Search

A case involving a 67 year old man with an immunocytoma initially presenting as Waldenström's macroglobulinemia which transformed into a high grade malignant lymphoma of immunoblastic type after treatment with cyclophosphamide and corticosteroids over 5 months is presented. IgM (kappa) present in the serum in the phase of immunocytoma was demonstrated also on the less differentiated cells of the high grade lymphoma. The permanent production of the same immunoglobulin molecule suggests that both morphologically different malignancies derived from one B cell clone.

The protective effect of a new inhaled steroid, fluocortin butyl (FCB), was compared to that of disodium cromoglycate (DSCG) and beclomethasone dipropionate (BDP) in patients with extrinsic asthma by means of the allergen-inhalation challenge test. Three different groups of 12 patients each participated in the study. One group was treated with FCB and BDP, the two others with FCB and DSCG, all in a randomized crossover study plan. After an initial allergen challenge (FEV1 fall greater than 15%), the patients were allocated to either treatment for 7-10 days. A second challenge test was then carried out, followed by a washout period of 4 days. The treatments were then crossed-over, and a third allergen challenge was carried out at the end of the second treatment period. With BDP 5 of 12 patients were protected; with FCB, 6 of 12 in two groups and 8 of 12 patients in a third group. With DSCG 3 of 12 patients were protected in the group in which the last medication was given 12 h before challenge, and 8 of 12 patients in the second group in which medication was given 1-2 h before challenge. In the same groups on FCB no such time-dependent effect was observed. No statistically significant differences were found between either FCB and BDP, or FCB and DSCG in either group.

The authors investigated the therapeutic effect of diflucortolone valerate as an ointment in 40 patients with inflammatory dermatoses of various etiology. They described the antiphlogistic and antipruritic effect of the preparation as excellent and practically devoid of any side effects and cosmetic problems.

Five hundred and seventy-five patients with various steroid-responsive dermatoses were studied for up to six weeks in eighty-eight separate general practices using a new topical corticosteroid. Temetex (diflucortolone valerate 0-1%). It was concluded that Temetex is both effective and well tolerated in a wide variety of conditions, especially eczema and psoriasis. It was also shown that a large-scale general practice trial can be carried out efficiently with a very high compliance rate.

Diflucortolone valerate was clinically investigated as a fatty ointment in 30 dermatological patients. Although this form of application is a special presentation for the treatment of very dry dermatoses, patients with not so dry and weeping dermatoses were also treated in this trial, the object being to include the role played by the vehicle in the results of therapy. Very good to good results were achieved in 80% of the cases treated, while the result was observed to be poor in only 10% of the cases. This latter percentage is comprised for the greater part of patients who had previously been treated with other corticoids and of patients with weeping dermatoses.

Thrombocytopenia developed in a 21-year-old patient with sarcoidosis when corticosteroid therapy was discontinued. Platelet-associated IgGs were elevated. High-dose cortisone did not affect the thrombocytopenia. However, platelet counts remained normal for more than 1.5 years following intravenous treatment with a single course of human gammaglobulins.

The clinical effect and the side effects of a new steroid, Fluocortin butylester (FCB) in the topical treatment of hay fever was studied in a double-blind trial. The drug was administered by inhalation of a fine powder through a special inhalator (Rhinolator). The material comprised 31 patients, and the treatment period was three weeks. There was a highly significant difference in favour of FCB compared with placebo as regards the nasal symptoms blockage and discharge. Side effects were few and mild.

The object of the present study was to investigate the clinical efficacy of Nerisona Fatty Ointment in very dry skin conditions. A total of 37 patients, most of them with chronic dermatoses, was treated. Either very good or good results were achieved in 83.8% of the cases. The side effects observed were very slight.

The characteristic large cells in the blood of a patient with Sézary syndrome underwent immunocytological and cytochemical changes during polychemotherapy, which caused transient regression of skin lesions. Tartrate-resistant acid phosphatase was demonstrable in a few cells only after chemotherapy; initially, only 2% T cells and 26% B cells could be demonstrated in the blood by immunocytological methods; after cytostatic therapy, 35% T cells but no B cells were detected.

