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Diabetic ketoacidosis occurred in a woman without a prior history of glucose intolerance. The condition was associated with the combined administration of terbutaline and betamethasone. The patient required insulin therapy for the remainder of her pregnancy but had no further insulin requirements postpartum.
The blanching activities of Betnovate cream, lotion, ointment and scalp application (each containing 0.1% betamethasone (as the 17-valerate] were determined using healthy human subjects over a 32 h period in both the occluded and unoccluded modes. Considering that all four formulation types contained the same label concentration of corticosteroid, it may be presumed that the formulations would show similar topical drug availability: this was, however, not found to be the case. The scalp application demonstrated the highest topical availability in both the occluded and unoccluded modes. The lotion formulation showed the greatest increase in topical availability on occlusion and the ointment formulation was the least sensitive to the effects of occlusion. These differences, due solely to the effects of the vehicle, may have important clinical implications.
The influence of betamethasone (celestone) was studied on the fetal lung development in pregnant rats of Wistar strain. It was shown that the drug was without effect, administered singly. After treatment of the pregnant rats for a period of 3 days with a dose of 0.100 mg/kg the content of the lung surfactant in their amniotic fluids was increased, manifested by an elevation of the threshold dilution (TD), determined by the method of the black foam film. Administration of two-fold higher dose did not cause quicker synthesis of surfactant. The morphological examination of the fetal lung showed that celestone accelerated the synthesis, maturation and secretion of surfactant and intensified differentiation of prealvelocytes of I and II types after the 18th day of the fetal development, which occurred a day earlier than in the control rats.
A multicenter open clinical evaluation of 0.05 percent betamethasone dipropionate in optimized cream vehicle for the treatment of psoriatic lesions was conducted to investigate its efficacy. There were 348 patients with moderate to severe psoriasis who completed the three-week clinical trial. Three hundred and ten patients used the cream twice a day and another 38 patients used it once a day. All patients responded well to treatment. Significant improvement was observed at all follow-up visits on days 8, 15, and 21 (p less than 0.001) for measures of erythema, induration, and scaling of lesions. The response was equally impressive whether the patient's psoriatic status prior to the treatment was stable or worsening, involved more than 50 percent of the skin surface or less, or had lasted more than ten years or less. The response of psoriasis to once-a-day application of cream was as good as that seen with twice-a-day application. Side effects, noted in a small percentage of patients, were burning, dry skin, and pruritus. We conclude that the cream is a safe and highly effective treatment for psoriasis. The once-a-day application is probably adequate for control of psoriasis.
A multicenter, double-blind study compared the effectiveness of two highly potent topical corticosteroids in patients with moderate to severe signs of psoriasis. Left/right paired comparisons of clobetasol propionate ointment 0.05 percent, and an optimized formulation of betamethasone dipropionate ointment 0.05 percent, were made in 130 patients with roughly symmetrical psoriatic lesions. The ointments were applied by the patients twice daily, without occlusion, for two weeks. Both drugs were shown to be highly effective and were well tolerated. Significantly more patients showed greater improvement on the side treated with clobetasol propionate. Follow-up evaluation two weeks after the treatment period showed statistically significant (p less than 0.001) longer remissions resulting from the use of clobetasol propionate.
