Adverse events reported following live, cold-adapted, intranasal influenza vaccine

Context  In June 2003, the US Food and Drug Administration licensed a trivalent live, attenuated influenza vaccine (LAIV-T) for intranasal administration to healthy persons 5 to 49 years of age. Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably. Objective  To identify adverse events reported following LAIV-T administration after licensure. Design, Setting, and Participants  All adverse events reported to the US Vaccine Adverse Event Reporting System (VAERS) during the 2003-2004 and the 2004-2005 influenza seasons. Main Outcome Measures  Numbers and proportions of reported adverse events and reporting rates of adverse events per 100 000 vaccinees. Results  Approximately 2 500 000 persons received LAIV-T during the first 2 postlicensure seasons. As of August 16, 2005, VAERS received 460 adverse event reports for vaccinations received from August 2003 through July 2005. No fatalities were reported. There were 7 reports of possible anaphylaxis, 2 reports of Guillain-Barré syndrome, 1 report of Bell palsy, and 8 reports of asthma exacerbation among individuals with a prior asthma history. Events in individuals for whom the vaccine was not indicated accounted for 73 reports (16%). Conclusions  Reports to VAERS in the first 2 seasons of LAIV-T use did not identify any unexpected serious risks with this vaccine when used according to approved indications. Like many vaccines and other medical products, LAIV-T may rarely cause anaphylaxis. Secondary transmission of the vaccine virus merits further investigation. Reports of asthma exacerbations in vaccinees with prior asthma history highlight the risks of vaccine use inconsistent with approved labeling.      

Psychological effect, pathophysiology, and management of androgenetic alopecia in men

Androgenetic alopecia In men, or male pattern baldness, is recognized increasingly as a physically and psychologically harmful medical condition that can be managed effectively by generalist clinicians. This article discusses the clinical manifestations, epidemiology, physical and psychosocial importance, pathophysiology, diagnosis, and management of androgenetic alopecia in men. Androgenetic alopecia affects at least half of white men by the age of 50 years. Although androgenetic alopecia does not appear to cause direct physical harm, hair loss can result in physical harm because hair protects against sunburn, cold, mechanical injury, and ultraviolet light. Hair loss also can psychologically affect the balding individual and can Influence others' perceptions of him. A progressive condition, male pattern baldness is known to depend on the presence of the androgen dihydrotestosterone and on a genetic predisposition for this condition, but its pathophysiology has not been elucidated fully. Pharmacotherapy, hair transplantation, and cosmetic aids have been used to manage male pattern baldness. Two US Food and Drug Administration-approved hair-loss pharmacotherapies-the potassium channel opener minoxidil and the dihydrotestosterone synthesis inhibitor finasteride--are safe and effective for controlling male pattern baldness with long-term daily use. Regardless of which treatment modality is chosen for male pattern baldness, defining and addressing the patient's expectations regarding therapy are paramount in determining outcome.     

p57Kip2 (cdkn1c): sequence, splice variants and unique temporal and spatial expression pattern in the rat pancreas

The cyclin-dependent kinase (CDK) inhibitor p57Kip2 (CDKN1C) is a negative regulator of cell proliferation, binding to a variety of cyclin-CDK complexes and inhibiting their kinase activities in vitro. The p57Kip2 gene is imprinted and the maternal allele is expressed in terminally differentiated cells, including human beta-cells. Somatic loss of p57Kip2 expression is associated with increased beta-cell proliferation in the focal form of Hyperinsulinism of Infancy. We cloned and sequenced the rat ortholog of p57Kip2, and demonstrate that it is highly homologous to the mouse gene. However, the human and rodent genes are quite divergent. Despite having highly homologous C- and N-terminal domains, the mid-portion of the human gene is entirely different from that of its rodent counterparts. Expression of p57Kip2 was evaluated during fetal and postnatal development, and a highly cell-specific, temporal and spatial expression profile was found. In contrast to other tissues, the expression pattern in rat pancreas was entirely opposite from that previously reported in man, with high levels of expression in rodent exocrine cells, but no expression in beta-cells during any stage of development. These findings demonstrate that p57Kip2 expression is highly regulated. In the pancreas, the functional significance of this gene appears to be quite different in humans when compared with rodents, suggesting that a better understanding of the function of this protein may provide new insights into the mechanisms involved in the control of human beta-cell mass.     

Body composition of children aged 1 to 12 years with biliary atresia or Alagille syndrome

BACKGROUND: Growth and body composition have not been well described in older children with biliary atresia or Alagille syndrome living with their native liver. To optimize nutritional management of these conditions it is essential to understand the normal growth characteristics. OBJECTIVES: The purpose of this study was to evaluate and compare the growth and body composition of children, particularly school-age children, with biliary atresia and Alagille syndrome. METHODS: A single observer measured height, weight, arm anthropometry and skin fold thickness in subjects aged 1 to 12 years with biliary atresia or Alagille syndrome who had not undergone liver transplantation. RESULTS: Forty-six subjects (10 biliary atresia/36 Alagille syndrome) were assessed. Biliary atresia subjects were below average in height for age with normal weight and elevated body mass index. Mean fat stores were mildly depressed. The z-scores for body mass index and weight for age were inversely correlated with age. Alagille subjects were stunted and had low body weight and reduced fat and muscle stores. Body mass index z-score was inversely correlated with age despite improved cholestasis. CONCLUSIONS: Children with Alagille syndrome had significant growth deficits as measured by weight, height and upper arm anthropometry at all ages studied. In contrast, subjects with biliary atresia had normal weights and heights. However, body mass index and weight for age z-scores were lower in the older biliary atresia subjects. Few studies of anthropometry in biliary atresia or Alagille syndrome have included the school-aged child. This study addresses this gap in knowledge and provides baseline data for nutritional interventions in these patients.