Análisis de coste-efectividad y coste-utilidad de ingenol mebutato versus diclofenaco 3% e imiquimod 5% en el tratamiento de la queratosis actínica en España / Cost-Effectiveness and Cost-Utility Analysis of Ingenol Mebutate Versus Diclofenac 3% and Imiquimod 5% in the Treatment of Actinic Keratosis in Spain

OBJETIVO: Realizar un análisis coste-efectividad y coste-utilidad de ingenol mebutato en el tratamiento de la queratosis actínica en España. MÉTODOS: Se realizó la adaptación de un modelo de Markov que simuló una cohorte de pacientes (73 años de media) con queratosis actínica en un horizonte temporal de 5 años. Los comparadores fueron diclofenaco 3% e imiquimod 5%. El análisis se desarrolló desde la perspectiva del Sistema Nacional de Salud, incluyendo costes directos sanitarios (PVPIVA con la deducción obligatoria, € 2015). La estimación de recursos se llevó a cabo por un panel de expertos y los costes unitarios se obtuvieron de bases de datos de costes nacionales. La tasa de descuento considerada fue del 3% anual. Se realizaron análisis de sensibilidad determinísticos y probabilísticos. RESULTADOS: Ingenol mebutato fue más eficiente frente a diclofenaco, con 0,192 aclaramientos incrementales en la cara y el cuero cabelludo y 0,129 en el tronco y las extremidades. Los costes totales fueron de 551,50€ y 622,27€ comparados con 849,11€ y 844,93€ en diclofenaco (cara y cuero cabelludo y tronco y extremidades, respectivamente). Es decir, ingenol mebutato es una alternativa de tratamiento dominante frente a diclofenaco 3%. Ingenol mebutato también mostró una mayor eficacia frente a imiquimod 5%, con 0,535 vs. 0,503 aclaramientos ganados, y unos costes totales de 551,50€ vs. 527,89€, siendo la relación coste-efectividad incremental resultante de 728,64€/aclaramiento adicional. CONCLUSIONES: Ingenol mebutato resultó ser una estrategia dominante vs. diclofenaco, y eficiente, es decir, presentó mayor efectividad y mayores costes (relación coste-utilidad incremental inferior a 30.000€/AVAC) vs. Imiquimod

OBJECTIVE: To perform a cost-effectiveness and cost-utility analysis of ingenol mebutate in the treatment of actinic keratosis in Spain. METHODS: We used an adapted Markov model to simulate outcomes in a cohort of patients (mean age, 73 years) with actinic keratosis over a 5-year period. The comparators were diclofenac 3% and imiquimod 5%. The analysis was performed from the perspective of the Spanish National Health System based on direct costs (2015 retail price plus value added tax less the mandatory discount). A panel of experts estimated resources, taking unit costs from national databases. An annual discount rate of 3% was applied. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The effectiveness of ingenol mebutate-with 0.192 and 0.129 more clearances gained in treatments for face and scalp lesions and trunk and extremity lesions, respectively-was superior to diclofenac's. The total costs of treatment with ingenol mebutate were lower at € 551.50 (face and scalp) and € 622.27 (trunk and extremities) than the respective costs with diclofenac (€ 849.11 and € 844.93). The incremental cost-effectiveness and cost-utility ratios showed that ingenol mebutate was a dominant strategy vs diclofenac. Ingenol mebutate also proved to be more effective than imiquimod, based on 0.535 and 0.503 additional clearances, and total costs of € 551.50 and € 527.89 for the two drugs, respectively. The resulting incremental cost-effectiveness ratio was € 728.64 per clearance gained with ingenol mebutate vs imiquimod. CONCLUSIONS: Ingenol mebutate was a dominant treatment option vs diclofenac and was efficient vs imiquimod (i.e., more effective at a higher cost, achieving an incremental cost-utility ratio of<€30000/quality-adjusted life-years)

Cost-Effectiveness and Cost-Utility Analysis of Ingenol Mebutate Versus Diclofenac 3% and Imiquimod 5% in the Treatment of Actinic Keratosis in Spain. / Análisis de coste-efectividad y coste-utilidad de ingenol mebutato versus diclofenaco 3% e imiquimod 5% en el tratamiento de la queratosis actínica en España.

