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Efficacy of a betamethasone dipropionate topical glycol preparation in the management of severe psoriasis.

A multicenter, double-blind clinical evaluation of three formulations of betamethasone dipropionate was conducted in 258 patients with severe psoriasis. The results obtained after a standard two-week treatment period clearly indicated that a new glycol preparation produced significantly greater improvement than the ointment and cream formulations currently in clinical use. Twenty-one percent of the patients treated with the new formulation had clearing of all signs and symptoms of psoriasis within the two-week span. Sixty-eight percent of those treated with this new preparation reported complete disappearance of scaling, the major cosmetically disturbing sign of the disease. Adverse drug effects were uncommon and were of a limited dermatologic nature. They were equally distributed among treatment groups

Administration, Topical↗

Treatment of psoriasis of the scalp with betamethasone 17, 21-dipropionate plus salicylic acid lotion ('Diprosalic').

In an open study, 38 patients suffering from psoriasis of the scalp with various degrees of severity and duration, were treated for 4 weeks with a lotion containing 0.05% betamethasone 17, 21-dipropionate and 2% salicylic acid in a paraben-free vehicle containing isopropyl alcohol. The results showed agreement between the overall evaluation of response by patients and the physician using a 60 mm visual scale analogue. Marked relief of symptoms appeared after 1 week of treatment while clinical improvement appeared after 2 weeks. Slight degree of induration was present in 1 patient after 4 weeks of treatment, while 8 patients showed slight degree of scaling. After 2 weeks, excoriation disappeared in all the patients treated. Overall tolerance and cosmetic acceptability of the preparation were good.

Adolescent↗

[Betamethasone in the prevention of respiratory distress syndrome. Results of 6 years' experience (author's transl)].

The purpose of this study was to find out whether the administration of corticosteroids to mothers with threatening premature labour reduced the risk of respiratory distress syndrome (RDS) in premature babies. Between XOU4 and 1979, the mothers of 62 children received 4 doses of a long-acting betamethasone preparation intramuscularly at 12-hour intervals followed, if required by 2 booster doses 15 days later. Salbutamol injections were sometimes given to delay labour. During the same period, the mothers of 81 other children (control group) with unavoidable premature delivery were left untreated. The incidence of RDS was similar in both groups. A study of the various factors likely to modify the incidence of RDS showed the same lack of effectiveness of the treatment. Neonatal mortality and morbidity did not appear to be altered.

Betamethasone↗

Increased theophylline metabolism in premature infants after prenatal betamethasone administration.

The pattern of theophylline metabolites in plasma was studied in 9 preterm neonates of 28-35 weeks gestation. In infants not exposed to corticosteroids prenatally, metabolite formation was dependent on gestational age, postnatal age and/or duration of theophylline therapy. Infants prenatally exposed to betamethasone clearly showed evidence of demethylation and oxidation of theophylline during the first week of life, indicating prenatal activation of the hepatic monooxygenase enzyme system. Preliminary half-life data suggests that activation of hepatic metabolism may not affect initial elimination of theophylline.

Aging↗

[Use of betamethasone in heart surgery].

Clinical experience carried out on 88 high risk patients subjected to open-heart surgery with ECC is reported. The series was subdivided into two groups of patients (A and B) and to these were applied the same surgical and anaesthesiological approaches and the same extracorporeal perfusion technique. In Group B, however, a different method of myocardial protection was employed, in the form of preventive administration of pharmacological doses of betamethasone (3 mg/kg). The results point to a marked reduction in the incidence of postoperative complications in the heart, lungs and bloodstream in Group B compared with Group A.

Adolescent↗

[Betamethasone in the treatment of hypertrophic scars].

Creams containing corticosteroids are not efficient in the treatment of scar hypertrophy. In 23 patients Betamethason as a cristal suspension was injected into 32 hypertrophic scars by means of a jet-injector. The preparation has proven to reduce bulk and tension in mature scars, but had no effect on fresh and active scar formation, nor in preoperative prevention. The jet-injector is of advantage.

Betamethasone↗

Betamethasone and adult rat lung surfactant lipids.

Betamethasone (2 mg/kg/day) was administered to adult male rats (n = 15) for one week by daily subcutaneous injections. Thereafter the lungs were lavaged and lamellar bodies (intracellular surfactant storage granules) were isolated from the tissue. Lipid analyses showed two- to fourfold higher amounts of total phospholipids and disaturated phosphatidylcholine compared with the control. These changes were not found in the kidney liver and were not present in plasma membrane, mitochondrial or microsomal fractions from lungs. It was concluded that glucocorticoids plays a significant effect in increasing the lung surfactant lipid pools of adult rat lungs by changing the phospholipid content of lamellar bodies.

Animals↗

The effect of betamethasone on phosphatidylcholine species composition in fetal rat lungs.

