中华皮肤科杂志 ›› 2021, Vol. 54 ›› Issue (12): 1063-1070.doi: 10.35541/cjd.20210324

• 论著 • 上一篇    下一篇

奥马珠单抗治疗慢性自发性荨麻疹的疗效及安全性分析

宋晓婷1    刘擘1    陈玉迪2    于淼1，3     廖双璐1    栾婷婷1，3    赵作涛1   

  1. 1北京大学第一医院皮肤性病科  国家皮肤与免疫疾病临床医学研究中心  北京市皮肤病分子诊断重点实验室  100034；2北京医院皮肤科 国家老年医学中心  中国医学科学院老年医学研究院  100730；3北京大学护理学院  100191
  • 收稿日期:2021-04-21 修回日期:2021-09-21 发布日期:2021-12-01
  • 通讯作者: 赵作涛 E-mail:zhaozuotaotao@163.com
  • 基金资助:
    国家自然科学基金中德合作项目（GZ901）

Efficacy and safety of omalizumab for treatment of chronic spontaneous urticaria

Song Xiaoting1, Liu Bo1, Chen Yudi2, Yu Miao1,3, Liao Shuanglu1, Luan Tingting1,3, Zhao Zuotao1   

  1. 1Department of Dermatology and Venereology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Diseases, Beijing 100034, China; 2Department of Dermatology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China; 3Peking University School of Nursing, Beijing 100191, China
  • Received:2021-04-21 Revised:2021-09-21 Published:2021-12-01
  • Contact: Zhao Zuotao E-mail:zhaozuotaotao@163.com
  • Supported by:
    Joint Sino-German Research Project of National Natural Science Foundation of China and DFG（GZ901）

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摘要： 【摘要】 目的 回顾分析奥马珠单抗治疗慢性自发性荨麻疹（CSU）的疗效、安全性及停药复发情况。方法 回顾北京大学第一医院皮肤科门诊2018年2月至2021年1月使用奥马珠单抗治疗的CSU病例，分析其临床特征，采用门诊随访形式，通过荨麻疹控制评分（UCT）、皮肤病生活质量指数（DLQI）评估疾病严重程度，监测不良事件及停药后复发情况。正态分布的计量资料组间比较采用独立样本t检验或方差分析，非正态分布的计量资料组间比较采用Mann-Whitney U检验、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 纳入59例CSU患者，奥马珠单抗治疗至少3个月，其中45例治疗达6个月，15例达12个月。经奥马珠单抗治疗，UCT从基线期3.0（1.0，6.0）分上升至第1个月11.0 （3.0，14.0）分和第3个月15.0 （12.0，16.0）分（均P < 0.05）。DLQI从基线期16.0（12.0，20.0）分下降至第1个月7.0 （1.0，13.0）分和第3个月1.0 （0.0，4.0）分（均P < 0.05）。疾病部分或完全控制的比例在基线期为0，第1个月上升至44.1%，第3个月达78.0%，第6个月达88.9%。疾病对生活质量存在重度或极重度影响的比例在基线期为84.7%，第1个月降至30.5%，第3个月降至15.3%，第6个月降至4.4%。对奥马珠单抗治疗完全反应组和部分反应组比无反应组病程更短（t = -2.894，P = 0.011；t = -2.511，P = 0.036）；完全反应组比部分反应组和无反应组治疗时间更长（t = 2.479，P = 0.039；t = 2.677，P = 0.022）。慢反应组与快反应组相比，基线DLQI更高（Z = -2.622，P = 0.009），基线UCT更低（Z = -2.746，P = 0.006）。19例患者病情完全控制后停药，其中13例（68.4%）在停药7（5，8）周后复发，复发后UCT评分高于治疗前（Z = 3.172，P = 0.001），复发组比未复发组病程更长（Z = -2.635，P = 0.007）。复发后5例重新开始奥马珠单抗治疗，均再次得到部分或完全控制。治疗期间报告不良反应事件均为轻中度。结论 奥马珠单抗能够有效控制CSU症状，提高患者生活质量，且安全性较好，但停药后复发率高，复发后重新开始奥马珠单抗治疗仍有效。

关键词: 荨麻疹, 治疗结果, 慢性自发性荨麻疹, 奥马珠单抗

Abstract: 【Abstract】 Objective To retrospectively evaluate efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria（CSU）, as well as recurrence after its withdrawal. Methods Clinical data on patients with CSU, who received omalizumab treatment in Peking University First Hospital from February 2018 to January 2021, were collected and analyzed retrospectively. Through outpatient follow-up, urticaria control test （UCT） and dermatology life quality index （DLQI） were recorded to assess disease severity, and adverse events and recurrence after omalizumab withdrawal were monitored. Comparisons of normally distributed measurement data between groups were carried out using t test or analysis of variance, comparisons of non-normally distributed measurement data between groups using Mann-Whitney U test, Wilcoxon signed-rank test or Kruskal-Wallis H test, and comparisons of enumeration data between groups using chi-square test or Fisher′s exact test. Results A total of 59 patients with CSU were included and treated with omalizumab for at least 3 months, of whom, 45 were treated for more than 6 months, and 15 for more than 12 months. After the start of omalizumab treatment, UCT scores increased from 3.0 （1.0, 6.0） points at baseline to 11.0 （3.0, 14.0） points at 1 month and 15.0 （12.0, 16.0） points at 3 months （both P < 0.05）; DLQI scores decreased from 16.0 （12.0, 20.0） points at baseline to 7.0 （1.0, 13.0） points at 1 month and 1.0 （0.0, 4.0） points at 3 months （both P < 0.05）. The proportion of patients achieving partial or complete disease control increased from 0 at baseline to 44.1% at 1 month, 78.0% at 3 months, and 88.9% at 6 months. The proportion of patients whose quality of life was severely or extremely severely affected by CSU decreased from 84.7% at baseline to 30.5% at 1 month, 15.3% at 3 months, and 4.4% at 6 months. The disease duration was significantly shorter in the complete response group and partial response group than in the non-response group （t = -2.894, -2.511, P = 0.011, 0.036, respectively）; the treatment duration was significantly longer in the complete response group than in the partial response group and non-response group （t = 2.479, 2.677, P = 0.039, 0.022, respectively）. Compared with the rapid response group, the slow response group showed higher DLQI scores （Z =－2.622, P = 0.009） and lower UCT scores （Z =－2.746, P = 0.006） at baseline. Nineteen patients withdrew omalizumab after complete control of CSU, of whom 13 （68.4%） experienced relapse 7.0 （5.0, 8.0） weeks after the withdrawal, and showed significantly higher UCT scores at relapse than at baseline （Z = 3.172, P = 0.001）. The disease duration was significantly longer in the recurrence group than in the non-recurrence group （Z =－2.635, P = 0.007）. After recurrence, 5 patients restarted omalizumab treatment, and all of them regained partial or complete disease control. The adverse events reported during the treatment were all mild to moderate. Conclusions Omalizumab can effectively and safely control symptoms of CSU and improve the quality of life of patients with CSU. However, recurrence frequently occurs after omalizumab withdrawal, and reinitiating omalizumab treatment after recurrence is still effective.

Key words: Urticaria, Treatment outcome, Chronic spontaneous urticaria, Omalizumab