Stimulation of the surfactant production in fetal cells by ambroxol (metabolite VIII of bromhexine) has been investigated in human and animal experiments. There are no contraindications for the prenatal use of ambroxol, which is also well tolerated in high dose. Therefore the 1st Department of Obstetrics and Gynecology in Vienna took part in a multicentric clinical trial, where the allocation between cortisone and ambroxol was randomised in a double blind fashion. The 1st Department included 34 women between 30 and 36 weeks of pregnancy with premature labour or indicated premature induction. Amniotic fluid samples were taken by amniocentesis before therapy to prove lung immaturity by measurement of the L/S ratio and the dynamic surface tension. Following doses were used for this clinical trial group A: 1,000 mg ambroxol in 500 ml 5% glucose infusion i.v. daily from day 1 to day 5 and 2 ml placebo-injection i.m. on day 1 and day 2, group B: 8 mg Betamethasone i.m. on day 1 and day 2 and 500 ml 5% glucose infusion with a placebo daily from day 1 to day 5. The patients were treated at least 3 days; in all cases amniotic fluid samples were taken after therapy, to examine the L/S ratio and the dynamic surface tension. 29 women of the 34 fulfilled the above criteria, 15 in group A and 14 in group B (1 twin pregnancy). With the pretreatment parameters of lung maturity being similar in both groups ambroxol was found to lead to a marked but not significant improvement of the L/S ratio and the surface tension.(ABSTRACT TRUNCATED AT 250 WORDS)
The effect of fluoromethalone 0.1% suspension (FML), clobetasone butyrate 0.1% (Eumovate) and betamethasone phosphate 0.1% (Betnesol) in post-operative inflammation was studied in 60 eyes (50 patients) in a randomized trial. No significant differences were noted, although two patients required higher penetration steroids than FML or Eumovate. Betnesol seemed to have a greater tendency to cause raised intraocular pressure than FML. In this series, however, the authors are unable to comment on differences between Eumovate and Betnesol.
A randomized control study of the antiemetic activity of betamethasone (B) vs. methylprednisolone (MP) was carried out. Fifty-six patients receiving CDDP (60 mg/m2-80 mg/m2) were entered. B (8 mg/body on day 1, 4 mg/body on days 2 and 3) was administered intravenously in 18 patients, and MP (1,000 mg/body on day 1, 500 mg/body on days 2 and 3) was administered intravenously in 19 patients. Severe vomiting occurred in 5 of the 19 (26.3%) with MP, 10 of the 18 (55.6%) with B, and 11 of 19 (57.9%) controls. Severe nausea occurred in 3 of the 19 (15.8%) with MP, 6 of the 18 (33.3%) with B, and 5 of the 19 (26.3%) controls. Methylprednisolone was thus considered effective (P less than 0.05) for CDDP-induced emesis.
A randomized, double-blind study compared the efficacy and safety of amcinonide and betamethasone dipropionate ointments, applied twice daily for two weeks, in the treatment of patients with moderate to severe psoriasis. Thirty-four patients were enrolled; thirty patients had had psoriasis for more than one year, and in the majority of patients, it was stable or slowly exacerbating. Significant improvement from baseline was observed with both ointments at weeks 1 and 2. The two drugs showed comparable cosmetic acceptability. Adverse cutaneous symptoms experienced were burning (both groups), itching (amcinonide), and stinging (beta-methasone); no serious adverse effects were reported.
Effectiveness of two creams, one containing desoxymethasone 0.25%, the other betamethasone dipropionate 0.05% was compared double blind, intraindividually. The preparations were used in symmetric areas of psoriasis. Final evaluation shows desoxymethasone cream to be significantly more active concerning reduction of erythema and overall improvement of lesions.
Betamethasone 17, 21-dipropionate (BDP) does not have glycogenic activity and antagonizes cortisol in glycogenesis in fetal rat liver explants. In an attempt to elucidate whether BDP commonly has an antagonistic effect on the glucocorticoid responsive system in fetal rat liver, effects on activities of glycogen synthase and tyrosine aminotransferase were examined. Cortisol increased both total and a activities of glycogen synthase at concentrations above 3 x 10(-8)M. BDP, unlike cortisol, did not increase total synthase activity at 10(-6)M and antagonized cortisol (10(-6)M), but like cortisol, it did increase synthase a activity. Both cortisol and BDP increased tyrosine aminotransferase activity at concentrations above 10(-8)M, BDP did not always act as an antagonist in the glucocorticoid responsive systems in fetal rat liver.
