Variation in renal parameter values after a change in antiretroviral therapy from elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide to bictegravir/emtricitabine/tenofovir-alafenamide / Variación de los valores de los parámetros renales tras un cambio en la terapia antirretroviral de elvitegravir/cobicistat/emtricitabina/tenofoviralafenamida a bictegravir/emtricitabina/ tenofovir-alafenamida

El cambio de EVG/COBI/FTC/TAF a BIC/FTC/TAF es una estrategia para optimizar la terapia antirretroviral. Nuestro objetivo fue analizar cómo variaban los parámetros analíticos renales tras cambiar tratamiento. Los objetivos secundarios fueron determinar si edad y sexo de los pacientes y el tiempo que habían tomado cobicistat previamente condicionaba la posible variación de los parámetros renales. Se realizó un estudio piloto observacional, descriptivo y ambispectivo. Los parámetros renales se obtuvieron de las analíticas previas más cercanas al cambio (considerándose este valor el basal) y después de 12, 24 semanas y 12 meses tras cambiar tratamiento. Se incluyeron 60 pacientes. En los niveles de creatinina sérica, se observó cambio a las 24 semanas (aumento medio de 0,06 mg/dL, p=0,025) y a los 12 meses (aumento medio de 0,03 mg/dL, p=0,05). Considerando la tasa de filtración glomerular (CKD-EPI), hubo bajada en los 3 períodos analizados, pero sin significación estadística. No hubo influencia del sexo, edad ni tiempo que los pacientes habían tomado cobicistat previamente. (AU)

Switching of EVG/COBI/FTC/TAF to BIC/FTC/TAF is a valid strategy for antiretroviral therapy optimization. Our aim was to analize how the variation of analytical parameters for renal function estimation after the change of their treatment. Secondary objectives were to determine if age and sex of the patients and the time they have previously taken cobicistat conditions the possible variation in renal parameters. An observational, descriptive and ambispective pilot study was performed. The renal laboratory parameters were obtained from the previous laboratory tests closest in time to the change (this value being considered the baseline) and after 12, 24 weeks and 12 months after a change in treatment with BIC/FTC/TAF. 60 patients were included. Regarding serum creatinine levels, a change in serum creatine levels was observed at 24 weeks (mean increase of 0.06 mg/dL, p=0.025) and at 12 months (mean increase of 0.03 mg/dL, p=0.05). Considering glomerular filtration (CKD-EPI), there was downward trend in the 3 periods analyzed, but statistical significance was not reached. There was no influence of sex, age and the length of time that the patients had taken cobicistat before the change. (AU)

Resultados en calidad de vida comunicados por pacientes en tratamiento antirretroviral / Health-related quality of life among people livingwith human immunodeficiency virus infection

OBJETIVO: Conocer las impresiones de los pacientes con terapia antirretroviral acerca de su calidad de vida relacionada con la salud (CVRS), salud y bienestar general respecto a la infección por VIH. MATERIAL Y MÉTODOS: Estudio observacional, descriptivo, prospectivo y transversal. Se incluyeron pacientes mayores de edad VIH positivos que recogiesen tratamiento en el Servicio de Farmacia durante 3 meses. Como medida de la CVRS, se utilizó el World Health Organization Quality of Life in HIV-infected Persons instrument (WHOQOL-HIV-BREF) versión castellano. Se midieron seis dominios: capacidad física, factores psicológicos, nivel de independencia, relaciones sociales, entorno y creencias personales/religiosas/espirituales más 5 preguntas específicas de infección por VIH/SIDA. El cuestionario fue anónimo y auto-administrado. Se recogieron edad, sexo, estado civil y nivel de educación máximo alcanzado. Se calcularon medianas y rangos intercuartílicos (IQR) para cada dominio, así como los posibles factores influyentes. RESULTADOS: Se incluyeron 69 pacientes. 72,5% varones. Edad (mediana [IQR]) = 50,4 [55,1-43] años. Nivel de educación: ninguno 5,8%; educación primaria 37,7%; secundaria 47,8%; terciaria 8,7%. Estado civil: casado/a 21,9%; en pareja 15,9%; divorciado/a 7,2%; soltero/a 47,8%; viudo/a 7,2%. Resultados para cada dominio: capacidad física (mediana [IQR]) = 75 [65-80]; factores psicológicos = 68 [57-76]; nivel de independencia = 70 [59-80]; relaciones sociales = 65 [58-80]; entorno = 70 [64-80] y creencias personales/religiosas/espirituales = 63 [55-75]. Resultado global = 67 [71-78]. La edad (≤ 50 años) se relacionó con la CVRS (diferencia de medias IC95%; p) en el dominio de capacidad física (11,41 IC95% 4,12-18,69; p = 0,03), nivel de independencia (10,47 IC95% 1,85-19,08; p = 0,018) y en el resultado global (8,33 IC95% 1,99-14,67; p = 0,011). CONCLUSIONES: La CVRS fue inferior en el dominio de creencias personales, seguida por las relaciones sociales. La edad superior a 50 años se relacionó con una peor CVRS

