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PubMed1988

[Effect of topical glucocorticoids on endogenous cortisol production].

In a randomized double blind study, we investigated the systemic effects of 3 different ointments containing corticoids. Every 7 patients out of a total of 21 patients suffering from various skin diseases were daily treated with 40 g of one of the 3 corticoid preparations over 8 days (group A: 0.05% clobetasol-17-propionate; group B: 0.25% fluocortolone trimethyl acetate; group C: 0.25% fluocortolone trimethyl acetate + 0.25% fluocortolone capronate). The plasma cortisol levels were determined by radioimmune assay. In group B and C, we did not observe any effect on the pituitary-adrenal axis, whereas in group A the plasma cortisol levels were extremely low already after 1 day of corticoid application. This adrenal suppression did not return to normal within 4 days after discontinuation of the corticoid. Our results suggest that highly potent topical corticoids are capable of adrenal suppression even without occlusive dressing and even in healthy persons.

Administration, Topical↗
PubMed1985

Na-K pump activity in erythrocytes of patients with endogenous and exogenous glucocorticoid excess.

The mechanism of glucocorticoid-induced hypertension is not clarified. Recent data suggest an alteration of active electrolyte transport systems by glucocorticoids. We therefore studied the activities of the Na-K pump by measuring the Na-K-ATPase activity in erythrocyte ghosts and the ouabain-sensitive uptake of rubidium in erythrocytes of patients with Cushing's syndrome and of patients with exogenous glucocorticoid excess after treatment with fluocortolone or ACTH. Na-K-ATPase activity was significantly increased in patients with Cushing's syndrome and in patients treated with ACTH compared to the controls. Similarly, total uptake of 86Rb and the ouabain-sensitive uptake in erythrocytes were found to be above the control range both in patients with Cushing's syndrome and in patients treated with fluocortolone. There was no difference in furosemide-sensitive uptake of 86Rb. The results demonstrate an increased maximal activity of the Na-K pump in patients with glucocorticoid excess.

Adrenocorticotropic Hormone↗
PubMed1977

[Clinico-experimental testing for anti-inflammatory activity of external corticosteroids].

Clinical trials of the anti-inflammatory activity of corticosteroids for external use The influence on skin temperature of 4 corticoid-containing formulations and 3 steroid-free bases was tested in 9 subjects in whom no pathological skin changes were present but who were known to be sensitive to metal ions (chromium and nickel). The effect of the preparations on the healthy skin (vasoconstrictive effect) after a duration of action of 2 and 6 h was compared with the effect on skin sites treated subsequently with the contact allergens for a period of 24 h. In the procedure used the trial preparations were allowed to act for 2 and 6 h under occlusive dressing, or for 4 and 8 h, the dressing being removed for 2 h in each case. The allergization produced an increase in temperature at the skin surface which was influenced in various ways by the trial preparations. Whereas no statistically significant differences in the effect of the individual steroid topicals were found the healthy skin, in the evaluatin of the overall anti-inflammatory effect on the pathological skin processes, some distinct differences in effect were found. On comparing the results the following lowing order was obtained for the overall anti-inflammatory effect: 1. Fluprednylidene acetate 0.1% score 4.5, 2. Difluocortolone-valerate 0.1% score 8.5, 3. Fluocortolone trimethylacetate 0.25% + fluocortolone caproate 0.25% score 12, 4. Desoxymethasone 0.1% score 15, The steroid-free bases tested simultaneously did not exhibit clear effects on the temperature in the normal or inflamed skin. The results of the test procedure described are reproducible and can be evaluated by statistical method; the method thus seems appropriate for comparative studies of steroid-containing topicals. The special value in the procedure is the possibility of testing the effect of the preparations directly in a standardised inflammation model which is directly related to use in patients with inflammatory skin diseases, and of establishing in this way in which preparations the anti-inflammatory effect obtained exceeds the general effect common to all steroids.

Administration, Topical↗
PubMed1982

Detection and comparative evaluation of aldosterone antagonists in glucocorticoid-treated, adrenalectomized rats.