OBJECTIVE: To perform a cost-effectiveness and cost-utility analysis of ingenol mebutate in the treatment of actinic keratosis in Spain. METHODS: We used an adapted Markov model to simulate outcomes in a cohort of patients (mean age, 73 years) with actinic keratosis over a 5-year period. The comparators were diclofenac 3% and imiquimod 5%. The analysis was performed from the perspective of the Spanish National Health System based on direct costs (2015 retail price plus value added tax less the mandatory discount). A panel of experts estimated resources, taking unit costs from national databases. An annual discount rate of 3% was applied. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The effectiveness of ingenol mebutate-with 0.192 and 0.129 more clearances gained in treatments for face and scalp lesions and trunk and extremity lesions, respectively-was superior to diclofenac's. The total costs of treatment with ingenol mebutate were lower at € 551.50 (face and scalp) and € 622.27 (trunk and extremities) than the respective costs with diclofenac (€ 849.11 and € 844.93). The incremental cost-effectiveness and cost-utility ratios showed that ingenol mebutate was a dominant strategy vs diclofenac. Ingenol mebutate also proved to be more effective than imiquimod, based on 0.535 and 0.503 additional clearances, and total costs of € 551.50 and € 527.89 for the two drugs, respectively. The resulting incremental cost-effectiveness ratio was € 728.64 per clearance gained with ingenol mebutate vs imiquimod. CONCLUSIONS: Ingenol mebutate was a dominant treatment option vs diclofenac and was efficient vs imiquimod (i.e., more effective at a higher cost, achieving an incremental cost-utility ratio of<€30000/quality-adjusted life-years).

[Gastroschisis. Preterm elective cesarean and immediate primary closure: our experience]. / Gastrosquisis. Cesárea electiva pretérmino y cierre primario inmediato; nuestra experiencia.

PURPOSE: Our experience en treatment of gastroschisis using a protocol with elective preterm delivery by caesarean section at 34-35 weeks and immediate primary abdominal wall closure. METHODS: During a period of 18 month we treated 5 patients with gastroschisis using the following management pathway: Starting at 30th week of gestation, weekly ultrasound evaluation of fetal gut and pulmonary maturation with corticosteroids. Delivery by elective caesarean section between 34-35 weeks or earlier if evidence of bowel compromise was reported en ultrasound study. Immediate surgical correction after birth with primary closure was preformed under control of abdominal pressure. RESULTS: Mean gestational age of our patient was 33,94 weeks, and mean birth weight was 2154 gr. None of the cases present inflammatory peel and we found no difficulties for reduction of the gut at time of surgery. Two patients presented an intestinal malrotation. Extubation was preformed 36-48 hours after surgery. We started a trofic diet at 3,6 days and parental nutrition was retired after a mean period of 15,8 days. The mean time of hospital stay was 33,4 days. One patient with intestinal obstruction had a consideriously increased length of hospital stay of 74 days. CONCLUSIONS: A management pathway for gastroschisis with selective preterm delivery by caesarean section and immediate surgical treatment probably reduces the experience of inflammatory peel. This pathway permits a early initiation of oral feeding, reduces times of parenteral nutrition and need of central catheters, and shortens length of hospital stay.

Gastrosquisis. Cesárea electiva pretérmino y cierre primario inmediato; nuestra experiencia / Gastroschisis. preterm elective cesarean and immediate primary closure: our experience

Objetivos. Presentar nuestra experiencia de 5 casos de gastrosquisis con un protocolo de parto por cesárea electiva entre las 34-35 semanas de gestación y cierre primario inmediato en una nota clínica. Material y métodos. En un periodo de 18 meses se han tratado 5pacientes con gastrosquisis con el siguiente protocolo: monitorización ecográfica semanal a partir de los 30 semanas y maduración pulmonar fetal; cesárea electiva entre las 34 y 35 semanas o ante la presencia de signos ecográficos de sufrimiento intestinal; corrección quirúrgica inmediata postparto con cierre primario de la pared bajo control de la presión abdominal. Resultados. La edad gestacional media de los pacientes ha sido de33,94 semanas, el peso medio fue de 2.154 g. No observamos engrosamiento de las asas (peel) en ninguno de los casos y no objetivamos dificultad para la reducción de las asas en la cavidad abdominal. Dos pacientes presentaron una mal rotación intestinal asociada. Se logró la extubación entre las 36 y 48 horas. Instauramos una dieta trófica a los3,6 días de media. La retirada de la nutrición parenteral fue posible a los15,8 días de media y el alta hospitalaria, a los 33,4 días de media. Un caso de oclusión intestinal pre-alta alargó considerablemente la estancia hospitalaria de este paciente (74 días).Conclusiones. Nuestra experiencia apoya el manejo terapéutico de las gastrosquisis mediante cesárea electiva pretérmino y tratamiento quirúrgico inmediato, probablemente sirve para evitar la aparición del temido peel. Este protocolo permite iniciar una dieta oral precozmente ,reduce el tiempo de nutrición parenteral, la necesidad de vías centrales con el riesgo de sepsis y acorta la estancia hospitalaria (AU)

