Evaluación de la vacuna pandémica antigripal A/H1N1 adyuvada MF59. Revisión sistemática de la literatura / Assessment of the MF59-adjuvanted pandemic influenza A/H1N1 vaccine. Systematic review of literature

Objetivo: Evaluar la eficacia y la seguridad de la vacuna adyuvada MF59 en la gripe pandémica en población infantil. Métodos: Se ha elaborado una revisión sistemática de la literatura médica (2005-2012). Para ello se realizó una búsqueda bibliográfica en fuentes de datos electrónicas como MedLine o Embase y búsqueda manual en revistas especializadas, utilizando descriptores MeSH y términos de búsqueda libre. Los criterios de inclusión fueron ensayos clínicos que incluyeran a niños vacunados frente a la gripe A/H1N1 con la vacuna adyuvada MF59 y se comparaba frente a otras dosis vacunales con o sin adyuvante MF59, registrando resultados de seguridad e inmunogenicidad. La calidad de los ensayos clínicos se evaluó utilizando los criterios del cuestionario CASPe. Resultados: Se seleccionaron 4 ensayos clínicos de calidad moderada. Los efectos adversos locales y sistémicos fueron de carácter leve o moderado, sin diferencias entre los grupos vacunados. Los porcentajes de seroconversión y seroprotección alcanzados fueron superiores con las vacunas que utilizaron el adyuvante MF59. Los títulos de anticuerpos alcanzados también fueron mayores en las vacunas adyuvadas. Conclusiones: La vacuna pandémica antigripal adyuvada con MF59 presenta un buen perfil de eficacia y seguridad. Los efectos adversos que puede ocasionar son comunes y se presentan de manera similar a los que acontecen al utilizar vacunas no adyuvadas (AU)

Objective: To assess the efficacy and safety of MF59-adjuvanted pandemic influenza A/H1N1vaccine in children. Methods: A systematic review of the literature was performed after searching the MedLine and Embase electronic databases, and manual search in specialties journals, with MeSH terms and free terms. Inclusion criteria were clinical trials with children vaccinated with MF59-adjuvanted influenza A/H1N1 vaccine, compared with other vaccines doses with/without MF59-adjuvanted. The immunogenicity and safety of the vaccine was recorded. The quality of the studies included was assessed by CASPe checklist. Results: Four clinical trials with moderate quality were selected. The local and systemic adverse effects were rare and mild, with no differences between groups. Seroconversion and seroprotection levels were higher with MF59-adjuvanted vaccines. Antibody titres were also higher with the adjuvant vaccines. Conclusions: The adjuvant vaccine has a good efficacy and safety profile. The adverse effects that may occur are common and appear similarly in both vaccination groups (AU)

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: a meta-analysis.

Pneumococcal infections are a major cause of morbidity and mortality worldwide. Pneumococcal conjugate vaccines represent major progress in the prevention of invasive pneumococcal disease in the paediatric population. We performed a meta-analysis, in accordance with the PRISMA statement, in order to assess the immunogenicity and safety of 13-valent pneumococcal conjugate vaccines in infants. A literary search was conducted using electronic databases and specialized journals were searched manually. Inclusion criteria were: clinical trials with infants vaccinated with 13-valent pneumococcal conjugate, compared to 7-valent vaccine. We recorded the results in terms of the immunogenicity and safety of the vaccines. The quality of the studies included was assessed using the CASP and Jadad checklists. We included nine randomized clinical trials of 258 potentially relevant references in the meta-analysis. The studies included had high-moderate quality. Both vaccines were well tolerated in all groups of infants, and most local reactions and systemic events were of mild or medium intensity and typical of any injected vaccine. All studies included in the meta-analysis showed high immunogenicity for both pneumococcal vaccines in all tested serotypes. An anti-polysaccharide antibody concentration of ≥0.35 µg/mL was achieved in at least 89% of the infants. Our results suggest that the 13-valent pneumococcal conjugate vaccine has a similar safety profile, and is as effective as, the 7-valent vaccine in the prevention of invasive pneumococcal disease caused by the seven common serotypes, and could provide expanded protection against the six additional serotypes.