The efficacy and tolerance of 0.1% diflucortolone valerate (Nerisona) in cream, ointment and fatty ointment formulations were investigated in a study in which no control preparations were used. The study was conducted in 657 children over a period of three weeks. The results were compared with those of a trial with the same design conducted with 4,878 adults. Our observations were mainly concentrated on the two groups eczema/dermatitis and neurodermatitis (atopic dermatitis). Nearly 90% of the children taking part in the study exhibited these clinical pictures. By far the best therapeutic results were obtained in neurodermatitis. There was only one therapy failure among 198 patients (99.5%). Overall the results obtained in children were markedly better than those recorded for adults.

Nerisone cream (diflucortolon valerate 0.1%) has been clinically compared with fluocinolon-acetate on a double blind basis. The trial was carried out on 30 patients. The author comments that the results, in spite of some slight casuisties, appear to indicate a certain superiority of Nerisone cream when compared with the competitor's preparation.

Fluocortin butylester (FCB), a locally active corticosteroid, was inhaled as a fine powder mixed with lactose using the rhinolator in a comparative double-blind, crossover study against placebo. Fifty patients of both sexes and aged from 16 to 46 years with an established seasonal allergic rhinitis, but free of symptoms, took part in this trial. The determination of the protective action after allergen provocation was performed after seven days treatment with 4 mg FCB or placebo. Measurements of the nasal resistance and the temperature were taken after provocation. The symptoms of nose and eyes were recorded. The protective effect of FCB against nasal provocation with grass pollen extracts was statistically proved.

Twenty-one patients suffering from different autoimmune diseases (14 from systemic lupus erythematosus, 4 from rheumatoid arthritis, one from Sjögren's syndrome, one from systemic hypersensitivity vasculitis, and one from diffuse proliferative glomerulonephritis) were treated with a combined immuno-suppressive regimen. Cyclosporin was given at a dose of 5 mg/kg/day together with steroids. In addition, the rheumatoid arthritis patients also received methotrexate. In all patients a kidney biopsy was performed after a treatment period of 17 to 42 months (mean duration 21.7 months). The cumulative cyclosporin dose at the time of biopsy varied from 1.071 to 4.587 mg/kg. Patients suffering from systemic lupus erythematosus and rheumatoid arthritis were assessed according to a scoring system set up for this purpose. The combined therapy proved useful in these patients as reflected in the diminution of the respective activity scores, improvement of kidney function, and diminution of proteinuria. Histological examination of the kidney biopsy specimens showed only minimal activity in patients with systemic lupus erythematosus. No unequivocal signs of renal toxicity could be detected. In the last group, the condition of the patient with Sjögren's syndrome was stabilized and the patient with systemic vasculitis improved clinically. Neither patient had signs of kidney lesions. The patient with diffuse proliferative glomerulonephritis, in whom kidney biopsy was performed before and after treatment, showed improvement of kidney function, diminution of proteinuria, and diminution of inflammatory activity within the kidney, and no signs of cyclosporin toxicity.

Therapeutic efficacy and practicability of an interval treatment were investigated in a multi-center study in a total of 1573 patients with psoriasis or eczema, respectively. Fluocortolone monohydrate as Syracort and Syracerin as steroid-free "partner drug" were applied at 4-13-day intervals. The findings and established results substantiate equivalent therapeutic success in comparison with consistent treatment. Starting from the premise that the risk of steroid-induced skin lesions can be reduced, if not avoided, by interval application of topical corticoids one may consider steroid application at intervals as superior to consistent therapy.

The anti-inflammatory effect of the new topical corticosteroid fluocortin butyl ester is approximately equal to that of hydrocortisone acetate but it has the advantage that systemic side-effects are lacking. Vitamin A acid and benzoyl peroxide have brought significant advances in the topical treatment of acne. For the treatment of chloasma and other hyperpigmentations the combination of vitamin A acid and hydroquinone with a corticoid is considerably more effective than any of the single components alone. Povidone-iodine with its extraordinarily low sensitization rate has proved useful for external antimicrobial treatment. Extensive or multiple precancerous lesions are effectively treated with 5-fluorouracil. New hair growth can be induced in alopecia areata by the local application of DNCB.

A 34 year old white male patient suffering from seropositive "probable" rheumatoid arthritis developed a severe hypocomplementemic mesangiocapillary glomerulo-nephritis. Rheumatoid factors (Latex test, Waaler-Rose titer) and IgM were markedly elevated in the serum. The third component of complement (C3) was markedly depressed, while the fourth component (C4) was within normal range. The rapid progression of the disease forced us to start an immunosuppressive drug therapy using azathioprine and steroids. Despite marked clinical improvement, e.g. normalisation of complement components, renal function, the disappearance of rheumatoid factor and proteinuria, the second biopsy taken two years later showed unchanged histological and immuno-histological changes of the glomerula.