After betamethasone treatment, a significant diminution of the monoenoic phosphatidylcholine 32 carbon species (palmitoyl-palmitoleyl phosphatidylcholine and palmitoleyl-palmitoylphosphatidylcholine) and the phosphatidylcholine 34 carbon species (primarily palmitoyl-oleoyl-phosphatidylcholine) could be demonstrated both in absolute and relative terms, while the palmitic acid portion in the phosphatidylcholine fatty acids was nearly unchanged. This is consistent with a significant reduction of the palmitoleic and oleic acid portions of the total phosphatidylcholine fatty acids in the lungs of rat fetuses.

Animals↗

Fluocinonide compared with betamethasone in the treatment of eczema and psoriasis.

Good results have been obtained with a single daily application of fluocinonide ('Metosyn') to one area as compared with a twic-daily application of betamethasone 17-valerate ('Betnovate') to a similar area on the opposite side in the treatment of eczema and psoriasis. These conditions are difficult to control even in favourable circumstances and have a tendency to relapse despite any form of treatment. Both creams were entirely acceptable to the patients involved and during the course of the trial no patient expressed dissatisfaction with either the mode of treatment or the preparation involved.

Betamethasone↗

[Antiinflammatory effects of the betamethasone sodium phosphate enema on carrageenan induced colitis in the rabbit].

The effect of the betamethasone sodium phosphate (BSP) enema on the colonic mucosal lesions in the carrageenan induced colitis (rabbit) was examined laboratory and histologically. The effect of drugs were evaluated by the changes of body weight, fecal occult blood, blood analysis, and histological examinations. Fecal occult blood were highly positive in the physiological saline treated but less positive in the BSP groups. In the blood analysis, anemia was not detected in both groups. Histological findings such as the defect of superficial epithelium, crypt abscess, inflammatory cell infiltration, atrophic changes, defect of muscularis mucosae, goblet cell depletion, goblet cell depletion, ulcer formation, and edematous change were scored to evaluate the colonic mucosal lesions. These scores (Mean +/- S.D.) were 4.4 +/- 1.96, 7.7 +/- 3.67 for BSP, physiological saline groups respectively. From these results, BSP enema showed an antiulcerative effect on the entire colonic lesions in the carrageenan induced colitis in the rabbit.

Animals↗

Study of the in vitro penetration of the topical glucocorticoid betamethasone-17-valerate from solution-type gels into a multilayer membrane system.

The in vitro transport of betamethasone-17-valerate (1) into a multilayer membrane system has been investigated. Subsaturated formulations of 1 were studied as formed by mixing appropriate propylene glycol/water cosolvent systems. The AUC (drug concentration in acce ptor membrane as a function of time) and the diffusivity of the drug in the vehicle were used to evaluate the results of the in vitro transport. The importance and relationship between solubility, partition coefficient, and diffusivity for the process of in vitro penetration of 1 are discussed.

Betamethasone Valerate↗

A comparison of the safety, tolerability, and efficacy of fluticasone propionate ointment, 0.005%, and betamethasone-17,21-dipropionate ointment, 0.05%, in the treatment of eczema.

A randomized, double-blind, parallel group study involving thirteen centers compared the safety, tolerability, and efficacy of twice-daily applications of fluticasone propionate ointment, 0.005%, and betamethasone-17, 21-dipropionate ointment, 0.05%, in ninety-two patients with moderate-to-severe eczema. Safety assessments included routine clinical laboratory evaluations, morning plasma cortisol levels, and reporting of adverse events. Efficacy assessments included (1) physician's gross assessment of clinical response of the target lesion, (2) severity of signs and symptoms of eczema, and (3) patients' assessment of treatment effects. Both treatments were well tolerated and showed minimal suppression of the hypothalamic-pituitary-adrenal axis as evidenced by morning plasma cortisol concentration determinations. Statistically significant improvement in the severity of each sign/symptom was found as early as two weeks following treatment initiation in both groups. The two treatments were found to be similar following two and four weeks of therapy with regard to almost all efficacy variables.

Administration, Topical↗

Epidermal cell DNA content and intermediate filaments keratin 10 and vimentin after treatment of psoriasis with calcipotriol cream once daily, twice daily and in combination with clobetasone 17-butyrate cream or betamethasone 17-valerate cream: a comparative flow cytometric study.

Calcipotriol and corticosteroids, two therapy modalities frequently prescribed in the treatment of psoriasis, are often used in combination. The aim of the present study was to determine whether the cell biological response pattern of concurrent use of calcipotriol and corticosteroids is different from calcipotriol monotherapy. Forty patients with chronic plaque psoriasis were divided at random in four parallel groups and treated for 8 weeks with: (1) calcipotriol cream (50 micrograms/g once daily); (2) calcipotriol cream twice daily; (3) calcipotriol and clobetasone 17-butyrate (0.5 mg/g) creams; and (4) calcipotriol and betamethasone 17-valerate (1 mg/g) creams. Before and after treatment keratotome biopsies were taken and single cell suspensions prepared for flow cytometric analysis. Flow cytometric multiparameter quantification of markers for proliferation (TO-PRO-3), differentiation (antikeratin 10) and inflammation (antivimentin) was used to evaluate all four therapy modalities. A statistically significant decrease of the percentage of basal cells in S- and G2M-phase (proliferation) was obtained with all therapy modalities, except for calcipotriol monotherapy applied once daily. A significant reduction of the number of vimentin-positive cells (non-keratinocytes) was observed following combined treatment with calcipotriol and clobetasone butyrate. In contrast, monotherapy with calcipotriol had virtually no effect on the number of vimentin-positive cells. It can be concluded that: (i) calcipotriol monotherapy, applied once daily was less antiproliferative compared with twice daily applications of calcipotriol or the combined treatment with corticosteroids and that (ii) the combination of calcipotriol and corticosteroids proved to have a marked effect on the percentage of non-keratinocytes, in contrast to the modest effect of calcipotriol.

