[Effectiveness and safety of Very Low Calory Diets in obese patients]. / Evaluación de la efectividad y seguridad de Dietas de Muy Bajo Contenido Calórico en pacientes obesos.

PURPOSE: To evaluate effectiveness, safety and adherence of Very Low Calory Diet (VLCD) in patients with obesity. METHODS: Observational prospective descriptive study. Patients with BMI >30 kg/m2 who started VLCD were included. We arranged 3 pharmacotherapeutical consultations, picking up the variables: age, sex, BMI, side effects and number of VLCD cycles. We defined effectiveness as weight loss in absolute and relative terms and weight loss rate (kg/week); safety as incidence and severity of side effects by the Pharmacovigilance Spanish System (SEFV); and adherence by a SMAQ adapted questionnaire. RESULTS: 29 women and 15 men were included, with a mean of 42 years. 5 patients did not complete the follow-up. Effectiveness: weight loss average was 7kg (IQR 9,5 a 5,3) and relative of 6,7%, (p < 0.0005). The weight loss rate was 1,2kg per week (IQR 1,6 a 0,9). SAFETY: 33% of the patients described side effects. All of them were mild (37% constipation, 16% dizziness, 12% anxiety, 5% headache, 2% gases y 2% epigastrical pain). ADHERENCE: 84% of the patients were adherent by the SMAQ adapted questionnaire: 74% in the first cycle and 92% in the following ones. The relation between the number of cycles and the adherence did not get statistical differences (p = 0,1127). CONCLUSIONS: Effectiveness and adherence to the treatment could improve in obese patients by setting interdisciplinary measures in the daily clinical practice.

Evaluación de la efectividad y seguridad de Dietas de Muy Bajo Contenido Calórico en pacientes obesos / Efectiveness and safety of very low calory diets in obese patients

Objetivos: Evaluar efectividad, seguridad y adherencia de Dietas de Muy Bajo contenido Calórico (DMBC) en pacientes con obesidad. Método: Estudio descriptivo prospectivo observacional. Se incluyeron pacientes con IMC >30 kg/m2 que inician tratamiento con DMBC. Se realizaron tres consultas farmacéuticas, recogiéndose las variables: edad, sexo, IMC, efectos adversos y número de ciclos de DMBC. Se definió efectividad como la pérdida de peso en términos absolutos y relativos, y la tasa de pérdida de peso kg/semana; seguridad como incidencia y gravedad de efectos adversos según el Sistema Español de Farmaco vigilancia (SEFV); y adherencia a través de un cuestionario SMAQ adaptado. Resultados: Se incluyeron 29 mujeres y 15 hombres; media de 42 años. 5 pacientes no completaron el seguimiento. Efectividad: la mediana de pérdida de peso fue de 7 kg (RIQ 9,5a 5,3) y relativa de 6,7%, (p < 0,0005). La tasa de pérdida de peso kg/semana fue de 1,2 kg (RIQ 1,6 a 0,9). Seguridad: el 33% de los pacientes refirieron efectos adversos. Todos fueron leves (37% estreñimiento, 16% mareos, 12% ansiedad, 5% cefaleas, 2% gases y 2% dolor epigástrico). Adherencia: el 84% de los pacientes fueron adherentes segúnel cuestionario SMAQ adaptado, en 1er ciclo un 74% y un 92%en sucesivos. La relación entre el número de ciclos y la adherencia, no alcanzó diferencias significativas (p = 0,1127). Conclusiones: La efectividad y la adherencia al tratamiento son mejorables a través de la implantación de medidas interdisciplinares de seguimiento activo al paciente obeso en la práctica clínica diaria

