Pharmacokinetics and safety of single oral doses of lomefloxacin.

The pharmacokinetics of 100 mg, 200 mg, 400 mg, 600 mg, and 800 mg of lomefloxacin, a quinolone antimicrobial, were examined in a single sequential rising dose, placebo-controlled, crossover study. Each of 30 healthy male subjects (6 per group) received placebo and one dose of lomefloxacin, separated by 5 days. Test results (physical examinations, laboratory and hematology panels, vital signs, neurological and ophthalmological examinations, EEG or urinalysis) revealed no clinically significant differences compared to baseline. Mean Cmax values (0.92 micrograms ml-1 to 6.99 micrograms ml-1) increased linearly with dose. Mean tmax averaged 1.13 +/- 0.5 h and mean t1/2, 7.8 +/- 1.0 h over all doses. There was a small influence of dose on the AUC0-48. Mean urinary concentrations during the first 4 h postdosing ranged from 79 to 454 micrograms ml-1. Urine concentrations remained greater than or equal to 15 micrograms ml-1 over 24 h at the lowest dose. Maximum urinary excretion rate, Rmax, ranged from 5.84 mg h-1 to 34.90 mg h-1. Dose normalized Rmax and XU96 (per cent of dose) were unaffected by dose. Mean renal clearance decreased at higher doses. In conclusion, lomefloxacin was well tolerated in doses up to 800 mg. Lomefloxacin is rapidly absorbed with an elimination half-life of approximately 8 h. The data suggest that the drug can be effectively administered once daily.

Microbioluminometry assay: determination of erythromycin activity in plasma or serum.

A microbioluminometry assay (MBA) was developed for the quantitative analysis of erythromycin activity in human plasma or serum. The MBA method is adapted from turbidimetric methods and utilizes an enzyme-catalyzed bioluminescence reaction to quantitate the growth of Staphylococcus aureus in liquid culture medium. Statistical analysis of data obtained in method validation studies and in more than 500 assays of standard curve and control samples demonstrates consistent reproducibility and accuracy within theoretical limits. The MBA was shown to be more sensitive than agar diffusion assays with a lower limit of sensitivity less than 20.0 ng/mL and coefficients of variation less than 10%. Cumulative results of 178 assays of spiked control plasma samples in the range of 0.14-2.18 micrograms/mL show 11.2% of individual determinations are greater than +/- 15% the expected value, and 5.6% of individual determinations are greater than +/- 20% the expected value. Bioavailability profiles obtained with MBA are consistent with reported data for erythromycin. Values for 206 subject samples analyzed by MBA and agar diffusion assays showed a high degree of correlation (r = 0.9525) between the two methods. The MBA technique provided high sample throughput because of the use of microtiter plate technologies; it is also economical since it requires less sample and reagents.

Sources of support perceived by parents of children with cancer: implications for counselling.

Providing social support for families of pediatric cancer patients remains a challenge. The perceived helpfulness of 11 potential support sources was assessed by 107 parents of children with cancer. They rated the spouse, the medical community, and parents from a mutual help group as the most helpful. Mental health professionals and the church were seen less frequently and perceived as less helpful. No significant differences were found in the patterns of social support among parents with children in different stages of treatment. More than half the parents responding to a question on what they needed most during their children's illness mentioned emotional support and counselling. Mental health professionals may find that crisis/supportive and educative models and frequent contact are useful counselling approaches in dealing with families of cancer patients. A team approach to pediatric oncological treatment, consisting of a primary physician, nurse, and psychological consultant, may be a way to optimize the early and flexible involvement of psychosocial staff in total care.

Development of brief measures of psychological adjustment to medical illness applied to cancer patients.

The interrater reliability and validity of brief interview rated measures of psychosocial adjustment were examined in four sequential studies. A total of 25 videotaped interviews with cancer patients were rated by 105 social workers, nurses, physicians, and specialists in psychosocial oncology. The Rating of Psychosocial Function (RPF), Coping Adequacy Rating (CAR), and Global Adjustment to Illness Scale (GAIS) were used by various rating groups with an indication of interrater agreement. Agreement on ratings was not influenced by the length of interview (15 vs. 30 minutes) but appeared to the affected by the structure of the interview and profession of the raters. All three instruments showed a measure of matching with clinical impressions in addition to demonstrating a measure of both convergent and divergent construct validation. The GAIS was chosen as most adequately reflecting their clinical impression by a majority of raters. With a degree of training, any of the three instruments could be used to assess psychosocial adjustment with some measure of confidence in the validity of the rating.

The pathology of breast cancer in women irradiated for acute postpartum mastitis.

The gross and microscopic pathology of breast cancers in women irradiated for acute postpartum mastitis was compared to the breast cancers found in the sisters of the irradiated women. Fifty-one cancers in 50 irradiated women and 25 cancers in 24 nonirradiated women were examined. In considering the lesions in the two populations, the size, location, histologic type, histologic grade, inflammatory response, lymphatic and blood vascular invasion, nipple involvement, axillary lymph node metastases, and menopausal status at the time of diagnosis were statistically indistinguishable. The only parameter that was different in the two populations was the desmoplastic response to the malignant lesion (P = 0.04). The control population had more marked fibrosis within the cancers compared with the irradiated women. With the exception of stromal response, this study shows that breast cancer in irradiated women is similar in the parameters evaluated to breast cancer in a control population.