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Digestion 1981A double-blind crossover trial compared prednisolone, 40 mg given orally on alternate days, with placebo as a maintenance treatment for ulcerative colitis in remission.... (Clinical Trial)
Clinical Trial
A double-blind crossover trial compared prednisolone, 40 mg given orally on alternate days, with placebo as a maintenance treatment for ulcerative colitis in remission. In each patient, the study was over two periods of 3 months. Of 24 patients who completed both periods, 11 relapsed while taking placebo but not while taking prednisolone, and 1 relapsed on prednisolone but did not on placebo (p less than 0.01). 1 patient had to stop prednisolone because of hyperglycaemia; other side effects noted were mild. Prednisolone, cautiously used in this way, could be justified for the few patients who relapse frequently despite sulphasalazine.
Topics: Administration, Oral; Adult; Aged; Clinical Trials as Topic; Colitis, Ulcerative; Double-Blind Method; Female; Humans; Male; Middle Aged; Prednisolone
PubMed: 7030837
DOI: 10.1159/000198667 -
Kokuritsu Iyakuhin Shokuhin Eisei... 2000The raw material for prednisolone sodium phosphate was examined for the preparation of the "Prednisolone Sodium Phosphate Reference Standard (Control 001)". The...
The raw material for prednisolone sodium phosphate was examined for the preparation of the "Prednisolone Sodium Phosphate Reference Standard (Control 001)". The analytical data obtained were: pH, 7.9; optical rotation, [alpha]D20 = +98.0 degrees; UV spectrum, lambda max of 248 nm and specific absorbance in ethanol at 248 nm = 306.7; IR spectrum, same as that of the Prednisolone Sodium Phosphate Reference Standard (Control 892); thin-layer chromatography, five impurities were detected at 200 micrograms; high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 3.7%; residual solvent, 0.0% (ethanol) and 0.0% (hexane); loss on drying, 2.7%. Based on the above results, the raw material was authorized as the Prednisolone Sodium Phosphate Reference Standard (Control 001) of the National Institute of Health Sciences.
Topics: Chromatography, High Pressure Liquid; Chromatography, Thin Layer; Government Agencies; Japan; Prednisolone; Reference Standards
PubMed: 11534118
DOI: No ID Found -
The Journal of Clinical Endocrinology... Apr 1990To determine the pharmacokinetic changes of prednisolone associated with differing therapy regimens, we studied 15 patients with various diseases who were treated with... (Comparative Study)
Comparative Study
To determine the pharmacokinetic changes of prednisolone associated with differing therapy regimens, we studied 15 patients with various diseases who were treated with daily doses of prednisolone and were then placed on an intermittent regimen, [administration for 4 consecutive days (on-day period), followed by 3 days cessation (off-day period)]. The mean duration of the study and the mean total dosage were 1.6 months and 2.4 g in the daily period, respectively, and 4.7 months and 3.5 g in the intermittent period, respectively. Blood was drawn for 6 h after iv administration of 20 mg prednisolone (average, 0.36 mg/kg). Plasma total and free prednisolone concentrations were measured by RIA. On-day and off-day tests were performed during the same week. The mean MCR of both total and free prednisolone decreased significantly in the daily and on-day periods compared with the pretreatment values. The decreased MCR during the on-day period was restored to the pretreatment level during the off-day period. A similar trend was observed in the changes in half-life, prolongation in the daily and on-day periods compared with the pretreatment value, and restoration to the pretreatment level during the off-day period. These alterations were not associated with the total duration or the total dosage of prednisolone administered. The results indicate that the pharmacokinetic parameters of prednisolone may periodically change during the intermittent regimen, and that off-day and on-day parameters are similar to those before therapy and during the daily period, respectively.
Topics: Adolescent; Adult; Age Factors; Body Weight; Drug Administration Schedule; Female; Half-Life; Humans; Male; Metabolic Clearance Rate; Middle Aged; Prednisolone; Regression Analysis
PubMed: 2318951
DOI: 10.1210/jcem-70-4-957 -
Clinical and Experimental Dermatology Jan 1986
Topics: Adult; Female; Humans; Iontophoresis; Kinetics; Male; Prednisolone; Skin Diseases
PubMed: 3708894
DOI: 10.1111/j.1365-2230.1986.tb00424.x -
The Analyst May 1980
Topics: Chromatography, High Pressure Liquid; Drug Stability; Prednisolone; Quality Control
PubMed: 7396220
DOI: 10.1039/an9800500455 -
Journal of the American Medical... Aug 1958
Topics: Methylprednisolone; Prednisolone
PubMed: 13563202
DOI: No ID Found -
Diseases of the Colon and Rectum Nov 1984The therapeutic efficacy of prednisolone metasulphobenzoate enemas in the treatment of distal colitis has been compared with that of low-dose oral prednisolone, in a... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
The therapeutic efficacy of prednisolone metasulphobenzoate enemas in the treatment of distal colitis has been compared with that of low-dose oral prednisolone, in a single-blind, cross-over trial. Treatment with steroid enemas resulted in symptomatic and sigmoidoscopic evidence of improvement more frequently than treatment with a dosage of oral steroid calculated to achieve similar plasma prednisolone levels. In addition to demonstrating, for the first time, that prednisolone metasulphobenzoate enemas are effective in the treatment of colitis, this study suggests that their efficacy is due to a local action rather than systemic absorption.
