ABSTRACT
Objective:To explore the prolonged therapeutic regimen for patients with plaque psoriasis, who showed a positive response to 4-week treatment with tazarotene/betamethasone dipropionate cream, but were not completely cured.Methods:A multicenter, randomized, open-labelled, parallel-controlled clinical study was conducted. A total of 232 patients with plaque psoriasis were collected, who showed a positive response to previous 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured with the psoriasis area and severity index[PASI] improvement rate being 50%-90%. At week 5, they were randomly and equally divided into 2 groups: test group receiving treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream once a day, and control group receiving a sequential regimen of 0.05% tazarotene gel on weekdays once a day followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream on weekends once a day. After 2-and 4-week prolonged treatment, the efficacy and safety of the 2 therapeutic regimens were evaluated and compared. Measurement data were compared between 2 groups by using covariance analysis or t test, and enumeration data were compared by using chi-square test. Results:From the 5th to the 8th week, 200 out of the 232 patients completed the treatment. Data collected from 110 patients in the test group and 112 in the control group were enrolled into the full analysis set, and those from both 113 patients in the test group and control group were enrolled into safety analysis set. After consecutive 6-and 8-week treatment, the decline rates of the PASI score were 73.05% ± 16.69% and 78.46% ± 15.40% respectively in the test group, which were significantly higher than those in the control group (66.73% ± 21.77%, 67.02% ± 34.19%, respectively, both P < 0.05) . After 6-week treatment, the proportion of subjects who achieved PASI90 was significantly higher in the test group (14 cases, 12.7%) than in the control group (5 cases, 4.5%, χ2=4.842, P=0.028) ; After 8-week treatment, the proportions of subjects who achieved PASI75 and PASI90 (61.8%, 23.6%, respectively) were significantly higher in the test group than in the control group (48.2%, 12.5%, respectively, both P < 0.05) . During the consecutive 8-week treatment, there was no significant difference in the incidence rate of adverse reactions between the test group (15.0%) and control group (23.9%, χ2=2.822, P=0.093) . Conclusion:For patients who showed a positive response to 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured, the continuous use of 0.05%/0.05% tazarotene/betamethasone dipropionate cream for 4 weeks is a superior therapeutic regimen compared with the sequential regimen of 0.05% tazarotene gel followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream.
ABSTRACT
BACKGROUND: In the treatment of vitiligo, topical corticosteroids are known to be effective, but are associated with serious adverse effects. Many studies have shown that topical calcipotriol is a promising therapeutic modality in vitiligo. In some studies, combined calcipotriol and betamethasone dipropionate ointment has been shown to be a more effective and well tolerated treatment for vitiligo. The combination therapy seems to synergistically act as an immunosuppressive and a pigment restorative agent. OBJECTIVE: We investigated the clinical efficacy of CCB (Combination Calcipotriol and Betamethasone dipropionate) gel compared with that of betamethasone dipropionate alone in the repigmentation of vitiligo. METHODS: In an intraindividual right-left comparison study (n=20), a CCB gel was applied once daily to a lesion on one side, and betamethasone dipropionate cream was applied to a lesion on the other side. The degree of repigmentation was assessed according to the Vitiligo Area Scoring Index (VASI) at baseline, 4, 12, 24, and 48 weeks. RESULTS: The CCB gel treated group showed a remarkably improved therapeutic outcome compared to the betamethasone dipropionate monotherapy group: the percentages of VASI relative to the baseline at CCB gel treated sites were 82.73+/-8.17%, 70.45+/-14.05%, 62.73+/-17.52%, and 56.24+/-18.49% at 4, 12, 24, and 48 weeks after treatment, respectively; while those of the other sites receiving betamethasone dipropionate were 89.55+/-7.24%, 84.55+/-10.60%, 77.73+/-14.38%, and 73.48+/-12.93%. Adverse effects such as atrophy and burning sensations were much less after CCB gel treatment than after betamethasone monotherapy. CONCLUSION: CCB gel is more effective and tolerable than betamethasone dipropionate monotherapy in repigmentation therapy for vitiligo.
Subject(s)
Adrenal Cortex Hormones , Atrophy , Betamethasone , Burns , Sensation , VitiligoABSTRACT
Psoriasis is a chronic T lymphocyte mediated autoimmune inflammatory disorder that affects the skin, joints, and tendons. Betamethasone dipropionate (BD) has anti-inflammatory, immunosuppressive,and antiproliferative activity. The aim of this study was to investigate and evaluate a nanoemulsion topical gel of betamethasone dipropionate. For the preparation of nanoemulsion eucalyptus oil and babchi oil was taken. Nanomulsions were prepared by aqueous phase-titration method. Pseudoternary phase diagrams were constructed for the identification of nanoemulsion existence zones. Prepared nanoemulsions were subjected to different thermodynamic stability tests and characterized for droplet size, viscosity and refractive index. In vitro skin permeation of betamethasone dipropionate through rat abdominal skin was determined by the Franz diffusion cell. The prepared nanoemulsion gel is a potential vehicle for improved topical delivery of BD for better treatment of psoriasis.