An improved method for the evaluation of aldosterone antagonists in adrenalectomized, glucocorticoid-treated rats is described. The method involved assessing the pharmacological effects of spironolactone and potassium canrenoate and comparing them with the action of prorenone and potassium prorenoate, respectively. Adrenalectomized rats were pretreated with fluocortolone caproate (10 mg/kg s.c.), a long-acting glucocorticoid, immediately after surgery. Fluocortolone (1.25 mg/kg s.c.), a short acting preparation, was administered 4 days after this treatment. On the 5th day after adrenalectomy, the actual diuresis experiment was performed. The rats received a continuous i.v. infusion of aldosterone [1 microgram/(kg x h)] for 10, 15 or 20 h. Spirnolactone or prorenone (6.7, 13.4 or 26.8 mg/kg of each steroid) were administered in single oral doses 1 h before or 4 h after the start of the i.v. infusion. Potassium canrenoate and potassium prorenoate (1.9, 3.8, or 6.7 mg/(kg x h) of each compound) were infused intravenously over 10 or 15 h. Urine was collected in 1 h fractions and the anti-aldosterone activity was assessed by the ability of the compounds to reverse the aldosterone effect on the Na/K ratio. The anti-aldosterone activity of the steroids studies was clearly detectable with the method described. Prorenone was as potent as spironolactone and potassium prorenoate was on the average 3.9 times as potent as potassium canrenoate. The method appears suitable for the characterization of the time course and duration of anti-aldosterone activity and for the calculation of relative potencies in comparison to standard compounds.

Adrenalectomy↗
PubMed1993

Combined cyclosporin A-steroid-MTX treatment in endogenous non-infectious uveitis.

Thirty-two patients with endogenous uveitis resistant to treatment with high doses of cortisone and other immunosuppressive agents were treated with cyclosporin A (at an initial dose of 5 mg/kg/die, subsequently modified according to individual clinical response), fluocortolone and methotrexate. Total and lasting disease remission was obtained in all patients, together with the recovery of normal visual acuity in 20 cases and its significant improvement in the remaining 12. Furthermore, in all patients the total disappearance of all ocular inflammatory activity was observed and maintained for a period of 10.87 +/- 5.31 (6-18) months. No signs of renal or hepatic toxicity were observed in any of the patients. A form of hirsutism appeared in only two cases.

Adolescent↗
PubMed1993

Deposits of paraprotein in small vessels as a cause of skin ulcers in Waldenström's macroglobulinemia.

A 71-year-old man presented with epistaxis and large ulcers on arms and legs. A monoclonal IgM-kappa gammopathy and high levels of cryoglobulins were found. Histology of the affected skin showed deposits of paraprotein in the small vessels, causing luminal obstruction. This in turn caused ischemic skin lesions, which were successfully treated with cortisone (fluocortolone 100 mg/day every second day) and cyclophosphamide (100 mg/day).

Aged↗
PubMed1976

Investigations on the influence of different corticosteroids on the development of galactose cataracts in rats.

The influence of daily subcutaneous injections of 5 different corticosteroids (15 mg/kg body weight) on the development of galactose opacities in young rats of approximately 60g body weight was investigated. Progress of cataracts was evaluated by planimetry of lens photos. The three glucocorticosteroids used (cortisol, prednisolone, fluocortolone) induced a slight acceleration of cataract development, while a mineralocorticoid (desoxy-corticosterone) caused a marked retardation. A temporary retardation was also observed with fluocortinbutyl, a rapidly metabolized steroid for topical use.

Adrenal Cortex Hormones↗
PubMed1986

Adrenocortical responsiveness after discontinuous corticosteroid therapy.

Plasma cortisol levels and the response of the adrenal gland to 0.25 mg ACTH administration were measured in 12 patients receiving 15 mg or more of a short-acting steroid (fluocortolone or prednisone) on three out of four days, in 10 patients on daily steroid treatment (15 mg prednisone or more per day), and in 9 normal subjects. The basal plasma cortisol level of the first group was between that of patients on daily prednisone treatment and that of normal subjects. The adrenal function in patients on the three out of four day treatment schedule appeared to be slightly diminished, yet still within the accepted limits for adrenals capable of responding adequately to stress. The adrenal function proved insufficient in all patients on daily steroids. The three out of four day steroid regimen thus offers a solution with many advantages over continuous steroid treatment for patients refractory to the alternate-day schedule.