[Assessment of the MF59-adjuvanted pandemic influenza A/H1N1 vaccine. Systematic review of literature]. / Evaluación de la vacuna pandémica antigripal A/H1N1 adyuvada MF59. Revisión sistemática de la literatura.

OBJECTIVE: To assess the efficacy and safety of MF59-adjuvanted pandemic influenza A/H1N1 vaccine in children. METHODS: A systematic review of the literature was performed after searching the MedLine and Embase electronic databases, and manual search in specialties journals, with MeSH terms and and free terms. Inclusion criteria were clinical trials with children vaccinated with MF59-adjuvanted influenza A/H1N1 vaccine, compared with other vaccines doses with/without MF59-adjuvanted. The immunogenicity and safety of the vaccine was recorded. The quality of the studies included was assessed by CASPe checklist. RESULTS: Four clinical trials with moderate quality were selected. The local and systemic adverse effects were rare and mild, with no differences between groups. Seroconversion and seroprotection levels were higher with MF59-adjuvanted vaccines. Antibody titres were also higher with the adjuvant vaccines. CONCLUSIONS: The adjuvant vaccine has a good efficacy and safety profile. The adverse effects that may occur are common and appear similarly in both vaccination groups.

Disfunción eréctil en pacientes intervenidos de cáncer de próstata. Revisión sistemática de la literatura médica / Erectile dysfunction in patients with prostate cancer who have undergone surgery: Systematic review of literature

Objetivo: Evaluar la aparición de la disfunción eréctil en pacientes con cáncer de próstata sometidos a prostatectomía radical (PR) retropúbica, prostatectomía laparoscópica y/o prostatectomía robótica. Material y métodos: Revisión sistemática de la literatura médica mediante búsqueda bibliográfica (2000–2010) en MedLine, Embase, Cochrane Library, Center for Review Dissemination, ECRI y Hayes. Los términos Mesh fueron «Prostatectomy», «Prostatic neoplasm», «Transuretral resection prostate», «Impotence» y los términos libres fueron «erectile dysfunction» y «prostatectomy». Los estudios incluían pacientes con cáncer de próstata intervenidos para la extirpación de la glándula mediante cirugía abierta (retropúbica), laparoscópica o robótica. Resultados: Se seleccionaron diez estudios observacionales de calidad moderada y 29 series de casos de baja calidad. Los estudios observacionales presentaban los menores porcentajes de disfunción eréctil en pacientes intervenidos mediante cirugía robótica (3–51%). La PR retropúbica (36–91%) y la laparoscópica registraban cifras superiores de aparición de impotencia. Los estudios que comparaban intervenciones, cirugía y radioterapia obtenían con las radiaciones menores índices de disfunción sexual (3–72%). En las series de casos, los menores porcentajes de disfunción eréctil acontecieron en pacientes con cirugía robótica (22%), seguido de cirugía laparoscópica (40%) y de PR retropúbica (41,4%). Conclusiones: Los resultados, aunque deben interpretarse con cautela dada la limitada calidad de los estudios, presentan efectos similares en la evaluación de las diferentes técnicas quirúrgicas, observándose que la cirugía robótica registra los menores porcentajes en relación con la aparición de impotencia sexual (AU)