Purpose: To evaluate effectiveness, safety and adherence of Very Low Calory Diet (VLCD) in patients with obesity. Methods: Observational prospective descriptive study. Patients with BMI>30 kg/m2 who started VLCD were included. We arranged 3 pharmaco therapeutical consultations, picking up the variables: age, sex, BMI, side effects and number of VLCD cycles. We defined effectiveness as weight loss in absolute and relative terms and weight loss rate (kg/week); safety as incidence and severity of side effects by the Farmaco vigilance Spanish System (SEFV); and adherence by a SMAQ adapted questionnaire. Results: 29 women and 15 men were included, with a mean of 42years. 5 patients did not complete the follow-up. Effectiveness: weight loss average was 7kg (IQR 9,5 a 5,3) and relative of6,7%, (p < 0.0005). The weight loss rate was 1,2kg per week (IQR 1,6 a 0,9).Safety: 33% of the patients described side effects. All of them were mild (37% constipation, 16% dizziness, 12% anxiety, 5% headache,2% gases y 2% epigastrical pain).Adherence: 84% of the patients were adherent by the SMAQ adapted questionnaire: 74% in the first cycle and 92% in the following ones. The relation between the number of cycles and the adherence did not get statistical differences (p = 0,1127). Conclusions: Effectiveness and adherence to the treatment could improve in obese patients by setting interdisciplinary measures in the daily clinical practice (AU)

Development and application to clinical practice of a validated HPLC method for the analysis of ß-glucocerebrosidase in Gaucher disease.

The main objective of our study is to develop a simple, fast and reliable method for measuring ß-glucocerebrosidase activity in Gaucher patients leukocytes in clinical practice. This measurement may be a useful marker to drive dose selection and early clinical decision making of enzyme replacement therapy. We measure the enzyme activity by high-performance liquid chromatography with ultraviolet detection and 4-nitrophenyl-ß-d-glucopyranoside as substrate. A cohort of eight Gaucher patients treated with enzyme replacement therapy and ten healthy controls were tested; median enzyme activity values was 20.57mU/ml (interquartile range 19.92-21.53mU/ml) in patients and mean was 24.73mU/ml (24.12-25.34mU/ml) in the reference group, which allowed the establishment of the normal range of ß-glucocerebrosidase activity. The proposed method for leukocytes glucocerebrosidase activity measuring is fast, easy to use, inexpensive and reliable. Furthermore, significant differences between both populations were observed (p=0.008). This suggests that discerning between patients and healthy individuals and providing an approach to enzyme dosage optimization is feasible. This method could be considered as a decision support tool for clinical monitoring. Our study is a first approach to in depth analysis of enzyme replacement therapy and optimization of dosing therapies.

Crataegus laevigata decreases neutrophil elastase and has hypolipidemic effect: a randomized, double-blind, placebo-controlled trial.

Crataegus laevigata is a medicinal plant most commonly used for the treatment of heart failure and psychosomatic disorders. Based on previous experimental findings, this double-blind placebo-controlled study was aimed at finding beneficial effects of C. laevigata on biomarkers of coronary heart disease (CHD). The study included 49 diabetic subjects with chronic CHD who were randomly assigned to the treatment for 6 months with either a micronized flower and leaf preparation of C. laevigata (400 mg three times a day) or a matching placebo. Blood cell count, lipid profile, C-reactive protein, neutrophil elastase (NE) and malondialdehyde were analyzed in plasma at baseline, at one month and six months. The main results were that NE decreased in the C. laevigata group compared to the placebo group. In the C. laevigata group, baseline figures (median and interquartile range) were 35.8 (4.5) and in the placebo group 31 (5.9). At the end of the study, values were 33.2 (4.7) ng/ml and 36.7 (2.2) ng/ml, respectively; p<0.0001. C. laevigata, added to statins, decreased LDL cholesterol (LDL-C) (mean±SD) from 105±28.5 mg/dl at baseline to 92.7±25.1 mg/dl at 6 months (p=0.03), and non-HDL cholesterol from 131±37.5 mg/dl to 119.6±33 mg/dl (p<0.001). Differences between groups did not reach statistical significance at 6 months. No significant changes were observed in the rest of parameters. In conclusion, C. laevigata decreased NE and showed a trend to lower LDL-C compared to placebo as add-on-treatment for diabetic subjects with chronic CHD.

