合成与生物DMARDs疗效的系统文献综述：为2025年EULAR类风湿关节炎管理建议更新提供依据
该系统文献综述检索了2022年1月14日至2025年1月22日发表的随机对照试验，评估csDMARDs、bDMARDs、tsDMARDs及糖皮质激素治疗类风湿关节炎的疗效。共纳入72项研究，涵盖3-4期RCT评估多种药物、2期RCT评估12种新化合物、策略试验及RA相关间质性肺病抗纤维化治疗等。结论指出，虽新药3期试验有限，但策略性和头对头研究为完善既定治疗算法提供了重要见解。
要点
- 系统综述纳入72项研究，为2025年EULAR类风湿关节炎管理建议更新提供疗效证据。
- 3-4期RCT评估了羟氯喹、艾拉莫德、来氟米特、甲氨蝶呤及多种生物/靶向合成DMARDs。
- 策略试验比较传统治疗与bDMARD或tsDMARD策略，并探索滑膜活检指导治疗等精准医学方法。
核心结论
- 该系统文献综述与安全性综述共同为2025年EULAR类风湿关节炎管理建议更新提供依据。
- 尽管新型药物的3期试验有限，策略性和头对头研究为完善既定治疗算法提供了重要见解。
研究设计与样本
- 检索Medline、Embase、Cochrane Central Register of Controlled Trials和Web of Science，纳入2022年1月14日至2025年1月22日发表的随机对照试验。
- 补充检索从数据库建库至2025年1月22日关于DMARDs、糖皮质激素和抗纤维化药物治疗RA相关间质性肺病及预防RA的研究。
- 共识别12567条参考文献，审查390篇全文，最终纳入72项研究。
主要发现
- 3-4期RCT评估了csDMARDs（羟氯喹、艾拉莫德、来氟米特、甲氨蝶呤）、bDMARDs（阿巴西普、otilimab、ozoralizumab）和tsDMARDs（ivarmacitinib、peficitinib、托法替布）。
- 12种新化合物在2期RCT中评估，3篇文章研究糖皮质激素。
- 策略试验比较传统治疗与基于bDMARD或tsDMARD的策略，并探索滑膜活检指导治疗和治疗药物监测等精准医学方法。
- 额外证据涉及DMARD减量；两项RCT评估抗纤维化药物（尼达尼布和吡非尼酮）治疗RA相关间质性肺病；7项研究评估DMARDs在高危人群中预防RA。
临床怎么用
- 本综述证据可用于支持2025年EULAR类风湿关节炎管理建议的更新，指导DMARDs和糖皮质激素的临床使用。
局限性
- 新型药物的3期随机对照试验数量有限。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
Ann Rheum Dis. 2026 Jun;85(6):1039-1054. doi: 10.1016/j.ard.2026.03.020. Epub 2026 Apr 16. ABSTRACT OBJECTIVES: This systematic literature review (SLR) updated evidence on the efficacy of disease-modifying antirheumatic drugs (DMARDs) and glucocorticoids (GCs) to inform the 2025 update of the European Alliance of Associations for Rheumatology (EULAR) management recommendations for rheumatoid arthritis (RA). METHODS: Medline (PubMed), Embase (OVID), Cochrane Central Register of Controlled Trials, and Web of Science were searched for randomised controlled trials (RCTs) of conventional-synthetic, biological, and targeted-synthetic DMARDs (csDMARDs, bDMARDs, tsDMARDs), as well as GCs and biosimilars, published from 14 January 2022 to 22 January 2025. Additional searches on DMARDs, GCs, and antifibrotics for RA-associated interstitial lung disease (RA ILD), and on DMARDs and GCs for preventing RA in at-risk individuals, were conducted from database inception to 22 January 2025. RESULTS: A total of 12,567 references were identified; 390 full-texts were reviewed, and 72 studies were included. Phase 3-4 RCTs evaluated csDMARDs (hydroxychloroquine, iguratimod, leflunomide, and methotrexate), bDMARDs (abatacept, otilimab, and ozoralizumab), and tsDMARDs (ivarmacitinib, peficitinib, and tofacitinib). Twelve novel compounds were assessed in phase 2 RCTs, and 3 articles investigated GCs. Strategic trials compared conventional therapies with bDMARD- or tsDMARD-based strategies and explored precision-medicine approaches such as synovial biopsy-guided treatment and therapeutic drug monitoring. Additional evidence addressed DMARD tapering. Two RCTs assessed antifibrotics (nintedanib and pirfenidone) for RA ILD, and 7 studies evaluated DMARDs for RA prevention in at-risk populations. CONCLUSIONS: This SLR, together with the safety review, informed the 2025 update of the EULAR RA management recommendations. Although few phase 3 trials on novel agents were available, strategic and head-to-head studies provided important insights that enabled further refinement of the established treatment algorithm. PMID: 41997804 | DOI: 10.1016/j.ard.2026.03.020
引用
- 指南共识 · 间质性肺病：Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2025 update of the EULAR recommendations for the management of rheumatoid arthritis
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。