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[摘要]
目的 系统评价生物制剂和小分子药物治疗生物学初治银屑病关节炎患者的有效性及安全性,为临床用药提供循证依据。方法 在PubMed、Web of Science、Cochrane Library、Embase、中国学术期刊全文数据库( CNKI)、万方数据库( WanfangData)、维普生物医学数据库( VIP)、中国生物医学文献数据库( CBM) 8个数据库中检索相关文献,检索时限为建库至2024年1月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.3和Stata16.0软件进行网状Meta分析。结果 共纳入25项研究,包括12 121例患者,涉及16种药物的21种不同药物剂量。网状Meta分析的结果显示: ①在美国风湿病学会评分改善≥20%应答率( ACR20)方面,累计概率排名曲线下面积( SUCRA)排名前3的干预措施依次为Golimumab 50 mg SCQ4W( 99.2%) >Infliximab 5 mg·kg-1 IVQ8W( 90.7%)>Etanercept 25 mg SCBIW( 87.3%); ②在银屑病面积和严重程度指数评分改善≥75%应答率( PASI75)方面,SUCRA排名前3的干预措施依次为Infliximab 5 mg·kg-1IVQ8W(96.8%) >Golimumab 50 mg SCQ4W(94.4%) >Ixekizumab80mg SCQ2W(77.9%); ③在健康评估问卷残疾指数(HAQDI)方面,SUCRA排名前3的干预措施依次为Golimumab 50 mg SCQ4W(98.8%)>Ixekizumab 80 mg SCQ2W(81%) >Guselkumab 100 mg SCQ4W( 67.7%); ④在最小疾病活动应答率( MDA)方面,SUCRA排名前3的干预措施依次为Secukinumab300 mg SCQ4W( 81.4%) >Secukinumab 150 mg SCQ4W( 81.2%) >Ixekizumab 80 mg SCQ4W( 69.6%); ⑤在安全性方面,SUCRA排名前3的干预措施依次为Golimumab 50 mg SCQ4W( 83.8%) >Apremilast 30 mg POBID( 78.7%) >Ustekinumab90 mg SCQ12W( 76%)。结论 当前证据显示,对ACR20和安全性严重不良事件( SAE)进行综合分析,Golimumab 50 mgSCQ4W表现出来的疗效最好,可能为目前生物学初治PSA患者最有效的药物。但由于受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。
[Key word]
[Abstract]
Objective To systematically evaluate the efficacy and safety of biologics and small molecule drugs in the treatment of patients with psoriatic arthritis and to provide evidence-based evidence for clinical use. Methods The relevant literatures were searched in eight databases, including PubMed, Web of Science, Cochrane Library, Embase, CNKI, Wanfang Data, VIP, and CBM. The search time was from the establishment of the database to January 2024. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. A network Meta-analysis was performed using RevMan 5.3 and Stata 16.0 software. Results A total of 25 studies were included, involving 12 121 patients and 21 different drug dosages of 15 drugs. The results of the network Meta-analysis showed that: ① The American College of Rheumatology score improved ≥20% response rate (ACR20), the top three interventions in terms of cumulative probability ranking area under the curve (SUCRA) were Golimumab 50 mg SCQ4W (99.2%) > Infliximab 5 mg·kg-1 IVQ8W (90.7%) > Etanercept 25 mg SCBIW (87.3%). ② Psoriasis area and severity index scores improved ≥75% response rate (PASI75), the top three SUCRA interventions were infliximab 5 mg·kg-1 IVQ8W (96.8%) > Golimumab 50 mg SCQ4W (94.4%) > Etanercept 80 mg SCQ2W (77.9%). ③ In terms of the Health Assessment Questionnaire Disability Index (HAQ-DI), the top three SUCRA interventions were Golimumab 50 mg SCQ4W (98.8%) > Etanercept 80 mg SCQ2W (81%) > Guselkumab 100 mg SCQ4W (67.7%). In terms of safety, the top three SUCRA interventions were Golimumab 50 mg SCQ4W (83.8%) > Apremilast 30 mg POBID (78.7%) > Ustekinumab 90 mg SCQ12W (76%). Conclusion Current evidence suggests that Golimumab 50 mg SCQ4W is the drug of choice for patients with biologically incipient PsA in terms of both efficacy and safety. However, due to the limited number and quality of included studies, the above conclusions need to be verified by more high-quality studies.
[中图分类号]
R979.5
[基金项目]