[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評(píng)價(jià)生物制劑和小分子藥物治療生物學(xué)初治銀屑病關(guān)節(jié)炎患者的有效性及安全性,為臨床用藥提供循證依據(jù)。方法 在PubMed、Web of Science、Cochrane Library、Embase、中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)( CNKI)、萬方數(shù)據(jù)庫(kù)( WanfangData)、維普生物醫(yī)學(xué)數(shù)據(jù)庫(kù)( VIP)、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)( CBM) 8個(gè)數(shù)據(jù)庫(kù)中檢索相關(guān)文獻(xiàn),檢索時(shí)限為建庫(kù)至2024年1月。由2名研究者獨(dú)立篩選文獻(xiàn)、提取資料并評(píng)價(jià)納入研究的偏倚風(fēng)險(xiǎn)后,采用RevMan5.3和Stata16.0軟件進(jìn)行網(wǎng)狀Meta分析。結(jié)果 共納入25項(xiàng)研究,包括12 121例患者,涉及16種藥物的21種不同藥物劑量。網(wǎng)狀Meta分析的結(jié)果顯示: ①在美國(guó)風(fēng)濕病學(xué)會(huì)評(píng)分改善≥20%應(yīng)答率( ACR20)方面,累計(jì)概率排名曲線下面積( SUCRA)排名前3的干預(yù)措施依次為Golimumab 50 mg SCQ4W( 99.2%) >Infliximab 5 mg·kg-1 IVQ8W( 90.7%)>Etanercept 25 mg SCBIW( 87.3%); ②在銀屑病面積和嚴(yán)重程度指數(shù)評(píng)分改善≥75%應(yīng)答率( PASI75)方面,SUCRA排名前3的干預(yù)措施依次為Infliximab 5 mg·kg-1IVQ8W(96.8%) >Golimumab 50 mg SCQ4W(94.4%) >Ixekizumab80mg SCQ2W(77.9%); ③在健康評(píng)估問卷殘疾指數(shù)(HAQDI)方面,SUCRA排名前3的干預(yù)措施依次為Golimumab 50 mg SCQ4W(98.8%)>Ixekizumab 80 mg SCQ2W(81%) >Guselkumab 100 mg SCQ4W( 67.7%); ④在最小疾病活動(dòng)應(yīng)答率( MDA)方面,SUCRA排名前3的干預(yù)措施依次為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的干預(yù)措施依次為Golimumab 50 mg SCQ4W( 83.8%) >Apremilast 30 mg POBID( 78.7%) >Ustekinumab90 mg SCQ12W( 76%)。結(jié)論 當(dāng)前證據(jù)顯示,對(duì)ACR20和安全性嚴(yán)重不良事件( SAE)進(jìn)行綜合分析,Golimumab 50 mgSCQ4W表現(xiàn)出來的療效最好,可能為目前生物學(xué)初治PSA患者最有效的藥物。但由于受納入研究數(shù)量和質(zhì)量的限制,上述結(jié)論尚待更多高質(zhì)量研究予以驗(yàn)證。
[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.
[中圖分類號(hào)]
R979.5
[基金項(xiàng)目]