Calidad en la conservación de los medicamentos termolábiles en el ámbito domiciliario / Quality of storage of thermolabile drugs in patients’ homes

ObjetivoEvaluar las condiciones de conservación en el domicilio del paciente de 2 medicamentos termolábiles, el etanercept (Enbrel®) y el adalimumab (Humira®), y establecer la posible influencia sobre la temperatura (Ta) media de conservación de variables como el número de personas que viven en el domicilio, la edad de los pacientes o la antigüedad de la nevera.Material y métodosEstudio observacional prospectivo. La muestra estuvo constituida por 60 pacientes en tratamiento con Enbrel® o Humira®. Se utilizaron tarjetas con un sensor térmico integrado, VarioSens®, que se colocaron sobre el embalaje externo del medicamento, programadas para registrar la Ta cada 90min, durante aproximadamente 30 días. Se empleó como variable principal la Ta media de conservación detectada en los frigoríficos.ResultadosLos resultados confirmaron que existe mayor riesgo de conservación inadecuada mantenida (más de 24h consecutivas) cuando la Ta media del frigorífico está fuera del rango 2–8°C (riesgo relativo=3,9; intervalo de confianza del 95%=1,95–7,93; p<0,0001). Treinta y cinco pacientes (58,3%) tenían el medicamento a una Ta media fuera del rango establecido. Se observaron diferencias significativas en la Ta media de conservación en función de la antigüedad del frigorífico, inferior o superior a 5 años (p=0,029). La antigüedad superior a 5 años supuso un factor de riesgo para una conservación inadecuada (riesgo relativo=1,68; intervalo de confianza al 95%=1,04–2,71), con p=0,023 en la prueba de la Ji al cuadrado de Pearson.ConclusionesEs necesario establecer procedimientos que garanticen la trazabilidad de las condiciones de conservación de los medicamentos termolábiles a nivel domiciliario. Las nuevas tecnologías lo permiten, facilitan el asesoramiento al paciente y la toma de decisiones en cuanto a dispensación y reutilización en caso de devolución, y mejoran así nuestra calidad asistencial(AU)

ObjectiveTo evaluate storage conditions of two thermolabile drugs, etanercept and adalimumab, in patients’ homes, and the possible influence over the average storage temperature of variables such as the number of people living at home, age of the patient or age of the refrigerator.Materials and methodsProspective observational study. The sample consisted of 60 patients treated with Enbrel® or Humira®. Data loggers cards were used, with an integrated thermal sensor VarioSens®, which were placed on the outer packaging of the product, programmed to record temperatures every 90min for approximately 30 days. The average storage temperature recorded in refrigerators was used as the main variable.ResultsIt was shown that there is a greater risk of not maintaining adequate storage when the mean temperature of the refrigerator is outside a range of 2–8°C, RR=3.9 (95% CI=1.95–7.93), P=0.0001. A total of 35 patients (58.3%) stored medicines outside the correct temperature range. There were significant differences in average storage temperatures depending on the whether the age of the refrigerator was greater or less than 5 years, P=0.029. Older than 5 years represents a risk factor for inadequate storage, RR=1.68 (95% CI=1.04–2.71), P=0.023 with the Pearson chi-squared test.ConclusionsProcedures need to be established to ensure traceability of the storage of heat-labile drugs in patients’ homes. New technologies allow this to be done, by providing advice to patients and for making decisions regarding dispensing and reuse in the event of return, thus improving our quality of care(AU)

[Quality of storage of thermolabile drugs in patients' homes]. / Calidad en la conservación de los medicamentos termolábiles en el ámbito domiciliario.

OBJECTIVE: To evaluate storage conditions of two thermolabile drugs, etanercept and adalimumab, in patients' homes, and the possible influence over the average storage temperature of variables such as the number of people living at home, age of the patient or age of the refrigerator. MATERIALS AND METHODS: Prospective observational study. The sample consisted of 60 patients treated with Enbrel or Humira. Data loggers cards were used, with an integrated thermal sensor VarioSens, which were placed on the outer packaging of the product, programmed to record temperatures every 90 min for approximately 30 days. The average storage temperature recorded in refrigerators was used as the main variable. RESULTS: It was shown that there is a greater risk of not maintaining adequate storage when the mean temperature of the refrigerator is outside a range of 2-8 degrees C, RR = 3.9 (95% CI = 1.95-7.93), P = 0.0001. A total of 35 patients (58.3%) stored medicines outside the correct temperature range. There were significant differences in average storage temperatures depending on the whether the age of the refrigerator was greater or less than 5 years, P = 0.029. Older than 5 years represents a risk factor for inadequate storage, RR = 1.68 (95% CI = 1.04-2.71), P = 0.023 with the Pearson chi-squared test. CONCLUSIONS: Procedures need to be established to ensure traceability of the storage of heat-labile drugs in patients' homes. New technologies allow this to be done, by providing advice to patients and for making decisions regarding dispensing and reuse in the event of return, thus improving our quality of care.