PURPOSE: To know about quality of life, health and general well-being among people living with HIV who take antiretroviral therapy. MATERIAL AND METHODS: Cross-sectional descriptive prospective observational study. Adults with HIV's infection and antiretroviral therapy dispensed by our Pharmacy Service during 3 months were included. World Health Organization Quality of Life in HIV-infected Persons instrument (WHOQOL-HIV-BREF) was used to explore the quality of life (QoL). The scores denote an individual's perception of QoL in six domains: physical, psychological, level of independence, social relationships, environment and spirituality. Items are rated on a 5-point Likert scale with a transformed maximum score of 100 points per item. Five questions are specific to HIV/AIDS (Q:4,8-10,17). The questionnaire was self-administered. Age (≤ 50 years), gender, civil status and level of studies was also collected. The questionnaire, anonymous and voluntary, was returned in the next visit to our centre. Median and interquartile range was calculated for each domain. Relationship among scores and demographic variables was explored. RESULTS: 69 patients were included (response rate 45.1%), 72.5% male. Age (median [IQR]) = 50.4 [55.1-43] years. Education received: none 5.8%; primary school 37.7%; secondary 47.8%; tertiary 8.7%. Civil status: married 21.9%; living as married 15.9%; divorced 7.2%; single 47.8%; widowed 7.2%. Results of domains transformed score: physical (median [IQR]) = 75 [65-80], psychological = 68 [57-76]; level of independence = 70 [59-80]; social relationships = 65 [58-80], environment = 70 [64-80]; and spirituality = 63 [55-75]. Global score = 67 [71-78]. Age (≤ 50 years) was the only variable related with test score (mean difference (IC95%; p); physical domain (11.41 (4.12-18.69); 0.03), level of independence (10.47 (1.85-19.08); 0.018) and global score (8.33 (1.99-14.67); 0.011). CONCLUSIONS: QoL score was lower regarding spirituality domain followed by social relationships. Age over 50 was statistically associated with a worse self-reported QoL

Stability of carboplatin infusion solutions used in desensitization protocol.

Carboplatin hypersensitivity reactions are one of the major clinical challenges in treating patients with relapse/recurrent ovarian malignancies. Desensitization protocols allow the continuation of treatment in patients who have presented hypersensitivity reactions by gradually re-introducing small amounts of the drug up to full therapeutic doses. Carboplatin desensitization protocol is based on three solutions that are usually prepared in the chemotherapy centralized units of hospital pharmacies. First and second solutions are diluted under the established concentration limit to guarantee the stability of the preparation. We developed a specific high-performance liquid chromatography assay to determine the stability of carboplatin infusion solutions that have been diluted to 0.2 mg/mL and 0.02 mg/mL in 250 mL of 5% dextrose in polypropylene infusion bags which were stored 24 h protected from light at room temperature. Samples were withdrawn at t = 0 h, 3 h, 6 h, and 24 h. The analytical column was a Zorbax eclipse XDB-C18 (150 mm × 4.6 mm; 5 µm particle size). The mobile phase had a flow rate of 1 mL/min under isocratic conditions of water-methanol (98:2, v/v). For 0.2 mg/mL solution, the high-performance liquid chromatography assay revealed no significant losses in carboplatin concentration. However, in 0.02 mg/mL solution remaining carboplatin was > 105% the initial dose after 3 h of storage at room temperature. The ultraviolet-visible spectra analysis showed that carboplatin remained intact during the study in 0.2 mg/mL solution, but some changes were detected in 0.02 mg/mL solution. Thus, 0.2 mg/mL carboplatin solution is stable for 24 h at room temperature in 5% dextrose polypropylene infusion bags but stability could not be proved for 0.02 mg/mL solution.

