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钙泊三醇倍他米松乳膏治疗银屑病的疗效评价。

Review of Calcipotriene and Betamethasone Dipropionate Cream in the Treatment of Psoriasis.

机构信息

Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC, USA.

出版信息

Ann Pharmacother. 2023 Mar;57(3):341-347. doi: 10.1177/10600280221105508. Epub 2022 Jun 22.

DOI:10.1177/10600280221105508
PMID:35730211
Abstract

OBJECTIVE

To review the pharmacokinetics, efficacy, and safety of recently approved calcipotriene and betamethasone dipropionate (C-BD) cream.

DATA SOURCES

A literature review was conducted using MEDLINE (PubMed) and ClinicalTrials.gov from 2002 to mid-May 2022.

STUDY SELECTION AND DATA EXTRACTION

Articles in English discussing the use of C-BD cream in the treatment of psoriasis were included.

DATA SYNTHESIS

In 2 phase I trials, there was no phototoxic or photoallergic skin reaction at irradiated C-BD cream sites at baseline, 24 hours, 48 hours, and 72 hours postirradiation. In 2 phase III trials, after 8 weeks of treatment, more subjects treated with C-BD cream achieved Physician's Global Assessment treatment success (37.4%), compared to C-BD topical suspension (TS) (22.8%, < 0.0001) and vehicle (3.7%, < 0.0001). More subjects had greater mean percentage decline in Modified Psoriasis Area Severity Index (Trial 1: 52.9% and Trial 2: 64.6%), when compared to C-BD TS (Trial 1: 51.3%, < 0.0001 and Trial 2: 56.4%, < 0.0001) and vehicle (Trial 1: 22.9%, < 0.0001 and Trial 2: 20.0%, < 0.0001).

RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE

Psoriasis has a multifactorial pathogenesis and topical treatments are considered first line. Poor adherence is a major hurdle in management; the combination of 2 separate first-line drugs may address this by decreasing the complexity of treatment regimens. A cream formulation can be preferred, and C-BD is now Food and Drug Administration (FDA) approved as one.

CONCLUSIONS

Newly FDA-approved C-BD cream with novel polyaphron dispersion (PAD) technology provides a safe efficacious combination therapy for mild-to-moderate psoriasis which may be preferred by some patients.

摘要

目的

综述最近批准的卡泊三醇和倍他米松二丙酸酯(C-BD)乳膏的药代动力学、疗效和安全性。

资料来源

使用 MEDLINE(PubMed)和 ClinicalTrials.gov 从 2002 年到 2022 年 5 月中旬进行了文献回顾。

研究选择和数据提取

纳入了讨论 C-BD 乳膏治疗银屑病的英文文章。

数据综合

在 2 项 I 期试验中,在基线、照射后 24 小时、48 小时和 72 小时,照射部位的 C-BD 乳膏均无光毒性或光过敏皮肤反应。在 2 项 III 期试验中,治疗 8 周后,接受 C-BD 乳膏治疗的患者中有更多的人达到了医生整体评估治疗成功(37.4%),而 C-BD 局部混悬剂(TS)(22.8%,<0.0001)和赋形剂(3.7%,<0.0001)。与 C-BD TS(试验 1:51.3%,<0.0001;试验 2:56.4%,<0.0001)和赋形剂(试验 1:22.9%,<0.0001;试验 2:20.0%,<0.0001)相比,接受 C-BD 乳膏治疗的患者有更大的改良银屑病面积严重程度指数(试验 1:52.9%和试验 2:64.6%)平均百分比下降。

与患者护理和临床实践的相关性

银屑病的发病机制具有多因素性,局部治疗被认为是一线治疗。依从性差是管理中的主要障碍;联合使用两种单独的一线药物可能会通过减少治疗方案的复杂性来解决这个问题。乳霜制剂可能会受到一些患者的青睐,C-BD 现已获得美国食品和药物管理局(FDA)批准。

结论

具有新型多相分散(PAD)技术的新批准的 C-BD 乳膏为轻度至中度银屑病提供了一种安全有效的联合治疗方法,可能会受到一些患者的青睐。

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