RESUMO
BACKGROUND: We measured the effect of 30 milliliters (mL) of 4% lidocaine gel on the breasts and chest wall of healthy women covered for 1 h on plasma concentrations of lidocaine and its principal metabolite, monoethylglycinexylidide (MEGX), electrocardiogram (EKG) results, and adverse events. MATERIALS AND METHODS: This institutional review board-approved, prospective, open-label study complied with the Health Insurance Portability and Accountability Act (HIPAA). The study evaluated 10 healthy women aged 42-75 years with 30 mL of 4% lidocaine gel on the skin of the breasts and chest wall covered for 1 h. Cardiac and neurological assessments were performed and blood was drawn for lidocaine and MEGX levels at baseline and 1/2, 1, 2, 3, 4, 6, and 8 h after application. EKGs were performed before application and at 3 h. Subjects provided informed written consent. Primary and secondary outcomes were plasma concentrations of lidocaine and MEGX and frequency of adverse events, respectively. Statistical analysis included paired t-tests for EKGs and repeated measures regression for vital signs. RESULTS: No lidocaine was detected in the blood of 9 of 10 subjects. One subject had low plasma concentrations of lidocaine just above the level of detection the first 4 h after application only. No MEGX was detected. Mean decrease in heart rate was likely multifactorial. CONCLUSION: Thirty mL of 4% lidocaine gel on the breasts and chest wall covered for 1 h in healthy women resulted in plasma concentrations of lidocaine and MEGX well below therapeutic or toxic levels and no clinically significant adverse events.
RESUMO
BACKGROUND: Current assessments of cardiac rejection in murine transplant models rely on subjective estimates of the force of the palpable heart beat that have limited sensitivity and precision. METHODS: We used 2-dimensional echocardiography to evaluate changes in left ventricular posterior wall thickness (PWT) in a heterotopic cardiac mouse transplant model of rejection. Nine allografts and 6 isografts were imaged daily for 6 days and harvested. Thirteen allografts were imaged daily and harvested at day 3. RESULTS: Intraobserver variability on PWT was 0.003 +/- 0.09 mm, interobserver variability 0.09 +/- 0.11 mm. Allograft PWT increased after transplantation (0.74 +/- 0.02 mm to 1.28 +/- 0.05 mm at day 5, P <.0001). For isografts, PWT remained constant (0.73 +/- 0.03 mm to 0.85 +/- 0.01 mm) after an initial increase at day 1. Palpation failed to identify rejection at day 3 whereas PWT was already increased (1.15 +/- 0.02 mm in the allografts at day 3 vs 0.85 +/- 0.02 mm in the isografts, P <.0001). There was a relation between histologic score and PWT (P <.0001). CONCLUSION: Two-dimensional echocardiography allows the noninvasive detection and follow-up of cardiac rejection after transplantation. It eliminates the subjectivity of palpation and provides quantitative and reliable indices of rejection.