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奥马珠单抗治疗慢性荨麻疹的真实世界疗效:一项临床观察研究。

Real-World Effectiveness of Omalizumab in Chronic Urticaria: A Clinical Observational Study.

机构信息

Department of Dermatology and Venereology, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China.

Peking University School of Medicine, School of Clinical Medicine, Beijing, China.

出版信息

Int Arch Allergy Immunol. 2024;185(7):718-728. doi: 10.1159/000538011. Epub 2024 Mar 21.

Abstract

INTRODUCTION

The purpose of this study was to assess the clinical effectiveness and safety profile of omalizumab as a therapeutic intervention for chronic urticaria (CU).

METHODS

From March 1, 2023, to September 30, 2023, data on a cohort comprising 96 patients with CU, who underwent treatment with omalizumab at our medical institution's allergy clinic, were systematically compiled. Subsequent to the administration of omalizumab, the therapeutic efficacy was assessed utilizing the 7-day urticaria activity score and the urticaria control test.

RESULTS

Based on the statistical analysis, the mean duration of therapeutic intervention was 2.4 ± 1.3 months, with a corresponding mean cumulative dosage of 765 ± 450 mg. Of the subset of 42 patients with CU who were subjected to a follow-up period exceeding 3 months, it was observed that the treatment led to complete symptom remission, and no instances of recurrence were documented. Notably, there were statistically significant differences in the treatment duration and the cumulative dosage between patients who experienced co-morbid conditions and those who did not (p < 0.01, 95% CI: 0.280-1.326; p < 0.01, 95% CI: 0.597-2.997). Furthermore, there were significant differences in the treatment duration and cumulative dosage between patients in the combined allergic rhinitis group and those in the non-combined allergic rhinitis group (p < 0.01, 95% CI: 0.204-1.305; p = 0.01, 95% CI: 0.326-2.860).

CONCLUSION

Omalizumab demonstrates efficacy in the management of CU among Chinese patients by exerting effective symptom control and facilitating the regression of skin lesions. The assessment of its therapeutic efficacy typically requires a 12-week treatment period. Moreover, the co-occurrence of CU with other allergic disorders serves as a pertinent consideration for the adjustment of omalizumab dosing regimens.

摘要

简介

本研究旨在评估奥马珠单抗作为慢性荨麻疹(CU)治疗干预措施的临床疗效和安全性。

方法

从 2023 年 3 月 1 日至 2023 年 9 月 30 日,系统地收集了在我们医疗机构过敏诊所接受奥马珠单抗治疗的 96 例 CU 患者的队列数据。在使用奥马珠单抗治疗后,利用 7 天荨麻疹活动评分和荨麻疹控制测试评估治疗效果。

结果

根据统计分析,治疗干预的平均持续时间为 2.4 ± 1.3 个月,相应的累积剂量为 765 ± 450mg。在接受随访超过 3 个月的 42 例 CU 患者亚组中,观察到治疗导致完全症状缓解,且无复发记录。值得注意的是,患有合并症的患者和无合并症的患者在治疗持续时间和累积剂量方面存在统计学显著差异(p < 0.01,95%置信区间:0.280-1.326;p < 0.01,95%置信区间:0.597-2.997)。此外,在合并过敏性鼻炎组和非合并过敏性鼻炎组的患者之间,治疗持续时间和累积剂量也存在显著差异(p < 0.01,95%置信区间:0.204-1.305;p = 0.01,95%置信区间:0.326-2.860)。

结论

奥马珠单抗通过有效控制症状和促进皮损消退,对中国患者的 CU 具有疗效。评估其治疗效果通常需要 12 周的治疗期。此外,CU 与其他过敏疾病同时发生是调整奥马珠单抗剂量方案的一个重要考虑因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8861/11216351/fa10160edfe4/iaa-2024-0185-0007-538011_F01.jpg

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