2-years retrospective observational case-control study on survival and marginal bone loss of implants in patients with hereditary coagulopathies.

BACKGROUND: Evaluating 2-years implant loss and marginal bone loss in patients with hereditary coagulopathies, comparing with a healthy control group. MATERIAL AND METHODS: 37 implants in 13 patients (17 haemophilia A, 20 Von-Willebrand disease) versus 26 implants in 13 healthy patients. Data measured through Lagervall-Jansson index (after surgery, at prosthetic loading, at 2 years). STATISTICS: Chi-square, Haberman's, ANOVA, Mann-Whitney-U. Significance p<0.05. RESULTS: Haemorrhagic accidents in 2 coagulopathies patients (non-statistical differences). Hereditary coagulopathies patients suffered more hepatitis (p<0.05), HIV (p<0.05) and less previous periodontitis (p<0.01). Non-statistical differences in marginal bone loss among groups. 2 implants were lost in the hereditary coagulopathies and none in the control group (non-statistical differences). Hereditary coagulopathies patients had longer (p<0.001), and narrower implants (p<0.05) placed. 43.2% external prosthetic connection in hereditary coagulopathies patients (p<0.001); change of prosthetic platform more frequent in control group (p<0.05). 2 implants lost: external connection (p<0.05). Survival rate 96.8% (hereditary coagulopathies 94.6%, control group 100%). CONCLUSIONS: Implant and marginal bone loss at 2 years is similar in patients with hereditary coagulopathies and control group. Precautions should be taken on the treatment for hereditary coagulopathies patients, through prior haematological protocol. Implant loss only occurred in in a patient with Von-Willebrand´s disease.

Sinoviortesis radioisotópica en pacientes en edad pediátrica y adolescentes con hemofilia / Radioisotope synoviorthesis in paediatric and adolescent patients with haemophilia

Objetivo. Valorar la eficacia terapéutica y las complicaciones de la sinoviortesis radioisotópica observadas en pacientes en edad pediátrica y adolescentes con hemofilia. Material y métodos. Estudio prospectivo de cohorte histórica en el que se incluyó, de forma consecutiva, a 20 pacientes varones con hemofilia (edad media 13,1 años, rango: 4-17 años). El diagnóstico de sinovitis se estableció clínicamente y se confirmó por radiología simple o RMN). Evaluación mediante la clasificación de Fernández-Palazzi. Criterios de inclusión: menores de 18 años de edad con hemofilia y más de un hemartros en menos de 3 meses, manteniéndose una sinovitis crónica a pesar de intensificar el tratamiento profiláctico. Criterios de exclusión: cualquier contraindicación para la realización de la sinoviortesis. Se realizaron 27 sinoviortesis radioisotópicas con citrato de 90Y colidal o sulfuro 186Re coloidal. La eficacia del procedimiento se evaluó a los 6 meses mediante comparación clínica pre- y postratamiento. Tiempo medio de seguimiento: 64,9 meses (rango 18-109 meses). Resultados. En 19 de las 27 sinoviortesis (70,3%) hubo una respuesta buena o excelente y en 8 articulaciones (29,7%), respuesta parcial. Se repitió el procedimiento en 3 articulaciones de 3 pacientes diferentes debido a la aparición de nuevo hemartros, obteniendo en todos los casos una respuesta buena o excelente. Apareció reacción inflamatoria postratamiento en 4 casos (14,8%), que mejoraron con tratamiento médico. No se observaron lesiones malignas ni premalignas durante el seguimiento. Conclusión. La sinoviortesis radioisotópica es un procedimiento efectivo, en pacientes en edad pediátrica y adolescentes con hemofilia, mínimamente invasivo, fácil de realizar, seguro y con complicaciones mínimas (AU)