Purpose. Our experience en treatment of gastroschisis using a protocol with elective preterm delivery by caesarean section at 34-35 weeks and immediate primary abdominal wall closure. Methods. During a period of 18 month we treated 5 patients with gastroschisis using the following management pathway: Starting at 30thweek of gestation, weekly ultrasound evaluation of fetal gut and pulmonary maturation with corticosteroids. Delivery by elective caesarean section between 34-35 weeks or earlier if evidence of bowel compromise was reported en ultrasound study. Immediate surgical correction afterbirth with primary closure was preformed under control of abdominal pressure. Results. Mean gestational age of our patient was 33,94 weeks, and mean birth weight was 2154 gr. None of the cases present inflamatory peel and we found no difficulties for reduction of the gut at time of surgery. Two patients presented an intestinal malrotation. Extubation was preformed 36-48 hours after surgery. We started atrophic diet at 3,6 days and parental nutrition was retired after a mean period of 15,8 days. The mean time of hospital stay was 33,4 days. One patient with intestinal obstruction had a consideriously increased length of hospital stay of 74 days. Conclusions. A management pathway for gastroschisis with selective preterm delivery by caesarean section and immediate surgical treatment probably reduces the experience of infl ammatory peel. This pathway permits a early initiation of oral feeding, reduces times of parenteral nutrition and need of central catheters, and shortens lengthof hospital stay (AU)

Tacalcitol in the treatment of psoriasis vulgaris: the Spanish experience.

BACKGROUND: A group of vitamin D derivatives has revealed to be an efficient treatment for psoriasis. Different types of studies have been designed to confirm the efficacy of its use without relevant side-effects. OBJECTIVE: Evaluation of tolerability and efficacy of tacalcitol ointment in moderate psoriasis. DESIGN: A 2-month multicentre prospective open-label observational study in patients with psoriasis treated with tacalcitol ointment. METHODS: A cohort of patients with psoriasis vulgaris seeking medical advice and being treated with tacalcitol based on the decision of their dermatologists was selected. A 2-month follow-up was performed to assess efficacy and tolerability of tacalcitol in an ointment formulation (4 microg/g) once daily. A psoriatic lesion was selected in each patient in order to assess clinical symptoms (erythema, desquamation and thickness) by means of five-point scale: 0 (none) to 4 (maximal severity). Percentages of involved skin, adverse effects, physicians' global assessments of efficacy and tolerability, and patients' global satisfaction scores were also evaluated after 15-30 days (first visit) and 2 months (second visit) of treatment. RESULTS: A total of 556 patients were included. Mean psoriasis duration was 10.1 years (range, 0-61 years). Follow-up data were available for 493 patients in first follow-up visit and 449 in second (final) visit. Adverse events were uncommon (1.0% and 0.6% of patients in first and second follow-up visits, respectively). At first follow-up visit, mean decrease in selected lesions surface area (from a baseline value of 185.8 cm(2) per lesion) was 11.1 cm(2) (95% CI, 1.6-20.6; P = 0.0213). After 2 months of treatment, mean scores for erythema, desquamation and thickness changed from 2.2 +/- 0.8 to 1.1 +/- 0.8 (19% of patients with no erythema at final visit); from 2.4 +/- 0.8 to 0.6 +/- 0.7 (55% of patients with no desquamation); and from 2.2 +/- 0.9 to 0.8 +/- 0.6 (51% of patients with less thickness), respectively. Mean percentage of total body skin involvement was 14% (7.5% and 6.9% of anterior and posterior body surface, respectively). After 2 months of treatment, a 3.2% (95% CI, 2.7-3.8; P = 0.0001) and 3.0% (95% CI, 2.4-3.6; P = 0.0001) decrease was observed in the percentage of involved anterior and posterior skin surface area, respectively. Efficacy and tolerability evaluation by investigators was very good or good in 94% and 74% of patients, respectively; 78% of patients evaluated study treatment as satisfactory/very satisfactory. More than 80%, 50-80% and less than 50% of prescribed doses were used by 88%, 9.3% and 2.3% of patients, respectively. CONCLUSIONS: Tacalcitol was highly effective in the symptomatic treatment of moderate psoriasis. Compliance was very high, probably due to the easy and convenient application. Physicians' global assessments of tacalcitol were excellent, both for tolerability and efficacy. Excellent tolerability was confirmed by the low rate of adverse events. Our results in an everyday clinical setting show that tacalcitol is a useful therapy in patients with moderate psoriasis.

