Nanomedicines: From Bench to Bedside and Beyond

Advancing nanomedicines from concept to clinic requires integration of new science with traditional pharmaceutical development. The medical and commercial success of nanomedicines is greatly facilitated when those charged with developing nanomedicines are cognizant of the unique opportunities and technical challenges that these products present. These individuals must also be knowledgeable about the processes of clinical and product development, including regulatory considerations, to maximize the odds for successful product registration. This article outlines these topics with a goal to accelerate the combination of academic innovation with collaborative industrial scientists who understand pharmaceutical development and regulatory approval requirements—only together can they realize the full potential of nanomedicines for patients.     

A population-based analysis of pediatric breast cancer

Purpose

The purpose of this study was to evaluate trends in demographics and outcomes of pediatric breast cancer in a United States population-based cohort.

Sex‐related Disparity in Surgical Mortality among Pediatric Patients

Background. It has been reported that gender differences in cardiovascular outcomes found in adults also are present in children who undergo surgical repair for congenital heart disease. Methods. California statewide hospital discharge data 1989–99 were used to study outcomes in children <18 years undergoing cardiac surgery. Hospital discharge data were linked to death registry data to study postdischarge death within 30 days of discharge. We used logistic regression to evaluate the effect of gender on mortality controlling for age, race and ethnicity, type of insurance, household income, date and month of surgery, type of admission, hospital case volume, and various types of procedures. Results. There were 25 402 cardiac surgery cases with 1505 in‐hospital deaths (mortality rate of 5.92%). An additional 37 deaths occurred within 30 days after hospital discharge. Crude mortality rates for males (5.99%) and females (5.84%) were not significantly different. However, fewer neonates were female and females underwent a higher proportion of low‐risk procedures than males. Logistic regression revealed that females, compared with males, had a significantly higher odds ratio (OR) for in‐hospital mortality (OR = 1.18, P < .01) and overall (up to 30 days post discharge) mortality (OR = 1.18, P < .01). The risk‐adjusted length of hospital stay was similar between females and males while charges per hospital day were slightly higher in females than males. The prevalence of Down syndrome, pulmonary hypertension, and failure to thrive were higher in females. Conclusions. Female gender is associated with an 18% higher in‐hospital and 30‐day postdischarge mortality as compared with male gender. There was no difference in length of hospital stay between males and females. The mechanism by which female gender acts as a risk factor requires further investigation.     

Bilateral arthrography of the wrist

In order to determine the true significance of a positive arthrogram in the investigation of wrist pain, a prospective trial was carried out in 60 patients, using the opposite asymptomatic wrist as a control. Of the 46 patients with positive findings in the symptomatic wrist, 34 (74%), had positive arthrograms in the opposite, asymptomatic, wrist. As a result of this, we conclude that a unilateral arthrogram is of little diagnostic value and we recommend the use of the opposite, asymptomatic, wrist as a control.     

An in vivo investigation into bond failure rates with a new self-etching primer system.

Self-etching primers have recently been introduced to simplify the orthodontic bonding process. The aim of this study was to compare the effectiveness of such a product with conventional 2-stage etching and priming with 37% o-phosphoric acid and a conventional unfilled primer. Twenty consecutive patients having orthodontic bonds placed were selected to participate in this cross-mouth control study. Diagonally opposite quadrants were randomly allocated to either the self-etching primer group or the conventional etching and priming group. A total of 364 teeth were bonded with a light-cured diacrylate adhesive; bond failures were then monitored over 6 months. There were 20 bond failures (10.99%) in the self-etching primer group and 9 bond failures (4.95%) in the conventional etch and priming group over this period. The results were analyzed with the McNemar test and 95% confidence interval. The difference between the failure proportions was -0.06 with an associated 95% confidence interval of -0.121 to 0.001. This study produced weak evidence to suggest that bond failures with a self-etching primer will be higher than those with conventional etching and priming. This increased likelihood of bond failure must be weighed against the time advantage of the self-etching primer when used at the initial bonding appointment.