Role of TNF-alpha in sensitization of nociceptive dorsal horn neurons induced by application of nucleus pulposus to L5 dorsal root ganglion in rats.

Herniation of the nucleus pulposus (NP) from lumbar intervertebral discs commonly results in radiculopathic pain and paresthesia (sciatica). While traditionally considered the result of mechanical compression of the dorsal root ganglion (DRG) and/or spinal nerve root, recent studies implicate pro-inflammatory mediators released from or evoked by NP, a possibility that was presently investigated. Single-unit recordings were made from L5 wide dynamic range dorsal horn neurons in pentobarbital-anesthetized rats. Autologous NP was harvested from a coccygeal disc and placed onto the exposed L5 DRG. A control group had subcutaneous adipose tissue or saline placed similarly. To test involvement of tumor necrosis factor-alpha (TNF-alpha), a third group received autologous NP plus local soluble TNF-alpha receptor type 1 (0.013 microg) which binds TNF-alpha to prevent its action. In each group, neuronal responses to graded heat (38-50 degrees C) and mechanical (von Frey filaments 4-76 g) stimuli were recorded prior to and at three successive hourly intervals following each treatment. Responses to noxious heat and mechanical stimuli were significantly enhanced 1 h post-NP and remained elevated thereafter. Thermally and mechanically evoked responses were not significantly affected in control rats or those treated with NP + soluble TNF-alpha receptor type 1. These results indicate that sensitization of nociceptive spinal neuronal responses develops quickly following exposure of the DRG to NP, and that TNF-alpha is involved. This electrophysiological model of herniated NP may prove useful in further characterizing the role of inflammatory mediators in hyperalgesia and allodynia resulting from lumbar disc herniation.

Topical anti-inflammatory activity of some Asian medicinal plants used in dermatological disorders.

The topical anti-inflammatory activity of extracts from Cassia angustifolia, Rheum palmatum, Coptis chinensis, Phellodendron amurense and Scutellaria baicalensis, plants used in traditional East Asian medicine against different skin disorders, was studied. Though in different degree, all the extracts significantly inhibited the edema induced by 12-O-tetradecanoylphorbol-13-acetate (TPA), in both single or multiple application, oxazolone, and arachidonic acid (AA). None of the extracts inhibited in vitro the activity of phospholipase A(2) (PLA(2)) from Naja naja.

Elaboración de una guía basada en la evidencia científica con criterios explícitos para la validación e intervención farmacéutica de la prescripción de antimicrobianos / Compiling a scientific evidence-based guide with explicit criteria for antimicrobial prescription validation and pharmaceutical intervention

Objetivo: el propósito de nuestro trabajo es la realización de una guía con criterios explícitos de la validación de la prescripción de antimicrobianos con objeto de garantizar la evidencia científica y evitar la subjetividad en la validación e intervención farmacéutica .Material y métodos: se han definido los criterios explícitos de validación en farmacoterapia antimicrobiana y se ha realizado una revisión sistemática de la literatura especializada con el fin de garantizar la evidencia científica de los distintos apartados que componen cada criterio de validación. Para cada criterio se han establecido unos apartados especificándose el nivel de verificación de las condiciones del paciente para efectuar la validación de la prescripción, y se han identificado los criterios susceptibles de una intervención directa. Resultados: los criterios de validación se han expresado en tablas: Reacciones de hipersensibilidad; antibióticos teratogénicos; uso de antibacterianos en lactancia; espectro de actividad; asociaciones de antibióticos; posología y ajuste en insuficiencia renal y/o hepática; duración de tratamiento; administración y compatibilidad. Conclusión: el disponer de guías con criterios basados en la evidencia científica facilita el proceso de la validación y contribuye a la identificación de un mayor número de prescripciones alertantes que potencialmente puedan inducir problemas, favoreciendo nuestro posicionamiento estratégico en torno a la farmacoterapia del paciente (AU)

Hirudinas: nuevas perspectivas en terapia antitrombótica / Hirudine: new perspectives in antithrombotic therapy

Lepirudina y desirudina son dos nuevos antitrombóticos de origen recombinante derivados de la hirudina natural, un potente inhibidor específico de la trombina. Aunque son básicamente similares, sus indicaciones son diferentes y planteamos un análisis crítico de su potencial beneficio como antitrombóticos. Desirudina está indicada para la prevención de trombosis venosa profunda en cirugía electiva de prótesis de cadera y rodilla. En diversos estudios comparativos ha mostrado mayor eficacia que las heparinas, lo que podría justificar la significativa repercusión sobre el coste directo de la terapia antitrombótica, siempre que se delimite su uso a pacientes de alto riesgo. Lepirudina es un anticoagulante eficaz y seguro en el tratamiento de pacientes con TIH-II, revirtiendo rápidamente la trombocitopenia. Su uso quedaría reservado únicamente a aquellos pacientes con TIH-II que todavía requieren anticoagulación, por lo que es previsible un reducido consumo y una implicación mínima en el coste global de la terapia antitrombótica. (AU)

Anti-inflammatory activity of unusual lupane saponins from Bupleurum fruticescens.