Hiperalgesia asociada al tratamiento con opioides / Opioid-induced hyperalgesia

La hiperalgesia inducida por opioides es una reacción paradójica caracterizada por una percepción intensificada de dolor relacionada con el uso de estos medicamentos en ausencia de progresión de la enfermedad o de síndrome de retirada. A diferencia de los casos de tolerancia, definida como pérdida de potencia analgésica durante el uso prolongado de opioides, no se produce mejoría con el escalado de dosis. La hiperalgesia inducida por opioides se ha manifestado en pacientes con dosis de mantenimiento y retirada, pacientes con dosis elevadas o escalado de dosis y pacientes con dosis ultra bajas. Para establecer un diagnóstico diferencial es importante tener en cuenta que un incremento de dosis puede producir una mejoría temporal en pacientes con tolerancia pero no en los que han desarrollado hiperalgesia. La prevalencia de dicho fenómeno es desconocida, pero puede ser más frecuente de lo esperado y muchas veces no reconocido. El mecanismo subyacente no está bien definido, pero existen diversos estudios experimentales tanto en modelos animales como en humanos en los que se observa que la hiperalgesia no está desencadenada por un único factor, sino que son muchos los implicados. Entre los mecanismos propuestos destacan: la mediación del receptor NMDA (N-metil-D-aspartato) activado por la liberación presináptica de glutamato, la modulación por la proteína-kinasa de calcio/calmodulina, el aumento en el número de nociceptores o la liberación de neurotransmisores excitadores. Se han realizado diversos estudios para describir la expresión y la relevancia de la hiperalgesia inducida por opioides en distintos grupos de pacientes: ex-adictos a opioides en tratamiento de mantenimiento con metadona, en exposición perioperatoria, en voluntarios sanos o en dolor crónico. Existen diferentes estrategias de tratamiento disponibles; entre las más aceptadas se encuentra la reducción en la dosis del opioide utilizado, la rotación del opioide o la asociación al tratamiento de otro tipo de analgésico. Otras opciones son los antagonistas del receptor NMDA o la terapia combinada con los inhibidores de la COX-2. En el presente trabajo se revisan los avances recientes en el conocimiento de los mecanismos subyacentes que la producen, los estudios clínicos realizados así como las diferentes estrategias de tratamiento disponibles (AU)

Opioid induced hyperalgesia is a paradoxical reaction characterized by an enhanced perception of pain related to the use of these drugs in the absence of disease progression or withdrawal syndrome. In contrast to cases of tolerance, defined as the loss of analgesic potency during prolonged use of opioids, no improvement is seen with dose escalation. Opioid induced hyperalgesia could be manifested in the context of maintenance dosing and withdrawal, at very high or escalating doses, and at ultra-low doses. To establish a differential diagnosis is important to consider that increasing the dose may produce a temporary improvement in patients with tolerance but not in those who develop hyperalgesia. Pathogenesis of this phenomenon is not well defined, but there are several experimental studies in animal models and in humans that have shown that hyperalgesia is not triggered by a single factor. Proposed mechanisms include: NMDA receptor mediation, modulation by the calcium/calmodulin protein kinase, the increase in the number of nociceptors or excitatory neurotransmitters release. There are different treatment strategies available, such as the reduction in the dose of opioid used, opioid rotation or association of other analgesic. Other options are NMDA receptor antagonists or combination therapy with COX-2 inhibitors. In this paper we review recent advances in the understanding of the underlying mechanisms, clinical studies and available treatment strategies (AU)

Use of a closed-system drug transfer device (PhaSeal) and impact on preparation time.

PhaSeal is a closed-system drug transfer device which has demonstrated to protect against occupational exposure to antineoplastic agents. Our aim was to assess the impact of the incorporation of PhaSeal on the processing time of chemotherapy. The study was a prospective simulation study which compared the processing times with the traditional open-system technique and using the closed-transfer system. Four experienced pharmacy technicians prepared six batches with each method simulating simple chemotherapy admixture operations. We compared the mean times obtained by student's t test and evaluated the "learning effect" between days by ANOVA. The average percentage of time saving with PhaSeal was 31.7% (time per batch [mean +/- SD] 6.44+0.73 vs. 9.44+0.98 minutes). Mean difference was statistically significant (3.0 min IC95% 2.50-3.50; p>0.0001). No significant learning curve effect was detected. The BD Medical/Carmel Pharma PhaSeal system, in addition to its protective properties, is able to save time in the elaboration process which leads to organization advantages for hospital pharmacy services.