Estudio multicéntrico de la eficacia del tratamiento intraarticular con ácido hialurónico (Adant) en artrosis de rodilla / Multicenter clinical trial on the efficacy of intra-articular hyaluronic acid (Adant®) in osteoarthritis of the knee

Fundamento: El objetivo de este ensayo fue evaluar la eficacia y la seguridad del tratamiento con ácido hialurónico en pacientes con artrosis de rodilla, siguiendo un diseño prospectivo, multicéntrico y no controlado con un seguimiento de 6 meses. Material y métodos: Los 10 centros participantes incluyeron un total de 112 pacientes evaluables con diagnóstico de artrosis de rodilla tanto clínico (criterios ARA) como radiológico: leve (grados 1-2 de Kellgren and Lawrence [KL]); moderado (grado 3 de KL), y grave (grado 4 de KL). La eficacia del tratamiento con cinco inyecciones intraarticulares de ácido hialurónico (Adant, Tedec-Meiji Farma, S.A.) se evaluó comparando la puntuación basal, de los signos y síntomas clínicos (dolor, movilidad y función basado en la escala propuesta por The Knee Society) con los obtenidos en las visitas postratamiento. La seguridad se valoró mediante registro sistemático de acontecimientos adversos durante todo el estudio. Resultados: Todos los parámetros de eficacia estudiados (dolor, movilidad, deambulación y subida/bajada de escaleras) pusieron de manifiesto una mejoría significativa (p = 0,0001) en todas las visitas de seguimiento con respecto a los valores basales. El 64 por ciento de los pacientes presentó una respuesta muy buena (incremento > 20 por ciento respecto a la puntuación basal) durante al menos 6 meses tras la última administración de ácido hialurónico. El porcentaje de acontecimientos adversos por inyección, con independencia de su relación con el tratamiento, fue del 3,6 por ciento y el de acontecimientos adversos posible/probablemente relacionados fue del 1,3 por ciento: vértigo (n = 2), dolor de rodilla (n = 2), edema (n = 1), prurito (n = 1) e hipersensibilidad (n = 1). Únicamente este último supuso abandono del tratamiento. Conclusión: La administración de ácido hialurónico intraarticular parece que es una alternativa segura y bien tolerada para el tratamiento de la artrosis de rodilla tanto leve como grave, con una duración de los efectos de, al menos, 6 meses (AU)

[Validity of the protocol for evaluating the inappropriate use of hospitalization]. / Validez del protocolo de evaluación del uso inapropiado de la hospitalización.

BACKGROUND: The study was carried out in order to assess the inter-observer reliability and validity in respect of clinical appraisal given by the Appropriateness Evaluation Protocol (AEP), in the context of the Spanish Public Hospital System. MATERIAL AND METHOD: In order to assess the reliability a total of 614 hospital stays chosen at random from 56 hospital admissions were independently analysed by three reviewers (two doctors and one nurse). In order to assess the validity, the findings obtained by the nurse were compared with the majority opinion given by the 7 hospital specialists in respect of each of hospital stays under evaluation. As part of the analytical procedure, indices for observed agreement, and specific agreement were calculated, as well as the Kappa statistic, all forming of various random samples of 614 hospital stays. In order to assess the predictive validity of the AEP, its sensitivity, specificity and predictive values were all measured against the majority clinical judgement. RESULTS: The study exhibited a high degree of inter-observer reliability (specific agreement > 64%, kappa > 0.75) and a reasonable validity in comparison with the consensus of opinions formed by a least 4 or 5 of its 7 clinical reviewers (specific agreement > 61%, kappa > 0.64), these values decreasing notably when the consensus of 6 or 7 of the reviewers was required. The AEP revealed a high degree of sensitivity and a low degree of specificity in comparison with the majority clinical assessment, thus minimising the occurrence of false results when the stay was regarded as appropriate, and producing false negatives (appropriate hospital stays regarded as inappropriate) varying in degree from moderate to very high. CONCLUSIONS: The results showing high reliability and moderate validity regarding clinical assessment shows the AEP to be a useful instrument in the sifting-out of inappropriate use of hospitalisation, although they do not allow a definitive judgement to be made concerning the efficiency of hospital services nor judgements regarding individual cases.

Epidermal growth factor receptors in human breast and endometrial carcinomas.

The incidence and levels of epidermal growth factor receptor (EGFR) were studied in 67 breast tumors and 22 endometrial carcinomas. Estrogen receptors (ER) were also measured in all samples and progesterone receptors (PR) were analyzed in 57 breast samples and 21 endometrial tumors. A high level of EGFR expression is found in both breast and endometrial carcinomas, although the incidence of EGFR content is greater in breast carcinomas. 36% of breast tumors had EGFR at levels 3-49.5 fmol/mg membrane protein, whereas this percentage of positivity was 27% for endometrial tumors. In 51% of breast carcinoma and 73% of endometrial tumors, there was a positive ER content, whereas 53% of breast tumors and 62% of endometrial carcinomas were positive. A clear inverse relationship between EGFR content and ER and PR status has been observed in breast tumors. Our data confirm the previously described inverse correlation between expression of EGFR and estrogen receptors in human breast cancer. We also show here that there is a similar inverse relationship between EGFR content and ER levels in endometrial tumors.