Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study.

OBJECTIVE(S): The aim of this study was to investigate the bleeding pattern and cycle control of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a combined oral contraceptive (COC) containing 0.02 mg EE and 0.1 mg levonorgestrel (LNG). STUDY DESIGN: In this phase III, randomized, controlled, double-blind, double-dummy, multicenter trial, healthy women aged 18-45 years (smokers aged 18-35 years) received either the EE/GSD patch and a placebo tablet (n=171), or a placebo patch and the COC (n=175) for seven 28-day cycles. Bleeding control was assessed in two 90-day reference periods. RESULTS: Mean number of bleeding/spotting days was comparable across treatment groups in both reference periods (p>.05). Mean number of bleeding/spotting episodes was also comparable in reference period 1; however, there were fewer bleeding/spotting episodes for COC in reference period 2 (3.4 versus 3.1; p=.01). Mean length of bleeding/spotting episodes was comparable across treatment groups for both reference periods (p>.05). Withdrawal bleeding occurred consistently in both groups over the entire treatment period, but its absence was more common in the COC group in cycles 4 and 6 of reference period 2 (p<.01). Intracyclic bleeding was comparable between groups. CONCLUSION(S): Bleeding pattern and cycle control with the EE/GSD patch was comparable to an EE/LNG-containing COC. IMPLICATIONS STATEMENT: The findings suggest that bleeding patterns with the EE/GSD patch are similar to an EE/LNG-containing COC, except for absence of withdrawal bleeding, which was less common in patch users. The EE/GSD patch may constitute an additional contraceptive option for women.

Beneficial effects of modest systemic hypothermia on locomotor function and histopathological damage following contusion-induced spinal cord injury in rats.

OBJECT: Local spinal cord cooling (LSCC) is associated with beneficial effects when applied following ischemic or traumatic spinal cord injury (SCI). However, the clinical application of LSCC is associated with many technical difficulties such as the requirement of special cooling devices, emergency surgery, and complicated postoperative management. If hypothermia is to be considered for future application in the treatment of SCI, alternative approaches must be developed. The objectives of the present study were to evaluate 1) the relationship between systemic and epidural temperature after SCI; 2) the effects of modest systemic hypothermia on histopathological damage at 7 and 44 days post-SCI; and 3) the effects of modest systemic hypothermia on locomotor outcome at 44 days post-SCI. METHODS: A spinal cord contusion (12.5 mm at T-10) was produced in adult rats that had been randomly divided into two groups. Group 1 rats (seven in Experiment 1; 12 in Experiment 2) received hypothermic treatment (epidural temperature 32-33 degrees C) 30 minutes postinjury for 4 hours; Group 2 rats (nine in Experiment 1; eight in Experiment 2) received normothermic treatment (epidural temperature 37 degrees C) 30 minutes postinjury for 4 hours. Blood pressure, blood gas levels, and temperatures (epidural and rectal) were monitored throughout the 4-hour treatment period. Twice weekly assessment of locomotor function was performed over a 6-week survival period by using the Basso-Beattie-Bresnahan locomotor rating scale. Seven (Experiment 1) and 44 (Experiment 2) days after injury, animals were killed, perfused, and their spinal cords were serially sectioned. The area of tissue damage was quantitatively analyzed from 16 longitudinal sections selected from the central core of the spinal cord. CONCLUSIONS: The results showed that 1) modest changes in the epidural temperature of the spinal cord can be produced using systemic hypothermia; 2) modest systemic hypothermia (32-33 degrees C) significantly protects against locomotor deficits following traumatic SCI; and 3) modest systemic hypothermia (32-33 degrees C) reduces the area of tissue damage at both 7 and 44 days postinjury. Although additional research is needed to study the therapeutic window and long-term benefits of systemic hypothermia, these data support the possible use of modest systemic hypothermia in the treatment of acute SCI.

Analysis of mercury in hair of EPA region V population.

A scoping study, the National Human Exposure Assessment Survey (NHEXAS) was conducted in EPA Region V from July 1995 to May 1997. This probability-based population study provided an opportunity to examine the mercury levels in 182 participants who provided hair samples. A sensitive analytical procedure based on atomic fluorescence spectrometry was developed and evaluated for the analysis of Hg in approximately 5 mg of human hair. The correlation coefficient (r), the precision, and bias were 0.9983, < or = 1.6%, and < or = 8%, respectively, for standard curves in the hair matrix. The method detection limit (MDL), recovery of Hg in a certified sample (NIES-13), precision (% RSD) for duplicate extract analysis, and precision for duplicate sample analysis averaged 12 ppb (range 4 to 22 ppb), 100 +/- 3% (N=27), 4.6 +/- 2.8 (N=18), and 12.5 +/- 7.4 (N=17), respectively, over the 7 to 8 months of sample analysis. The low MDL yielded 95% of the samples with measurable values, permitting the entire distribution of Hg levels to be characterized. Comparison of annualized Hg distribution in hair with and without background correction revealed a negligible bias on the distribution (1.47% at the 90th percentile). Also, a comparison of the unweighted and nonannualized weighted Hg levels throughout the percentile distribution indicated a small deviation in the upper tail (95th percentile) and is attributable to the small sample size (N=182). The mean, median, and maximum of the annualized Hg levels in hair were 287, 204, and 3505 ppb, respectively. The 75th percentiles were 335 and 368 ppb for the weighted annualized and unweighted distributions, respectively. The percent of individuals in three age categories (0-24, 25-49, and 50 years and older) who exceeded the 75th percentile showed a linear increase with age. Males (N=81) had 10% and 20% lower mean levels than females (N=101) for unweighted and annualized weighted Hg data, respectively. The application of this methodology for characterizing hair Hg levels in fish-eating populations is discussed.