Background: The aim of this study was to evaluate the course of hemoglobin (HGB) concentration and hematocrit (HCT) in donor blood during and after preparatory plasmaphereses (PP) without NaCl and with an infusion of 500 ml 0.9% NaCl during PP. Methods: After informed consent 32 plasma donors were studied in a crossover design. They underwent PP once without NaCl infusion and once, on a different day, with infusion of 500 ml 0.9% NaCl. HGB concentration and HCT values in donor blood were analyzed using a Sysmex KX-21N analyzer. The values of HGB concentration and HCT before PP were set to 100%. Changes in HGB concentration and HCT were calculated in percent directly after PP, and after 24 and 72 h. Results: During PP, there was a notable change in HGB concentration (11.2 ± 4.0%) and HCT (11.6 ± 3.9%) in donor blood. The difference between the 2 samples without and with NaCl was highly significant (p < 0.001). After 24 and 72 h, all differences were reduced. Conclusion: We observed significant changes in HGB concentration and HCT in donor blood during PP. We recommend a concomitant infusion of 500 ml 0.9% NaCl during PP to all donors.

Gemifloxacin is a novel fluoroquinolone with a broad spectrum of antibacterial activity. The objective of this double-blind, randomized, placebo-controlled, 2-way crossover study was to demonstrate the lack of a pharmacokinetic interaction between gemifloxacin and digoxin. During two 14-day treatment periods, healthy elderly volunteers received digoxin (0.25 mg, once daily) co-administered on days 8–14 with either gemifloxacin (320 mg, p.o., once daily) or placebo. On day 14 of each period, blood samples and urine were collected for 24 h post dose and analysed for digoxin levels by radioimmunoassay. Steady-state digoxin pharmacokinetics were not affected by multiple dosing with gemifloxacin. There was no significant difference in digoxin values for the area under the plasma concentration-time curve over the dosing interval 0–24 h (AUC_(0–24)) or the trough plasma concentration (C24) after co-administration with either gemifloxacin or placebo. Geometric means for AUC_(0–24) and C24 were 18.1 and 17.8 ng·h/ml and 0.597 and 0.566 ng/ml, respectively. The point estimates (90% confidence intervals) for AUC_(0–24) and C24 (digoxin + gemifloxacin):(digoxin + placebo) were 1.01 (0.93, 1.10) and 1.05 (0.95, 1.16), respectively, entirely within the equivalence range (0.80, 1.25). There were no marked differences between co-administration regimens for maximum observed plasma concentration (C_max) or renal clearance values. Gemifloxacin was well tolerated during co-administration with digoxin, and the incidence of adverse events was similar to that seen with placebo. There were no clinically relevant changes in vital signs, electrocardiogram readings or laboratory parameters. In conclusion, this study demonstrates that gemifloxacin may be co-administered with digoxin without the need for digoxin dose adjustment.

No abstract