Estudio de utilización de Tenofovir DF en el tratamiento antirretroviral de gran actividad / Use study of tenofovir DF in higly active anti-retroviral therapy

Objetivo: Describir la eficacia y seguridad de tenofovir. Métodos: Estudio descriptivo, observacional. Análisis por intención de tratar. La variable principal fue la proporción de pacientes con supresión de la carga viral plasmática del VIH hasta indetectable. Las variables secundarias fueron la respuesta inmunológica, proporción de pacientes con variación positiva del número de CD4+ y la seguridad (eventos adversos clínicos y valores bioquímicos y hematológicos). Se midió la causalidad por el algoritmo de Naranjo. Resultados: Se seleccionaron 154 pacientes, 12 fueron excluidos de todos los análisis. Las variables de eficacia fueron: La proporción de pacientes que disminuyeron la carga viral a 50 copias/ml o menos fue 28,16%, la media de descenso fue -1,29 ± 0,97 log10 copias/ml. La media de aumento de CD4 fue de 40,27 ± 141,50 cel/mm3 La seguridad fue similar a la ficha técnica, destacando tres casos de Síndrome de Fanconi. Conclusión: Tenofovir supone un antirretroviral de gran efectividad en el hospital con un perfil de seguridad óptimo

Objective: Describe the efficacy and safety of tenofovir. Methods: Observational, descriptive study. Data were analyzed for the intention-to-treat sample. The primary efficacy end-point included the proportion of patients with HIV-1 RNA level of 50 copies/ml or less. Secondary efficacy end points was the increase of the CD4 cell count at week 48. The primary safety end-point was the number of patients with abnormalities (clinical adverse events and laboratory toxicities). The causality of the adverse effects was measured by the Naranjo algorithm Results: 154 subjects were enrolled; 12 were excluded from all analyses. Efficacy end points: Plasma HIV-1 RNA response: -1.29 ± 0.97 log10 copies/ml; Patients with HIV-1 RNA levels of 50 copies/ml or less: 28.16%; CD4 cell count response: 40.27 ± 141.50 cel/mm3. Safety profile was similar to showed at prescribing information, 3 Fanconi Syndrome were detected. Conclusion: Tenofovir supposes an antiretroviral of high effectiveness in our hospital, with an optimum safety profile

Influencia del tratamiento antihipertensivo sobre la variabilidad de la presión arterial y diferencias entre mujeres pre y posmenopáusicas / Influence of antihypertensive treatment on the variability of blood pressure and differences between pre and postmenopausal women

Objetivo. Analizar la influencia del tratamiento antihipertensivo en la variabilidad de la presión arterial (PA) y sus diferencias entre mujeres pre y posmenopáusicas. Métodos. Se realizó un estudio prospectivo en Atención Primaria, seleccionándose 112 mujeres con hipertensión arterial (HTA) leve-moderada no controlada cuya monitorización ambulatoria de la presión arterial (MAPA) (Spacelabs 90207) inicial presentó unas presiones arteriales sistólicas (PAS) y presiones arteriales diastólicas (PAD) medias diurnas superiores a 135 y/o 85 mmHg. Se prescribieron antihipertensivos según práctica clínica habitual. Se compararon las PAS y PAD clínicas y ambulatorias y los índices de variabilidad (IV) de la PAS, PAD, PAM globales, diurnas y nocturnas iniciales y a las 8 semanas. Se compararon en función de su estado hormonal: GA: menopáusicas; GB: premenopáusicas. Resultados. Finalizaron 103 mujeres con una edad media de 53,06 (DE: 10,3 años) (N: GA, 50; GB, 53). El IV de la PAS y PAD diurna inicial fue de 12,2 (DE: 2,9) y 9,9 (DE: 2,08) y el IV final de 12,7 (DE: 10,2) y 8,9 (DE: 1,9) (p = NS), respectivamente, sin diferencias entre los IV de las PA de 24 horas, diurnas o nocturnas. Los IV diurnos iniciales y finales fueron de 11,1 (DE: 2,2) y 10,6 (DE: 2,6) para la PAS y 8,5 (DE: 1,8) y 8,7 (DE: 2) para la PAD en el grupo de premenopáusicas y 13,8 (DE: 3) y 14,7 (DE: 13,8) para la PAS y 9,3 (DE: 2,2) y 9,1 (DE: 1,8) para la PAD en el grupo de posmenopáusicas. No se observaron diferencias en los IV entre ambos grupos, ni en sus descensos medios, excepto para el IV de la PAS 24 horas con descenso medio significativo entre inicio y final en posmenopáusicas. Conclusiones. No se observan diferencias en los IV entre pre y posmenopáusicas. El tratamiento antihipertensivo produce un descenso del IV de las PAS de 24 horas en posmenopáusicas

