摘要
目的评价度普利尤单抗治疗中重度特应性皮炎(AD)的长期有效性及安全性。方法本研究为回顾性研究,收集2021年3月至10月就诊于唐山市工人医院及南湖医院变态反应科的中重度AD患者,给予度普利尤单抗治疗。所有入组患者均给予度普利尤单抗负荷剂量600 mg皮下注射,后每2周300 mg皮下注射,第16周后均调整为每4周300 mg皮下注射的治疗方案,治疗周期为36周。于第0、4、8、12、16、24及36周收集患者研究者整体评分(IGA)、湿疹面积和严重程度指数(EASI)、瘙痒数字评价量表(NRS)、皮肤生活质量指数(DLQI)、源自患者的湿疹评价(POEM)评分、医院焦虑和抑郁量表(HADS)评分,并行总IgE、IL-2、IL-4、IL-5检查,记录治疗过程中出现的不良反应。采用Wilcoxon秩和检验对全部患者结束随访时各项评分和治疗前进行比较。结果纳入60例青少年及成人中重度AD患者,其中54例患者完成36周的治疗及随访。IGA评分均值由基线3.65±0.48降至16周0.96±0.95(P<0.05),0.59±0.59(P<0.05);EASI均值由基线22.72±7.14降至16周1.78±1.08(P<0.05),36周0.59±1.09(P<0.05)。NRS、POEM、DLQI、HADS各量表评分均值治疗36周内均呈持续下降趋势,差异均有统计学意义(P<0.05)。注射度普利尤单抗后总IgE、IL-4、IL-5呈下降趋势,IL-2呈上升趋势。研究期间,2例患者出现注射局部红肿,1例患者出现双手多个指间关节疼痛,无患者发生结膜炎,无药物相关性严重不良反应发生。结论本研究初步证实度普利尤单抗长期治疗中重度AD的有效性和安全性,即使16周后治疗间隔延长为4周,仍具有良好疗效。
Objective To evaluate the long-term efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis(AD).Methods This is a retrospective study.Patients with moderate to severe AD who visited the Allergy Department of Tangshan Workers Hospital and Nanhu Hospital from March 2021 to October 2021 were enrolled and treated with dupilumab.All patients were given dupilumab with a loading dose of 600 mg subcutaneously,and then 300 mg subcutaneous injection every 2 weeks.After the 16th week,300 mg subcutaneous injection was given every 4 weeks.The investigator global assessment(IGA),eczema area and severity index(EASI),numericalrating scale(NRS),dermatology life quality index(DLQI),patient oriented eczema measure(POEM),hospital anxiety and depression scale(HADS)were collected and evaluated at baseline,the 4th,8th,12th,16th,24th,and 36th week.The total IgE,IL-2,IL-4,and IL-5 were examined,and the adverse events during the treatment were recorded.Wilcoxon rank sum test was used to compare the scores of all patients at the end of follow-up and those before treatment.Results A total of 60 adolescent and adult patients with moderate to severe AD were enrolled in the study,and 54 of them completed 36 weeks of treatment and follow-up.IGA mean score decreased from 3.65±0.48 at baseline to 0.96±0.95 at 16th week(P<0.05),and 0.59±0.59 at 36th week(P<0.05);EASI mean score decreased from 22.72±7.14 at baseline to 1.78±1.08 at 16th week(P<0.05),and 0.59±1.09 at 36th week(P<0.05).The mean scores of NRS,POEM,DLQI,and HADS showed a continuous downward trend within 36 weeks of treatment,and the differences were statistically significant.Total IgE,IL-4,and IL-5 showed a decreasing trend,while IL-2 showed an increasing trend after dupilumab injection.During the study period,two patients developed redness and swelling at the local injection site,one patient had multiple interphalangeal joint pain in both hands,and no patient developed conjunctivitis or drug-related serious adverse reactions.Conclusions This study preliminarily confirmed that dupilumab has long-term efficacy and safety in the treatment of moderate to severe AD,with sustained efficacy even when the treatment interval has extended to 4 weeks after 16 weeks.
作者
武颖
张正旭
王龙飞
赵庚雷
郝国栋
WU Ying;ZHANG Zheng-xu;WANG Long-fei;ZHAO Geng-lei;HAO Guo-dong(Department of Allergy,Tangshan Workers Hospital,Tangshan 063000,Hebei,China;Department of Nephrology,Tangshan Hospital of Traditional Chinese Medicine,Tangshan 063000,Hebei,China;Department of Otolaryngology,Tangshan Union Hospital,Tangshan 063006,Hebei,China;Department of Allergy,Tangshan Workers Hospital,Tangshan Nanhu Hospital,Tangshan 063000,Hebei,China)
出处
《中华临床免疫和变态反应杂志》
CAS
2023年第2期120-126,共7页
Chinese Journal of Allergy & Clinical Immunology
基金
河北省中医药管理局(2023413)。