Adolescent↗
PubMed2005

[Ranking of systemic steroids after normal-risk keratoplasty. Results of a randomized prospective study].

BACKGROUND: The aim of this study was to evaluate the efficacy of sole application of topical steroids after normal-risk keratoplasty. PATIENTS AND METHODS: This randomized prospective clinical study assessed 40 patients who had undergone penetrating normal-risk keratoplasty. Twenty patients were treated exclusively with prednisolone acetate 1% eye drops 5x/day for 6 months postoperatively. Another 20 patients additionally received systemic fluocortolone 1 mg/kg body weight per day tapered within 3 weeks postoperatively. The main outcome measures included clear graft survival, ratio of graft rejection, and side effects. RESULTS: The mean postoperative follow-up was 18+/-9 months. Three graft rejections were observed in the group receiving only topical steroids. Two graft rejections were observed in the group administered combined systemic and topical steroid therapy. None of the patients has developed irreversible graft failure so far. CONCLUSION: Sole topical steroid application seems to be an effective immune prophylaxis in patients undergoing penetrating normal-risk keratoplasty.

Aged↗
PubMed1985

False-positive results in the radioimmunoassay detection of stilbene derivatives after administration of fluorinated corticosteroids to animals.

During routine inspections, indications were found that the therapeutic use of fluocortolone or dexamethasone can cause false-positive results in the detection of stilbene derivatives by radioimmunoassay (RIA) in samples of animal origin. After experimental application of the fluorinated corticosteroids to rabbits or calves, the assumed false-positive RIA results were confirmed. The kinetics after application of dexamethasone were concomitant with the elimination of radioactive [3H]dexamethasone. Furthermore, it could be demonstrated that [3H]dexamethasone was transformed in the faeces of rabbits and calves. The metabolites formed were not completely separated by the extraction procedure used for the RIA and seemed to be responsible for the false-positive results.

Animals↗
PubMed1996

Psychopathological and neuropsychological effects of 8-days' corticosteroid treatment. A prospective study.

Corticosteroids often induce a variety of psychiatric symptoms, such as alterations of mood, neuropsychological deficits and even psychotic states. To date, only a few studies have specifically addressed behaviour as well as cognitive functioning in patients under steroid treatment. Fifty ophthalmologic patients participated in this prospective study. They received methylprednisolone or fluocortolone at doses of 119 +/- 41 mg/day in the beginning and 75 +/- 22 mg after 8 days of treatment. Psychopathology and neuropsychological functioning were examined before and after steroid therapy, mood was self-rated on days 0, 3, 5 and 8. No marked psychopathological abnormalities such as psychosis, dementia or delirious states were observed. However, a significant proportion of patients suffered from an organic mood disorder, 26-34% experienced a hypomanic syndrome, 10-12% a depressive syndrome. Most neuropsychological tests did not reveal significant effects of steroid treatment. Performance of Word Fluency and Trail Making A improved, while the Auditory-Verbal-Learning and the Digit-Symbol showed a worsening. Psychopathological and neuropsychological effects were not significantly correlated.

Administration, Oral↗
PubMed1999

Effects of systemic steroid treatment in chronic polypoid rhinosinusitis evaluated with magnetic resonance imaging.