Objective. Analyze the influence of antihypertensive treatment in variability of blood pressure (BP) and its differences between pre-and postmenopausal women. Methods. A prospective study was conducted in primary health care, enrolling 112 women with uncontrolled mild-moderate HBP whose initial ambulatory blood pressure monitoring (ABPM) (Spacelabs 90207) showed mean daytime SBP and DBP greater than 135 and/or 85 mmHg. Antihypertensive drugs were prescribed according to the usual clinical practice. Clinical and ambulatory SBP and DBP were compared as well as variability indexes (VI) of initial global daytime and nighttime SBP, DBP, MBP at 8 weeks. They were compared based on their hormone status: GA: menopausal; GB: premenopausal. Results. A total of 103 women with a mean age of 53.06 (SD 10.3 years) (N: GA, 50; GB, 53) completed the study. The VI of the initial daytime SBP and DBP was 12.2 (SD: 2.9) and 9.9 (SD: 2.08) and the final VI was 12.7 (SD: 10.2) and 8.9 (SD: 1.9) (p = NS) respectively, without differences between VI of the 24 hour, daytime or nighttime BP. The initial and final daytime VI were 11.1 (SD: 2.2) and 10.6 (SD: 2.6) for SBP and 8.5 (SD: 1.8) and 8.7 (SD: 2) for DBP in the premenopausal group and 13.8 (SD: 3) and 14.7 (SD: 13.8) for SBP and 9.3 (SD 2.2) and 9.1 (SD 1.8) for DBP in the postmenopausal group. No differences were observed in VI between both groups or in their mean decreases except for the VI of the 24-hour SBP that had a significant mean decrease between initial and final VI in postmenopausal subjects. Conclusions. No differences were observed in the VI between pre and postmenopausal subjects. Antihypertensive treatment causes a decrease of 24 hour SBP VI in postmenopausal subjects

[Use study of tenofovir DF in highly active anti-retroviral therapy]. / Estudio de utilización de Tenofovir DF en el tratamiento antirretroviral de gran actividad.

OBJECTIVE: Describe the efficacy and safety of tenofovir. METHODS: Observational, descriptive study. Data were analyzed for the intention-to-treat sample. The primary efficacy end-point included the proportion of patients with HIV-1 RNA level of 50 copies/ml or less. Secondary efficacy end points was the increase of the CD4 cell count at week 48. The primary safety end-point was the number of patients with abnormalities (clinical adverse events and laboratory toxicities). The causality of the adverse effects was measured by the Naranjo algorithm. RESULTS: 154 subjects were enrolled; 12 were excluded from all analyses. Efficacy end points: Plasma HIV-1 RNA response: -1.29 +/- 0.97 log10 copies/ml; Patients with HIV-1 RNA levels of 50 copies/ml or less: 28.16%; CD4 cell count response: 40.27 +/- 141.50 cel/mm3. Safety profile was similar to showed at prescribing information, 3 Fanconi Syndrome were detected. CONCLUSION: Tenofovir supposes an antiretroviral of high effectiveness in our hospital, with an optimum safety profile.

