奥马珠单抗治疗儿童慢性荨麻疹的疗效和安全性回顾研究  

Efficacy and safety of omalizumab in the treatment of chronic urticaria in children:a retrospective study

作　　者：岳淑珍 树叶[1] 罗鸯鸯[1] 李珂瑶 张圆圆 汤建萍[1] 韦祝[1] Yue Shuzhen;Shu Ye;Luo Yangyang;Li Keyao;Zhang Yuanyuan;Tang Jianping;Wei Zhu(Department of Dermatology,Hunan Children′s Hospital,Changsha 410007,China)

机构地区：[1]湖南省儿童医院皮肤科,长沙410007

出　　处：《中华皮肤科杂志》2024年第4期354-358,共5页Chinese Journal of Dermatology

摘　　要：目的观察奥马珠单抗治疗儿童慢性荨麻疹的疗效和安全性。方法采用回顾性研究方法。收集2021年1-12月湖南省儿童医院皮肤科门诊收治的慢性荨麻疹患儿,根据用药方案不同,分为对照组和联合组。联合组采用皮下注射奥马珠单抗(150 mg,4周1次)联合常规剂量抗组胺药物治疗,对照组采用加倍剂量或联合抗组胺药物治疗。疗程3个月至半年,在治疗开始3、6、12个月后观察临床疗效、不良反应,治疗结束后3、6个月观察复发情况。结果共入组46例慢性荨麻疹患儿。联合组23例,男13例,女10例;年龄6~17岁,其中6~12岁16例,13~17岁7例;治疗前血清总IgE水平增高11例(IgE增高亚组)、正常12例(IgE正常亚组)。对照组23例,男13例,女10例;年龄6.33~16岁,其中6~12岁15例,13~17岁8例。治疗开始3、6、12个月后,联合组总有效率均为86.96%(20/23),对照组分别为52.17%(12/23)、56.52%(13/23)、56.52%(13/23),联合组疗效均优于对照组(P值分别为0.010、0.022、0.022)。治疗开始3、6、12个月后,联合组6~12岁患儿有效率均为14/16,13~17岁患儿均为6/7,两年龄组有效率差异无统计学意义(均χ^(2)=0.01,P=0.907)。治疗开始3、6、12个月后,对照组6~12岁患儿总有效率分别为5/15、6/15、5/15,疗效均低于联合组(P值分别为0.002、0.006、0.006)。联合组IgE增高亚组3、6、12个月有效率均为9/11,IgE正常亚组均为11/12,两组有效率差异均无统计学意义(均P=0.484)。治疗过程中两组患儿均未发现严重不良反应,仅对照组有2例轻度嗜睡。治疗结束后3个月,联合组16例均无复发,对照组6例中2例复发,联合组复发率低于对照组(P=0.030);治疗结束后6个月,联合组16例均无复发,对照组6例中有3例复发,联合组的复发率低于对照组(P=0.022)。结论奥马珠单抗联合常规剂量抗组胺药治疗儿童慢性荨麻疹不良反应少,能提高临床有效率,降低复发率。Objective To evaluate the efficacy and safety of omalizumab in the treatment of chronic urticaria in children.Methods A retrospective study was conducted.Patients with chronic urticaria were collected from the Department of Dermatology,Hunan Children′s Hospital from January to December 2021,and divided into a control group and a combination group according to different medication regimens.The patients in the combination group received subcutaneous injections of omalizumab(150 mg,once every 4 weeks)combined with conventional-dosage antihistamines,while the patients in the control group were only treated with double-dosage or multiple types of antihistamines.The course of treatment was 3 to 6 months.The clinical efficacy and adverse reactions were observed at 3,6,and 12 months after the start of treatment,and the recurrence was observed at 3 and 6 months after the end of treatment.Results A total of 46 children with chronic urticaria were collected.There were 13 males and 10 females in the combination group;they were aged from 6 to 17 years,including 16 aged from 6 to 12 years and 7 aged from 13 to 17 years;according to the total serum IgE levels before treatment,the patients in the combination group were divided into an increased IgE subgroup(11 cases)and a normal IgE subgroup(12 cases).In the control group,there were 13 males and 10 females;they were aged from 6.33 to 16 years,including 15 aged from 6 to 12 years and 8 aged from 13 to 17 years.At 3,6,and 12 months after the start of treatment,all the total response rates in the combination group were 86.96%(20/23),which were all significantly higher than those in the control group(52.17%[12/23],56.52%[13/23],56.52%[13/23],P=0.010,0.022,0.022,respectively).In the combination group,the response rates at 3,6,and 12 months after the start of treatment were all 14/16 in the children aged 6 to 12 years and 6/7 in those aged 13 to 17 years,and there were no significant differences between the two age groups(allχ^(2)=0.01,all P=0.907);in the control group,the response

关 键 词：荨麻疹 儿童 治疗 生物制剂 复发 奥马珠单抗 慢性荨麻疹 

分 类 号：R758.24[医药卫生—皮肤病学与性病学]