Objective. To assess the outcome and adverse-effects of the radioisotope synoviorthesis in paediatric and adolescent patients with haemophilia. Material and Methods. Prospective study of historical cohort was conducted. A total of 20 consecutive haemophiliacs with a mean age of 13.1 years (range 4-17) were included with a mean follow-up of 64.9 months (range 18-109). The diagnosis of synovitis was established on the basis of clinical follow-up including radiological images (radiography and/or MRI). For evaluation, the classification proposed by Fernandez-Palazzi was used. Inclusion criteria: Patients aged less than 18 years old with haemophilia and more than one haemarthrosis in less than 3 months remaining a chronic synovitis despite prophylactic therapy intensification. Exclusion criteria: Any contraindication for radionuclide synoviorthesis. Twenty-seven radioisotope synoviorthesis with 90Y-citrate-colloid and/or 186Re-sulphide-colloid were done. The effectiveness of the procedure was assessed through pre and posttreatment clinical comparison at 6 months after radioisotope synoviorthesis. Results. Nineteen of the 27 synoviorthesis (70.3%) had a good or excellent response and 8 joints (29.7%) had partial response. It was necessary to repeat the procedure in 3 joints in 3 different patients, obtaining in all cases a good or excellent response. We appreciated inflammatory reaction after procedure in 4 cases (14.8%), which improved with analgesics and nonsteroidal anti-inflamatory drugs. None of the patients presented malignant or premalignant lesions during the follow-up. Conclusion. The radionuclide synoviorthesis is a very effective procedure in paediatric and adolescent patients with hemophilia, being a minimally invasive procedure, easy to perform, safe and with minimal side effects (AU)

Radioisotope synoviorthesis in paediatric and adolescent patients with haemophilia.

OBJECTIVE: To assess the outcome and adverse-effects of the radioisotope synoviorthesis in paediatric and adolescent patients with haemophilia. MATERIAL AND METHODS: Prospective study of historical cohort was conducted. A total of 20 consecutive haemophiliacs with a mean age of 13.1 years (range 4-17) were included with a mean follow-up of 64.9 months (range 18-109). The diagnosis of synovitis was established on the basis of clinical follow-up including radiological images (radiography and/or MRI). For evaluation, the classification proposed by Fernandez-Palazzi was used. INCLUSION CRITERIA: Patients aged less than 18 years old with haemophilia and more than one haemarthrosis in less than 3 months remaining a chronic synovitis despite prophylactic therapy intensification. EXCLUSION CRITERIA: Any contraindication for radionuclide synoviorthesis. Twenty-seven radioisotope synoviorthesis with (90)Y-citrate-colloid and/or (186)Re-sulphide-colloid were done. The effectiveness of the procedure was assessed through pre and posttreatment clinical comparison at 6 months after radioisotope synoviorthesis. RESULTS: Nineteen of the 27 synoviorthesis (70.3%) had a good or excellent response and 8 joints (29.7%) had partial response. It was necessary to repeat the procedure in 3 joints in 3 different patients, obtaining in all cases a good or excellent response. We appreciated inflammatory reaction after procedure in 4 cases (14.8%), which improved with analgesics and nonsteroidal anti-inflamatory drugs. None of the patients presented malignant or premalignant lesions during the follow-up. CONCLUSION: The radionuclide synoviorthesis is a very effective procedure in paediatric and adolescent patients with hemophilia, being a minimally invasive procedure, easy to perform, safe and with minimal side effects.

Autorización de usos de medicamentos fuera de indicación en un hospital de tercer nivel / Off-label approval of drug use in a tertiary hospital

Fundamento y objetivo. Comisión de Farmacia y Terapéutica (CFT) evalúa peticiones de usos fuera de indicación con un modelo de informe abreviado. El objetivo fue realizar un análisis descriptivo de esta actividad y estudiar la tasa de autorizaciones. Material y métodos. Estudio descriptivo de los informes de la CFT del hospital entre septiembre de 2009 y abril de 2011. Se analizó tipo de fármaco por grupo terapéutico y por tipo de dispensación, indicación y servicio peticionario. Además, se estudió la decisión final adoptada como variable principal y porcentaje de solicitudes aprobadas según características del medicamento evaluado, indicación solicitada, alternativas usadas, evidencia y coste, como resultados secundarios. Resultados. De un total de 51 solicitudes analizadas, un 60,8% fueron medicamentos de uso hospitalario y un 54,9% citostáticos. Destacaron las indicaciones oncohematológicas (43,2%) y autoinmunes (35,3%). Los servicios con más peticiones fueron Hematología (11 peticiones aprobándose el 72,7%), Oncología y Pediatría (10 peticiones aprobándose el 50% para ambas). Se aprobaron el 60,8% de las peticiones. De las no autorizadas, 11 no agotaron las alternativas terapéuticas y 8 no presentaban evidencia suficiente para ser aceptadas. El 47,1% de los medicamentos solicitados tenían un coste/paciente entre 10.000-100.000 euros aprobándose el 58,3% (coste por tratamiento completo si tenía duración definida o coste por año en tratamientos crónicos). Conclusión. Hay una gran actividad de la CFT que crece con los años. La mayoría de las solicitudes son de fármacos de uso hospitalario, sobre todo de citostáticos por Oncohematología. Existe una alta tasa de autorización con una alta variabilidad según servicio y tipo de evidencia. La diferencia, entre aprobados y no aprobados respecto al coste sigue una lógica de coste-efectividad(AU)

