Chen X Q, Jia X Y, Wu J J, Huang M, Sun W, Ji Ningfei
Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
Department of Respiratory and Critical Care Medicine, Xishan People's Hospital of Wuxi City, Wuxi 214000, China.
Zhonghua Yi Xue Za Zhi. 2022 Jul 26;102(28):2201-2209. doi: 10.3760/cma.j.cn112137-20211109-02480.
To evaluate the efficacy and safety of omalizumab in patients with refractory allergic asthma using meta-analysis. We searched databases including PubMed, Web of Science, Embase and the website of ClinicalTrials. gov registry for randomized controlled trials (RCTs), using the search terms: ("anti-IgE" OR "anti-immunoglobulin E" OR "anti-IgE antibody" OR "omalizumab" OR "rhuMAb-E25" OR "Xolair") AND ("allergic asthma"). The time was up to September 19th 2020. Review Manager 5.4 software and Stata16 software were used to calculate pooled or , perform heterogeneity test, and assess publication bias. Fifteen RCTs with 6 316 patients in total (omalizumab, =3 469; placebo, =2 847) met our selection criteria. Comparing with placebo, omalizumab reduced the risk of asthma exacerbations during both stable-inhaled corticosteroid (ICS) phase (=0.69, 95%: 0.63-0.75, <0.001; =39.0%, =0.090) and ICS-reduction phase (=0.55, 95%: 0.46-0.66, <0.001; =41.0%, =0.180), reduced emergency visits (=0.53, 95%: 0.38-0.73, <0.001; =0, =0.420), made a significant reduction in dosage of ICS (1.35, 95%: 1.25-1.45, <0.001; =22.0%, =0.280) and even withdrew from ICS completely (=1.80, 95%: 1.41-2.31, <0.001; =57.0%, =0.070). Omalizumab significantly improved asthma-related quality of life (=1.81, 95%: 1.51-2.17). The use of rescue bronchodilators was significantly reduced in the omalizumab group (=0.78, 95%: 0.67-0.92) but there was no significant difference in the dosage of rescue bronchodilators (puff per day) (=-0.32, 95%: -0.77-0.13). Patients taking omalizumab did not increase the frequency of any adverse events (=1.01, 95%: 0.98-1.03) and serious adverse events (=0.89, 95%: 0.74-1.06). Omalizumab is an ideal adjunctive treatment for refractory allergic asthma with good efficacy and safety. Further randomized controlled trials are needed to determine the appropriate duration of treatment.
采用荟萃分析评估奥马珠单抗治疗难治性过敏性哮喘患者的疗效和安全性。我们检索了包括PubMed、Web of Science、Embase和ClinicalTrials.gov注册网站在内的数据库,以查找随机对照试验(RCT),检索词为:(“抗IgE”或“抗免疫球蛋白E”或“抗IgE抗体”或“奥马珠单抗”或“重组人源化抗IgE单克隆抗体-E25”或“Xolair”)以及(“过敏性哮喘”)。检索时间截至2020年9月19日。使用Review Manager 5.4软件和Stata16软件计算合并比值比(OR)或平均差(MD),进行异质性检验,并评估发表偏倚。共有15项RCT符合我们的纳入标准,总计6316例患者(奥马珠单抗组3469例;安慰剂组2847例)。与安慰剂相比,奥马珠单抗在稳定吸入糖皮质激素(ICS)阶段(OR = 0.69,95%CI:0.63 - 0.75,P < 0.001;RR = 39.0%,RD = 0.090)和ICS减量阶段(OR = 0.55,95%CI:0.46 - 0.66,P < 0.001;RR = 41.0%,RD = 0.180)均降低了哮喘急性发作风险,减少了急诊就诊次数(OR = 0.53,95%CI:0.38 - 0.73,P < 0.001;RR = 0,RD = 0.420),显著降低了ICS用量(MD = 1.35,95%CI:1.25 - 1.45,P < 0.001;RR = 22.0%,RD = 0.280),甚至完全停用了ICS(OR = 1.80,95%CI:1.41 - 2.31,P < 0.001;RR = 57.0%,RD = 0.070)。奥马珠单抗显著改善了哮喘相关生活质量(MD = 1.81,95%CI:1.51 - 2.17)。奥马珠单抗组使用急救支气管扩张剂的情况显著减少(OR = 0.78,95%CI:0.67 - 0.92),但急救支气管扩张剂的用量(每日喷数)无显著差异(MD = -0.32,95%CI:-0.77 - 0.13)。服用奥马珠单抗的患者未增加任何不良事件(OR = 1.01,95%CI:0.98 - 1.03)和严重不良事件(OR = 0.89,95%CI:0.74 - 1.06)的发生频率。奥马珠单抗是难治性过敏性哮喘的理想辅助治疗药物,疗效和安全性良好。需要进一步开展随机对照试验以确定合适的治疗疗程。