关键词: 血管水肿, 遗传性, 临床试验, 有效性研究, 生物制剂, 拉那利尤单抗, 安全性

Abstract: 【Abstract】 Objective To investigate the efficacy and safety of lanadelumab in the treatment of hereditary angioedema. Methods Databases including PubMed, Embase, Cochrane Library, CNKI, Wanfang data and Sinomed were searched from the inception of the databases to November 9, 2022 for clinical trials of lanadelumab in the treatment of hereditary angioedema. The primary outcome was the number of disease episodes during treatment, and the secondary outcomes were plasma high-molecular-weight kininogen levels and patient quality of life scores. Safety evaluation indicators were incidence rates of adverse events. Results A total of 6 clinical studies were included, including 3 randomized controlled trials and 3 observational studies. Among them, 4 studies showed a significant decrease in the number of monthly attacks in patients with hereditary angioedema after the treatment with lanadelumab; 2 studies showed a significant inhibition in the cleavage of plasma high-molecular-weight kininogen after lanadelumab treatment; 4 studies showed a noticeable improvement in the patient quality of life after treatment. None of the 6 studies reported serious treatment-related adverse events. Common adverse events were headaches and injection site reactions, which were generally controllable. Conclusion Lanadelumab is a biological agent with good efficacy and safety, which can be used for the long-term prevention of hereditary angioedema attacks.

Key words: Angioedemas, hereditary, Clinical trial, Validation studies, Biological agents, Lanadelumab, Safety