Tonacci Alessandro, Billeci Lucia, Pioggia Giovanni, Navarra Michele, Gangemi Sebastiano
Clinical Physiology Institute, National Research Council of Italy (IFC-CNR), Pisa, Italy.
Institute of Applied Sciences and Intelligent Systems "Eduardo Caianiello" (ISASI), National Research Council of Italy (CNR), Messina, Italy.
Pharmacotherapy. 2017 Apr;37(4):464-480. doi: 10.1002/phar.1915. Epub 2017 Mar 23.
Omalizumab is recombinant humanized monoclonal antibody to immunoglobulin E. Guidelines for the treatment of chronic idiopathic urticaria (also known as chronic spontaneous urticaria) recommend the use of omalizumab as third-line therapy in addition to high doses of histamine receptor type 1 (H ) antihistamines when they are unsuccessful as first- and second-line therapy. We performed a systematic review of the literature to identify studies that evaluated the efficacy of omalizumab for the treatment of chronic idiopathic urticaria, in both controlled and real-world settings, to assess its potential role as a preferred therapy. The PubMed, ScienceDirect, LILACS (Latin American and Caribbean Health Sciences Literature), and Google Scholar databases were searched between January 1, 2000, and November 21, 2016. The search was limited to articles published in peer-reviewed journals in the English language, and 29 studies were included in this review. Omalizumab 300 mg administered every 4 weeks appears to be the most effective and safe dosage, with a rapid response time, for the treatment of chronic idiopathic urticaria, with few minor adverse effects, and appears to be safe in the offspring of pregnant patients who received the drug. However, as published studies of omalizumab are sparse, future studies are warranted. When findings are confirmed in larger studies, due to its efficacy, safety, and increased benefit/cost ratio, omalizumab could become the preferred method of treatment for chronic idiopathic urticaria in patients unresponsive to H antihistamines.
奥马珠单抗是一种重组人源化抗免疫球蛋白E单克隆抗体。慢性特发性荨麻疹（又称慢性自发性荨麻疹）治疗指南建议，当大剂量的1型组胺受体（H₁）抗组胺药作为一线和二线治疗无效时，可将奥马珠单抗作为三线治疗药物使用。我们对文献进行了系统综述，以确定在对照和实际应用环境中评估奥马珠单抗治疗慢性特发性荨麻疹疗效的研究，从而评估其作为首选治疗方法的潜在作用。我们检索了2000年1月1日至2016年11月21日期间的PubMed、ScienceDirect、LILACS（拉丁美洲和加勒比卫生科学文献数据库）和谷歌学术数据库。检索仅限于发表在同行评审英文期刊上的文章，本综述纳入了29项研究。每4周注射一次300mg奥马珠单抗似乎是治疗慢性特发性荨麻疹最有效、最安全的剂量，起效迅速，不良反应轻微，且对接受该药物治疗的孕妇的后代似乎也是安全的。然而，由于已发表的关于奥马珠单抗的研究较少，有必要开展进一步的研究。如果在更大规模的研究中得到证实，鉴于其疗效、安全性以及较高的效益成本比，奥马珠单抗可能会成为对H₁抗组胺药无反应的慢性特发性荨麻疹患者的首选治疗方法。
