This double-blind, randomized, parallel-group comparative study investigated the phototoxic potential of gemifloxacin mesylate, a potent, novel fluoroquinolone antimicrobial. Forty healthy male and female volunteers received repeat dosing for 7 days with 160 mg or 320 mg of gemifloxacin (o.d., p.m.), 500 mg of ciprofloxacin (b.d.) or placebo (b.d.). On day 5 (large step) and day 6 (small step), graded series of wavebands were irradiated onto the back of each volunteer (phototesting). Skin reactions were assessed 0–30 min (immediate erythema) and 24 and 48 h (delayed erythema) after irradiation. Both gemifloxacin, 320 mg o.d., and ciprofloxacin, 500 mg b.d., were associated with mild phototoxicity following 7 days of administration. The range of mean phototoxic indices (the ratio of minimal erythemal dose at baseline compared with that on day 7 at the end of dosing) was 1.00–2.19 for gemifloxacin and 0.97–2.23 for ciprofloxacin. The abnormal responses occurred within the ultraviolet A region (335–365 ± 30 nm) and were maximal at 24 h. Susceptibility to phototoxicity had cleared 48 h after stopping the drug. The phototoxicity observed with gemifloxacin, 160 mg o.d., was lower than that at the higher dose and similar to that of placebo, suggesting that gemifloxacin phototoxicity is dose dependent. There were no clinically important changes in the safety profiles of gemifloxacin and ciprofloxacin compared with placebo in healthy volunteers after 7 days of repeat dosing. This study demonstrated that gemifloxacin, 320 mg o.d. given for 7 days, has a low potential to cause mild photosensitivity which is similar to that of ciprofloxacin, 500 mg b.d., given for the same period.
The implementation of circulated guidelines has been audited, by assessing the extent to which nutritional goals were set and achieved and recording the levels of morbidity as a result of complications. Adults receiving artificial nutritional support were studied over a six month period. Nutritional assessment was used to determine adequacy of prescription and efficacy of the support. Energy requirements were retrospectively calculated and compared with prescriptions and actual intakes. Complications and interruptions to the regimens which resulted in lost feeding time were recorded, as were patient outcomes. Nutrient prescriptions were inadequate, delivery of prescriptions was incomplete and thus nutrient supply inadequate.
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