中华皮肤科杂志 ›› 2023, Vol. 56 ›› Issue (6): 518-524.doi: 10.35541/cjd.20220287

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[开放获取]   奥马珠单抗治疗慢性荨麻疹的疗效和安全性回顾性分析

杨娜丽    许秋阳    吴含文    叶雅慧    朱吉玲    刘晶晶    李智铭   

  1. 温州医科大学第一附属医院皮肤性病科，温州  325000
  • 收稿日期:2022-04-24 修回日期:2022-10-18 发布日期:2023-06-05
  • 通讯作者: 李智铭 E-mail:zmli0328@163.com
  • 基金资助:
    国家自然科学基金（82002727）；浙江省自然科学基金（LY22H160030）

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

Yang Nali, Xu Qiuyang, Wu Hanwen, Ye Yahui, Zhu Jiling, Liu Jingjing, Li Zhiming   

  1. Department of Dermatology and Venereology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, Zhejiang, China
  • Received:2022-04-24 Revised:2022-10-18 Published:2023-06-05
  • Contact: Li Zhiming E-mail:zmli0328@163.com
  • Supported by:
    National Natural Science Foundation of China （82002727）; Natural Science Foundation of Zhejiang Province （LY22H60030）

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摘要： 【摘要】 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-Wallis H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300 mg，48例（19.0%）为150 mg。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。

关键词: 荨麻疹, 生物制剂, 治疗结果, 生活质量, 毒性作用, 慢性荨麻疹, 奥马珠单抗

Abstract: 【Abstract】 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 1st, 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, and then 30 （93.8%） achieved partial or complete control. Adverse events were reported in 8 patients （3.2%）, and all were mild or moderate. Conclusion Omalizumab was effective in the real-world treatment of CU, and could improve patients′ quality of life, with a favorable safety profile.

Key words: Urticaria, Biological agents, Treatment outcome, Quality of life, Toxic actions, Chronic urticaria, Omalizumab

引用本文

杨娜丽 许秋阳 吴含文 叶雅慧 朱吉玲 刘晶晶 李智铭. [开放获取]   奥马珠单抗治疗慢性荨麻疹的疗效和安全性回顾性分析[J]. 中华皮肤科杂志, 2023,56(6):518-524. doi:10.35541/cjd.20220287

Yang Nali, Xu Qiuyang, Wu Hanwen, Ye Yahui, Zhu Jiling, Liu Jingjing, Li Zhiming. Efficacy and safety of omalizumab in the treatment of chronic urticaria: a retrospective analysis[J]. Chinese Journal of Dermatology, 2023, 56(6): 518-524.doi:10.35541/cjd.20220287