Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Rheumatology (Oxford). 2023 Aug 1;62(8):2652-2660. doi: 10.1093/rheumatology/kead088.
The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA.
A protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least 2 years was performed. The primary outcome investigated was adverse events (AEs). We performed random-effects meta-analyses and used the Cochrane RoB tool and GRADE to assess risk of bias and quality of evidence (QoE).
Six trials with 1078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95% CI 0.86, 1.34; P = 0.52); however, the QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest did not differ from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19-1.65; moderate QoE). Concerning benefit, we found moderate to high quality evidence of improvement in disease activity (DAS28: -0.23; -0.43 to -0.03), function (HAQ -0.09; -0.18 to 0.00), and Larsen scores (-4.61; -7.52 to -1.69). In other efficacy outcomes, including Sharp van der Heijde scores, there was no evidence of benefits with GCs.
There is very low to moderate QoE for no harm with long-term low dose GCs in RA, except for an increased risk of infections in GC users. The benefit-risk ratio might be reasonable forusing low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties.
本研究旨在评估长期低剂量糖皮质激素（GCs）治疗类风湿关节炎（RA）的安全性和疗效。
我们对比较低剂量 GCs（≤ 7.5mg/天泼尼松）与安慰剂治疗至少 2 年的双盲、安慰剂对照随机试验（RCT）进行了方案化系统评价和荟萃分析（PROSPERO 编号：CRD42021252528）。主要结局是不良事件（AEs）。我们进行了随机效应荟萃分析，并使用 Cochrane RoB 工具和 GRADE 评估了偏倚风险和证据质量（QoE）。
纳入了 6 项共 1078 名参与者的试验。没有证据表明 AEs 的风险增加（发生率比 1.08；95%CI 0.86，1.34；P = 0.52）；然而，QoE 较低。GC 组与安慰剂组在死亡、严重 AEs、因 AEs 退出和特殊关注 AEs 的风险无差异（极低至中度 QoE）。GC 组更常发生感染（风险比 1.4；1.19-1.65；中度 QoE）。关于获益，我们发现疾病活动度（DAS28：-0.23；-0.43 至 -0.03）、功能（HAQ：-0.09；-0.18 至 0.00）和 Larsen 评分（-4.61；-7.52 至 -1.69）有改善，且证据质量为中至高。在其他疗效结局，包括 Sharp van der Heijde 评分中，GC 组无获益证据。
长期低剂量 GCs 治疗 RA 无明显危害（除了 GC 使用者感染风险增加），但证据质量为极低至中度。考虑到中至高质量的疾病修饰作用证据，低剂量长期 GCs 的获益-风险比可能合理。
