Godse Kiran, Rajagopalan Murlidhar, Girdhar Mukesh, Kandhari Sanjiv, Shah Bela, Chhajed Prashant N, Tahiliani Sushil, Shankar D S Krupa, Somani Vijay, Zawar Vijay
Department of Dermatology, Dr. D. Y. Patil Medical College and Hospital, Mumbai, Maharashtra, India.
Department of Dermatology, Apollo Hospitals, Chennai, Tamil Nadu, India.
Indian Dermatol Online J. 2016 Jan-Feb;7(1):6-11. doi: 10.4103/2229-5178.174314.
Chronic spontaneous urticaria (CSU) affects 1% of the world population and also their quality of life, and 50% of these patients are refractory to H1-antihistamines. Omalizumab is a humanized monoclonal anti-IgE antibody that binds with free IgE antibodies and reduces the circulating levels of free IgE. This reduction in free IgE prevents mast-cell degranulation. The EAACI/GA2LEN/EDF/WAO guidelines recommend omalizumab as the third-line of therapy as an add-on to antihistamines. The recommended dose of omalizumab is 300 mg, 4 weekly in the management of CSU refractory to standard of care with H1-antihistamines in adults and adolescents ≥12 years of age. In some patients, a dose of 150 mg may be acceptable. Omalizumab has a good safety profile. However, due to the biologic nature of the drug, all patients administered omalizumab must be observed for 2 h after administration for anaphylactoid reactions. There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of omalizumab. While no particular dose adjustment is recommended, omalizumab should be administered with caution in these patients.
慢性自发性荨麻疹（CSU）影响着全球1%的人口及其生活质量，其中50%的患者对H1抗组胺药难治。奥马珠单抗是一种人源化抗IgE单克隆抗体，可与游离IgE抗体结合并降低游离IgE的循环水平。游离IgE的这种减少可防止肥大细胞脱颗粒。欧洲变态反应和临床免疫学会/全球变态反应和哮喘欧洲网络/欧洲皮肤病论坛/世界变态反应组织指南推荐奥马珠单抗作为抗组胺药的附加治疗的三线疗法。奥马珠单抗的推荐剂量为300mg，每4周一次，用于治疗对H1抗组胺药标准治疗难治的成人和≥12岁青少年的CSU。在一些患者中，150mg的剂量可能是可以接受的。奥马珠单抗具有良好的安全性。然而，由于该药物的生物学性质，所有接受奥马珠单抗治疗的患者在给药后必须观察2小时以防类过敏反应。目前尚无关于肾功能或肝功能受损对奥马珠单抗药代动力学影响的研究。虽然不建议进行特殊的剂量调整，但在这些患者中使用奥马珠单抗时应谨慎。