Objective: To assess erectile dysfunction in patients with prostate cancer undergoing surgery by radical prostatectomy, laparoscopic prostatectomy or robotic prostatectomy. Material and methods: Systematic Review of literature based on a search strategy (2000–10) in MedLine, Embase, Cochrane Library, CRD, ECRI, and Hayes. Mesh terms used were 'Prostatectomy', 'Prostatic Neoplasm', 'Transuretral Resection Prostate', 'Impotence' and as free terms 'erectile dysfunction' and 'prostatectomy'. Studies included patients with prostate cancer underwent by prostatectomy radical with open surgery (retropubic), laparoscopic or robotic surgery. Results: Ten observational studies with moderate quality and 29 case series with low quality were selected. Observational studies showed lower percentages of erectile dysfunction after intervention in the patients underwent robotic surgery (3–51%). Radical surgery (36–91%) and laparoscopic surgery showed higher values of impotence. In the studies that compared surgery versus radiotherapy, the results were better for radiotherapy (3–72% erectile dysfunction). In the case series, lower percentages of erectile dysfunction were shown in patients underwent to robotic surgery (22%), the following was for laparoscopic surgery (40%) and open radical prostatectomy (41.4%). Conclusions: This result should be considered with caution because of the low methodological quality of the studies included. However, the different surgical techniques assessed showed similar effects in the two types of studies included and we found that robotic surgery presented lower percentages of sexual impotence (AU)

[Erectile dysfunction in patients with prostate cancer who have undergone surgery: Systematic review of literature]. / Disfunción eréctil en pacientes intervenidos de cáncer de próstata. Revisión sistemática de la literatura médica.

OBJECTIVE: To assess erectile dysfunction in patients with prostate cancer undergoing surgery by radical prostatectomy, laparoscopic prostatectomy or robotic prostatectomy. MATERIAL AND METHODS: Systematic Review of literature based on a search strategy (2000-10) in MedLine, Embase, Cochrane Library, CRD, ECRI, and Hayes. Mesh terms used were Prostatectomy, "Prostatic Neoplasm, Transuretral Resection Prostate, Impotence and as free terms erectile dysfunction and prostatectomy. Studies included patients with prostate cancer underwent by prostatectomy radical with open surgery (retropubic), laparoscopic or robotic surgery. RESULTS: Ten observational studies with moderate quality and 29 case series with low quality were selected. Observational studies showed lower percentages of erectile dysfunction after intervention in the patients underwent robotic surgery (3-51%). Radical surgery (36-91%) and laparoscopic surgery showed higher values of impotence. In the studies that compared surgery versus radiotherapy, the results were better for radiotherapy (3-72% erectile dysfunction). In the case series, lower percentages of erectile dysfunction were shown in patients underwent to robotic surgery (22%), the following was for laparoscopic surgery (40%) and open radical prostatectomy (41.4%). CONCLUSIONS: This result should be considered with caution because of the low methodological quality of the studies included. However, the different surgical techniques assessed showed similar effects in the two types of studies included and we found that robotic surgery presented lower percentages of sexual impotence.

[Assessment of the PCA3 test for prostate cancer diagnosis: a systematic review and meta-analysis]. / Evaluación del test PCA3 para el diagnóstico de cáncer de próstata: revisión sistemática y metanálisis.

OBJECTIVE: To assess the efficacy of diagnostic techniques based on PCA3 gene for early detection of prostate cancer. We carried out a systematic review of scientific literature and subsequent meta-analysis. MATERIAL AND METHODS: A literature search (2000-09) in MEDLINE, EMBASE, Cochrane Library, CRD, ECRI, Hayes databases and journals of Cancer and Urology. MESH terms used were "Prostatic Neoplasms", Prostate-Specific Antigen", "Antigens, Neoplasm", "Sensitivity and Specificity", "Predictive Value of Tests", and free terms "upm3", "PCA3", "dd3", "aptima PCA3" and "prostate cancer antigen 3". Patients were adults. The intervention was to determine the PCA3 gene, from urine samples for diagnosis of prostate cancer. The quality of the studies was checked according to QUADAS criteria. We calculated diagnostic accuracy rates and developed a meta-analysis to synthesize results. RESULTS: 14 studies of diagnostic tests were selected, with moderate-high quality. The sensitivity was between 46.9% and 82.3%, specificity ranged from 56.3% to 89%, positive predictive value had a range of 59.4-97.4% and negative predictive value 87.8-98%. The meta-analysis detected the existence of a threshold effect and heterogeneity between studies. Global sensitivity values was 0.85 [CI 0.84-0.87], specificity 0.96 [CI 0.96-0.97], positive likelihood ratio 22.21 [CI 15.12-32.63], and negative of 0.15 [CI 0.13-0.18]. CONCLUSIONS: Detection techniques have acceptable diagnostic accuracy rates for using in the diagnosis of prostate cancer.

