目的通过分析真实世界奥马珠单抗治疗人工荨麻疹的数据，评估奥马珠单抗治疗人工荨麻疹的临床疗效和安全性。
方法回顾分析北京大学第一医院皮肤科门诊2018年2月到2021年5月完成16周奥马珠单抗治疗的人工荨麻疹病例资料，比较治疗前后关键摩擦阈值（CFT）和激发试验瘙痒评分、荨麻疹控制评分（UCT）、皮肤病生活质量指数（DLQI）、慢性荨麻疹生活质量问卷（CU-Q2oL），记录治疗期间患者报告的不良事件。治疗前后组内数据比较采用Wilcoxon符号秩和检验。
结果纳入27例完成16周奥马珠单抗治疗的人工荨麻疹患者。27例患者基线期CFT均为4，UCT为7.0（5.0，8.0）分，DLQI为9.0（6.0，10.0）分，CU-Q2oL为63.0（50.0，72.0）分。在治疗第4周，9例（33.3%）患者CFT由4降为0，27例患者UCT评分上升至14.0（12.0，16.0）分（ Z = 4.548， P<0.05），DLQI下降至2.0（0.0，2.0）分（ Z = 4.513， P<0.05），CU-Q2oL下降至32.0（25.0，41.0）分（ Z = 4.433， P<0.05）。治疗第16周，UCT升至15.0（14.0，16.0）分，DLQI降至0.0（0.0，1.0）分，CU-Q2oL降至25.0（23.0，30.0）分。治疗期间无药物相关严重不良事件报告。
结论奥马珠单抗可有效改善人工荨麻疹的症状，提高患者生活质量，且具有良好的安全性。
ObjectiveTo evaluate clinical efficacy and safety of omalizumab in the treatment of symptomatic dermographism by analyzing real-world data.
MethodsClinical data were collected from patients with symptomatic dermographism who completed 16-week treatment with omalizumab in Department of Dermatology, Peking University First Hospital from February 2018 to May 2021, and retrospectively analyzed. The analysis was done by comparing data obtained before and after the treatment, including critical friction thresholds (CFTs) , pruritus scores in a provocation test, as well as urticaria control test (UCT) , dermatology life quality index (DLQI) and chronic urticaria quality of life questionnaire (CU-Q2oL) scores. Adverse events reported by patients during the treatment were recorded. Wilcoxon signed-rank test was applied for the analysis of clinical data before and after the treatment.
ResultsA total of 27 patients with symptomatic dermographism who completed 16 weeks of omalizumab treatment were included. At baseline, the CFTs of all the 27 patients were 4, and their UCT, DLQI and CU-Q2oL scores were 7.0 (5.0, 8.0) , 9.0 (6.0, 10.0) , 63.0 (50.0, 72.0) points respectively. At week 4, the CFTs decreased from 4 to 0 in 9 patients (33.3%) , the UCT scores increased to 14.0 (12.0, 16.0) points ( Z = 4.548, P<0.05) , and the DLQI and CU-Q2oL scores decreased to 2.0 (0.0, 2.0) and 32.0 (25.0, 41.0) points respectively in the 27 patients ( Z = 4.513, 4.433, respectively, both P<0.05) . At week 6, the UCT scores increased to 15.0 (14.0, 16.0) points, and the DLQI and CU-Q2oL scores decreased to 0.0 (0.0, 1.0) and 25.0 (23.0, 30.0) points respectively in the 27 patients. No drug-related serious adverse events were reported during the treatment.
ConclusionOmalizumab can effectively improve the symptoms of symptomatic dermographism and patients′ quality of life with a good safety profile.
宋晓婷,刘擘,陈玉迪,等. 奥马珠单抗治疗27例人工荨麻疹回顾分析[J]. 中华皮肤科杂志,2021,54(12)：1092-1096.
DOI:10.35541/cjd.20210473版权归中华医学会所有。
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