Capillary gas chromatography-mass spectrometry quantitative determination of hydroxytyrosol and tyrosol in human urine after olive oil intake.

Recent in vitro studies have demonstrated antioxidant properties of some virgin olive oil phenolic compounds. One of the prerequisites to extrapolate these data to an in vivo situation is the knowledge of their bioavailability in humans. In the present work we describe an analytical method which enables us to perform hydroxytyrosol and tyrosol quantitative determinations in human urine. This method was successfully used in bioavailability studies of both phenolic compounds after acute olive oil administration. Virgin olive oil was administered to healthy volunteers after a low phenolic diet. The dose administered of both phenolic compounds was estimated in reference to free forms of hydroxytyrosol and tyrosol present in virgin olive oil extracts before and after being submitted to hydrolytic conditions. These conditions mimic those occurring during digestion. Urine samples were collected before and after acute olive oil intake and analyzed by capillary gas chromatography-mass spectrometry. Hydroxytyrosol and tyrosol urinary recovery increased in response to olive oil administration, obtaining maximal values in the first 4 h. Our results further indicate that hydroxytyrosol and tyrosol are mainly excreted in conjugated form, since only 5.9 +/- 1.4% (hydroxytyrosol) and 13.8 +/- 5.4% (tyrosol) of the total amounts excreted in urine were in free form.

[Externally induced prescriptions, degree of agreement and ... possibility of change in primary care?]. / Prescripción inducida, grado de conformidad y ... posibilidad de cambio en atención primaria?

OBJECTIVE: To find whether externally induced prescriptions (EIP) condition attendance through their prevalence, quality, the degree of agreement of the PC doctor and his/her capacity to alter them. DESIGN: Cross-sectional study of use of indication-prescription type medicines. SETTING: Health district. PARTICIPANTS: 2656 prescriptions for 678 patients interviewed. MEASUREMENTS: Each interview recorded: type of visit, age, sex, work situation, existence or otherwise of social problems and/or psychiatric pathology; doctor-patient relationship, pharmaceutical preparations (PP) prescribed and those which the patient remembers he/she is taking, indication, origin, duration, speciality of the prescribing person, agreement of the PC doctor issuing the prescription and the possibility of his/her changing it. For each prescription the following was analysed: therapeutic group, intrinsic value, time it lasts, cost and whether it is a recently marketed PP. MAIN RESULTS: 90% of visits to the doctor end in prescription. 58% of patients remember taking one or more EIP. 72% of the prescriptions analysed were externally caused. They came mostly from the public health system (66%), private medicine (20%) and self-medication (11%). There was no PC agreement with almost half these EIPs, but only 13% could be changed. The EIPs without agreement and without possibility of change were greater in: women, the elderly, people on a pension, psychiatric pathologies and in cases of bad doctor-patient relationship. The EIPs originated in health insurance companies, pharmacies, self-medication, former GPs and private doctors. They were associated with ill-defined signs and symptoms, circulatory diseases and locomotive disease. We found no significant differences in expenditure or use of PP recently put onto the market between self-medication and EIP, though there were in quality. CONCLUSIONS: The current model of prescribing medication causes consultations to be greatly "medicinised" at the expense of EIP. Doctors only alter a small part of the EIPs they don't agree with. Longitudinal studies are needed to monitor patients to find the evolution of EIPs (withdrawal, replacement, dragging on or new external prescription).

Prescripción inducida, grado de conformidad y... ¿posibilidad de cambio en atención primaria? / Externally induced prescriptions, degree of agreement in primary care and... the possibility of change in primary care?

