度普利尤单抗联合米诺环素或联合米诺环素及系统糖皮质激素治疗大疱性类天疱疮的队列研究  

Dupilumab combined with minocycline or with minocycline and systemic glucocorticoids for the treatment of bullous pemphigoid:a cohort study

作　　者：胡珺鈺 陈丹阳 陈喜雪[1] 王明悦[1] Hu Junyu;Chen Danyang;Chen Xixue;Wang Mingyue(Department of Dermatology and Venereology,Peking University First Hospital,National Clinical Research Center for Skin and Immune Diseases,Beijing Key Laboratory of Molecular Diagnosis on Dermatoses,NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics,Beijing 100034,China)

机构地区：[1]北京大学第一医院皮肤性病科、国家皮肤与免疫疾病临床医学研究中心、皮肤分子诊断北京市重点实验室、国家药品监督管理局化妆品质量控制与评价重点实验室,北京100034

出　　处：《中华皮肤科杂志》2024年第10期917-924,共8页Chinese Journal of Dermatology

摘　　要：目的比较度普利尤单抗联合米诺环素或联合米诺环素及系统糖皮质激素(sGC)与米诺环素单药或联合sGC在大疱性类天疱疮(BP)患者中的疗效、用药剂量及安全性。方法本研究为回顾性队列研究。回顾分析2021年3月至2022年6月就诊于北京大学第一医院皮肤性病科且采用米诺环素单药或联合sGC(M-MG组)、度普利尤单抗联合米诺环素或联合米诺环素及sGC(MD-MGD组)的BP患者。比较两组疾病控制(DC)率、达DC时间、疾病完全缓解(CR)率、达CR时间及BP疾病面积指数(BPDAI)评分、药物使用情况、皮肤瘙痒症状缓解时间、复发情况及不良反应发生情况。生存分析通过绘制Kaplan-Meier(KM)曲线采用Log-rank检验。两组患者按1∶1进行倾向性评分匹配以控制混杂因素。结果共纳入患者164例,M-MG组110例,男62例,女48例,年龄(74.6±12.8)岁;MD-MGD组54例,男33例,女21例,年龄(74.6±13.3)岁。随访2周时,两组患者达DC比例差异无统计学意义(P=0.341);M-MG组米诺环素剂量、使用sGC患者比例、sGC剂量及sGC累积剂量均高于MD-MGD组(均P<0.05)。随访过程中两组共152例(92.7%)患者达DC,两组DC率、达DC时间差异无统计学意义(P>0.05);52例(31.7%)患者达CR,MD-MGD组(16/54,29.6%)与M-MG组CR率(36/110,32.7%)差异无统计学意义(χ^(2)=0.16,P=0.689),但达CR时间[M(Q1,Q3):98.5(78.0,185.2)d]短于M-MG组[223.5(175.2,277.0)d,P=0.001]。KM生存曲线分析显示,MD-MGD组累积疾病CR率高于M-MG组(P=0.024)。随访过程中共73例(44.5%)患者记录了瘙痒缓解时间,MD-MGD组[54例,14.0(3.0,14.0)d]较M-MG组更短[19例,14.0(7.0,19.0)d;P=0.015]。倾向性评分匹配后,M-MG组和MD-MGD组分别纳入42例患者;随访过程中M-MG组与MD-MGD组CR率差异无统计学意义(P>0.05),M-MG组达CR时间长于MD-MGD组(P=0.019);KM生存曲线分析显示,MD-MGD组累积疾病CR率高于M-MG组(P=0.041)。164例患者中,58例(35.4%)出现不良事件,11例(6.70%)出现3级及以上重度不良�Objective To compare the efficacy,dosage,and safety of dupilumab combined with minocycline or with minocycline and systemic glucocorticoids(sGC)versus minocycline alone or in combination with sGC in patients with bullous pemphigoid(BP).Methods A retrospective cohort study was conducted on BP patients who visited the Department of Dermatology,Peking University First Hospital from March 2021 to June 2022 and were treated with one of the following two therapeutic regimens:minocycline alone or in combination with sGC(M-MG group),and dupilumab combined with minocycline or with minocycline and sGC(MD-MGD group).Disease control rates,time to disease control,complete remission rates,time to complete remission,BP disease area index(BPDAI)scores,drug usage,time to pruritus relief,relapse rates,and occurrence rates of adverse reactions were compared between the two groups.Survival analysis was performed using Kaplan-Meier(KM)curves and Log-rank test.Confounders were controlled by 1∶1 matching on the propensity score in the two groups.Results A total of 164 patients were collected,including 110 in the M-MG group(62 males and 48 females,aged 74.6±12.8 years)and 54 in the MD-MGD group(33 males and 21 females,aged 74.6±13.3 years).After two-week follow-up,there was no significant difference in the disease control rate between the two groups(P=0.341);however,the minocycline dose,proportion of patients using sGC,sGC dose,and cumulative sGC dose were all significantly higher in the M-MG group than in the MD-MGD group(all P<0.05).A total of 152 patients(92.7%)achieved disease control in the two groups during the follow-up,while the disease control rate and time to disease control did not differ between the two groups(both P>0.05);52 patients(31.7%)achieved complete remission,there was no significant difference in the complete remission rate between the MD-MGD group(16/54,29.6%)and M-MG group(36/110,32.7%;χ^(2)=0.16,P=0.689),but the time to complete remission(M[Q1,Q3])was significantly shorter in the MD-MGD group(98.5[78.0,185.

关 键 词：类天疱疮 大疱性 度普利尤单抗 米诺环素 系统糖皮质激素 疗效 安全性 

分 类 号：R758.66[医药卫生—皮肤病学与性病学]