Quality of life in patients with scalp psoriasis treated with calcipotriol/betamethasone dipropionate scalp formulation: a randomized controlled trial
Quality of life in patients with scalp psoriasis treated with calcipotriol/betamethasone dipropionate scalp formulation: a randomized controlled trial
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DOI：
10.1111/j.1468-3083.2009.03221.x
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发表时间：
2009-08-01
影响因子：
9.2
通讯作者：
Segaert, S.
中科院分区：
文献类型：
--
作者：
Ortonne, J. P.;Ganslandt, C.;Segaert, S.
背景头皮寻常型银屑病对个体有显著的心理社会影响，影响其生活质量（QoL）。目的评价卡泊三醇加二丙酸倍他米松头皮制剂或卡泊三醇头皮溶液治疗头皮银屑病对生活质量的影响方法这项为期8周的随机、双盲研究，比较了每日一次，双组分头皮制剂（卡泊三醇50 μ g/g+倍他米松0.5 mg/g，作为二丙酸盐; Xamiol，LEO Pharma A/S，巴勒鲁普，丹麦），每日两次卡泊三醇头皮溶液（50 μ g/mL; Daivonex（R），LEO Pharma A/S）在患有覆盖>= 10%头皮的至少中度严重性的头皮银屑病的患者中的应用。评估了QoL（第0、2、4、8周）使用36项简明健康调查表结果用两种复合头皮制剂治疗（n = 207）导致SF-36 v2较基线显著改善（第8周，身体成分总结，P = 0.005;第2、4、8周，心理成分总结，P < 0.05）。卡泊三醇头皮溶液组（n = 105）仅在心理健康总评中观察到较基线的显著变化（P = 0.04，第8周）。Skindex-16较基线的变化显著有利于双化合物头皮制剂。结论双复方头皮制剂在改善头皮银屑病患者生活质量方面上级优于卡泊三醇头皮溶液。
Background Psoriasis vulgaris of the scalp has a significant psychosocial impact on individuals affecting their quality of life (QoL). A combination of calcipotriol and betamethasone dipropionate in a formulation suitable for treatment of scalp psoriasis has been developed.Objective To assess the impact of treatment with either calcipotriol plus betamethasone dipropionate scalp formulation or calcipotriol scalp solution on QoL in patients with scalp psoriasis (both within and between treatment groups).Methods This 8-week, randomized, investigator-blind study, compared the once-daily, two-compound scalp formulation (calcipotriol 50 mu g/g plus betamethasone 0.5 mg/g as dipropionate; Xamiol, LEO Pharma A/S, Ballerup, Denmark) with twice-daily calcipotriol scalp solution (50 mu g/mL; Daivonex (R), LEO Pharma A/S) in patients with scalp psoriasis of at least moderate severity covering >= 10% of the scalp. QoL was assessed (weeks 0, 2, 4, 8) using the 36-item Short Form Health Survey (version 2; SF-36v2) and Skindex-16.Results Treatment with the two-compound scalp formulation (n = 207) resulted in significant improvements from baseline on the SF-36v2 (Physical Component Summary, P = 0.005, week 8; Mental Component Summary, P < 0.05, weeks 2, 4, 8). A significant change from baseline in the calcipotriol scalp solution group (n = 105) was seen only on the Mental Component Summary (P = 0.04, week 8). Change from baseline in Skindex-16 was significantly in favour of the two-compound scalp formulation. Change was significant on both total score and individual scales.Conclusion The two-compound scalp formulation was superior to calcipotriol scalp solution in improving QoL in patients with scalp psoriasis.