[Cost-effectiveness analysis of tenofovir versus zidovudine in combination therapy with efavirenz and lamivudine for the treatment of HIV in naive patients]. / Análisis coste-eficacia de tenofovir versus zidovudina en terapia combinada con efavirenz y lamivudina para el tratamiento de VIH en pacientes no pretratados.

OBJECTIVES: To assess tenofovir + lamivudine + efavirenz versus zidovudine + lamivudine + efavirenz in treatment-naive patients using a cost-effectiveness analysis. METHODS: A decision tree was designed. Effectiveness was estimated from clinical trials. Viral load and CD4 cells count were chosen as endpoints for health outcome. Both healthcare and treatment costs were considered, and univariate sensitivity tests were performed. RESULTS: The regimen including tenofovir would have a yearly cost of 10,116.61 Euros when effective, and of 12,140.40 Euros in case of therapeutic failure. The regimen including zidovudine would have a yearly cost of 7,470.36 Euros when effective, and of 8,964.90 Euros in case of therapeutic failure. The cost of switching to the regimen with tenofovir represents 14,765.86 Euros per year per additional patient with non-detectable viral load. After 3 years, the expected yearly cost is 8,765.83 Euros for the regimen including tenofovir versus 8,894.36 Euros for the regimen including zidovudine. CONCLUSION: The regimen including zidovudine is less costly in the short run when compared to the regimen including tenofovir. Both regimens become financially similar when extending the study horizon.

Análisis coste-eficacia de tenofovir versus zidovudina en terapia combinada con efavirenz y lamivudina para el tratamiento de VIH en pacientes no pretratados / Cost-effectiveness analysis of tenofovir versus zidovudine in combination therapy with efavirenz and lamivudine for the treatment of HIV in naive patients

Objetivos: Evaluar los regímenes en pacientes no pretratados de tenofovir + lamivudina + efavirenz versus zidovudina + lamivudina + efavirenz mediante un estudio coste-eficacia. Métodos: Se diseñó un árbol de decisiones. Se estimó la eficaciaa través de ensayos clínicos. Para valorar la medida sobre los resultados de la salud se consideró la carga viral y los CD4. Se consideraron costes asistenciales y de tratamiento, y se realizó un análisis de sensibilidad univariante. Resultados: El régimen con tenofovir tendría un coste anual, en caso de ser efectivo, de 10.116,61 €, mientras que si existefallo terapéutico el coste sería de 12.140,40 €. El régimen que incluye zidovudina tendría un coste anual de 7.470,36 € en caso de ser efectivo, y un coste de 8.964,90 €, en caso de fallo terapéutico.El coste de pasar al régimen que incluye tenofovir supone 14.765,86 € al año por paciente adicional con carga viral indetectable. En 3 años, el coste anual esperado es de 8.765,83 € para el régimen que incluye tenofovir frente a 8.894,36 € del régimen que incluye zidovudina. Conclusión: El régimen que incluye zidovudina es menos costoso a corto plazo que el que incluye tenofovir. Si ampliamos el horizonte del estudio, los dos regímenes se equiparan económicamente

Objectives: To assess tenofovir + lamivudine + efavirenz versus zidovudine + lamivudine + efavirenz in treatment-naive patients using a cost-effectiveness analysis. Methods: A decision tree was designed. Effectiveness was estimated from clinical trials. Viral load and CD4 cells count were chosen as end points for health outcome. Both healthcare and treatment costs were considered, and univariate sensitivity tests were performed. Results: The regimen including tenofovir would have a yearly cost of € 10,116.61 when effective, and of € 12,140.40 in case of therapeutic failure. The regimen including zidovudine would have a yearly cost of € 7,470.36 when effective, and of € 8,964.90 incase of therapeutic failure. The cost of switching to the regimen with tenofovir represents € 14,765.86 per year per additional patient with non-detectable viral load. After 3 years, the expected yearly cost is € 8,765.83 for the regimen including tenofovir versus € 8,894.36 for the regimen including zidovudine. Conclusion: The regimen including zidovudine is less costly in the short run when compared to the regimen including tenofovir. Both regimens become financially similar when extending the study horizon

