean body mass index (BMI) was 49.7(6.3) kg/m2. 13.2% (n=29) suffered a bone fracture after surgery; the time until the first fracture was 7.9(3.8) years (55.2% secondary to a casual fall). The rate of fracture incidence was 19.6 per 1000 person-years (95%CI: 1.3-2.7), prevalence was 13.4% (95%CI: 8.9-18.0). The risk of bone fractures seems to increase with longer postoperative evolution time. PTH (pg/ml) levels were significantly higher in patients with fractures (1 year, 98.1 vs. 77.8; 5 years, 162.5 vs. 110.3 p<0.05, adjusted HR 1.10; 95%CI 1.01-1.11). Subjects with a higher %EWL had less risk of fractures after surgery (adjusted HR 0.97; 95%CI 0.94-0.99). Moreover, 25(OH)D levels were lower, and osteocalcin and ß-Crosslaps levels were slightly higher (not significant) in patients with fractures. CONCLUSION: BPD is related to important changes in bone metabolism, which can lead to an increased risk of bone fractures. Assessing the risk of fractures should be part of BS patient care.

A review of the pharmacological interactions of ivermectin in several animal species.

The antiparasitic activity of ivermectin depends on the presence of an active drug concentration at the site of parasites location for an adapted length of time. Ivermectin interactions with another concurrently administered drug can occur. Concomitant administration of some drugs can increase the bioavailability of simultaneously administered ivermectin. This can, in some cases, become a useful pharmacological strategy to improve its antiparasitic efficacy and to delay the development of resistance in livestock or, in other cases, lead to adverse drug reactions and toxicities. On the other hand, other interactions can result in lower levels of this drug, determining that moderate resistant residual populations of the parasites may persist to contaminate pastures. The characterisation of ivermectin interactions can be used to predict and optimise the value of the parasiticide effects. This article reviews the pharmacological interactions of ivermectin in several domestic animal species.

Intervention to improve awareness of the risk factors for osteonecrosis of the jaw in patients under treatment with bisphosponates. Randomised clinical trial. / Intervención para la mejora del conocimiento de los factores de riesgo para el desarrollo de osteonecrosis maxilar en pacientes a tratamiento con bisfosfonatos. Ensayo clínico aleatorizado.

PURPOSE: To evaluate the effectiveness of a health education programme on knowledge and reduction of the risk factors for bisphosphonate-related osteonecrosis of the jaw. METHODS: An experimental study control group without intervention was performed with 60 subjects who had started treatment with bisphosphonates in the University Hospital of León from October to December 2014. Patients in the experimental group received a structured education intervention in two sessions. The data was collected from a heteroadministered questionnaire at the beginning and at the end of the study period for both groups. RESULTS: The educational intervention designed showed a significantly increased adherence to healthy behaviours related to oral hygiene such as mechanical control of plaque and the use of clorhexidine prior to invasive oral procedures. All subjects reported that they had not been advised to maintain a good level of oral health before starting treatment. After the intervention high percentages of recognition of early diagnostic measures starting from a baseline total ignorance of them were determined. No conclusive information about the use of removable dental prostheses, toxic habits or maintaining proper metabolic control in patients with diabetes mellitus was observed. CONCLUSIONS: Improving adherence to healthy behaviours related to oral health following the intervention, as well as their contribution to the early identification of warning signs of jaw osteonecrosis, stresses the importance of the use of health education as a tool in routine clinical practice.

Evaluation of the Association Metformin: Plantago ovata Husk in Diabetic Rabbits.

In this experimental study we have investigated whether the inclusion of the dietary fiber Plantago ovata husk could be recommended as coadjuvant in treatments with oral hypoglycemic drugs. We evaluated the use of Plantago ovata husk-metformin association in diabetic rabbits by determining its effects on glucose and insulin concentrations. Six groups of 6 rabbits were used. Groups 1 to 3 were fed with standard chow and groups 4 to 6 with chow supplemented with Plantago ovata husk (3.5 mg/kg/day). Two groups (numbers 1 and 4) were used as controls (receiving standard or supplemented chow), two groups (numbers 2 and 5) received metformin orally, and the other two (numbers 3 and 6) were treated orally with metformin and psyllium. Plasma glucose concentrations were lower in groups fed with fiber-supplemented chow whereas insulin levels showed important interindividual variations. Glucose pharmacokinetics parameters showed significant differences in Cmax and t(max) in relation to fiber intake. Insulin pharmacokinetics parameters after treatment with oral metformin showed an important increase in Cmax, AUC, and t(max) in animals fed with fiber. We conclude that Plantago ovata husk intake can contribute to the oral antihyperglycemic treatment of type 2 diabetes.

Enrofloxacin: pharmacokinetics and metabolism in domestic animal species.

Enrofloxacin is a fluorquinolone exclusively developed for use in veterinary medicine (1980). The kinetics of enrofloxacin are characterized, in general terms, by high bioavailability in most species and rapid absorption after IM, SC or oral administration. However, several studies reported that enrofloxacin showed low bioavailability after oral administration in ruminants. This drug has a broad distribution in the organism, excellent tissue penetration and long serum half-life. Also, enrofloxacin is characterized by a low host toxicity, a broad antibacterial spectrum and high bactericidal activity against major pathogenic bacteria (both Gram-positive and Gram-negative), and intracellular organisms found in diseased animals. The kinetics vary according to the route of administration, formulation, animal species, age, body condition, and physiological status, all of which contribute to differences in drug efficacy. The pharmacokinetic properties of drugs are closely related to their pharmacological efficiency, so it is important to know their behavior in each species that is used. This article reviews the pharmacokinetics of enrofloxacin in several domestic animal species.

