Efectividad y eficiencia de la dalbavancina en condiciones reales de uso / Effectiveness and efficiency of dalbavancin in real clinical practice use

Objetivos: El tratamiento de las infecciones por Gram positivos supone un reto asistencial, en un contexto en el que están aumentando las resistencias antibióticas. La dalbavancina, gracias a su alta vida media y alta actividad frente a Gram positivos, puede ser una buena opción terapéutica. Nuestros objetivos son conocer los usos, efectividad y eficiencia de la dalbavancina en pacientes del Hospital General Universitario de Valencia. Métodos: Se realiza un estudio descriptivo retrospectivo y un análisis de costes de los pacientes tratados con dalbavancina en el Hospital General Universitario de Valencia. Resultados: 15 pacientes (con 17 episodios de infección) fueron incluidos, con un Charlson medio de 3,7. Se trataron 4 infecciones de piel y partes blandas, 6 infecciones osteoarticulares y 7 infecciones intravasculares, aislándose en el 70,6% de los casos un Gram positivo. La tasa de curación fue del 59%, sin efectos adversos por la dalbavancina ni exitus en relación con la infección. Se evitaron 239 días de hospitalización, lo cual supone un ahorro de 6.556,02 € por paciente. Conclusiones: Series clínicas como la actual permiten analizar el papel de la dalbavancina en la práctica médica habitual y demuestran su importante función en el ahorro de recursos económicos. (AU)

Objectives: The treatment of Gram-positive infections it’s a medical challenge, in a context in which antibiotic resistances are increasing. Dalbavancin, due to its long half-life and high activity against Gram-positive bacteria, could be a good therapeutic option. Our objectives are to know the uses, effectiveness and efficiency of dalbavancin in patients of the General University Hospital of Valencia. Methods: A retrospective descriptive study and a cost analysis of patients treated with dalbavancin are carried out at the General University Hospital of Valencia. Results: 15 patients (with 17 episodes of infection) were included, with a mean Charlson index of 3.7. Were treated 4 skin and soft tissue infections, 6 osteoarticular infections and 7 intravascular infections. A Gram-positive bacteria was isolated in 70.6% of the patients. The cure rate was 59%, with no adverse effects due to dalbavancin or death in relation to infection. 239 days of hospitalization were saved with outpatient treatment, which means a saving of € 6,556.02 per patient. Conclusions: Clinical series like ours allow us to analyse the role of dalbavancin in routine medical practice and demonstrate its important function in saving economic resources. (AU)

[Clinical experience in opioid switch for noncancer chronic pain treatment]. / Experiencia clínica en cambio de opioides en el tratamiento del dolor crónico no oncológico.

BACKGROUND: The implementation of opioid switch (OS) as a strategy in non-malignant chronic pain has been scarcely proved. This article aims to evaluate the results of OS in a Pain Treatment Unit. METHODS: This is an observational retrospective study in which all patients who had been subjeted to OS for a period of 18 months were selected. All of them had been treated with opiods plus adyuvants for more than 6 months and had a visual analog scale (VAS) of at least 5, either with or without adverse effects. Two variables were defined: clinical improvement, as a reduction equal or superior to 3 in VAS or the elimination of two or more adverse effects; equianalgesic dose reduction is the difference between initial and final opioid dose. RESULTS: 7 out of 9 (77%) patients showed clinical improvement. Median equianalgesic dose reduction was 37% (-72% +18%). Five patients (55%) presented adverse effects to opioids before the OS but only one (11%) after OS. CONCLUSIONS: OS was beneficial for the management of non-malignant chronic pain patients who have poor response to opioid treatment and/or with adverse effects. A secure OS should include a reduction in equianalgesic opioid dose. Prospective studys would achieve a mayor consensus for the applicance of OS in non-malignant chronic pain treatment.

