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《Chinese Journal of New Drugs and Clinical Remedies》 2013-06
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Efficacy, safety and quality of life of topical calcipotriol betamethasone dipropionate in treatment of psoriasis vulgaris

MA Li,HUANG Lan,HUANG Qiong,YANG Qin-ping(Department of Dermatology,Huashan Hospital,Fudan University,SHANGHAI 200040,China)  
AIM To assess the clinical efficacy,safety and influence on quality of life of topical calcipotriol betamethasone dipropionate ointment(Daivobet) in Chinese patients with stable psoriasis vulgaris.METHODS In this double-blind,active-controlled,parallel study,80 patients were randomly allocated into two groups to receive either calcipotriol betamethasone ointment once daily in the evening and placebo once daily in the morning(trial group) or calcipotriol ointment twice daily(control group).The safety and efficacy of the two regimens were evaluated at the end of week 1,2 and 4 after the first dosage.RESULTS After 4 weeks of the treatment,the effective rate of calcipotriol betamethasone group(76%,29/38) was significantly higher than calcipotriol monotherapy group(42%,16/38,P 0.01),while the improvement of dermatology life quality index(DLQI) of the trial group was also greater than the control group with significant difference(P 0.01).After 1 and 2 weeks of the treatment,the patients in the trail group experienced a greater reduction in the psoriasis area and severity index(PASI) compared with those in the control group with statistical significance(P 0.05).A greater improvement was also observed in the area percentage of lesions and visual analog scale(VAS) at the end of week 1,2 and 4 in the trial group than the control group(P 0.05 or P 0.01).No severe adverse event occurred during the study.The incidence of drug related adverse reactions of the trial group and the control group showed no statistical difference(20% vs.28%,P 0.05).CONCLUSION Once daily calcipotriol betamethasone ointment is an effective,safe and convenient treatment with a rapid onset of action for stable psoriasis vulgaris in Chinese patients which also improves the patients’ life quality markedly.
【CateGory Index】: R758.63
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