Evaluación del test PCA3 para el diagnóstico de cáncer de próstata: revisión sistemática y metanálisis / Assessment of the PCA3 test for prostate cancer diagnosis: A systematic review and meta-analysis

Objetivos: Evaluar la eficacia de las técnicas diagnósticas basadas en el gen PCA3 para el diagnóstico del cáncer de próstata. Para ello, se ha realizado una revisión sistemática de la literatura científica y posterior metanálisis. Material y métodos: Búsqueda bibliográfica (2000–09) en MedLine, Embase, Cochrane Library, CRD, ECRI, Hayes y en revistas especializadas de Cáncer y Urología. Se utilizaron los descriptores «Prostatic Neoplasms», «Prostate-Specific Antigen», «Antigens, Neoplasm», «Sensitivity and Specificity», «Predictive Value of Tests» y términos libres «upm3», «pca3», «dd3», «aptima pca3» y «prostate cancer antigen 3». La población eran adultos y la intervención consistía en la determinación del gen PCA3, a partir de muestras de orina, para el diagnóstico de cáncer de próstata. La calidad de los estudios se analizó según los criterios QUADAS. Se calcularon los índices de validez diagnóstica y se elaboró un metanálisis para sintetizar los resultados. Resultados: Se incluyeron 14 estudios de pruebas diagnósticas, de calidad moderada-alta. La sensibilidad estuvo comprendida entre 46,9–82,3%; la especificidad osciló entre 56,3–89%; el valor predictivo positivo tuvo un rango de 59,4–97,4%; y el valor predictivo negativo entre 87,8–98%. El metanálisis detectó la existencia de efecto umbral y de heretogeneidad entre los estudios, ofreciendo valores de sensibilidad global de 0,85 (IC 0,84–0,87), especificidad de 0,96 (IC 0,96–0,97), cociente de probabilidad positivo de 22,21 (IC 15,12–32,63) y negativo de 0,15 (IC 0,13–0,18). Conclusiones: Las técnicas de detección presentan aceptables índices de validez diagnóstica para poder usarlas en el diagnóstico de cáncer de próstata (AU)

Objective: To assess the efficacy of diagnostic techniques based on PCA3 gene for early detection of prostate cancer. We carried out a systematic review of scientific literature and subsequent meta-analysis. Material and methods: A literature search (2000–09) in MEDLINE, EMBASE, Cochrane Library, CRD, ECRI, Hayes databases and journals of Cancer and Urology. MESH terms used were "Prostatic Neoplasms", Prostate-Specific Antigen", "Antigens, Neoplasm", "Sensitivity and Specificity", "Predictive Value of Tests", and free terms "upm3", "PCA3", "dd3", "aptima PCA3" and "prostate cancer antigen 3". Patients were adults. The intervention was to determine the PCA3 gene, from urine samples for diagnosis of prostate cancer. The quality of the studies was checked according to QUADAS criteria. We calculated diagnostic accuracy rates and developed a meta-analysis to synthesize results. Results: 14 studies of diagnostic tests were selected, with moderate-high quality. The sensitivity was between 46.9% and 82.3%, specificity ranged from 56.3% to 89%, positive predictive value had a range of 59.4–97.4% and negative predictive value 87.8–98%. The meta-analysis detected the existence of a threshold effect and heterogeneity between studies. Global sensitivity values was 0.85 [CI 0.84–0.87], specificity 0.96 [CI 0.96–0.97], positive likelihood ratio 22.21 [CI 15.12–32.63], and negative of 0.15 [CI 0.13–0.18]. Conclusions: Detection techniques have acceptable diagnostic accuracy rates for using in the diagnosis of prostate cancer (AU)