Objetivos. Conocer si la medicación inducida (MI) condiciona la asistencia a través de su prevalencia, su calidad, el grado de conformidad del médico y su capacidad de modificarla. Diseño. Estudio transversal de utilización de medicamentos del tipo prescripción-indicación. Emplazamiento. Área básica de salud. Participantes. Dos mil seiscientas cincuenta y seis prescripciones correspondientes a 678 pacientes entrevistados. Mediciones. En cada entrevista se recogen: tipo de visita, edad, sexo, situación laboral, existencia o no de problemática social y/o de patología psíquica; relación médico-paciente, presentaciones farmacéuticas (PF) recetadas y las que recuerda estar tomando, indicación, origen, duración, especialidad del inductor, conformidad del transcriptor y posibilidad de cambio. En cada prescripción se analizan: grupo terapéutico, valor intrínseco, cronicidad, coste y si se trata de una PF de reciente comercialización. Resultados principales. Un 90 por ciento de las visitas acaba con prescripción. Un 58 por ciento de los pacientes recuerda tomar una o más MI. Fueron inducidas un 72 por ciento de las prescripciones analizadas, que provenían en su mayoría de la asistencia pública (66 por ciento), de la medicina privada (20 por ciento) y de automedicaciones (11 por ciento). No existe conformidad en casi la mitad de la MI, pudiéndose modificar, tan sólo, un 13 por ciento. La MI sin conformidad y sin posibilidad de cambio es superior en: mujeres, tercera edad, pensionistas, patologías psíquicas y mala relación médico-paciente. Procede principalmente de mutuas, farmacias, automedicaciones, antiguos cabeceras y privados. Se asocia a signos y síntomas mal definidos, enfermedades circulatorias y locomotoras. No encontramos diferencias significativas ni en el gasto, ni en la utilización de PF de reciente comercialización entre la medicación propia y la MI; sí las hay en lo que atañe a la calidad. Conclusiones. El actual modelo de prescripción de envases origina una gran medicalización de las consultas a expensas de la MI. El médico sólo modifica una pequeña parte de la MI sin su conformidad. Son precisos estudios longitudinales de monitorización de pacientes para conocer la evolución (retirada, sustitución, arrastre o nueva inducción) de la MI (AU)

[Synchronous multiple primary cancer of the lung: a rare association of small cell carcinoma as the main tumor plus epidermoid carcinoma]. / Neoplasia primaria múltiple pulmonar sincrónica: carcinoma microcítico como tumor principal y carcinoma epidermoide, una asociación infrecuente.

Multiple primary cancer (MPC), a rare finding, is most often seen in the breast. In the lung, this cancer is rare (accounting for between 1.5 and 3% of cases), with epidermoid carcinoma usually being the principal tumor. The presentation of small-cell carcinoma as the principal tumor in MPC is thought to be extremely rare. The criteria for pulmonary MPC described by Martini and Melamed continue to provide the definition of reference. Pulmonary MPC can manifest in a synchronically (simultaneous appearance) or metachronically (with more than two years' lapse in appearance). Patients so-affected are usually male and heavy smokers. Survival with this type of lung cancer is usually less than for a single form. We report the case of a patient with synchronous MPC of the lung, with small cell carcinoma as the principal tumor associated with epidermoid carcinoma. We review the literature on this subject.

Recovery of minimal change nephrotic syndrome and acute renal failure in a patient withRenal cell carcinoma.

We describe a 78-year-old patient with nephrotic syndrome due to minimal-change glomerulopathy, associated with a renal adenocarcinoma. Oliguric acute renal failure requiring hemodialysis was also observed. Surgical removal of the tumor and corticosteroid therapy resulted in resolution of the nephrotic state and improvement of the renal function. Nephrotic syndrome is an unusual complication of renal cell carcinomas, and the association of minimal-change glomerulopathy (MCG) and solid tumors is particularly uncommon. In spite of this, MCG should be considered in the nephropathies causing nephrotic syndrome and acute renal failure in patients with renal malignancies.