背景:本研究的目的是评估奥马珠单抗作为慢性荨麻疹(CU)治疗干预的临床有效性和安全性。
方法:从2023年3月1日至2023年9月30日,包括96名CU患者的队列数据,在我们医疗机构的过敏诊所接受了奥马珠单抗治疗,是系统地编译的。奥马珠单抗给药后,使用7日荨麻疹活动评分和荨麻疹对照试验评估治疗效果.
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,相应的平均累积剂量为765±450mg。在接受随访期超过3个月的42例CU患者中,据观察,治疗导致症状完全缓解,无复发病例记录.值得注意的是,出现合并症的患者和未出现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差异(p<0.01,95%CI:0.280-1.326;p<0.01,95%CI:0.597-2.997).此外,合并变应性鼻炎组和非合并变应性鼻炎组患者的治疗持续时间和累积剂量存在显着差异(p&lt;0.01,95%CI:0.204-1.305;p=0.01,95%CI:0.326-2.860)。
结论:奥马珠单抗通过有效控制症状并促进皮肤病变的消退,在中国患者中证明了治疗CU的有效性。评估其治疗功效通常需要12周的治疗期。此外,CU与其他过敏性疾病的共同发生是调整奥马珠单抗给药方案的相关考虑因素.
BACKGROUND: 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).
CONCLUSIONS: 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.