Fiblast (trafermin) in acute stroke: results of the European-Australian phase II/III safety and efficacy trial

BACKGROUND: Trafermin (basic fibroblast growth factor) has been shown to reduce infarct volume in acute ischemic stroke models, and to promote functional recovery and new synapse formation when given to animals with completed cerebral infarction. A previous study in acute stroke patients suggested that trafermin was safe and well tolerated when given over a 3-hour period over a wide dose range. METHODS AND RESULTS: Double-blind, parallel group, placebo-controlled trial of a single 24-hour intravenous infusion of trafermin. Patients having onset of stroke symptoms within 6 h and a baseline score of >/=7 on the NIH Stroke Scale (>/=2 motor) were randomized to receive 5 or 10 mg of trafermin or placebo intravenously infused over 24 h. The primary efficacy outcome was a categorized combination of the Barthel and Rankin scales assessed at 90 days. A total of 286 patients had been enrolled at 55 sites in 11 countries when the sponsor directed that enrollment be stopped because an interim analysis of efficacy data predicted too small a chance of demonstrating a statistically significant benefit after recruitment of the planned 900 patients. The 5-mg group showed a slight but nonsignificant advantage over placebo (OR 1.2, 95% CI 0.72-2.00, p = 0.48); the 10-mg group showed a nonsignificant disadvantage (OR 0.74, 95% CI 0.44-1.22, p = 0.24). Mortality rates at 90 days were 17% in the 5-mg group, 24% in the 10-mg group and 18% in the placebo group. Treatment with trafermin was associated with an increased leukocytosis and a decrease in blood pressure: mean decrease in systolic blood pressure from baseline was 19 mm Hg in the 5-mg group, 22 mm Hg in the 10-mg group and 8 mm Hg in the placebo group. In a post hoc subgroup analysis, patients in the 5-mg group treated more than 5 h after the onset of symptoms showed an apparent advantage over placebo (OR 2.1, 95% CI 1.00-4.41, p = 0.044; after age adjustment: OR 1.9, 95% CI 0.91-4.13, p = 0.08). CONCLUSIONS: With the proper treatment regimen, trafermin can likely be given safely to stroke patients. The 5-mg dose showed a trend toward a treatment advantage. The ideal time window for this agent may exceed 5 h. This may open new avenues for acute stroke therapy, aiming at enhancing recovery mechanisms rather than immediate neuroprotection.     

Receipt of preventive medical services at psychiatric visits by patients with severe mental illness

The authors used data from the National Ambulatory Medical Care Survey from 1992 to 1999 on 3,198 office visits to explore the extent to which psychiatrists provide clinical preventive medical services to patients with severe mental illness. Preventive services were provided during 11 percent of the visits. A multivariate analysis showed that preventive services were more likely to have been provided for patients with a chronic medical condition, for patients who were also seen by a nurse or other health provider during the visit, in rural areas, and during longer visits. Preventive services were less likely to have been provided during visits to health maintenance organizations and visits that took place later in the study period.     

A national agenda for Latino cancer prevention and control

Although cancer is a leading cause of morbidity and premature death among Latinos, there is limited knowledge of cancer-related issues and priorities of greatest significance to the Latino population, the largest minority group in the nation. This information is vital in helping to guide Latino cancer research, training, and awareness efforts at national, regional, and local levels. To help identify cancer issues of greatest relevance to Latinos, Redes En Accion, The National Hispanic/Latino Cancer Network, a major network among the National Cancer Institute's Special Populations Networks, conducted a survey of 624 key opinion leaders from around the country. Respondents were asked to rank the three cancer sites most important to Latinos in their region and the five issues of greatest significance for this population's cancer prevention and control. Recommendations were prioritized for three specific areas: 1) research, 2) training and/or professional education, and 3) awareness and/or public education. Among cancers, breast carcinoma was ranked number one, followed in order by cervical and lung carcinomas. The issues of greatest significance to Latinos were 1) access to cancer screening and care, 2) tobacco use, 3) patient-doctor communication, 4) nutrition, and 5) risk communication. This survey solicited information from scientists, health care professionals, leaders of government agencies, professional and community-based organizations, and other stakeholders in Latino health. The results laid the foundation for a national Redes En Accion Latino cancer agenda, thus providing a useful tool for individuals and organizations engaged in cancer prevention and control efforts among the Hispanic-Latino population.     

Ultrastructural ciliary findings in nasal obstructive diseases

Specific ultrastructural findings have widely been described in case of obstructive nasal diseases due to congenital defects. Ciliary impairment has in particular been observed as the main pathological feature in these conditions. In this study, nasal mucosal samples from different pathologies have been collected via the "brushing" technique and analysed by transmission electron microscopy. TEM analysis was focused on specific features, such as the numerical array of peripheral and central doublets of the cilium axoneme, including eventual microtubular disarrangement; partial or total loss of inner and/or outer dynein arms; defects of radial spokes and nexin links; disorientation of the ciliary axis in closely adjacent cilia, calculating the angle between the line crossing the central microtubular core and the horizontal ciliary axis and compound cilia (CC). Statistical comparison was carried out between study and control groups. A significant incidence of organic ciliary defects was found not only in patients with inflammatory processes, but mostly in those supposed to have a long-lasting nasal respiratory disease due to mechanical stenosis in relation to septum deviation and turbinate hypertrophy. Prevalence and percentage of compound cilia were instead more related to inflammatory conditions. The "brushing" technique can be considered an easy and reliable method for the assessment of the condition of the nasal mucosa. According to the findings derived from this study, mechanical nasal obstruction seems to cause major alterations on the nasal ciliary arrangement, thus determining a functional impairment on the whole nasal function.