The pharmacokinetics of fluocortolone (Ultralan oral) and its effect on plasma cortisol levels were investigated during long-term treatment of patients with rheumatic and haematological diseases with different doses of fluocortolone. Fluocortolone was administered in the morning and plasma levels of fluocortolone and cortisol were measured in samples obtained 1.5, 3, 4, and 5 h p. adm. by means of specific radioimmunoassays. Maximum concentrations of fluocortolone in plasma (Cmax) and areas under the fluocortolone plasma level curves (AUC) increased linearly with the dose. The peak time (tmax = 2.04 +/- 0.85 h) and the plasma half-life (t1/2 = 1.53 +/- 0.52 h) were independent of the dose administered. Cortisol suppression as indicated by morning cortisol levels below 50 ng/ml plasma was not observed with doses below 10 mg/d.

59 patients with various skin disorders - most of them in the acute stage - were treated in this trial. The topical investigational preparation was a cream containing 0.1% diflucortolone valerate. The results confirmed that the preparation has a quick-acting and effective antipruritic and antiphlogistic action. The results achieved were good or very good in 91.52% of cases and moderate in 8.47%. No side effects were observed.

A 43-year-old white man presented with a generalized eruption of lichen planus and tense blisters within the lichenoid lesions and also on clinically normal skin. Direct immunofluorescence (IF) studies revealed immunological and histopathological characteristics of lichen planus in the lichenoid lesions and of bullous pemphigoid in the bullous lesions, and indirect IF studies showed that the patient had circulating antibasement membrane antibodies. The coexistence of both disorders may indicate a possible link between the pathology in the junctional zone in lichen planus and the appearance of antibasement membrane zone antibodies and bullous lesions, respectively.

Diflucortolone valerate 0.1% (Nerisona), a new topical corticoid, was clinically investigated in ointment form in 51 patients suffering from neither weeping nor very dry allergic and inflammatory skin diseases. The results obtained were good, improvement being observed in 92.1% of the treated cases. The cosmetic properties of the preparation were excellent. No local or systemic side effects were observed.

The aim of the study was to compare the therapeutic effect of the new corticoid, diflucortolone valerate, with the effect of fluocinolone acetonide. The study was conducted as a randomised double-blind trial in 60 patients with various dermatoses. The results were good in 89% of the cases treated with diflucortolone valerate fatty ointment, while the same result was achieved in only 63.5% of the cases treated with fluocinolone acetonide ointment. No side effects were observed during the use of diflucortolone valerate fatty ointment, while local side effects occurred in 2 cases during the use of fluocinolone acetonide ointment.

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.

The authors report the results obtained in treatment of various autoimmune diseases using cyclosporin A (CyA) in association with fluocortolone and/or methotrexate and cyclophosphamide. In all patients treated, complete long-lasting remission of the disease both from a clinical point of view and regarding laboratory tests was obtained. In some cases, this remission has lasted for several years since onset of therapy. The results obtained demonstrate the efficacy of CyA in treatment of autoimmune diseases and show that association with fluocortolone and/or methotrexate and cyclophosphamide by exploiting the combined action of these drugs, has enabled relatively low doses to be used. These however are still sufficient to induce satisfactory immunosuppression and avoid side effects. In this context, the importance of monitoring drug blood levels is underlined, also in view of the fact that each patient has a different capacity for intestinal CyA absorption.

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.

Diflucortolone valerate 0.1% (investigational number SH K 183 MB) in the form of a cream was clinically investigated in 41 patients with dermatological disorders. All the patients had been treated previously with other topical preparations, but without success. Complete healing or distinct improvement of the objective and subjective symptoms of the disorders was achieved in 100% of the cases treated with the investigational preparation. No side effects were observed at all.

Bibliographic review of all the published cases of granuloma gluteale infantum and study of the second observation in Argentina. In this case there was a previous Leiner's erythrodermia treated with fluorinatec corticoid creams. The typical lesions appeared suddenly. The authors made a histopathologic study and a review of the pathogenetic theories on this dermatose. In the observation of authors the lesion disappeared in spite of persistence with the treatment with fluorinated corticoid creams, one of the causes of this dermatose according to some authors.