Efficacy of a moisturizer for pruritus accompanied by xerosis in patients undergoing dialysis: A multicenter, open-label, randomized verification study.

Xerosis and pruritus are common in patients undergoing dialysis. These symptoms are treated with moisturizers, but limited evidence supports the efficacy of such treatment. Our exploratory study suggested the effectiveness of a heparinoid-containing product for xerosis in dialysis patients. We conducted a multicenter, open-label, randomized, before-after, parallel-group comparative study to verify the exploratory study results (Clinical Trial Registry: UMIN000029360). Seventy-one Japanese patients undergoing dialysis with chronic kidney disease and xerosis were randomly assigned to receive a heparinoid-containing product for 2 weeks (group A [n = 36]) or 8 weeks (group B [n = 35]). Patients were instructed to apply the study product based on the fingertip unit method. The efficacy endpoints were the water content of the stratum corneum (WCSC), skin dryness score, pruritus visual analog scale score, and Dermatology Life Quality Index. Safety was assessed by monitoring adverse events. The mean WCSC (arbitrary units) was 26.0 ± 9.6 in group A and 25.2 ± 10.0 in group B at the start of treatment (week 0), significantly increased to 39.0±12.5 in group A and 38.5 ± 11.0 in group B (P < 0.0001 for both vs week 0) by week 2, and then decreased only in group A. Thus, the WCSC at week 4 (the primary endpoint) remained significantly higher in group B (36.4 ± 12.2 vs 28.8 ± 10.4; P = 0.0068). Other endpoints improved during treatment with the study product. One patient developed a rash and erythema as treatment-related adverse events. In conclusion, 8 weeks' application of a heparinoid-containing product was effective for xerosis in patients undergoing dialysis.

Dialyzability and pharmacokinetics of sitafloxacin following multiple oral dosing in infected hemodialysis patients.

The pharmacokinetics and dialyzability of oral sitafloxacin, a newly available quinolone, in infected intermittent hemodialysis patients have not been reported previously. Seven infected maintenance hemodialysis patients lacking residual renal function were enrolled. Sitafloxacin (50 mg after hemodialysis on the first day, on the next day and 4 h before scheduled hemodialysis session on the 3rd day) was orally administered. On the 3rd day, blood was taken from arterial and venous sides before and 2 and 4 h after session initiation. Another sampling was performed 1 h after the session and on the 5(th) day of the study. Pharmacokinetic parameters and dialyzability of sitafloxacin were evaluated. All patients exhibited improved symptoms without major problems. Drug concentrations in all arterial samples were above the MIC of targeted bacteria. Dialyzer clearance and elimination fraction were 49.9 ± 0.9 mL/min per m(2) and 53.3 ± 2.1%, respectively. Apparent half-life during dialysis session was significantly shorter than that after the session (4.0 ± 0.4 and 46.5 ± 3.6 h, during and after the session, respectively). Dialyzer clearance was positively correlated with urea reduction ratio and negatively correlated with serum albumin concentration. About 23% of the drug in the body was removed by dialysis. Rebound of the drug concentration after the dialysis was not seen. Oral dosing of this drug at 50 mg daily in maintenance hemodialysis patients provides a safe drug concentration compatible with that of healthy subjects orally receiving 100 mg daily. Because a significant amount of the drug was removed, administration might be undertaken after the dialysis session.

Influence of age on clock gene expression in peripheral blood cells of healthy women.

Recent studies have demonstrated a close relationship between circadian clock function and the development of obesity and various age-related diseases. In this study, we investigated whether messenger RNA (mRNA) levels of clock genes are associated with age, body mass index, blood pressures, fasting plasma glucose, or shift work. Peripheral blood cells were obtained from 70 healthy women, including 25 shift workers, at approximately 9:00 AM. Transcript levels of clock genes (CLOCK, BMAL1, PER1, and PER3) were determined by real-time quantitative polymerase chain reaction. Stepwise multiple regression analysis demonstrated that BMAL1 mRNA levels were correlated only with age (beta = -.50, p < .001). In contrast, PER3 levels were correlated with fasting plasma glucose (beta = -.29, p < .05) and shift work (beta = .31, p < .05). These results suggest that increased age, glucose intolerance, and irregular hours independently affect the intracellular clock in humans.

Alteration of circadian periodicity in core body temperatures of patients with acute stroke.

The effect of brain damage on body temperature rhythm was investigated by spectral analysis using the maximum entropy method. The rectal temperatures of 56 patients with acute stroke were recorded for 1-3 days by actigraphy. Many patients with disturbance of consciousness showed infradian rhythm. Ambulatory patients tended to have circadian rhythm, and non- ambulatory patients tended to show infradian rhythm. The study's findings suggest that impaired physical activity and disturbance of consciousness affect body temperature rhythm in patients with acute stroke.