Objetivo: Analizar la mejoría clínica de los pacientes sometidos a cambio de opioide y describir el protocolo utilizado para el cambio. Método: Estudio observacional retrospectivo. Se seleccionaron pacientes sometidos a cambio de opioide en el periodo de estudio (18 meses). Fueron criterios para cambio de opioide: tratamiento con fármacos escalón 3 de la escalera de la OMS junto a coadyuvantes durante más de 6 meses y presentar una escala análogo visual del dolor de al menos 5, con o sin efectos adversos asociados. Se definieron las variables: mejoría clínica, como una disminución superior o igual a 3 de escala análogo-visual, o la supresión de dos o más efectos adversos; y reducción de dosis equianalgésica, que se calculó mediante comparación de dosis equianalgésicas del opioide inicial y final. Resultados: Se estudiaron 9 pacientes de los que la variable mejoría clínica resultó positiva en 7 de ellos (77%). La reducción de dosis media fue del 37% (-72% +18%) con respecto a la dosis equianalgésica. Cinco pacientes (55%) presentaban reacciones adversas antes del cambio de opioide; mientras que sólo uno (11%) tras la intervención. Conclusiones: El cambio de opioide fue ventajoso en el manejo de pacientes con dolor crónico no oncológico y baja respuesta al tratamiento opioide y/o con efectos adversos. Para realizar un cambio de opioide con seguridad se debe reducir dosis inicialmente del nuevo opioide. Estudios prospectivos bien diseñados permitirían alcanzar mayor consenso para la aplicación del cambio de opioide en el manejo del dolor crónico no oncológico.

[Cutaneous toxicity associated with cetuximab treatment in metastatic colorectal cancer]. / Toxicidad cutánea asociada a cetuximab en cáncer colorrectal metastásico.

OBJECTIVE: To evaluate the impact and type of side-effects in patients treated with cetuximab and provide a description of the general measures and treatment. METHODS: Retrospective safety study. We included all patients that received cetuximab from January to December 2009. All information was obtained from the Pharmacy and Oncology Department's Access databases and reviewed the patient's medical history. All data was registered in an Excel workbook. Skin toxicity was graded by the current National Cancer Institute-Common Toxicity Criteria (NCI-CTC). RESULTS: During the study period 43 patients received treatment with cetuximab. Acneiform eruption was present in 30 of the cases (69.8%): 14 patients with grade 1 (48.3%), 13 with grade 2 (44.8%) and 3 with grade 3 (10.3%). These adverse effects appeared in a median of seven (4-28) days. In a median of 40 (20-56) days, ten patients (23.3%) presented xerosis, and three (7%) suffered painful fissures in hands and feet after a median of 28 (21-35) days. Paronychia was present in two patients after a median of 42 (35-49) days. Finally, an alteration in hair growth was observed in two patients with overgrowth of facial hair and one patient with overgrowth of the eyelashes. Five patients presented important conjunctivitis. Three infusion reactions occurred. A grade-based treatment algorithm was used for all patients that presented cutaneous toxicity. CONCLUSIONS: A considerable number of patients treated with cetuximab develop dermatological side-effects which left untreated could represent a threat to the efficacy of the therapy. Therefore effective management is mandatory, patient education and immediate treatment based on a grade-based algorithm to alleviate symptoms is necessary, so that patient compliance is guaranteed.

[Study of use of pemetrexed in non-small cell lung cancer]. / Estudio de utilización de pemetrexed en el cáncer de pulmón no microcítico.

OBJECTIVE: To study the effectiveness and safety of pemetrexed in non-small cell lung cancer. METHOD: Retrospective study (March 2006-May 2008) of pemetrexed use. Information was obtained from the Access database belonging to the Pharmacy and Oncology Departments, the registry of external consultations and clinical histories. Data were analysed using SPSS software version 12.0. Quantitative variables are expressed as the median (minimum-maximum). RESULTS: The study included 44 patients (61.7 [39-77] years old), mostly male (86%), smokers or former smokers (80%) with predominantly epidermoid/squamous disease (46%) or adenocarcinoma, in a good functional state (86%) and in stage > or =III upon beginning pemetrexed treatment (93%). Prior treatment with taxanes and taxane treatment along with a prior history of neutropoenia were the criteria for changing to pemetrexed in 34.4% and 22.7% of the patients, respectively. None of the patients presented a complete or partial response: 18.2% showed disease stability and 81.8% showed disease progression. The main reasons for discontinuing pemetrexed were progression of the disease (54.5%) and worsening of symptoms (15.9%). Median survival after beginning chemotherapy was 22.2 months (ranging from 16-28.4) and 7.8 months (4.4-11.2) after beginning pemetrexed treatment. These last figures were significantly higher in women and those with an ECOG of 0 to 1. The most common adverse effects were weakness and neurotoxicity. CONCLUSION: In each of the cases, pemetrexed was used as a second-line treatment or higher with a good safety profile. A complete or partial response was not reached in any of the cases, but survival after beginning pemetrexed was equal to or longer than that achieved in other studies.