Background and objective. The Pharmacy and Therapeutics Committee (PTC) evaluates the requests for off-label uses with an abbreviated report format. The aim of this study is to perform a descriptive analysis of this activity and to study the rate of approvals. Material and Methods. A descriptive study was performed on the PTC reports in a tertiary hospital between September 2009 and April 2011. The type of drug by treatment group and by type of dispensing, indication and requesting department was analysed. The final decision adopted was studied as the primary outcome, and the percentage of requests approved according to the characteristics of the drug evaluated, indication requested, alternatives used, evidence and cost, as secondary outcomes. Results. A total of 51 applications were analysed, of which 60.8% were drugs for hospital use and 54.9% cytostatic. The most requested indications were the onco-haematological (43.2%) and autoimmune (35.3%). Haematology was the department that made most requests (11 requests with 72.7% approved), Oncology and Paediatrics (both with 10 requests, with 50% approved). Almost two-thirds (60.8%) of the requests were approved. Of those that were not approved, 11 had not used up the therapeutic alternatives, and 8 had no evidence. Just under half (47.1%) of the drugs requested had a cost/patient between 10,000-100,000 euros,of which 58.3% were approved (cost per course of treatment if it had a defined period, or cost of treatment per year for chronic treatment). Conclusion. There is an increase in the activity of the PTC that is growing over the years. Most applications focus on drugs for hospital use and cytostatic drugs by Onco-haematology. There is a high rate of approval by the PTC, and high variability in the percentage of approval depending on the department and the evidence of use. The difference between approved and unapproved requests followed a logic of cost-effectiveness(AU)

[Off-label approval of drug use in a tertiary hospital]. / Autorización de usos de medicamentos fuera de indicación en un hospital de tercer nivel.

BACKGROUND AND OBJECTIVE: The Pharmacy and Therapeutics Committee (PTC) evaluates the requests for off-label uses with an abbreviated report format. The aim of this study is to perform a descriptive analysis of this activity and to study the rate of approvals. MATERIAL AND METHODS: A descriptive study was performed on the PTC reports in a tertiary hospital between September 2009 and April 2011. The type of drug by treatment group and by type of dispensing, indication and requesting department was analysed. The final decision adopted was studied as the primary outcome, and the percentage of requests approved according to the characteristics of the drug evaluated, indication requested, alternatives used, evidence and cost, as secondary outcomes. RESULTS: A total of 51 applications were analysed, of which 60.8% were drugs for hospital use and 54.9% cytostatic. The most requested indications were the onco-haematological (43.2%) and autoimmune (35.3%). Haematology was the department that made most requests (11 requests with 72.7% approved), Oncology and Paediatrics (both with 10 requests, with 50% approved). Almost two-thirds (60.8%) of the requests were approved. Of those that were not approved, 11 had not used up the therapeutic alternatives, and 8 had no evidence. Just under half (47.1%) of the drugs requested had a cost/patient between 10,000-100,000 euros,of which 58.3% were approved (cost per course of treatment if it had a defined period, or cost of treatment per year for chronic treatment). CONCLUSION: There is an increase in the activity of the PTC that is growing over the years. Most applications focus on drugs for hospital use and cytostatic drugs by Onco-haematology. There is a high rate of approval by the PTC, and high variability in the percentage of approval depending on the department and the evidence of use. The difference between approved and unapproved requests followed a logic of cost-effectiveness.