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每日一次的卡泊三醇倍他米松二丙酸酯凝胶与软膏制剂治疗寻常型银屑病的真实疗效:52周PRO-long研究的最终分析

Real-life effectiveness of once-daily calcipotriol and betamethasone dipropionate gel vs. ointment formulations in psoriasis vulgaris: final analysis of the 52-week PRO-long study.

作者信息

Lambert J, Hol C W, Vink J

机构信息

Department of Dermatology, Ghent University Hospital, Ghent, Belgium.

LEO Pharma BV, Amsterdam, Netherlands.

出版信息

J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2349-55. doi: 10.1111/jdv.13230. Epub 2015 Sep 3.

Abstract

BACKGROUND

Topical therapies are the mainstay of treatment for psoriasis vulgaris. The fixed combination of calcipotriol (Cal) 50 μg/g plus betamethasone 0.5 mg/g (as dipropionate; BD) is a first-line topical treatment and available as a gel or ointment. The use of these fixed combination products was compared in PRO-long, a long-term noninterventional study, for which interim results (4 and 12 weeks) have previously been reported.

OBJECTIVE

To describe and compare patients' perspectives on the fixed combination gel and ointment formulations; to include efficacy, adherence behaviour, treatment satisfaction and health-related quality of life (HRQoL) aspects during long-term real-life psoriasis management.

METHODS

PRO-long was a multicentre, prospective, observational, 52-week study of patients prescribed fixed combination Cal/BD gel or ointment in clinical practice. For final analysis the following were assessed at weeks 24, 36 and 52: differences in the proportion of patients with 'mild'/'very mild' disease according to patient's global assessment of disease severity, adherence behaviour, treatment satisfaction (nine-item treatment satisfaction questionnaire for medication) and HRQoL (Skindex-29).

RESULTS

Patients (n = 328) were prescribed once-daily Cal/BD gel (n = 152) or ointment (n = 176). At week 52, a higher proportion of patients reported that the severity of their psoriasis was 'mild'/'very mild' vs. baseline (gel: 60.2 vs. 47.1%; ointment: 58.8 vs. 42.4%), with greater treatment satisfaction reported in patients using gel vs. those using ointment. A higher proportion of patients found the gel 'easy' to use compared with the ointment (66.7 vs. 45.2%). Daily application of treatment took ≤ 5 min for 86.1% of patients using gel and 71.0% of patients using ointment.

CONCLUSION

This real-life study has demonstrated similar effectiveness between the Cal/BD formulations. However, over a 52-week treatment period, patients reported greater treatment satisfaction with the gel, which was considered easier to use, faster to apply and overall a more convenient product.

摘要

背景

局部治疗是寻常型银屑病治疗的主要方法。卡泊三醇(Cal)50μg/g加倍他米松0.5mg/g(丙酸酯;BD)的固定组合是一线局部治疗药物,有凝胶或软膏剂型。在一项长期非干预性研究PRO-long中对这些固定组合产品的使用情况进行了比较,该研究的中期结果(4周和12周)此前已报道。

目的

描述并比较患者对固定组合凝胶和软膏剂型的看法;纳入长期实际银屑病管理期间的疗效、依从行为、治疗满意度和健康相关生活质量(HRQoL)等方面。

方法

PRO-long是一项多中心、前瞻性、观察性、为期52周的研究,研究对象为临床实践中处方使用固定组合Cal/BD凝胶或软膏的患者。在第24、36和52周进行最终分析时评估以下指标:根据患者对疾病严重程度的整体评估,“轻度”/“非常轻度”疾病患者比例的差异、依从行为、治疗满意度(九项药物治疗满意度问卷)和HRQoL(Skindex-29)。

结果

患者(n = 328)被处方每日一次的Cal/BD凝胶(n = 152)或软膏(n = 176)。在第52周,与基线相比,报告银屑病严重程度为“轻度”/“非常轻度”的患者比例更高(凝胶:60.2%对47.1%;软膏:58.8%对42.4%),使用凝胶的患者报告的治疗满意度高于使用软膏的患者。与软膏相比,更高比例的患者认为凝胶“易于”使用(66.7%对45.2%)。使用凝胶的患者中有86.1%、使用软膏的患者中有71.0%每日涂抹治疗的时间≤5分钟。

结论

这项实际研究表明Cal/BD两种剂型的有效性相似。然而,在52周的治疗期间,患者报告使用凝胶的治疗满意度更高,并认为凝胶更易于使用、涂抹更快且总体上是更方便的产品。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ed4/5049671/0f2147b3c140/JDV-29-2349-g001.jpg

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