奥马珠单抗治疗慢性荨麻疹的疗效和安全性回顾性分析

Efficacy and safety of omalizumab in the treatment of chronic urticaria:a retrospective analysis

目的回顾分析中国浙南地区奥马珠单抗对慢性荨麻疹(CU)的疗效和安全性。方法回顾2018年1月1日至2021年8月1日期间于温州医科大学第一附属医院接受奥马珠单抗治疗的CU患者资料,通过门诊随访形式,使用7天荨麻疹活动评分(UAS7)、荨麻疹控制评分(UCT)、皮肤病生活质量指数(DLQI)对疾病活动、控制情况及生活质量进行评价,评估病情变化、停药后复发情况及不良事件。正态分布的计量资料组间比较采用独立样本t检验,非正态分布的计量资料组间比较采用Wilcoxon符号秩和检验或Kruskal-WallisH检验,计数资料组间比较采用卡方检验或Fisher精确检验。结果共纳入252例抗组胺药应答不佳的CU患者,基线UCT为(5.0±2.4)分,UAS7为(25.6±6.2)分,DLQI为(17.5±4.7)分;其中204例(81.0%)奥马珠单抗初始治疗剂量为300mg,48例(19.0%)为150mg。在观察终点即(12.0±1.4)个月,奥马珠单抗治疗整体控制率达到90.3%(224/248),其中137例(55.2%)达到完全控制(UCT=16分),87例(35.1%)实现部分控制(12分≤UCT<16分),24例(9.7%)不受控制(UCT<12分),而10例部分控制患者在治疗剂量增加后转向完全控制。研究期间统计显示50例(36.5%)出现复发,其中32例选择用奥马珠单抗再治疗,30例(93.8%)达到部分或完全控制。治疗期间8例(3.2%)报告不良反应事件,均为轻中度。结论真实世界中奥马珠单抗治疗CU有效,可改善生活质量,并具有良好的安全性。

Objective To retrospectively analyze clinical efficacy and safety of omalizumab in the treatment of chronic urticaria(CU)in southern Zhejiang,China.Methods A retrospective observational study was conducted on CU patients who received omalizumab treatment at the First Affiliated Hospital of Wenzhou Medical University from January 1st,2018 to August Ist,2021.Through the outpatient follow-up visits,the disease activity,condition control,and quality of life were evaluated using the 7-day urticaria activity score(UAS7),urticaria control test(UCT),and dermatology life quality index(DLQI).In addition,changes in disease condition,recurrence after withdrawal,and adverse events were assessed.Independent-sample t test was used for intergroup comparisons of normally distributed measurement data,Wilcoxon signed-rank sum test or Kruskal-Wallis H test was used for comparisons of non-normally distributed measurement data,and chi-square test or Fisher's exact test was used for comparisons of enumeration data.Results A total of 252 CU patients with poor response to antihistamines were included,with a baseline UCT score of 5.0±2.4 points,a UAS7 score of 25.6±6.2 points,and a DLQI score of 17.5±4.7 points;among them,204(81.0%)were treated with omalizumab at an initial dose of 300 mg,and 48(19.0%)with omalizumab at an initial dose of 150 mg.At the end points(12.0±1.4 months after the start of treatment),an overall control rate of 90.3%(224/248)was achieved after the omalizumab treatment;concretely,137(55.2%)patients achieved complete control(UCT=16 points),87(35.1%)achieved partial control(12 points≤UCT<16 points),and 24(9.7%)showed no response(UCT<12 points),while 10 with partial response shifted to complete control after dose increase.During the treatment period,recurrence occurred in 50 patients(36.5%),of whom 32 patients opted for retreatment with omalizumab.