ABSTRACT
Objective To investigate and compare the clinical effects of intraarticular injection of sodium hyaluronate and diprospan on knee osteoarthritis. Methods 94 patients with knee osteoarthritis were divided into two groups, the HA group and Cortieosteroid group. Each patient in the HA group was treated with intra-articular injection of sodium hyaluronate at 2.5 ml every week for 5 weeks, and each patient in the Corticosteroid group was treated with intra-articular injection of diprospan at 1ml on the first and fourth week. The clinical assessments included pain,joint effusion,and Lequesne Index. Assessments were done at baseline, at week 4, and week 12. Results 88 cases were followed up for 3 months. A significant decrease in VAS scores for pain and in Lequesne Index was found in both groups at week 4 when compared to baseline and there were no significant differences between the two groups. However,at 12 week improvement in pain score and Lequesne Index was found in favour of hyaluronic acid. In addition,diprospan seemed to have preferable short-term effect on patient with joint effusion. Conclusion Both intra-articular injection of sodium hyaluronate and diprospan provided clinically significant improvement in short-term and demonstrated that hyaluronic acid had a more long-term beneficial effect in patients with knee osteoarthritis.
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Objective: To set up a liquid chromatographic-tandem mass spectrometric (LC/MS/MS) method for determination of betamethasone in rabbit plasma. Methods: Betamethasone and the internal standard A0 were extracted from rabbit plasma by liquid-liquid extraction with diethyl ether-hexane (4:1,V/V). Chromatographic separation was performed on a Zorbax Eclipse XDB-C18 column with a mobile phase consisted of acetonitrile-5 mmol/L ammonium acetate-formic acid (80:20:0.1,V/V/V) at a flow-rate of 0.60 ml/min. A tandem mass spectrometer equipped with electrospray ionization source was used as detector and operated in the positive ion mode. Quantification was performed using multiple reaction monitoring (MRM) of the transitions m/z 393→m/z 373 and m/z 393→ m/z 355 for betamethasone,and m/z 489→m/z 357 for the internal standard. Results: The linear calibration curves were obtained within the concentration range of 15.0-1 000 pg/ml. The lower limit of quantification was 15.0 pg/ml. The intra- and inter-day relative standard deviation over the entire concentration range was less than 13.0%. The accuracy was in the range of -1.4%o to -0.6% in terms of relative error. The method was applied to a pharmacokinetic study of betamethasone dipropionate cream in rabbits. Maximal betamethasone plasma level was observed after (11.0±5.3) h and the Cmax. was (167±28) pg/ml,AUC0-1, was (4.24±1.68) ng · h · ml-1 after percutaneous administration of 0.5 g betamethasone dipropionate. Conclusion: This method is selective and sensitive,and can be used for the purpose of the pharmacokinetic study of betamethasone dipropionate cream.
ABSTRACT
Objetivo: Comparar el porcentaje de mejoría clínica entre aceponato de metilprednisolona versus dipropionato de betametasona tópicos, en niños con prepucio no retráctil. Material y métodos: De agosto del 2001 a noviembre de 2002 se realizó un estudio clínico, doble ciego y controlado en 34 niños con diagnóstico de prepucio no retráctil. Los niños fueron asignados al azar en los siguientes grupos de tratamiento tópico: grupo A; aceponato de metilprednisolona 0.1% y grupo B; dipropionato de betametasona a 0.05%. Resultados: De los 34 pacientes analizados se obtuvo mejoría en 88.2% (n = 15) del grupo A y 76.4% (n = 13) del grupo B, sin embargo, no hubo diferencia significativa en la comparación de porcentajes entre los dos grupos estudiados (χ2 = 0.2; p = 0.6). Conclusiones: El porcentaje de mejoría clínica entre los dos tratamientos de esteroides tópicos fue semejante.
OBJECTIVE: To compare clinical improvement between treatment with metilprednisolone aceponate vs. betamethasone dipropionate among children with nonretractable prepuce. MATERIAL AND METHODS: Between August 2001 and November 2002, we carried out a double blind and controlled clinical trial in 34 children with a diagnosis of nonretracable prepuce. Children were randomly assigned to one of the following groups and topical treatment was administered: Group A; metilprednisolone aceponate 0. I 1% and Group B; betamethasone dipropionate 0.05%. RESULTS: Improvement was noted in 88.2% of our sample studied; (n= 15) children from group A and 76.4% (n= 13) childrenfrom group B; however, we did not observe a significant difference when comparing percentages between the two groups (chi2 = 0.2; p = 0.6). CONCLUSIONS: The percentage of clinical improvement was similar between the two groups of topical steroid treatment administered.