Administration, Topical↗

Comparison of clobetasol propionate and betamethasone-17,21-dipropionate with reference to adrenal suppression.

32 adult hospitalized patients with common skin disorders were controlled in a double-blind comparison study with clobetasol propionate (Dermovat) and betamethasone-17,21-dipropionate (Diproderm) with regard to adrenal suppression. The latter, when assessed by plasma cortisol, was significantly greater in the dermovat-treated groups after the 1st and 2nd week with daily treatment with both 25 g and 15 g ointment. Daily treatment of skin areas greater than 25% with 25 g Diproderm also showed clear adrenal suppression, whereas no such effect was obtained with daily treatment with 10 g Diproderm of skin areas greater than 15%. In all cases, plasma cortisol levels were normal 1--2 weeks after the end of topical treatment.

Administration, Topical↗

[Use of corticosteroids betamethasone and prednisolone in the prevention of allergic reactions in patients undergoing heart surgery with artificial blood circulation].

The authors discuss measures preventing intraoperative allergic reactions in patients subjected to cardiopulmonary bypass surgery. A retrospective analysis of the incidence of allergic reactions in 1330 patients operated on the heart showed that cardiosurgical patients are liable to anaphylaxis because of intraoperative administrations of numerous drugs (besides anesthetics), specifically, antibiotics, protamine, etc., blood components, solutions. Comparison of the incidence of anaphylactic and anaphylactoid reactions allowed the authors to recommend corticosteroids to be added to anesthesiological protocols with prophylactic purpose. A new corticosteroid betamethasone is more effective than traditional prednisolone in equivalent doses as regards prevention and alleviation of allergic reactions in cardiosurgical patients.

Adult↗

Drug release from a suspension with a finite dissolution rate: theory and its application to a betamethasone 17-valerate patch.

A random walk method for a diffusion equation is applied to the model for a suspension with a finite dissolution rate developed by Ayres and Lindstrom in 1977. In the method, the diffusion of dissolved drug and dissolution of crystal are calculated separately using a simple BASIC program. The random walk method strictly meets the principle of the conservation of mass as the drug amount in each sublayer rather than the concentration at each subinterval is concerned in the ointment. The model is used to analyze the release of betamethasone 17-valerate from a pressure-sensitive silicone adhesive into a sink. The drug release from the 1.50 mg/mL patch shows no substantial discrepancy from that predicted by the classic suspension model assuming an infinite dissolution rate. However, the classic model overestimates the release from the 3.08 and 5.88 mg/mL patches. The disagreement is lessened when the dissolution rate is assumed to be finite. However, the model does not give a perfect explanation because the drug release from the 3.08 and 5.88 mg/mL patches in the early phase is faster than the model predicts.

Administration, Cutaneous↗

Identification of betamethasone and a major metabolite in equine urine.

Betamethasone and its major unconjugated metabolite, 6-beta-hydroxybetamethasone, were detected in equine urine by thin-layer chromatography and characterized by micro-liquid chromatography/mass spectrometry (micro-LC/MS). Their structures were confirmed by a combination of infrared spectroscopy and nuclear magnetic resonance spectroscopy.

Journal Article↗

Type-IV hypersensitivity to betamethasone valerate and clobetasol propionate: results of a multicentre study.

BACKGROUND: Most studies investigating steroid allergy have been performed with tixocortol pivalate, hydrocortisone butyrate and budesonide. Betnovate and Dermovate are widely prescribed in the U.K. but little is known about the frequency of sensitization to them. OBJECTIVES: To determine the optimum method to detect contact allergy to betamethasone valerate (BV) and clobetasol propionate (CP). METHODS: Seven centres tested consecutive patients attending for investigation of suspected allergic contact dermatitis to these steroids at a range of concentrations in different vehicles. RESULTS: Of 1562 patients tested, 16 (1%) reacted to either BV or CP. Ten patients (0.7%) reacted to BV and 13 (0.8%) to CP. Two patients of a further centre were included in analysis of dilutions and vehicles. Sixteen of a total of 25 reactions (64%) were identified with a 1% dilution in ethanol. CONCLUSIONS: Consideration should be given to adding BV and CP to a standard allergy series, given that both are frequently used in the treatment of eczema and that most patients sensitized to them are not identified with currently used markers of steroid allergy. If patch tests to BV and CP are initially negative, but an allergy is suspected, the patient should be further investigated. Further studies are required to identify the ideal patch test material.

Adult↗