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奥马珠单抗在慢性荨麻疹中的应用的中国专家共识(2021)

制定者:
中国皮肤性病专家编写小组

2021年12月4日

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中英对照

Chronic urticaria(CU)is a debilitating skin disease that lasts for more than 6 weeks with wheals and/or angioedema,including chronic spontaneous urticaria(CSU)and chronic inducible urticaria(CIndU).In China,the prevalence of this disease is high,more than 1%,and on the rise.CU has a major impact on the quality of life(QoL)of patients who frequently experience sleep disturbance,depression,and anxiety.Nearly one-third of patients with CSU,in China,are resistant to second generation H1-antihistamines(sgAHs),even at a fourfold dose(second line;off-label).Omalizu mab is approved for the treatment of CSU treatment in Europe and shows remarkable effificacy and safety.In China,regulatory approval for the use of omalizumab is pending,and its use in clinical practice varies widely.Consensus on omalizumab CU treatment in China is urgently needed.The aim of this article is to propose a practical omalizumab treatment algorithm for the management of antihistamine-resistant CSU and CIndU in adults and special population including children and adolescents,and pregnant or breast feeding women,to guide daily clinical practice in China.In the development of this consensus,an expert group including mainly dermatologists,allergists,but also pulmonologists,ENTs,immunologists,and pediatricians in Allergic Disease Prevention and Control Committee,Chinese Preventive Medicine Association,reviewed the existing evidence and developed consensus on the use of omalizumab in CU patients from China.The goal of this consensus is to assist clinicians in making rational decisions in the management of refractory CU with omalizumab.The key clinical questions covered by the treatment algorithm are:1)Omali zumab treatment routine strategy in both CSU and CIndU patients;2)Recommended dose and treatment duration for different age stratifification;3)Treatment duration for CU patients with other allergic comorbidities;4)Recommendation on omalizumab stopping strategy.

慢性荨麻疹 (CU) 是一种使人衰弱的皮肤病,持续6周以上,伴有风团和/或血管性水肿,包括慢性自发性荨麻疹 (CSU) 和慢性诱导性荨麻疹 (CIndU)。在中国,该疾病的患病率较高,超过1%,并且呈上升趋势。CU对经常发生睡眠障碍、抑郁和焦虑的患者的生活质量 (QoL) 有重大影响。在中国,近三分之一的 CSU 患者对第二代 H1-抗组胺药 (sgAHs) 耐药,即使是4倍剂量(二线;超说明书使用)也是如此。奥马利珠单抗在欧洲获批用于治疗CSU,并显示出显著的疗效和安全性。在中国,奥马利珠单抗的监管批准正在等待中,奥马珠单抗在成人和特殊人群(包括儿童和青少年、孕妇或哺乳期妇女)中的治疗方案是非常必要的。本文的目的是提出一种实用的奥马珠单抗治疗方案,用于治疗抗组胺药耐药的 CSU 和CIndU,以指导中国的日常临床实践。在本共识的制定过程中,由中华预防医学会变态反应疾病防治委员会的皮肤科医生、过敏症专科医生以及肺科医生、ENTs、免疫学家和儿科医生组成的专家组对现有证据进行了审查,并就奥马珠单抗在中国 CU 患者中的使用达成了共识。本共识的目的是协助临床医生对奥马珠单抗难治性 CU 的治疗做出合理的决策。治疗方案涵盖的临床问题是:1)CSU和 CIndU 患者的奥马珠单抗治疗常规策略;2)不同年龄分层的 CU 患者的推荐剂量和治疗持续时间;3)CU合并其他过敏合并症的患者的治疗持续时间;4)CU合并其他疾病的治疗方案。4)关于奥马珠单抗停药策略的建议。

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奥马珠单抗在慢性荨麻疹中的应用的中国专家共识(2021)
发布时间:  2021年12月4日
制定者:  
中国皮肤性病专家编写小组

257人浏览

0收藏

0次下载

摘要

Chronic urticaria(CU)is a debilitating skin disease that lasts for more than 6 weeks with wheals and/or angioedema,including chronic spontaneous urticaria(CSU)and chronic inducible urticaria(CIndU).In China,the prevalence of this disease is high,more than 1%,and on the rise.CU has a major impact on the quality of life(QoL)of patients who frequently experience sleep disturbance,depression,and anxiety.Nearly one-third of patients with CSU,in China,are resistant to second generation H1-antihistamines(sgAHs),even at a fourfold dose(second line;off-label).Omalizu mab is approved for the treatment of CSU treatment in Europe and shows remarkable effificacy and safety.In China,regulatory approval for the use of omalizumab is pending,and its use in clinical practice varies widely.Consensus on omalizumab CU treatment in China is urgently needed.The aim of this article is to propose a practical omalizumab treatment algorithm for the management of antihistamine-resistant CSU and CIndU in adults and special population including children and adolescents,and pregnant or breast feeding women,to guide daily clinical practice in China.In the development of this consensus,an expert group including mainly dermatologists,allergists,but also pulmonologists,ENTs,immunologists,and pediatricians in Allergic Disease Prevention and Control Committee,Chinese Preventive Medicine Association,reviewed the existing evidence and developed consensus on the use of omalizumab in CU patients from China.The goal of this consensus is to assist clinicians in making rational decisions in the management of refractory CU with omalizumab.The key clinical questions covered by the treatment algorithm are:1)Omali zumab treatment routine strategy in both CSU and CIndU patients;2)Recommended dose and treatment duration for different age stratifification;3)Treatment duration for CU patients with other allergic comorbidities;4)Recommendation on omalizumab stopping strategy.

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