Dipropionate Group Research Articles

A hypothesis of the Effect of a New Nasal Spray Made from Natural Medicines on Allergic Rhinitis in Animals

To verify the effect of a new nasal spray made from natural medicines on allergic rhinitis in animals. Methods: The main natural medicines contained in Acusine nasal spray plus essential traditional Chinese medicine contained in drugs for allergic rhinitis in Chinese market were used. By preparation process of extraction of traditional Chinese medicine such as steam distillation, ethanol extraction, a new nasal spray made from natural medicines was prepared. In the meantime, 24 BALB/c mice and New Zealand white rabbits were used. Then, mice were randomly divided into four group; control group, beclomethasone dipropionate group, Acusine group and new spray group, 6 mice in each group. Moreover, the effect of the new nasal spray made on passive cutaneous anaphylaxis was conducted by detecting absorptions of Evan’s blue (620nm) in the four groups. Allergic rhinitis models in 40 New Zealand white rabbits were established. Consequently, 40 allergic rhinitis models in rabbits were randomly divided into control group, Acusine group and new spray group, 10 rabbits in each group. The four groups were sprayed nasally with saline, Acusine spray and new spray respectively, three times/d, for 30 days. The nasal resistances in the four groups were measured with a rhinoresistometer. Moreover, their nasal mucosa was taken for HE staining. Consequently, their pathological manifestations were observed. The results: Absorption of Evan’s blue (620nm) of new spray group will be found significantly lower than Acusine group (P<0.05) and will have no significantly difference compared with beclomethasone dipropionate group(P>0.05). On the other hand, absorption of Evan’s blue (620nm) of beclomethasone dipropionate group will be significantly lower than Acusine group (P<0.05). Moreover, The nasal resistances of new spray group will be significantly lower than Acusine group (P<0.05) and will have no significantly difference compared with beclomethasone dipropionate group (P».05). Moreover, the nasal resistances of beclomethasone dipropionate group will be significantly lower than Acusine group (P<0.05). While, the nasal mucosa of control group will be found typical as nasal mucosa of allergic rhinitis. However, the nasal mucosa of beclomethasone dipropionate group, Acusine group and new spray group will be better than control group. Of them, new spray group will be the best. The nasal mucosa of beclomethasone dipropionate group will show the manifestation of drug-induced rhinitis. The conclusion: The invented new spray will not only have a better treatment effect on allergic rhinitis, similar with beclomethasone dipropionate, than Acusine Nasal Spray but also will not leave side effect on nasal mucosa, compared with beclomethasone dipropionate. Thus, the new spray made from natural medicines can be further studied as a better prescription drug, rather than an OTC like Acusine Nasal Spray, to replace beclomethasone dipropionate nasal spray. However, further study that would be required to produce a more meaningful answer.

Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial

Background Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects. Aim To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement. Methods Patients ( n = 84) with active Crohn's disease who achieved remission during a 2-week prednisone run-in period were randomised to receive beclomethasone dipropionate for 24 weeks or continue prednisone for a further 2 weeks followed by placebo for 22 weeks. The primary outcome was relapse rate (Crohn's Disease Activity Index score > 150 and an increase of ≥60 points from baseline) or withdrawal due to disease deterioration. Results The relapse rate was 23.3% and 53.8% in beclomethasone dipropionate and placebo groups, respectively ( p = 0.027). According to Kaplan–Meier analysis, the cumulative relapse rate was 38.0% in the beclomethasone dipropionate group and 56.0% in the placebo group ( p = 0.025). Six percent and 1.7% of all adverse events in the beclomethasone dipropionate and placebo groups, respectively, were endocrine-related. Conclusion These results demonstrate that beclomethasone dipropionate significantly reduces the relapse rate in post-active Crohn's ileitis patients compared with placebo after induction of remission with a short course of systemic steroids, and is well tolerated.