Valoración de la eficacia y seguridad de ibuprofeno retard en procesos reumatológicos agudos y crónicos / Assessment of the safety and efficacy of ibuprofen retard in acute and chronic rheumatologic conditions

Se realizó un estudio epidemiológico, observacional, prospectivo y multicéntrico en el que se incluyeron datos de 489 pacientes afectos de trastornos crónicos y agudos que cursaban con dolor. Un 28,6 por ciento de los pacientes demandaron asistencia médica por procesos crónicos y el 71,4 por ciento restante por procesos agudos. El 16 por ciento de los pacientes recibieron 1 comprimido de 600 mg de ibuprofeno retard al día, frente al 84 por ciento restante que recibió 2 comprimidos al día. Los pacientes permanecieron en tratamiento por un período de 14,7 ñ 6,1 días. El grado de satisfacción fue ligeramente superior en los pacientes con procesos agudos frente a los crónicos. Sólo 38 pacientes presentaron efectos secundarios mayoritariamente de carácter leve (87,8 por ciento) y de tipo gastrointestinal (76,2 por ciento). Únicamente un 1,4 por ciento de los participantes en el estudio abandonaron el tratamiento. Ibuprofeno retard presentó una elevada efectividad en el tratamiento de procesos agudos y crónicos con una excelente tolerabilidad (AU)

[Carcinoid tumor. An analysis of 131 cases]. / Tumor carcinoide. Análisis de 131 casos.

We would like to describe the characteristics of affection by carcinoid tumor in our surroundings. In so doing, we have reviewed the clinical histories of the 131 cases of carcinoid tumor diagnosed in our center between 1972 and 1990. The incidence has been 0.7 cases per 100,000 inhabitants per year. The age at diagnosis is from 8 to 88 years, and the proportion of men to women is practically 1. The most common locale affected the appendix (54 cases) followed by the bronchials (46 cases). The most common clinical presentation has been casual discovery and in the bronchials, in addition to hemoptysis and pneumonia. Carcinoid syndrome was found in only 4 cases, and of 17 determinations of indole acetic 5-hydoxi acid, only 2 resulted pathological. There were four cases of hepatic metastasis and two deaths related with the tumor.

Alpha chain disease of the stomach.

A case of gastric lymphoplasmocytoid lymphoma with alpha heavy chains in the serum is reported. The patient was a 20-year-old female who had a gastric lymphomatous ulcer and who died of acute bleeding, with no clinical or radiological signs of small intestine involvement. This seems to be the first reported case of gastrin alpha heavy chain disease.

[Necrotizing angiitis of small vessels. A clinical study of 25 patients with skin biopsy (author's transl)]. / Angiitis necrosante de pequeños vasos. Estudio clínico de 25 pacientes con biopsia cutánea.

Necrotizing angiitis or vasculitis exhibits a wide clinical spectrum characterized by many different cutaneous manifestations. Diagnosis must be confirmed by histopathology. We studied in retrospect 25 patients whose conditions had been diagnosed by skin biopsy. Histologic examination revealed infiltration by polynuclear cells and fibrinoid necrosis of the walls of the blood vessels in the skin. The great variety of clinical manifestations and etiologies stands out in a review of the records of these patients. Necrotizing angiitis has been found associated with mixed cryoglobulinemia; administration of drugs, milliary tuberculosis, bacterial meningitis, rickettsiosis, staphylococcal sepsis, pharyngotonsillitis, and rheumatoid arthritis. Necrotizing angiitis is a group of diseases with a great variety of clinical manifestations, ranging from benign to fatal. The various entities described to date have been more like different clinical forms of the same disease that distinct conditions. In cases of necrotizing angiitis caused by basically immunological mechanisms, the walls of the blood vessels may be impaired in varying diffuse degrees. The prognosis of the disease depends on the intensity of the inflammation and its repercussions on the parenchymas of different organs. The kidney is the most susceptible organ in this case. Treatment should be directed toward the avoidance of predisposing and etiologic factors, detection of the immunological reaction, requiring careful and individual attention in every case.