An intravenous bolus of betamethasone, at an approximate dosage of 3 mg/kg, was administered to 20 patients with septic shock. Treatment was repeated every four to six hours for periods ranging from 18 to 64 hours. Concomitant therapy included antibiotics in all patients and surgery in 10 patients. An additional patient underwent surgery after the conclusion of therapy. Clinical improvement was apparent within four hours after initiation of study medication in 14 (70%) patients. In the remaining six patients, improvement was observed no later than eight hours after the initial dose of the study agent. Reversal of shock was achieved in all patients, at which time treatment was discontinued. Tolerance to the study medication was excellent. No local or systemic adverse effects occurred.
The effect of Betamethasone and Bromhexine-Metabolite VIII, commonly used in RDS-prevention, was studied in pregnant rats and rabbits. 73 rats and 78 rabbits were treated for 4 days with doses, similar to those used in men. Cesarean section was performed in rats from the 18th-21th day of gestation (23 days), in rabbits from 27th-30th day (32 days). In the amniotic fluid, in fetal and maternal lungs the total phospholipid content, percentage of lecithins in total phospholipids and palmitic acid were determined and used as parameters for the surfactant content. There was no sign of induction with regard to synthesis. Premature deliveries and malformed fetusses were frequently observed under steroid-therapy. Clinical application should therefore be observed more critically.
In the recent past criticism has been voiced with regard to the efficacy and possible side effects of corticosteroid prophylaxis of fetal respiratory distress syndrome (RDS). Apparently the efficacy of this treatment has been over-estimated and the spectrum of possible side effects has not received enough critical attention. In view of the multiple indications that the fetal metabolism, above all, may be altered by this type of therapy, it seems necessary to search for other methods of surfactant stimulation. This paper presents the first clinical study on the use of carnitine (4 g for 5 days in combination with twice 8 mg beta-methasone versus twice 8 mg betamethasone alone). The patients on combination therapy showed a more marked increase in surfactant content of the amniotic fluid. Lung compliance determination in infants born within 72 hours of completion of therapy also revealed better results in the combination therapy group. There were also fewer clinically demonstrable RDS cases in this group. More research will be necessary to definitely establish the value of this new form of therapy.
At two university centres 46 patients presenting with symptomatic infective blepharitis or blepharoconjunctivitis participated in a double-blind study of a new antibiotic-steroid ointment containing gentamicin and betamethasone. There was no significant difference in response to 2 weeks of therapy between the patients treated with this ointment and those treated with either an ointment containing gentamicin alone or a placebo ointment. There was also no significant correlation between the clinical response and the results of the bacterial cultures of swabs obtained at the beginning and the end of the study. However, the patients treated with the placebo had a much higher rate of recurrence of their symptoms over a 6-week follow-up period. The patients who before treatment had associated rosacea, dry eyes and a long duration of symptoms showed a poor response to therapy.
A multicentric open study was conducted to evaluate the efficacy and safety of betamethasone dipropionate and salicylic acid lotion in 86 patients with psoriasis or other steroid-responsive dermatoses of nonscalp body areas. Medication was applied to affected areas for 14 to 31 days. Patients were evaluated weekly. Within 14 to 21 days of therapy, there were favorable results in 68/86 (79%) patients. A complete clearing or marked improvement of signs and symptoms was achieved in 78/86 (91%) patients; improvement occurred in 7/86 (8%). Treatment failed in one (1%) patient. Three transient adverse reactions were reported.
Dipalmitoyllecithinic (DPL) is the quantitatively largest and most active portion of the surfactant system. Hence only a quantitative DPL determination allows a relevant statement of fetal lung maturity. The antenatal prophylaxis of RDS should result in an increase of the DPL-level in a fetal lung. A new gaschromatographical method for determination of DPL was developed. The results were secured by gaschromatography-mass-spectrometry-couplings. After treatment with betamethasone an increase of the relative DPL-amount in fetal rat lung lecithin species was found, but not an increase of the lecithin-level in the lung-tissue. Corticosteroids probably induce transesterification of the lecithins.
Personal experience with the use of betamethasone, used orally in associated with various cytostatic drugs for inducing remission in acute lymphatic leucosis and some cases of lymphoproliferative disease is reported. The results obtained point to the effectiveness and tolerance of the drug, even in the high doses that are required to treat such blood diseases.