Extracts from Bupleurum fruticescens were examined for oral and topical anti-inflammatory activities. The BuOH extract proved to be active against carrageenan and tetradecanoylphorbol acetate acute edemas and allowed the isolation of three saponins identified by spectroscopic techniques as 3 beta-O-(O-alpha-L-rhamnopyranosyl-(1-->4)-O-[beta-D-glucopyranosyl- (1-->6)]-O-beta-D-glucopyranosyl)lup-20(29)-ene-23,28-dioic acid (fruticesaponin A), 3 beta-O-(O-alpha-L-rhamnopyranosyl-(1-->4)-O-beta-D-glucopyranosyl) lup-20(29)-ene-23,28-dioic acid 28-O-beta-D-glucopyranosyl ester (fruticesaponin B), and 3 beta-O-(O-alpha-L-rhamnopyranosyl-(1-->4)-O-[beta-D-glucopyranosyl- (1-->6)]-O-beta-D-glucopyranosyl)-lup-20(29)-ene-23,28-dioic acid 28-O-beta-D-glucopyranosyl ester (fruticesaponin C). These compounds were studied against carrageenan, tetradecanoylphorbol acetate, arachidonic acid and ethyl phenylpropiolate acute edemas. Fruticesaponin B, a bidesmosidic saponin with an unbranched saccharide moiety was the most active in all the tests applied.

Zanhasaponins A and B, antiphospholipase A2 saponins from an antiinflammatory extract of Zanha africana root bark.

A MeOH extract from Z. africana was examined for topical antiinflammatory activity and proved to be active against arachidonic acid (AA) acute edema, 12-O-tetradecanoylphorbol 13-acetate (TPA)-induced chronic inflammation, and oxazolone delayed-type hypersensitivity in mice. The extract also showed significant inhibitory activity of Naja naja phospholipase A2 when a polarographic method was used. Two oleanane-type triterpene saponins, zanhasaponins A (1) and B (2), and the cyclitol pinitol (4), isolated from the extract, were active as inhibitors of PLA2. A further saponin, zanhasaponin C (3) was inactive in this assay.

Effect of the basidiomycete Poria cocos on experimental dermatitis and other inflammatory conditions.

The hydroalcoholic extract from P. cocos was examined for oral and topical anti-inflammatory activities. It proved to be active against carrageenan, arachidonic acid, tetradecanoyl phorbol acetate (TPA) acute edemas, TPA chronic inflammation and oxazolone delayed hypersensitivity in mice. Two lanostane-type triterpenes were isolated and identified by spectroscopic methods as dehydrotumulosic and pachymic acids. Their ID50 on acute TPA edema was 4.7 x 10(-3) and 6.8 x 10(-4) mumol/ear, respectively.

Three new oleanane saponins from Zanha africana.

Three new saponins, zanhasaponins, A, B, and C, were isolated from the MeOH extract of the root bark of Zanha africana and were, respectively, identified by spectroscopic methods as 3-O-beta-D-glucuronopyranosyl-2 beta,16 alpha-dihydroxyolean-12-ene-23,28- dioic acid 28-O-alpha-L-rhamnopyranosyl(1-->2)-alpha-L-rhamnopyranoside (1); 3-O-beta-D-glucuronopyranosyl-2 beta,16 alpha-dihydroxyolean-12-ene- 23,28-dioic acid 28-O-beta-D-xylopyranosyl(1-->2)-alpha-L-rhamnopyranosyl(1-->2)-alpha-L- rhamnopyranoside (2); and 3-O-beta-D-glucuronopyranosyl-2 beta,16 alpha-dihydroxyolean-12-ene- 23,28-dioic acid 28-O-beta-D-xylopyranosyl(1-->3)-beta-D-xylopyranosyl (1-->2)-alpha-L-rhamnopyranosyl(1-->2)-alpha-L-rhamnopyranoside (3). These saponins proved to be effective in a model of topical inflammation induced by phorbol ester. The cyclitols quebrachitol, pinitol, and bornesitol were also identified.