两种度普利尤单抗注射方案联合激素治疗类天疱疮的疗效和安全性  

Efficacy and safety of two dupilumab injection regimens combined with steroid for bullous pemphigoid

作　　者：杨金 张臻[1] 刘书韬 高海清 陈姿桦 王兰庭 杨凡萍 陈圣安[1] 唐昶 骆肖群[1] YANG Jin;ZHANG Zhen;LIU Shu-tao;GAO Hai-qing;CHEN Zi-hua;WANG Lan-ting;YANG Fan-ping;CHEN Sheng-an;TANG Chang;LUO Xiao-qun(Department of Allergy and Immunology,Department of Dermatology,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院变态反应(过敏和免疫)科,皮肤科,上海200040

出　　处：《中华临床免疫和变态反应杂志》2023年第2期127-132,共6页Chinese Journal of Allergy & Clinical Immunology

基　　金：2021年医疗服务与保障能力提升项目(国家临床重点专科建设项目);复旦大学附属华山医院变态反应多学科联合诊疗团队建设(3030294001)。

摘　　要：目的分析两种度普利尤单抗注射方案联合小剂量激素治疗类天疱疮的疗效和安全性。方法80例类天疱疮患者非随机分为研究组A、B及对照组1、2。研究组A予度普利尤单抗首剂600 mg皮下注射,后每两周300 mg注射;研究组B予度普利尤单抗600 mg周,连续注射两周后,改为300 mg周连续注射两周,继以每两周予300 mg。研究组在治疗初始同时予小剂量激素[甲泼尼龙<0.4 mg(kg·d)]口服。对照组1仅予激素口服;对照组2采用静脉用免疫球蛋白联合口服激素。比较各组皮损控制时间、激素用量、疾病相关评分及抗体滴度变化及不良事件发生率。结果研究组B皮损控制时间(11 d)显著短于研究组A(14 d)(P<0.05),两研究组皮损控制时间均短于对照组(P<0.05)。研究组A及研究组B甲泼尼龙有效控制剂量(24.6及23.4 mg d)及累积用量(376.8及334.2 mg)均分别显著低于两对照组(P<0.05),两研究组间无统计学差异(P>0.05)。两研究组大疱性类天疱疮疾病面积指数(BPDAI)评分及呈现瘙痒评分相对于基线变化较对照组降低更显著(P<0.05);第2、4周,研究组B相关评分较基线变化显著高于研究组A。第4、6周,研究组A自身抗体BP180下降水平较单纯激素治疗组更显著(P<0.05)。研究组不良反应发生率明显低于对照组1(P<0.05)。结论度普利尤单抗联合小剂量激素治疗类天疱疮相较于既往系统治疗具有更好的疗效和安全性;前4周连续进行度普利尤单抗注射方案较传统注射方案,对于类天疱疮症状缓解表现更佳。Objective To analyze the efficacy and safety of two injection regimens of dupilumab combined with low-dose oral steroid in the treatment of bullous pemphigoid(BP).Methods Eighty BP patients were non-randomly divided into study groups A and B and control groups 1 and 2.Patients in study group A received initial subcutaneous injection of 600 mg dupilumab,followed by 300 mg every two weeks.Study group B received 600 mg dupilumab once a week for the first two weeks,and then injected 300 mg weekly for the next two weeks,followed by 300 mg biweekly.Both study groups were given low-dose oral steroid at the beginning of treatment.Control group 1 was administered oral steroid only;control group 2 received intravenous immunoglobulin combined with oral steroid.Time to disease control,the control dose and cumulative dosage of methylprednisolone,the disease-related scores,changes of autoantibody BP180,and incidence of adverse events were compared among different groups.Results The time to disease control in study group B(11 days)was significantly shorter than that in study group A(14 days)(P<0.05),and the time to control in both study groups was shorter than that in control groups(P<0.05).The effective control dose(24.6 and 23.4 mg d)and cumulative dosage(376.8 and 334.2 mg)of methylprednisolone in study group A and study group B were significantly lower than those of two control groups(P<0.05),but there was no statistical difference between the two study groups(P>0.05).The percentage decrease from baseline in bullous pemphigoid disease area index(BPDAI)scores and pruritus scores were more significant in study groups than those in control groups(P<0.05).In the 2nd and 4th week,the changes of related scores in study group B were significantly greater than those in study group A.At the 4th and 6th week,the level of autoantibody BP180 in study group A decreased more significantly than that in control group 1(P<0.05).The incidence of adverse reactions in the two study groups was significantly lower than that in control group 1(P<

关 键 词：度普利尤单抗 类天疱疮 2型炎症反应 自身免疫性大疱病 

分 类 号：R758.66[医药卫生—皮肤病学与性病学]