A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial

There is a need for new treatments for scalp psoriasis, as many topical treatments are cosmetically unacceptable and difficult to apply, resulting in poor compliance. To compare the efficacy and safety of a new, once-daily, two-compound scalp formulation (Xamiol; LEO Pharma A/S, Ballerup, Denmark) containing calcipotriol 50 microg g(-1) plus betamethasone 0.5 mg g(-1) (as dipropionate), with the active ingredients as single compounds in the same vehicle. This 8-week, multicentre, double-blind, parallel-group study, randomized adult patients with scalp psoriasis involving > 10% of the scalp to the two-compound scalp formulation (n = 568), betamethasone dipropionate 0.5 mg g(-1) (n = 563), or calcipotriol 50 microg g(-1) (n = 286). The primary efficacy measure was the proportion of patients with 'absence of disease' or 'very mild disease' according to investigators' assessments at week 8. The proportion of patients with 'absence of disease' or 'very mild disease' at week 8 was significantly higher in the two-compound group (68.4%) than the betamethasone dipropionate (61.0%, P = 0.0079) or calcipotriol (43.4%, P < 0.0001) groups. The proportion of patients rating their scalp psoriasis as 'clear' or 'almost clear' was significantly higher for the two-compound scalp formulation (69.6%) than for betamethasone dipropionate (59.9%, P = 0.0006) or calcipotriol (44.7%, P < 0.0001). The incidence of lesional/perilesional adverse events was lower in the two-compound and betamethasone dipropionate groups than the calcipotriol group. The two-compound scalp formulation was well tolerated and more effective in the treatment of scalp psoriasis than either of its individual components in the same vehicle.

Efficacy of the pulsed dye laser in the treatment of localized recalcitrant plaque psoriasis: a comparative study

Localized chronic plaque psoriasis, resistant to local therapy, may be very hard to treat. The treatment of these lesions with a pulsed dye laser (PDL) has been described before, but a comparative study between the PDL and a potent topical treatment has never been performed. To compare the efficacy of the PDL in the treatment of localized, recalcitrant plaque psoriasis with a potent topical therapy, using calcipotriol/betamethasone dipropionate (Dovobet) as an active comparator. Eight patients with psoriasis were treated with both PDL (585 nm) and calcipotriol/betamethasone dipropionate in an open, intrapatient, left-right comparison. A plaque severity score (sum score) and photographs were used to document the course of therapy. Patients reported pain on a visual analogue scale. Both treatments were well tolerated, although one patient left the study due to post-PDL treatment pain. A significant difference in the sum score 12 weeks after treatment was seen in favour of the PDL (62% vs. 19% reduction; P<0.05). Scores for erythema declined significantly at week 12 in both the PDL and the calcipotriol/betamethasone dipropionate group (P<0.001). Induration and desquamation scores were significantly reduced at week 12 in the PDL group, without a statistically significant reduction in calcipotriol/betamethasone-treated lesions. The pain scores declined with progressive PDL treatments, although not statistically significantly. PDL treatment might be considered for the treatment of localized, recalcitrant plaque psoriasis, when other topical therapies have failed.

Early onset of action and efficacy of a combination of calcipotriene and betamethasone dipropionate in the treatment of psoriasis

Background: Calcipotriene and betamethasone dipropionate are topical treatments for psoriasis vulgaris. Their mode of action is different. Improved risk/benefit may result with concomitant use of the two compounds together. A new vehicle has been created with the objective of obtaining optimal stability of both calcipotriene and betamethasone dipropionate in the combination product. Objective: We compared the clinical efficacy of a fixed combination of calcipotriene and betamethasone dipropionate in a new vehicle to calcipotriene in the new vehicle, betamethasone in the new vehicle, and the new vehicle alone. Methods: This was an international, multicenter, prospective, randomized, double-blind, parallel-group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. Results: The mean percentage reduction in PASI from baseline to end of treatment was 73.2% in the combination group (n = 301), 48.8% in the calcipotriene group (n = 308), 63.1% in the betamethasone dipropionate group (n = 312) and 28.8% in the new vehicle group (n = 107), (P < .001). The mean percentage reduction in PASI during the first week was 48.1%, 28.4%, 41.4%, and 21.5%, respectively (P < .001). Conclusion: A combination product of calcipotriene 50 μg/g and betamethasone dipropionate 0.5 mg/g in the new vehicle shows superior efficacy with a more rapid onset of action than the new vehicle containing either constituent alone in the treatment of psoriasis vulgaris. (J Am Acad Dermatol 2003;48:48-54.)

