奥马珠单抗在不同患者群体中的安全性

Kondrakhin A.P., Maksimov M.L., Schneider K.O.
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引用次数: 0

摘要

文章专门对评估奥马珠单抗临床安全性的研究进行了分析综述。分析表明,使用基因工程生物药物(尤其包括奥马珠单抗)的靶向疗法越来越多地用于治疗过敏性疾病。一般来说,大多数研究显示,奥马利珠单抗对成人和儿童支气管哮喘、过敏性鼻炎、过敏性休克、过敏性荨麻疹具有临床疗效。不过,也有个别报告让我们能够讨论与不良反应有关的使用该药物的个别限制。过敏性反应在使用奥马珠单抗期间最常见。有报告指出皮肤瘙痒和皮疹是不良反应。在儿童中,消化不良是一种常见症状。关于在使用奥马珠单抗的背景下引发恶性肿瘤的可靠数据尚未确定。作者指出,嗜酸性粒细胞肉芽肿伴多血管炎和血栓栓塞并发症是相当罕见的不良反应。作者提请注意,需要全面收集患者的过敏性病史,明确选择药物剂量,并在用药后数小时内对患者进行监测。分析数据是改进确保药品安全和向监管机构通报用药不良反应的系统的理论依据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
SAFETY OF OMALIZUMAB IN DIFFERENT PATIENT POPULATIONS
The article is devoted to an analytical review of studies to assess the clinical safety of omalizumab. The analysis showed that targeted therapy using genetically engineered biological drugs, which include, in particular, omalizumab, is increasingly used in the treatment of allergic diseases. In general, most studies show the clinical efficacy of omalisamab in bronchial asthma, allergic rhinitis, anaphylactic conditions, allergic urticaria, both in adults and children. However, there are isolated reports that allow us to talk about individual restrictions in the use of this drug associated with adverse reactions. Anaphylactic reactions have been most commonly reported during the administration of omalizumab. There are reports that indicate itching and rashes on the skin as undesirable reactions. In children, dyspeptic disorders are a common complaint. Reliable data on the initiation of malignancy processes against the background of the use of omalizumab have not been established. Quite rarely, as adverse reactions, the authors note eosinophilic granulomatosis with polyangiitis and thromboembolic complications. The authors draw attention to the need for a thorough collection of allergic anamnesis in patients, a clear selection of the dose of the drug, and monitoring patients in the first hours after the administration of the drug. The analysis data are the theoretical basis for improving the system for ensuring the safety of medicines and notifying supervisory authorities of adverse reactions to the use of medicines.
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