Topics: Acute Disease; Administration, Oral; Adult; Aged; Colitis, Ulcerative; Enema; Female; Humans; Male; Middle Aged; Prednisolone; Prospective Studies
PubMed: 6499602
DOI: 10.1007/BF02554591 -
Lakartidningen
Topics: Anti-Inflammatory Agents; Anticoagulants; Humans; International Normalized Ratio; Prednisolone; Warfarin
PubMed: 20180451
DOI: No ID Found -
Biological & Pharmaceutical Bulletin Jul 2006We investigated the pharmacokinetic behavior of palmitoyl prednisolone (Pal-PLS) and its liposomes with L-alpha-distearoylphosphatidylcholine (DSPC) and cholesterol...
We investigated the pharmacokinetic behavior of palmitoyl prednisolone (Pal-PLS) and its liposomes with L-alpha-distearoylphosphatidylcholine (DSPC) and cholesterol (Chol) with or without L-alpha-distearoylphosphatidylethanolamine-polyethylene glycol 2000 (DSPE-PEG 2000) after their intravenous administration in rats. Pal-PLS rapidly disappeared from the systemic circulation and prednisolone (PLS) was regenerated after the administration of DSPC/Chol liposomes. PEGylated liposomes including DSPE-PEG 2000, however, successfully maintained high blood concentrations of Pal-PLS and PLS. The blood profiles of drugs after the administration of liposomal Pal-PLS were analyzed according to a two-compartment model. The larger content of DSPE-PEG 2000 in DSPC/Chol liposomes showed a lower first order elimination rate constant from the central compartment (K(el)) and clearance (CL). The area under the concentration-time curve (AUC) of Pal-PLS and PLS in PEGylated liposomes was larger than DSPC/Chol liposomes. The mean resident time (MRT) of Pal-PLS and PLS was also prolonged by PEGylated liposomes. Although DSPC/Chol liposomes showed a high distribution of Pal-PLS in the liver and spleen, PEGylated liposomes significantly decreased the liver distribution of Pal-PLS. The biliary and urinary excretions of drugs for 240 min after drug administration were less than 1% of the administrated dose in any formulations. In conclusion, PEGylated liposomes, including Pal-PLS, are useful for maintain the PLS concentration in the blood after intravenous administration.
Topics: Animals; Bile; Kinetics; Liposomes; Male; Polyethylene Glycols; Prednisolone; Rats; Rats, Wistar; Tissue Distribution
PubMed: 16819184
DOI: 10.1248/bpb.29.1436 -
Annales de Dermatologie Et de... 1993Bullous pemphigoid is a bullous skin disease associated with basal membrane antibodies. At present, the first treatment of these lesions is with corticosteroids. In this... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
Bullous pemphigoid is a bullous skin disease associated with basal membrane antibodies. At present, the first treatment of these lesions is with corticosteroids. In this randomized study we compared the clinical results obtained with methylprednisolone (MePr) in 28 patients and with prednisolone methylsulfobenzoate (MsPr) in 29 patients. Both drugs were administered orally in daily doses of 1 to 1.5 mg/kg bodyweight. Three clinical data were examined: the number of bullous lesions, the intensity of pruritus and the extent of erythema after 5 then 10 days of treatment. After 10 days, the number of bullous lesions had decreased by 83 p. 100 with MePr and by 78 p. 100 with MsPr, and the decrease of pruritus had been significantly more pronounced in the MePr group than in the Ms group (p < 0.05). There had been no difference between treatments in the regression of erythema. Altogether, good results were obtained in 22/28 patients under MsPr (78.6 p. 100) and 18/29 patients under MePr (62.1 p. 100). This raises the question of the value of pharmacokinetic studies not only with these two corticosteroids, but also with prednisone which seems to be better absorbed.
Topics: Administration, Oral; Aged; Aged, 80 and over; Female; Humans; Male; Methylprednisolone; Pemphigoid, Bullous; Prednisolone; Treatment Outcome
PubMed: 8304707
DOI: No ID Found