BACKGROUND: The aim of this prospective study was to evaluate the efficacy of a combined (local and systemic) steroid therapy on the extent of chronic polypoid rhinosinusitis and patient symptoms. METHODS AND PATIENTS: Subjects of this study were 20 patients with severe chronic polypoid rhinosinusitis with total or subtotal narrowing of the all sinuses. A nasal budesonide spray (2 x 0.1 mg/day) and an oral fluocortolone medication with a daily reduction during a 12-day period (total dose: 560 mg = group 1) and a 20-day period (total dose: 715 mg = group 2), respectively, were administered. Before and after the steroid treatment we evaluated the extent of the sinusitis with MRI and patient symptoms with symptom-related questionnaires. RESULTS: A significant reduction (> 30%) of the chronic polypoid rhinosinusitis was observed in 50% of MRI findings. The steroid effect on polypoid masses was heterogeneous in different anatomic areas (maxillary sinus 40%, anterior ethmoid 19%, posterior ethmoid 33%, sphenoidal sinus 61%, frontal sinus 46%). Most sinusitis-related symptoms were distinctly diminished in most patients (80%). No major side effects were observed. CONCLUSIONS: A combined short-term steroid therapy is highly effective in chronic polypoid rhinosinusitis, reducing the mucosal inflammation mainly in the large sinuses and reducing the incidence of symptoms significantly. However, this therapy was insufficient in the anterior ethmoid and cannot replace the current surgical treatment concept of the osteomeatal complex in CPR. The indication for such a short-term steroid therapy is the preoperative treatment. It facilitates functional endoscopic sinus surgery by reducing the extent of surgical procedures, the time, and thereby the risks of sinus surgery.

Administration, Inhalation↗
PubMed1992

[Acquired protein C deficiency in ulcerative colitis. The cause of thromboembolic complications].

Three patients with an acute exacerbation of ulcerative colitis (a 40-year-old and a 31-year-old man and a 30-year-old woman) developed a protein C deficiency (serum protein C activity between 32 and 48%). In the two men the protein C deficiency was diagnosed only after the onset of severe thromboembolic complications (cavernous sinus thrombosis; pulmonary embolism) during heparin treatment. But in the woman protein C activity was measured immediately after hospital admission (in the knowledge of the first two cases) even before heparin administration was started. All three patients received treatment with sulphasalazine (3 g daily) and fluocortolone (60 mg daily), as well as full heparinization (22,500-36,000 IU daily). Protein C activity returned to normal on remission of the ulcerative colitis (in one case only after subtotal colectomy). These case reports show that acquired protein C deficiency can be reversed by rigorous treatment of the underlying disease.

Adult↗
PubMed1990

[Corticotropin-releasing hormone (CRH) test for monitoring glucocorticoid therapy].

Suppression of endogenous cortisol production was assessed by a corticotropin-releasing hormone (CRH) test 24 hours after the last dose of the glucocorticoid in 48 patients (27 women and 21 men; mean age 48.9 [21-69] years) who had been taking fluocortolone for inflammatory rheumatic disease. Both during a few weeks of treatment (9 patients) and after a year (39 patients) complete suppression of endogenous cortisol production occurred in 17 patients, partial suppression in 17. This suppression did not unequivocally correlate with the dosage or duration of treatment, but there was a tendency towards it at higher dose levels (15-30 mg). Cortisol response to the CRH test was unremarkable in 14 patients. These results suggest that secondary adrenal insufficiency is to a considerable extent dependent on individual factors. Correspondingly the degree of suppression of the adrenal axis cannot be predicted for an individual patient without suitable testing.

Adrenocorticotropic Hormone↗
PubMed2004

Syphilitic interstitial keratitis: treatment with immunosuppressive drug combination therapy.

OBJECTIVE: The following is a case presentation of congenital syphilitic keratitis in a boy 6 years of age who was successfully treated with an immunosuppressive drug combination therapy. METHODS: Congenital syphilitic keratitis was diagnosed by clinical findings and laboratory tests. The child was unresponsive to traditional treatment; thus, systemic immunosuppressive therapy, which consisted of oral cyclosporine 4 mg/kg/d, 6 days per week, and oral low-dose steroids (fluocortolone 0.8 mg/kg a week, given every other day), was initiated. RESULTS: Corneal disease showed great improvement with this therapy, with progressive healing of lesions in the first month of treatment and no signs of toxic renal, hepatic, or growth abnormalities. Recurrences of uveitis have not occurred, and corneal interstitial keratitis episodes have been limited to 3 in an 8-year period. After 6 months with no recurrences, a tapering off of the systemic therapy was initiated, and the child is still asymptomatic and without flare-ups. CONCLUSIONS: Congenital syphilitic keratitis is usually treated with topical steroids and cycloplegic drugs, which not only can be ineffective but can also lead to complications such as cataract and glaucoma. In the present case report, a pediatric patient affected by syphilitic interstitial keratitis was treated successfully with an immunosuppressive drug combination therapy.

