中华皮肤科杂志 ›› 2025, Vol. 58 ›› Issue (6): 536-539.doi: 10.35541/cjd.20240729

• 研究报道 • 上一篇    下一篇

奥马珠单抗治疗妊娠期或哺乳期慢性自发性荨麻疹患者8例临床分析

赵美茹1    肖萌1    张新美   张俊艳1    亓玉青2    王惠平1   

  1. 1天津医科大学总医院皮肤性病科  天津性传播疾病研究所,天津  300052;2天津医科大学总医院变态反应科,天津  300052
  • 收稿日期:2024-12-31 修回日期:2025-04-22 发布日期:2025-06-03
  • 通讯作者: 王惠平 E-mail:huiping1208@163.com
  • 基金资助:
    天津市医学重点学科(专科)建设项目(TJYXZDXK-057B)

Omalizumab for the treatment of eight patients with chronic spontaneous urticaria during pregnancy and lactation

Zhao Meiru1, Xiao Meng1, Zhang Xinmei1, Zhang Junyan1, Qi Yuqing2, Wang Huiping1   

  1. 1Department of Dermatovenereology, Tianjin Medical University General Hospital/Tianjin Institute of Sexually Transmitted Disease, Tianjin 300052, China; 2Department of Allergy, Tianjin Medical University General Hospital, Tianjin 300052, China
  • Received:2024-12-31 Revised:2025-04-22 Published:2025-06-03
  • Contact: Wang Huiping E-mail:huiping1208@163.com
  • Supported by:
    Tianjin Key Medical Discipline (Specialty) Construction Project(TJYXZDXK-057B)

摘要: 【摘要】 目的 探讨奥马珠单抗治疗妊娠期或哺乳期慢性自发性荨麻疹(CSU)患者的疗效和安全性。方法 本研究为单中心回顾性研究。收集2022年2月至2024年12月于天津医科大学总医院皮肤性病科及变态反应科门诊接受奥马珠单抗治疗的妊娠期或哺乳期CSU患者8例,其中妊娠期3例,哺乳期5例。分析患者的临床资料,包括年龄、CSU病程、奥马珠单抗开始治疗时间、其治疗剂量/间隔等。治疗随访过程中,使用7日荨麻疹活动度评分(UAS7)评估CSU患者的疾病活动度,同时记录不良事件。结果 8例患者年龄29 ~ 40(33.25 ± 3.81)岁,病程[M(Q1,Q3)]为2.8(1.6,5.2)年。妊娠期3例患者均为受孕前开始使用奥马珠单抗,剂量每3 ~ 4周300 mg,治疗3 ~ 8次后确认妊娠,之后顺利分娩;哺乳期5例患者均于哺乳期开始接受奥马珠单抗治疗,剂量150 ~ 300 mg/4周。8例患者接受奥马珠单抗注射3 ~ 24次,平均10.38次;奥马珠单抗治疗前,UAS7评分为6.0(2.8,23.5)分;治疗期间,UAS7评分为0 ~ 6分,患者CSU症状均完全控制或控制良好。3例妊娠期患者均未出现母体不良事件、小于胎龄低出生体重、早产(< 37周)、自然流产(< 28周)、先天畸形、婴儿不良事件;1例哺乳期患者在首次注射奥马珠单抗6 h后出现低热、乏力,48 h内自行缓解;其他4例哺乳期患者均未出现母体或婴儿不良事件。结论 奥马珠单抗可能是妊娠期及哺乳期CSU患者有效且安全的治疗选择。

关键词: 荨麻疹, 慢性自发性荨麻疹, 奥马珠单抗, 妊娠期, 哺乳期, 疗效, 安全性

Abstract: 【Abstract】 Objective To investigate the efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria (CSU) during pregnancy and lactation. Methods A single-center retrospective study was conducted. From February 2022 to December 2024, 8 pregnant or lactating patients with CSU who received omalizumab treatment were collected from the Departments of Dermatovenereology and Allergy, Tianjin Medical University General Hospital, including 3 pregnant and 5 lactating patients. Clinical data were analyzed, including the patients′ ages, disease duration of CSU, timing of omalizumab initiation, dosage and treatment intervals of omalizumab. During the treatment and follow-up, the 7-day urticaria activity score (UAS7) was used to evaluate disease activity of CSU patients, and adverse events were recorded. Results The ages of the 8 patients ranged from 29 to 40 (33.25 ± 3.81) years, and the disease duration of CSU (M [Q1, Q3]) was 2.8 (1.6, 5.2) years. Three patients began omalizumab treatment before conception, with a dose of 300 mg every 3 - 4 weeks; after 3 - 8 sessions of treatment, pregnancy was confirmed, followed finally by successful deliveries. Five patients started omalizumab treatment at doses of 150 - 300 mg/4 weeks during lactation. All the 8 patients received omalizumab injections for 3 - 24 sessions, with an average of 10.38 sessions. Before omalizumab treatment, the UAS7 scores were 6.0 (2.8,23.5) points; during the treatment, UAS7 scores decreased to 0 - 6 points, and CSU symptoms were completely controlled or well controlled. None of the 3 pregnant patients reported maternal adverse events, small-for-gestational-age or low-birth-weight infant outcomes, premature delivery (< 37 weeks), spontaneous abortion (< 28 weeks), congenital malformations in infants, or infant adverse events. One lactating patient developed a mild fever and fatigue 6 hours after the first omalizumab injection, which resolved spontaneously within 48 hours; the other 4 lactating patients did not experience any maternal or infant adverse events. Conclusion Omalizumab may be an effective and safe treatment option for CSU patients during pregnancy and lactation.

Key words: Urticaria, Chronic spontaneous urticaria, Omalizumab, Pregnancy, Lactation, Efficacy, Safety

引用本文

赵美茹 肖萌 张新美 张俊艳 亓玉青 王惠平. 奥马珠单抗治疗妊娠期或哺乳期慢性自发性荨麻疹患者8例临床分析[J]. 中华皮肤科杂志, 2025,58(6):536-539. doi:10.35541/cjd.20240729

Zhao Meiru, Xiao Meng, Zhang Xinmei, Zhang Junyan, Qi Yuqing, Wang Huiping. Omalizumab for the treatment of eight patients with chronic spontaneous urticaria during pregnancy and lactation[J]. Chinese Journal of Dermatology, 2025, 58(6): 536-539.doi:10.35541/cjd.20240729