RESUMEN
Defining the minimal clinically meaningful improvement (MCMI) is crucial to understanding the treatment effects on health-status measures. We estimated the MCMI on the quality of erection questionnaire (QEQ), a validated measure specific to assess erectile quality during sexual intercourse. Data were from two controlled trials of an investigational phosphodiesterase type 5 inhibitor. Improvement on the Erectile Function domain of the International Index of Erectile Function was used as the anchor. For men who improved by exactly 1 erectile dysfunction severity category (anchor group (n=95)), clinically meaningful improvement (CMI, estimated with mean QEQ total change score from baseline to end of treatment) and MCMI (estimated with the lower limit of the 95% confidence interval of the mean) were 22.4 (s.d., 2.2) and 18.0 points, respectively. For the difference between the anchor group and men with no change in severity category (n=116), CMI and MCMI were 17.7 (s.d., 2.9) and 12 points, respectively. Distribution-based analyses (baseline s.e. of measurement (s.e.m.)=7.99, end-of-treatment s.e.m.=8.22 and s.e. of difference=11.46) supported a proposed MCMI of 12 points. Convergence of anchor-based and distribution-based criteria supports at least a 12-point difference in QEQ scores between treatments as clinically important.
Asunto(s)
Disfunción Eréctil/psicología , Erección Peniana/psicología , Adulto , Anciano , Algoritmos , Interpretación Estadística de Datos , Método Doble Ciego , Disfunción Eréctil/tratamiento farmacológico , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Erección Peniana/fisiología , Inhibidores de Fosfodiesterasa 5 , Inhibidores de Fosfodiesterasa/uso terapéutico , Encuestas y Cuestionarios , Resultado del Tratamiento , Adulto JovenRESUMEN
Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely in men after taking sildenafil or other phosphodiesterase 5 inhibitors for erectile dysfunction (ED). The incidence of NAION in men receiving sildenafil treatment for ED was estimated using pooled safety data from global clinical trials and European observational studies. Based on clinical trial data in more than 13,000 men and on more than 35,000 patient-years of observation in epidemiologic studies, we estimated an incidence of 2.8 cases of NAION per 100,000 patient-years of sildenafil exposure. This is similar to estimates reported in general US population samples (2.52 and 11.8 cases per 100,000 men aged >or=50 years). The data cited herein do not suggest an increased incidence of NAION in men who took sildenafil for ED.
Asunto(s)
Disfunción Eréctil/tratamiento farmacológico , Neuropatía Óptica Isquémica/inducido químicamente , Inhibidores de Fosfodiesterasa/efectos adversos , Piperazinas/efectos adversos , Anciano , Humanos , Masculino , Persona de Mediana Edad , Purinas , Factores de Riesgo , Citrato de Sildenafil , SulfonasRESUMEN
Bilateral tibial osteotomy with fracturing of the fibula was performed on ten Wistar rats weighing 300--350 g. Intramedullary nailing was performed with 1.4 mm nails after reaming. On the left side solid stainless rods were used, while on the right side the nails had a middle part made of titanium-nickel wire covered with polyvinylchloride (PVC), giving the nail a high degree of flexibility. After 8 weeks, nine of the ten flexible nails showed fracture of the central wire. The continuity was, however, maintained by the PVC tube. The bones with flexible nailing always showed hypertrophic callus while there was only scanty callus on the side with rigid nailing. Strength, deformation at fracture and stiffness were measured in a three-point bending test after removal of the solid nails and the fibulae. The strength of the tibiae was greatest on the side with flexible nailing, as was the deformation at fracture. The mean stiffness was higher in the bones with rigid nails, but the difference here was not statistically discernible.
Asunto(s)
Fijación Intramedular de Fracturas , Fracturas Óseas/fisiopatología , Animales , Callo Óseo/fisiopatología , Peroné/lesiones , Peroné/cirugía , Fracturas Óseas/cirugía , Masculino , Ratas , Ratas Endogámicas , Cicatrización de HeridasRESUMEN
Medical and/or distal migration of the prosthetic stem was found in 63 out of 337 patients (19 per cent) treated surgically with a Christiansen hemiprosthesis, a Christiansen total hip prosthesis or a Charnley total hip prosthesis. Fractured bone cement, radiolucent zones at the cement/bone interface, resorption of the femoral calcar and cortical sclerosis were all associated with migration. Varus position of the Christiansen total hip prosthesis was significantly associated with medical migration, and a short stem was significantly associated with distal migration. The other structural variables could not be linked with migration. Distal migration was pain-inducing and was significantly associated with late infection. Medical migration had a less distinct association with pain, and was not correlated with infection. Both medical and distal migration were time-dependent, and 4 or more years after operation about 2.5 per cent of the prosthetic stems had migrated.
Asunto(s)
Fémur/diagnóstico por imagen , Prótesis de Cadera/efectos adversos , Cementos para Huesos , Estudios de Evaluación como Asunto , Estudios de Seguimiento , Humanos , Dolor/etiología , Probabilidad , Radiografía , Esclerosis/etiología , Factores de TiempoRESUMEN
Acetabular protrusion was found in 56 out of 211 patients fitted with a hemiprosthesis. The indication for operation was acute femoral neck fracture or failure following a previous internal fixation. A number of radiological variables were analysed with respect to their possible association with preoperative, operative and follow-up variables. After a preliminary screening of variables a deeper analysis was performed by fitting log-linear models to the data. Our analysis showed that the development of protrusion has a significant association with follow-up time. A previous hip operation was also significantly associated with the development of protrusion. This may be an indication for total hip replacement in some patients who now receive a hemiprosthesis as a secondary operation. Acetabular protrusion was significantly associated with the development of postoperative pain, while the other clinical symptoms and signs lacked any direct association with protrusion. Although acetabular protrusion and loosening of the prosthetic stem showed a significant association the analysis indicated that pain was primarily due to protrusion.
Asunto(s)
Acetábulo/diagnóstico por imagen , Prótesis de Cadera/efectos adversos , Estudios de Seguimiento , Humanos , Radiografía , Estadística como Asunto , Factores de TiempoRESUMEN
The Guillain-Barré syndrome has been studied by lumbar myelography with watersoluble contrast media in seven cases. Abnormalities, which consisted of widening of the nerve roots and obliteration of the root sleeves, were found in three of them. It is possible that myelography accentuated the symptoms in one case while the rest tolerated the examination well.