Child↗
PubMed2006

An open prospective pilot study on the use of rapamycin after penetrating high-risk keratoplasty.

BACKGROUND: The purpose of this study was to prove efficacy and safety of systemic immunosuppression with rapamycin following penetrating high-risk keratoplasty. Rapamycin has shown its immunosuppressive potential in the rat keratoplasty model and is a component of several immunosuppressive protocols after solid organ transplantation. In this pilot study, we compared the efficacy and safety of rapamycin and mycophenolate mofetil (MMF). METHODS: Ten patients (group 1) undergoing high-risk keratoplasty were included in this study, receiving rapamycin as postoperative immunoprophylaxis. Rapamycin was administered orally once daily (blood trough level 4-10 ng/ml) for 6 months. Thereafter, it was tapered over 2 weeks. The control group (group 2) consisted of 24 patients who received 1000 mg MMF twice daily for 6 months. All of the patients received postoperative medication with fluocortolone 1 mg/kg/day (tapered over 3 weeks) and prednisolone acetate eyedrops 5 times per day (tapered over 5 months). RESULTS: Mean follow-up of all patients (n=34) was 739 days. No immune reaction was observed in groups 1 and 2 during the first 6 months under immunosuppression. Two immune reactions occurred in group 1, and five in group 2 within a 2-year follow-up. All of the immune reactions were reversible. The side effects observed in both groups were mostly reversible. CONCLUSIONS: Rapamycin and mycophenolate mofetil seem to be similarly efficacious in preventing immune reactions after high-risk keratoplasty, as long as they are administered. However, we observed a broad spectrum of side effects from rapamycin.

Adult↗
PubMed2005

Topical FK506 as immunoprophylaxis after allogeneic penetrating normal-risk keratoplasty: a randomized clinical pilot study.

The purpose of this study was to evaluate for the first time the efficacy and safety of topical FK506 in patients undergoing penetrating normal-risk keratoplasty in a prospectively randomized clinical trial. Twenty patients were treated with FK506 0.06% three times per day for 6 months postoperatively. An additional 20 patients received five drops of prednisolone acetate 1% tapered within 6 months. All patients received 1 mg/kg bodyweight/day of systemic fluocortolon tapered within 3 weeks postoperatively. Clear graft survival, ratio of immune reactions and side effects were the main outcome measures. One year postoperatively all patients of the FK 506 group were free from immune reactions, in contrast to 84% in the steroid group (Kaplan-Meier values; P = 0.9 in the log rank test). None of the patients developed irreversible graft failure so far. In eight patients of the FK506 group premature withdrawal of the drug was deemed appropriate because of local side effects. FK506 might turn out to become an effective immunoprophylaxis in subjects undergoing penetrating normal-risk keratoplasty. Local discomfort should be further reduced.

Adult↗
PubMed1975

Clobetasone butyrate, a new topical corticosteroid: clinical activity and effects on pituitary-adrenal axis function and model of epidermal atrophy.

Clobetasone butyrate is a new corticosteroid, selected for study because of its combination of good activity in the vasoconstriction test and low systemic activity in animals. Formulated as an 0.05% ointment and cream (Molivate) it was clinically effective in patients with eczema, its activity being significantly greater than that of hydrocortisone 1% or fluocortolone 0.2% (Ultradil). Under conditions that predispose to maximal percutaneous absorption clobetasone butyrate ointment had minimal effect on hypothalamic-pituitary-adrenal function. In an animal model of cutaneous atrophy it caused less thinning of the epidermis than steroids other than hydrocortisone. Clobetasone butyrate 0.05% ointment and cream gave every indication of offering clinically effective topical anti-inflammatory activity with a wide margin of safety.

Administration, Topical↗