生物制剂治疗银屑病致结核风险评估——2704例多中心回顾性研究  

Assessment of the risk for tuberculosis in the treatment of psoriasis with biologics:a multicenter retrospective study of 2704 cases

作　　者：游霞 朱建建[1] 何平[1] 龙剑[1] 赵小娇 陈霄霄 YOU Xia;ZHU Jianjian;HE Ping;LONG Jian;ZHAO Xiaojiao;CHEN Xiaoxiao(Changde First People's Hospital,National Clinical Medical Research Center for Skin and Immune Diseases,Changde 415003,China)

机构地区：[1]常德市第一人民医院国家皮肤与免疫疾病临床医学研究分中心,湖南常德415003

出　　处：《皮肤性病诊疗学杂志》2023年第1期21-25,共5页Journal of Diagnosis and Therapy on Dermato-venereology

基　　金：湖南省卫健委科研计划资助项目(202204122852);常德市科技局项目(2019S201)。

摘　　要：目的通过分析生物制剂治疗银屑病致结核感染及激活风险,为其安全性提供理论依据。方法收集国家银屑病规范化诊疗中心数据库中2020年6月至2022年1月各分中心使用生物制剂治疗银屑病的患者2704例,分析其一般情况、结核感染筛查(PPD、QFT、胸片和/或胸部CT)、预防性抗结核治疗情况及治疗中结核感染监测、激活情况。结果2704例银屑病患者中,使用TNF-α抑制剂436例(16.12%),IL-17A抑制剂2240例(82.84%),IL-12/23抑制剂28例(1.04%)。在使用生物制剂前898例(33.21%)进行了结核筛查,其中85例(9.46%)筛查阳性。筛查阳性者中使用预防性抗结核治疗者23例(27.06%),采用异烟肼+利福平联合治疗3个月者20例;单异烟肼治疗6个月者3例。后续随访中,2例结核筛查阳性,发生率为7/10000(2/2704),均发生于使用TNF-α抑制剂(阿达木单抗)组,发生率为1%(2/200)。结论目前对银屑病患者进行生物制剂治疗前结核感染筛查比例低,进行结核病预防性治疗比例低;生物制剂治疗银屑病过程中结核激活的风险性相对较低,但使用TNF-α抑制剂者潜在性激活结核风险相对较高。建议使用前完善LTBI筛查,使用后定期评估结核激活情况。Objective To provide the evidence base for the safety of biologics in the treatment of psoriasis,we retrospectively analyzed tuberculosis(TB)infection and its activation in psoriatic patients treated with biologics.Methods Information of 2704 psoriatic patients treated with biologics was collected from the database of the National Standardized Diagnosis and Treatment Center for Psoriasis from June 2020 to January 2022.Data analyses included patients′general conditions,results of TB screening(PPD,QFT,chest X-ray and/or chest CT),preventive anti-TB treatment,and monitoring and activation of TB infection during the treatments.Results Out of 2704 subjects,436(16.12%)cases were treated with TNF-αinhibitors,while 82.84%(2240)and 1.04%(28)of the patients were treated with IL-17A inhibitors and IL-12/23 inhibitor,respectively.Prior to biological treatment,898(33.21%)cases were screened for TB,among which 85(9.46%)cases were TB positive.Out of the 85 cases with TB positive,20 cases were treated with isoniazid+rifampicin for 3 months,and 3 cases received mono-isoniazid treatment for 6 months.During the follow-up,TB reactivation was observed in 2 cases(2/200,1%),which both received TNF-αinhibitor(adalimumab).Conclusions Prior to biological treatments,only small portion of psoriatic patients receive TB screening and anti-TB treatment in China.Although the risk for TB reactivation is relatively low during biological treatment,TNF-αinhibitors have a higher risk for TB reactivation compared to other biologics.Thus,screening for LTBI before biological therapy and monitoring TB reactivation during biological therapy are still crucial in the treatment of psoriasis with biologics,particularly TNF-αinhibitors.

关 键 词：生物制剂 结核 银屑病 

分 类 号：R758.63[医药卫生—皮肤病学与性病学]