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根据糖皮质激素逐渐减量方案,巨细胞动脉炎中类固醇缓解治疗的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of steroid-sparing treatments in giant cell arteritis according to the glucocorticoids tapering regimen: A systematic review and meta-analysis.

机构信息

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, UMR-S 1136, AP-HP.Sorbonne Université, Hôpital Pitié-Salpêtrière, Département de Santé Publique, Paris, France.

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, UMR-S 1136, AP-HP, Hôpital Saint-Antoine, Service d'Accueil des Urgences, Paris, France.

出版信息

Eur J Intern Med. 2021 Jun;88:96-103. doi: 10.1016/j.ejim.2021.03.040. Epub 2021 Apr 18.

Abstract

OBJECTIVES

To assess the efficacy and safety of adjuvant therapies in newly diagnosed or relapsing giant cell arteritis (GCA) in terms of relapse rate at week 52 (primary outcome) and to assess the impact of GC tapering regimen on adjuvant effectiveness.

METHODS

For this systematic review and meta-analysis, we searched PubMed, EMBASE, CENTRAL, trial registries, from inception to November 2020. We included all randomized controlled trials (RCTs) and controlled prospective studies evaluating adjuvant treatments in GCA, without date or language restriction. Two reviewers independently selected studies, extracted data and assessed risk of bias. Quality of evidence was summarised with GRADE.

RESULTS

Of the 680 records identified, 16 studies were included (1,068 participants) evaluating various adjuvant therapies compared to GC only. No study compared adjuvants with each other. Risk of bias was high in 5/7 trials evaluating our primary outcome. Risk of relapse at week 52 was reduced for only the anti-IL6 and IL6-receptor drug class versus the control (RR=0.45, 95%CI 0.30-0.66, I2=38%), particularly tocilizumab (RR=0.38, 95%CI 0.23-0.63, I2=42%) with a moderate quality of evidence. We found no significant interaction according to GC tapering regimen. Our meta-analysis did not show a significant benefit for methotrexate. Except for dapsone, ciclosporine and hydroxychloroquine, other adjuvants did not seem to show increased risk of adverse events.

CONCLUSIONS

Tocilizumab seems to reduce the relapse rate in GCA at week 52 but the quality of evidence was moderate. No other molecule has shown efficacy. No significant interaction on relapse rate by GC tapering regimen was found.

STUDY REGISTRATION

PROSPERO CRD42020172011.

摘要

目的

评估新诊断或复发巨细胞动脉炎(GCA)患者辅助治疗的疗效和安全性,主要终点为第 52 周时的复发率,并评估 GC 减量方案对辅助治疗效果的影响。

方法

本系统评价和荟萃分析检索了 PubMed、EMBASE、CENTRAL、试验注册库,时间范围为建库至 2020 年 11 月。纳入所有评估 GCA 辅助治疗的随机对照试验(RCT)和对照前瞻性研究,无日期或语言限制。两名评审员独立筛选研究、提取数据并评估偏倚风险。采用 GRADE 方法总结证据质量。

结果

从 680 条记录中,纳入了 16 项研究(1068 名参与者),评估了各种辅助治疗与仅用 GC 治疗的比较。没有研究比较了不同的辅助药物。7 项评估主要结局的试验中,有 5 项试验的偏倚风险较高。仅抗 IL6 和 IL6 受体药物类别的药物与对照组相比,第 52 周时的复发风险降低(RR=0.45,95%CI 0.30-0.66,I2=38%),特别是托珠单抗(RR=0.38,95%CI 0.23-0.63,I2=42%),证据质量为中等。我们未发现 GC 减量方案存在显著的交互作用。我们的荟萃分析显示甲氨蝶呤没有显著获益。除了氨苯砜、环孢素和羟氯喹外,其他辅助药物似乎没有增加不良事件的风险。

结论

托珠单抗似乎可以降低 GCA 患者第 52 周时的复发率,但证据质量为中等。没有其他分子显示出疗效。未发现 GC 减量方案对复发率有显著影响。

研究注册

PROSPERO CRD42020172011。

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