Tsinghua University, Tsinghua, China.
Jikei University School of Medicine, Beijing, Japan.
J Dermatol. 2021 Jul;48(7):940-960. doi: 10.1111/1346-8138.15806. Epub 2021 May 25.
While many patients with psoriasis are candidates for topical agents, long-term treatment effects are unclear. This systematic review evaluated global findings from clinical trials and real-world studies of topical calcipotriol and the two-compound formulation of calcipotriol and betamethasone dipropionate for mild-to-moderate plaque psoriasis (including scalp psoriasis). PubMed, Embase and MEDLINE were searched for relevant English-language publications along with Chinese, Japanese, Korean and Latin American publication databases. Identified articles were screened by title and abstract against predefined inclusion/exclusion criteria. A narrative synthesis of key efficacy and safety findings from the full papers of selected publications was developed. Thirty-seven relevant papers were identified (25 English, 11 Chinese and one Japanese-language study) including 28 randomized controlled trials. While there was significant heterogeneity in study length, treatment intensity and clinical measures, following a critical review of the published data combined with expert opinion, the following clinical practice recommendations were agreed in order to assist healthcare providers: in adults, long-term treatment with calcipotriol/betamethasone dipropionate is well tolerated and efficacious for up to 1 year on an 'as needed' basis, and for up to 16 weeks on a fixed-treatment regimen. Calcipotriol is also well tolerated and efficacious when used long term (up to 52 weeks) 'as needed' and for up to 20 weeks on a fixed-treatment regimen. Used on an 'as needed' basis for up to 1 year, the safety and efficacy profile of fixed-dose combination calcipotriol/betamethasone dipropionate is more favorable than calcipotriol alone; regular consultation between patients and their dermatologist/primary care physician is required to review psoriasis symptoms and adjust treatment accordingly; a specific treatment goal should be agreed on initiation of topical agent(s) to determine when long-term treatment can begin or if a regimen change is warranted; and application frequency during the continued treatment phase should consider the patients' treatment expectations and goals.
虽然许多银屑病患者是局部治疗药物的候选者,但长期治疗效果尚不清楚。本系统评价评估了来自临床试验和真实世界研究的全球发现,这些研究评估了局部钙泊三醇和钙泊三醇与倍他米松二丙酸酯的两种化合物制剂治疗轻度至中度斑块型银屑病(包括头皮银屑病)的效果。通过标题和摘要在 PubMed、Embase 和 MEDLINE 搜索了相关的英文出版物,以及中文、日文、韩文和拉丁美洲出版物数据库。根据预先确定的纳入/排除标准筛选出的文章。从选定出版物的全文中综合了关键疗效和安全性发现的叙述性综述。确定了 37 篇相关文章(25 篇英文,11 篇中文和 1 篇日文研究),包括 28 项随机对照试验。尽管研究长度、治疗强度和临床指标存在显著异质性,但在对已发表数据进行批判性审查并结合专家意见后,达成了以下临床实践建议,以协助医疗保健提供者:对于成年人,在“按需”基础上,长达 1 年或在固定治疗方案上长达 16 周,长期使用钙泊三醇/倍他米松二丙酸酯治疗是耐受良好且有效的;在“按需”基础上长期使用(长达 52 周),或在固定治疗方案上长达 20 周,钙泊三醇的耐受性和疗效良好。在“按需”基础上使用长达 1 年,固定剂量联合钙泊三醇/倍他米松二丙酸酯的安全性和疗效特征优于单独使用钙泊三醇;需要患者与皮肤科医生/初级保健医生定期进行咨询,以评估银屑病症状并相应调整治疗;在开始使用局部药物时,应商定具体的治疗目标,以确定何时可以开始长期治疗或是否需要改变治疗方案;在继续治疗阶段的应用频率应考虑患者的治疗期望和目标。