度普利尤单抗在104例大疱性类天疱疮患者中的应用及疗效影响因素分析  

Application of dupilumab in the treatment of 104 patients with bullous pemphigoid and analysis of factors influencing the efficacy

作　　者：陈妍 陈丹阳 陈喜雪[1] 尚盼盼 王明悦[1] Chen Yan;Chen Danyang;Chen Xixue;Shang Panpan;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925-930,共6页Chinese Journal of Dermatology

摘　　要：目的探讨度普利尤单抗单药或联合其他药物治疗大疱性类天疱疮(BP)的短期及中期疗效、影响因素及安全性。方法采用单中心回顾性队列研究,分析2021年3月至2022年6月在北京大学第一医院皮肤性病科规律随访、应用度普利尤单抗治疗的成人BP患者的临床资料。度普利尤单抗每2周皮下注射300 mg(首剂加倍)。既往用药包括糖皮质激素、米诺环素、免疫抑制剂等,根据患者病情保持原有剂量或减少用量。在首次注射度普利尤单抗后第2周、第16周分别评价短期及中期有效率。治疗2周时疾病控制率的影响因素采用多因素logistic回归分析,并计算比值比(OR);采用多因素Cox回归模型分析影响随访16周内疾病控制的因素,并计算风险比(HR);影响瘙痒缓解时间的因素采用多元线性回归分析。结果共纳入BP患者104例,男60例,女44例,年龄(75.6±12.8)岁,病程[M(Q1,Q3)]4.0(2.0,17.0)个月。根据基线时皮疹面积占体表面积的百分比进行疾病严重程度分级:轻度17例、中度30例、重度31例和极重度26例;56例(53.9%)联合口服糖皮质激素,剂量为20.0(15.0,30.0)mg/d。治疗2周时,63例(60.6%)达到疾病控制,37例(35.6%)达到疾病大部分控制,短期有效率为96.2%。55例患者随访满16周,有效54例(98.2%),同时系统糖皮质激素剂量降为10.0(10.0,17.5)mg/d。104例患者16周内有92例(88.5%)实现疾病控制,疾病控制时间为14.0(13.0,26.0)d,瘙痒缓解时间为12.0(3.0,14.0)d。多因素logistic回归分析显示,基线疾病严重程度越高,2周疾病控制率越低(与极重度相比,轻度:OR=37.655,95%CI:3.664,386.981;中度:OR=12.143,95%CI:2.609,56.528;重度:OR=4.014,95%CI:1.121,14.369,均P<0.05)。多因素Cox回归分析显示,与极重度BP患者相比,轻度BP患者(HR=2.478,95%CI:1.200,5.114,P=0.014)和中度BP患者(HR=2.076,95%CI:1.067,4.038,P=0.031)在治疗随访16周内更易达到疾病控制。多元线性回归显示,病程影响瘙痒缓解�Objective To analyze the short-and medium-term efficacy,factors influencing the efficacy,and safety of dupilumab alone or in combination for the treatment of bullous pemphigoid(BP).Methods A single-center retrospective cohort study was conducted.Clinical data were collected from adult BP patients,who were regularly followed up and treated with dupilumab at the Department of Dermatology,Peking University First Hospital between March 2021 and June 2022.Dupilumab was administered subcutaneously every 2 weeks at a dose of 300 mg(except for the initial dose being 600 mg).Previous medications included glucocorticoids,minocycline,immunosuppressants,etc.,and their dose remained unchanged or decreased according to patient condition.The short-and medium-term response rates were evaluated at weeks 2 and 16 after the first injection of dupilumab,respectively.Multivariate logistic regression analysis was conducted to identify factors influencing the disease control rate at week 2,and odds ratios(ORs)were calculated;a multivariate Cox regression model was employed to analyze factors influencing the disease control rate within 16 weeks of follow-up,and hazard ratios(HRs)were calculated;multiple linear regression analysis was performed to determine factors associated with the time to pruritus relief.Results A total of 104 BP patients were eligible,including 60 males and 44 females;they were aged 75.6±12.8 years,and the disease duration(M[Q1,Q3])was 4.0(2.0,17.0)months.According to the percentage of the lesion area to the total body surface area,the disease severity was graded,and there were 17 mild cases,30 moderate cases,31 severe cases,and 26 extremely severe cases;56 patients(53.9%)were treated with dupilumab combined with oral glucocorticoids at doses of 20.0(15.0,30.0)mg/d.At week 2 after the start of treatment,63 patients(60.6%)achieved disease control,and 37(35.6%)achieved marked disease control,resulting in a short-term response rate of 96.2%.Fifty-five patients were followed up for 16 weeks,54(98.2%)achieved improvemen

关 键 词：类天疱疮 大疱性 度普利尤单抗 治疗结果 安全性 影响因素 

分 类 号：R758.66[医药卫生—皮肤病学与性病学]