Pharmacokinetic behavior of doxycycline after intramuscular injection in sheep.

OBJECTIVE: To determine the pharmacokinetics of a commercial formulation of doxycycline hyclate after IM administration of a single dose to sheep. ANIMALS: 11 healthy domestic sheep. PROCEDURES: For each sheep, doxycycline was administered as a single dose of 20 mg/kg, IM. Blood samples were obtained prior to and for 84 hours after doxycycline administration. Plasma concentrations of doxycycline were determined via high-performance liquid chromatography with UV detection. Pharmacokinetic data were analyzed with noncompartmental methods. RESULTS: Mean ± SD values for pharmacokinetic parameters included maximum plasma concentration (2.792 ± 0.791 µg/mL), time to reach maximum plasma concentration (0.856 ± 0.472 hours), mean residence time (91.1 ± 40.78 hours), elimination half-life (77.88 ± 28.45 hours), and area under the curve (65.67 ± 9.877 µg•h/mL). CONCLUSIONS AND CLINICAL RELEVANCE: Results indicated that doxycycline had prolonged absorption and elimination in sheep after IM administration. A daily dose of 20 mg/kg would be sufficient to reach effective plasma concentrations against Chlamydia spp (minimum inhibitory concentration, 0.008 to 0.031 µg/mL) and Staphylococcus aureus (minimum inhibitory concentration, 0.12 µg/mL). Doxycycline administered IM could be an option for therapeutic use in sheep, although further studies are needed.

Tissue distribution of enrofloxacin after intramammary or simulated systemic administration in isolated perfused sheep udders.

OBJECTIVE: To determine the tissue distribution of enrofloxacin after intramammary or simulated systemic administration in isolated perfused sheep udders by measuring its concentration at various sample collection sites. SAMPLE: 26 udders (obtained following euthanasia) from 26 healthy lactating sheep. PROCEDURES: For each isolated udder, 1 mammary gland was perfused with warmed, gassed Tyrode solution. Enrofloxacin (1 g of enrofloxacin/5 g of ointment) was administered into the perfused gland via the intramammary route or systemically via the perfusion fluid (equivalent to a dose of 5 mg/kg). Samples of the perfusate were obtained every 30 minutes for 180 minutes; glandular tissue samples were obtained at 2, 4, 6, and 8 cm from the teat base after 180 minutes. The enrofloxacin content of the perfusate and tissue samples was analyzed via high-performance liquid chromatography with UV detection. RESULTS: After intramammary administration, maximun perfusate enrofloxacin concentration was detected at 180 minutes and, at this time, mean tissue enrofloxacin concentration was detected and mean tissue enrofloxacin concentration was 123.80, 54.48, 36.72, and 26.42 µg/g of tissue at 2, 4, 6, and 8 cm from the teat base, respectively. Following systemic administration, perfusate enrofloxacin concentration decreased with time and, at 180 minutes, tissue enrofloxacin concentrations ranged from 40.38 to 35.58 µg/g of tissue. CONCLUSIONS AND CLINICAL RELEVANCE: By 180 minutes after administration via the intramammary or systemic route in isolated perfused sheep mammary glands, mean tissue concentration of enrofloxacin was greater than the minimum inhibitory concentration required to inhibit growth of 90% of many common mastitis pathogens in sheep. Use of either route of administration (or in combination) appears suitable for the treatment of acute mastitis in sheep.

The pharmacokinetics and interactions of ivermectin in humans--a mini-review.

Ivermectin is an antiparasitic drug with a broad spectrum of activity, high efficacy as well as a wide margin of safety. Since 1987, this compound has a widespread use in veterinary medicine and it use has been extended in humans. Here we present a brief review of the information available regarding the pharmacokinetics and interactions of ivermectin in humans. Awareness of these characteristics could improve the clinical efficacy of Ivermectin. All Authors declare that they do not have any Conflict of interest and that the work is original. All Authors agree that the contents of the manuscript are confidential and will not be copyrighted, submitted, or published elsewhere (including the Internet), in any language, while acceptance by the Journal is under consideration.

Seguridad de la ivermectina: toxicidad y reacciones adversas en diversas especies de mamíferos / Safety of ivermectin: toxicity and adverse reactions in several mammal species

La ivermectina es un fármaco antiparasitario muy utilizado en Medicina Veterinaria, dado su espectro de actividad que abarca tanto endo como ectoparásitos, elevada eficacia y amplio margen de seguridad. No obstante, su administración puede dar lugar a efectos tóxicos. La mayoría de ellos derivan de la sobredosificación del compuesto, aunque también se han descrito, a dosis terapéuticas, casos de susceptibilidad extrema a los efectos neurotóxicos del fármaco en determinadas razas o subpoblaciones de animales, así como reacciones anafilácticas por la destrucción masiva de parásitos.