A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis

Background: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 μg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized. Objective: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population. Methods: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 μg once daily, MFNS 100 μg once daily, MFNS 200 μg once daily, beclomethasone dipropionate 84 μg twice daily (168 μg/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29. Results: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group ( P ≤ .02). No significant differences were observed among the 3 MFNS groups. However, as treatment continued, symptoms in patients treated with MFNS 100 or 200 μg once daily continued to improve, whereas those treated with MFNS 25 μg once daily demonstrated little further improvement. By day 29, MFNS 100 and 200 μg once daily both were significantly more effective than MFNS 25 μg once daily in relieving symptoms of SAR, but MFNS 200 μg provided no additional benefit over MFNS 100 μg. All doses of MFNS were well tolerated, and cosyntropin stimulation tests performed before and after treatment found no evidence of hypothalamic-pituitary-adrenal axis suppression. Conclusion: These results indicate that the most appropriate therapeutic dosage of MFNS in the treatment of SAR in children 6 to 11 years of age is 100 μg once daily. In addition, MFNS at doses up to 200 μg once daily for 4 weeks was well tolerated and had no detectable effects on hypothalamic-pituitary-adrenal axis function. (J Allergy Clin Immunol 1999;104:107-14.)

Onset of action of aqueous beclomethasone dipropionate nasal spray in seasonal allergic rhinitis

Beclomethasone dipropionate nasal spray is widely used in the treatment of seasonal allergic rhinitis; however, the time of onset of action has not been determined. This study assessed the onset of action, level of relief, and efficacy of beclomethasone nasal spray in patients with seasonal allergic rhinitis. In a double-blind, randomized, placebo-controlled, parallel-group, multicenter, 7-day study, symptomatic patients were administered two inhalations of beclomethasone dipropionate (n = 80) or placebo (n = 81) into each nostril twice daily. Patients assessed the onset of action and level of relief at 6, 24, and 48 hours and at days 3 and 7. Investigators evaluated symptoms at days 0, 3, and 7 and response to therapy at days 3 and 7. The difference in the cumulative number of patients reporting relief of symptoms was statistically significant in favor of beclomethasone dipropionate by hour 24 ( P = 0.05). Patients in the beclomethasone dipropionate group experienced a greater level of relief than patients receiving placebo at hour 24, and improvement increased over the 7-day study compared with a decrease in relief in the placebo group. Beclomethasone dipropionate was significantly more effective than placebo in reducing symptoms ( P ≤ 0.02), and patients in the beclomethasone dipropionate group showed a more favorable response to treatment than did patients in the placebo group ( P < 0.01). Adverse events were minor in both groups. Beclomethasone dipropionate nasal spray produced significant onset of relief of symptoms the first day of treatment; improvement was sustained and increased over the course of the study.

A double-blind trial comparing the efficacy and safety of augmented betamethasone dipropionate lotion with fluocinonide solution in the treatment of severe scalp psoriasis

Scalp psoriasis is frequently recalcitrant to topical therapy. In this study the efficacy and safety of a super-potent (augmented betamethasone dipropionate 0.05% lotion) and a potent (fluocinonide 0.05% solution) topical corticosteroid were evaluated in the treatment of severe scalp psoriasis. A total of 169 subjects with severe psoriatic scaling of the scalp accompanied by induration, erythema, and pruritus/burning were enrolled in this randomized double-blind parallel-group trial of 3 weeks duration. Subjects applied the study medication twice daily and were evaluated five times during the study. Evaluations of individual disease parameters, the global response and the percentage improvement showed that both medications were effective in the treatment of severe scalp psoriasis. There was a significantly greater proportion of patients (P < 0.01) completely cleared of scaling at the end of therapy in the augmented betamethasone dipropionate group. There was a low incidence of treatment-related sidesffect...

Total and Differential Protein Levels in the Blood and Cerebrospinal Fluid in Rheumatoid Arthritis

OBJECTIVES: To determine the relationship between biochemical markers of bone metabolism and statural growth, and their suitability as surrogate markers of inhaled corticosteroid induced growth suppression. DESIGN: Randomised, double blind, placebo controlled comparison of inhaled beclomethasone dipropionate 200 micrograms twice daily as dry powder for six months. SETTING: Southampton. OUTCOME MEASURES: Serum osteocalcin, urinary deoxypyridinoline, and statural growth. SUBJECTS: 7 to 9 year old children with recurrent wheeze. RESULTS: There were no significant differences in serum osteocalcin between the beclomethasone dipropionate and placebo group measured at baseline or after three and six months9 treatment, while deoxy-pyridinoline was significantly higher in the placebo treated children after three months. Growth was significantly decreased in the beclomethasone dipropionate group over the course of the study. Growth over the six months, both in those receiving beclomethasone dipropionate and those receiving placebo, was significantly correlated with serum osteocalcin measured at three months and six months. CONCLUSION: Although serum osteocalcin shows excellent correlation with growth, it is a poor marker for decreased growth associated with use of inhaled corticosteroids.