[Effective therapy with a glycine-proline ointment in a patient with recurrent ulcers from prolidase deficiency]. / Tratamiento efectivo con un ungüento de glicina y prolina en un caso de úlceras recurrentes por déficit de prolidasa.

INTRODUCTION: Prolidase deficiency is a rare disease. Lower leg recalcitrant ulcerations are the most characteristic symptoms. CASE REPORT: Woman diagnosed of prolidase deficiency with leg recalcitrant and infected ulcerations. Dermatology service solicits a proline and glycline containing ointment after failing other topical treatment and a skin grafting. After initiation of treatment, ulcerations improved partially. FORMULA DESCRIPTION: According to "Real Decreto 175/2001, de 23 de febrero", Pharmacy service draws up an elaboration guide and a patient information leaflet of a proline 5%-glycine 5% water emulsive ointment. DISCUSSION: Topical application of a glycine-proline ointment is an alternative for the treatment of recalcitrant ulcerations and it has resulted in variable response. In our patient it has been effective, with a partial improvement of leg ulcerations and a decrease in admissions due to over infection.

[Assessment of nutritional status and of intestinal absorption in asymptomatic patients infected with the human immunodeficiency virus (HIV) with and without chronic hepatitis]. / Valoración del estado nutricional y de la absorción intestinal en pacientes asintomáticos infectados por el virus de la inmunodeficiencia humana (VIH) con y sin hepatitis C crónica.

OBJECTIVE: To compare nutritional status and intestinal absorption in asymptomatics HIV patients co-infected or not with hepatitis C virus. MATERIAL AND METHODS: 15 patients (9 men and 6 women) HIV seropositive in A1-A2 stage were classified in two groups, A were asymptomatics HIV patients and B were asymptomatic HIV patients with chronic hepatitis C. Nutritional status was determined by weight, height, % ideal weight, body mass index, triceps skinfold, midarm muscle circumference, grip dynamometry and body composition measured by bioelectrical impedance. Intestinal absorption was assesses with D-xilosa test in urine collected over 5 hours after fasting ingestion of 5 grams of D-xylosa. Statistical analysis was made with SPSS (v.11.0). RESULTS: Not statistically significative differences were found in the nutritional status between the two groups of patients. Asymptomatics HIV patients with chronic hepatitis C eliminate less D-xylosa in urine than patients without chronic hepatitis C, being this difference statistically significative. Three out of the eight patients (37.5%) of group B presented malabsorption (< 1.2 grams of D-xylosa in urine). In group A any patient had malabsorption. DISCUSSION: In our study, asymptomatic HIV patients have a good nutritional status, without differences between patients co-infected or not with hepatitis C virus. Intestinal absorption is altered in patients co-infected and this should be considered because of its potential clinical consequences.

[Multicenter study on the prevalence of hyperglycemia among hospitalized patients with parenteral nutrition]. / Estudio multicéntrico de prevalencia de hiperglucemia en pacientes hospitalizados con nutrición parenteral.

OBJECTIVE: The aim of this cross-sectional national multicentric study was to determine the prevalence of hyperglycemia in patients with parenteral nutrition and to assess other clinical factors associated with this complication. METHOD: All Spanish hospital pharmacy services were invited to participate in the study. RESULTS: Twenty eight (28) pharmacy services agreed to participate. The study included 442 patients. The prevalence of hyperglycemia (plasma levels > 200 mg/dL) was 26.7%. Eighty four point two per cent of the patients received less than 3.5 mg/kg/minute of glucose, this infusion rate being considered as the safe threshold. In most patients, follow-up of glycemia was based on capillary blood determination with reactive strips and in 27.6% of the cases in which insulin was prescribed, it was added to the parenteral nutrition bag, in full or in part. No significant correlations were found between glycemia and the clinical factors studied (disorders, fever, medication), except for insulin. CONCLUSIONS: This national multicentric study of the prevalence of hyperglycemia among patients with parenteral nutrition, leaded by hospital pharmacists, was a joint effort aimed to better understand this metabolic complication. Findings are consistent with those reported by other authors and have allowed us to describe the current situation.