钙泊三醇倍他米松软膏外用治疗寻常型银屑病的疗效、安全性及对患者生活质量的影响

Efficacy, safety and quality of life of topical calcipotriol betamethasone dipropionate in treatment of psoriasis vulgaris

目的研究钙泊三醇倍他米松软膏外用治疗稳定期寻常型银屑病患者的临床疗效、安全性及对患者生活质量的影响。方法采用随机、双盲、阳性药物平行对照的临床试验,共入组80例寻常型银屑病患者,随机纳入试验组或对照组,疗程4周。试验组早晨外用模拟剂软膏基质,晚间外用钙泊三醇倍他米松软膏;对照组早晚外用卡泊三醇软膏。于首次用药后1、2、4周末观察临床疗效及安全性。结果治疗4周末试验组有效率76%(29/38)高于对照组(42%,16/38),皮肤病生活质量指数(DLQI)的下降值也大于对照组,差异均有非常显著意义(P<0.01)。治疗1、2周末,试验组银屑病皮损面积和严重程度指数(PASI)较基线下降百分比大于对照组(P<0.05);治疗1、2、4周末,试验组皮损总面积占体表面积百分比及患者视觉模拟评分(VAS)的改善均优于对照组(P<0.05或P<0.01)。两组均无严重不良事件发生,试验组和对照组药物不良反应发生率无显著差异(20%vs.28%,P>0.05)。结论钙泊三醇倍他米松软膏治疗稳定期寻常型银屑病起效快、疗效好、用药安全方便,并可显著提高患者生活质量。

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 ofthe 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 efictive, 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.