Reparación de defectos osteocartilaginosos de la rótula de conejos con injertos libres de periostio / Repair tissue resurfacing in osteocartilaginous defects in rabbit's patellas treated with periosteal grafts

Se diseña un modelo experimental consistente en la realización de una úlcera condral de 6 mm, en la superficie articular de la rótula, en 48 conejos distribuidos en dos series. Mientras en la serie control (24 conejos) dicha úlcera se dejó a evolución espontánea, en la experimental (24 conejos) fue cubierta con plastia libre de periostio tibia¡, para poder investigar la posibilidad de regeneración del cartilago articular. Los resultados se valoraron microscópicamente a intervalos de 1, 2,4 y 8 semanas,comprobando la ausencia de regeneración espontánea y el desarrollo de un cartílago hialino a partir de la plastia de periostio, con lo que se demuestra la capacidad condrogénica de la misma y se sugiere la posibilidad de aplicación clínica en defectos del cartilago articular (AU)

Comparative study of the reconstruction of articular cartilage defects with free costal perichondrial grafts and free tibial periosteal grafts: an experimental study on rabbits.

The purpose of this study was to compare the chondrogenic potential of free perichondrial with free periosteal grafts in the resurfacing of full-thickness defects of patellar articular cartilage in rabbits. We used adolescent New Zealand rabbits weighing between 2.4 and 3.6 kg. A 6-mm wide and 3-mm thick defect was created on the patellar articular surface. A total of 30 rabbits were randomly divided into a control group and two test groups. One test group received free perichondrial grafts (PC); the other received free periosteal grafts (PO). All the animals were killed 8 weeks after surgery. All the histological samples were scored from 0 to 17 according to a standard scoring system. Differences in the quality of the regenerated tissue were only found between the control and the test groups. There were no statistically significant histological differences between the grafted defects of the PC and the PO groups that there are not on any of the variables. The results of this study support that there are not significant differences in the quality of the repair tissue when using these two types of biological grafts.

[An analysis of drug advertising in non-specialty medical journals]. / Análisis de la publicidad medicamentosa en revistas médicas no especializadas.

It has been evaluated drug advertisement in four medical journals during 1989. A questionnaire allows us to evaluate pharmacological and advertising data. The main results obtained are the following: amoxicillin + clavulanic acid was the more advertising drug; the ratio publicity/pharmacological information was 3:1; 60% of the advertising products were new drugs, and only a 6% were essentials drugs according to WHO; slogans were acceptable; generally, aspects such as dosage and toxicology are referred. However, it is necessary to improve information about drug use in elderly patients, patients with impaired renal functional, as well as the necessary information in adverse drug reactions.

[The effects of ticlopidine and nifedipine on platelet aggregation in patients with obliterating arteriopathy of the lower limbs]. / Efectos de la ticlopidina y el nifedipino sobre la agregación plaquetaria en pacientes con arteriopatía obliterante de miembros inferiores (AOMI).

This paper evaluates the antiaggregant action of ticlopidine and nifedipine in patients with obliterate arteriopathy in inferior limbs of arteriosclerotic etiology (OAIL). They were established 4 study groups: control, with health volunteers without treatment (N = 10); patients treated with placebo (n = 11); patients treated with 500 mg/day of ticlopidine (n = 12) and treated with 30 mg/day of nifedipine (n = 12). The last 3 groups the treatment duration was 30 days. It was studied the platelet aggregatory activity against ADP and collagen, before drug administration and at 15 and 30 days post-treatment. Our results suggest that: Platelet aggregation is increased in patients with AOMI compared with that observed in the control group. Ticlopidine inhibits platelet aggregation induced by ADP, but not that induced by collagen. Nifedipine doesn't produce any effect on platelet aggregation.