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孟鲁司特钠在特应性皮炎治疗中的超说明书用药的系统评价

A systematic review on the off-label use of montelukast in atopic dermatitis treatment.

作者信息

Chin Weng Khong, Lee Shaun Wen Huey

机构信息

School of Pharmacy, Monash University Malaysia, Subang Jaya, Malaysia.

Asian Centre for Evidence Synthesis in Population, Implementation and Clinical Outcomes (PICO), Global Asia in the 21st Century (GA21) Platform, Monash University Malaysia, Subang Jaya, Malaysia.

出版信息

Int J Clin Pharm. 2018 Oct;40(5):963-976. doi: 10.1007/s11096-018-0655-3. Epub 2018 May 18.

Abstract

Background Atopic dermatitis (AD) is the most common form of eczema. As leukotriene mediators are involved in the inflammatory phase of atopic dermatitis, montelukast has been suggested as a possible therapy. Aim of the review To evaluate the safety and efficacy of montelukast off-label use for the treatment atopic dermatitis. Method A search was performed from database inception until March 2018 in six electronic databases for randomized-controlled-trials examining the use of montelukast for AD. Results Among 301 articles screened, 11 studies met the inclusion criteria and were included in the review. The study populations consist of paediatric and adult subjects with moderate-to-severe AD. Montelukast use was shown to improve symptoms such as pruritus in four studies. Another 2 studies reported that montelukast could improve symptoms similar to the standard regimen of topical steroid and oral antihistamine. However, five studies reported that montelukast had no effects in symptoms alleviation. The use of montelukast was associated with a similar safety profile to placebo and well-tolerated with minimal adverse effects. Conclusion There is limited evidence to suggest that the off-label use of montelukast is effective in treating moderate-to-severe AD. Further research with larger study populations employing standardized endpoint measuring instrument is warranted to further investigate the off-label use of montelukast in AD treatment. Until then, the use of conventional treatments including optimal daily skin hydration should remain the mainstay in the management of atopic dermatitis. In fact, for moderate-to-severe condition, steroid sparing immune-suppressants should still be used clinically until more effective and safer alternative is discovered.

摘要

背景

特应性皮炎(AD)是最常见的湿疹形式。由于白三烯介质参与了特应性皮炎的炎症阶段,孟鲁司特已被提议作为一种可能的治疗方法。综述目的:评估孟鲁司特超说明书用药治疗特应性皮炎的安全性和有效性。方法:从数据库建立至2018年3月,在六个电子数据库中进行检索,以查找检验孟鲁司特用于特应性皮炎治疗的随机对照试验。结果:在筛选的301篇文章中,11项研究符合纳入标准并被纳入综述。研究人群包括患有中度至重度特应性皮炎的儿童和成人。四项研究表明使用孟鲁司特可改善瘙痒等症状。另外两项研究报告称孟鲁司特可改善与局部类固醇和口服抗组胺药标准方案相似的症状。然而,五项研究报告称孟鲁司特在缓解症状方面没有效果。孟鲁司特的使用与安慰剂具有相似的安全性,耐受性良好,不良反应最小。结论:仅有有限的证据表明孟鲁司特超说明书用药治疗中度至重度特应性皮炎有效。有必要开展更大规模的研究人群、采用标准化终点测量工具的进一步研究,以进一步调查孟鲁司特在特应性皮炎治疗中的超说明书用药情况。在此之前,包括最佳每日皮肤保湿在内的传统治疗方法仍应是特应性皮炎管理的主要手段。事实上,对于中度至重度病情,在发现更有效、更安全的替代方法之前,临床上仍应使用类固醇节约型免疫抑制剂。

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