Mitchell Sarah, Balp Maria-Magdalena, Samuel Miny, McBride Doreen, Maurer Marcus
RTI Health Solutions, Manchester, UK.
Novartis Pharma AG, Basel, Switzerland.
Int J Dermatol. 2015 Sep;54(9):1088-104. doi: 10.1111/ijd.12727. Epub 2014 Dec 16.
Patients with chronic spontaneous urticaria (CSU) are sometimes unresponsive to nonsedating, second-generation, H1 antihistamines; this study summarizes published clinical evidence for patients who remain symptomatic despite treatment.
To evaluate, via a systematic literature review, clinical evidence of management strategies for patients with CSU who remain symptomatic despite approved use of nonsedating H1 antihistamines.
Using a prespecified protocol, we searched MEDLINE, Embase, the Cochrane Library (1 January 1960-20 December 2011), and published conference abstracts (2010-2012). Rigorous criteria identified trials in patients with CSU who had a history of inadequate response to previous treatment or had used combination treatments. Trials evaluating treatment-naïve patients or first-line therapies were excluded.
Qualitative data synthesized from 26 randomized, controlled trials, four prospective studies, and one retrospective study showed cyclosporine, desloratadine plus dapsone or dipyridamole, montelukast, and omalizumab reduced urticaria activity scores, weals, and pruritus, versus placebo. Optimal treatment doses and durations were unclear due to varying trial durations, outcome measurement scales, and assessment timings. No safety concerns were reported.
This review confirms that available evidence to guide treatment choice for patients with CSU with inadequate response to H1 antihistamines varies in quality. Further research is warranted due to low-quality trials with methodological and reporting limitations.
慢性自发性荨麻疹(CSU)患者有时对非镇静性第二代H1抗组胺药无反应;本研究总结了尽管接受治疗仍有症状的患者的已发表临床证据。
通过系统的文献综述,评估尽管已批准使用非镇静性H1抗组胺药但仍有症状的CSU患者管理策略的临床证据。
我们按照预先指定的方案,检索了MEDLINE、Embase、Cochrane图书馆(1960年1月1日至2011年12月20日)以及已发表的会议摘要(2010 - 2012年)。严格的标准确定了有既往治疗反应不足史或使用过联合治疗的CSU患者的试验。排除评估初治患者或一线治疗的试验。
从26项随机对照试验、4项前瞻性研究和1项回顾性研究中综合的定性数据显示环孢素、地氯雷他定加氨苯砜或双嘧达莫、孟鲁司特和奥马珠单抗与安慰剂相比,降低了荨麻疹活动评分、风团和瘙痒。由于试验持续时间、结局测量量表和评估时间不同,最佳治疗剂量和疗程尚不清楚。未报告安全问题。
本综述证实,现有证据指导对H1抗组胺药反应不足的CSU患者的治疗选择,其质量各不相同。由于存在方法学和报告局限性的低质量试验,有必要进行进一步研究。