Endoláser en el tratamiento de patologías venosas en miembros inferiores. Revisión sistemática de la bibliografía / Endovenous laser in thetreament of venous patology in low members. Systematic review of scientific iterature

Objetivo. Evaluar la eficacia y seguridad del láser endovenoso en el tratamiento de la insuficiencia venosa delos miembros inferiores. Materiales y métodos. Diseño: revisión sistemática de la literatura científica. Fuente de datos: Medline (2003-marzo 2008), Embase (2003-marzo 2008), bases mantenidas por el Center for Reviews and Dissemination, Cochrane Library, Red Europea de Detección Precoz de Tecnologías y el registro norteamericano de ensayos clínicos ClinicalTrials.gov. Metodología: se incluyeron pacientes adultos con insuficiencia venosa de miembros inferiores.La intervención consistió en el tratamiento de la insuficiencia venosa mediante la utilización de láser endovenoso en comparación con la cirugía convencional. Como resultados se han elegido parámetros de seguridad (complicaciones y efectos adversos) y eficacia (porcentaje de oclusión de venas y grado de satisfacción del paciente). La calidad se valoró mediante criterios del programa CASPe y Jadad. Resultados. Se seleccionaron cuatro ensayos clínicos, cuatro informes de agencias de tecnologías sanitarias y una revisión sistemática. Los informes de agencias y la revisión mostraron intervalos de eficacia comprendidos entre 87,95 y 100%. Las complicaciones más frecuentes fueron equimosis, induración de la zona, hematoma, parestesias e hiperpigmentación. Los ensayos clínicos presentaban una eficacia del 89,6-98,4% a los tres meses de la intervención y complicaciones menores que en el grupo control. El tiempo de recuperación era menor en el grupo intervenido con endoláser y la satisfacción del paciente mayor. Conclusiones. La tecnología endoláser se presenta segura, con reacciones adversas típicas de intervenciones quirúrgicas, pero menores que con la cirugía convencional(AU)

La eficacia presenta en general porcentajes altos, aunque según aumenta el tiempo transcurrido desde la intervención, disminuye y se iguala con la cirugía convencional. La gran ventaja de esta técnica puede residir en el tiempo de recuperación y las molestias postoperatorias, que son menores que en la cirugía convencional(AU)

Aim. Assessment the efficacy and safety of endovenous laser in the treatment of venous insufficiency of lowmembers. Materials and methods. Design: systematic review of scientific literature. Source database: MedLine (2003-March 2008), Embase (2003-March 2008), Center for Reviews and Dissemination, Cochrane Library, European Agencyof Medicine, European Network of Early Detection of Technologies and the registry of clinical trials ClinicalTrials.gov.Methods: Inclusion criteria: adult patients with venous insufficiency of low members. Intervention: to treat venousinsufficiency by endovenous laser versus conventional surgery. Outcomes: safety parameters (complications and adverseeffects) and efficacy (% occlusion of veins and degree of satisfaction of patients). The quality was assessment by criteriaof the program CASPe and Jadad. Results. We selected four clinical trials, four reports of Health Technology Agenciesand a systematic review. The reports of agencies and the review showed ranges of efficacy between 87,95-100%. Themost frequent complications were equimosis, induration of the area, bruise, parestesias, and hyperpigmentation.Clinical trials showed an efficacy of 89,6-98,4% to three months of the intervention, and minor complications than insurgical group. Time of recovery and patient satisfaction were better in endovenous laser group. Conclusions. Endovenouslaser appears sure, with typical adverse reactions of surgical interventions, minor in conventional surgery. Theefficacy presents in general high percentages, though the more time pass from the intervention, it decreases the moreequal are the results to conventional surgery. The great advantage of this technology could reside in the recovery timeand postoperatory inconveniences, that are minor that with the conventional surgery(AU)