奥马珠单抗对慢性自发性荨麻疹患者的临床疗效和安全性分析

【摘要】 目的 观察奥马珠单抗治疗慢性自发性荨麻疹（CSU）的临床疗效和安全性。方法 回顾性分析2020年3 - 9月在中国医学科学院皮肤病医院诊断为CSU并接受奥马珠单抗（300 mg/4周，皮下注射）治疗3次的60例患者的临床资料。分别在第0、2、4、6、8、10、12周使用7 d荨麻疹活动评分（UAS7）和慢性荨麻疹生活质量评分（CU-Q2oL）评估患者的荨麻疹临床症状和生活质量。记录比较奥马珠单抗治疗前后其他药物使用的变化情况。组内治疗前后UAS7、CU-Q2oL比较采用配对t检验。结果 60例CSU患者均接受12周奥马珠单抗治疗。患者基线UAS7为（22.37 ± 8.88）分，治疗第1次后UAS7降至（2.01 ± 5.13）分，达到治疗平台期；第12周时降至（0.60 ± 2.63）分， 93.3%的患者UAS7降至0分，3.3%达良好控制（UAS7 1 ~ 6分）；UAS7降为0分所需时间为（22.4 ± 3.2） d。基线CU-Q2ol为（34.10 ± 15.01）分，治疗第1次后降至（2.41 ± 7.18）分，达到平台期，第12周为（0.56 ± 2.90）分， CU-Q2ol降至0分需要（21.15 ± 16.02） d。联用奥马珠单抗治疗后，既往治疗药物逐渐减量或停药，第12周时39例（65%）患者停用除奥马珠单抗外的治疗药物且症状达完全控制。治疗和随访过程中安全性良好，未发现不良反应。结论 奥马珠单抗（300 mg/4周）对CSU疗效显著且安全性好，为传统治疗效果不佳的CSU提供了新的治疗选择。

Clinical efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria

【Abstract】 Objective To evaluate the clinical efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria （CSU）. Methods Clinical data were collected from 60 patients, who were diagnosed with CSU and received subcutaneous injections of omalizumab at a dose of 300 mg once every 4 weeks for 3 sessions in Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College from March 2020 to September 2020, and retrospectively analyzed. At weeks 0, 2, 4, 6, 8, 10 and 12, urticaria activity score over 7 days （UAS7） and chronic urticaria quality of life （CU-Q2oL） score were used to evaluate clinical symptoms and quality of life of patients. Changes in the use of other drugs were evaluated before and after the treatment with omalizumab. Paired t test was used to compare UAS7 or CU-Q2oL score before and after treatment. Results All the 60 CSU patients received 12 weeks of omalizumab treatment. The baseline UAS7 score was 22.37 ± 8.88 points; after one session of the treatment, the UAS7 score dropped to 2.01 ± 5.13 points, reaching the treatment plateau; at week 12, it dropped to 0.6 ± 2.63 points, and 0 point （complete control） in 93.3% of the patients, 1 - 6 points （favorable control） in 3.3%; the time required for UAS7 score to decrease to 0 point was 22.4 ± 3.2 days. The baseline CU-Q2oL score was 34.10 ± 15.01 points; after one session of the treatment, the CU-Q2oL score dropped to 2.41 ± 7.18 points, reaching the treatment plateau; at week 12, it was 0.56 ± 2.90 points; the time required for CU-Q2oL score to drop to 0 point was 21.15 ± 16.02 days. After the combination treatment with omalizumab, a gradual decrease in dosage or withdrawal of previous therapeutic drugs was realized. At week 12, 39 patients （65%） achieved complete control, and withdrew all therapeutic drugs except omalizumab. During the treatment and follow-up, omalizumab showed good safety, and no adverse reactions were observed. Conclusion Omalizumab at a dose of 300 mg once every 4 weeks is markedly effective and safe for the treatment of CSU, providing a new treatment option for CSU patients with poor response to traditional therapy.