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Abstract：
This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75 years old treated with omalizumab for 16 to 40 weeks were evaluated. Omalizumab 150 mg does not result in clinically meaningful improvement (high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) -5; 95%CI -7.75 to -2.25), and the itch severity score (ISS)7 (MD -2.15; 95% CI -3.2 to -1.1) does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD -2.01; 95%CI -3.22 to -0.81) and decreases (moderate certainty) rescue medication use (MD -1.68; 95%CI -2.95 to -0.4). Omalizumab 300 mg results in clinically meaningful improvements (moderate certainty) of the UAS7 (MD -11.05; 95%CI -12.87 to -9.24), the ISS7 (MD -4.45; 95%CI -5.39 to -3.51), and QoL (high certainty) (DLQI; MD -4.03; 95% CI -5.56 to -2.5) and decreases (moderate certainty) rescue medication use (MD -2.04; 95%CI -3.19 to -0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91).
摘要：
本系统评价奥马珠单抗治疗慢性自发性荨麻疹(CSU)的疗效和安全性。PubMed,Embase,和Cochrane图书馆进行RCT搜索。考虑了关键和重要的CSU相关结果。使用GRADE评估偏倚风险和证据的确定性。评估了10个RCT，包括1620名年龄在12至75岁之间的受试者，这些受试者用奥马珠单抗治疗16至40周。Omalizumab150mg不会导致荨麻疹活动评分（UAS）7（平均差异（MD）-5;95CI-7.75至-2.25）的临床意义改善（高确定性），瘙痒严重程度评分（ISS）7（MD-2.15；95％CI-3.2至-1.1）不会提高（中度确定性）生活质量（QoL）（皮肤病学生活质量指数（DLQI）；MD-2.01；95CI-3.22至-0.81），并减少（中度确定性）抢救药物的使用（MD-1.68；95CI-2.95至-0.4）。奥马珠单抗300mg导致UAS7（MD-11.05;95CI-12.87至-9.24）的临床意义改善（中度确定性），ISS7(MD-4.45；95CI-5.39至-3.51)，和QoL（高确定性）（DLQI；MD-4.03；95％CI-5.56至-2.5），并减少（中度确定性）抢救药物使用（MD-2.04；95CI-3.19至-0.88）和药物相关的严重不良事件（RR0.77；95CI0.20至2.91）。
