Yu Shirley P, van Middelkoop Marienke, Ferreira Manuela L, Deveza Leticia, Bierma-Zeinstra Sita M A, Venkatesha Venkatesha, Hunter David J
Department of Rheumatology, Royal North Shore Hospital, New South Wales, Australia.
Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
Osteoarthr Cartil Open. 2023 Apr 11;5(2):100362. doi: 10.1016/j.ocarto.2023.100362. eCollection 2023 Jun.
To evaluate the efficacy of intra--articular (IA) glucocorticoid for knee or hip osteoarthritis (OA) in specific subgroups of patients according to the baseline severity of pain and inflammatory signs using individual patient data (IPD) from existing trials. Furthermore, this study aims to assess if a baseline pain cut-off was associated with clinically important effectiveness of IA glucocorticoid. This is an update of an IA glucocorticoid IPD meta-analysis by the OA Trial Bank.
Randomized trials evaluating one or more IA glucocorticoid preparations in hip and knee OA, published to May 2018 were selected. IPD of patient and disease characteristics and outcome measures were acquired. The primary outcome was pain severity at short-term follow-up (up to 4 weeks). Potential interaction effect of severe pain (≥70 points, 0-100 scale) and signs of inflammation at baseline were studied using a two-stage approach with general liner model followed by random effects model. Analysis of trend was conducted, assessing if a baseline pain cut-off was associated with the threshold for clinically important treatment effect of IA glucocorticoid compared to placebo.
Four out of 16 eligible randomized clinical trials (n = 641) were combined with the existing OA Trial Bank studies (n = 620), yielding 1261 participants from eleven studies. Participants with severe baseline pain compared to those with less severe pain had greater pain reduction at mid-term (around 12 weeks) (mean reduction: -6.90 (95%CI -10.91; -2.90)), but not at short- and long-term. No interaction effects were found between inflammatory signs and IA glucocorticoid injections compared to placebo at all follow-up time-points. Analysis of trend demonstrated treatment response to IA glucocorticoid from baseline pain levels >50 (0-100 scale) and above.
This updated IPD meta-analysis demonstrated that participants with severe pain compared to those with less severe pain at baseline experienced significantly more pain relief with IA glucocorticoid compared with placebo at mid-term.
利用现有试验的个体患者数据（IPD），根据疼痛和炎症体征的基线严重程度，评估关节内（IA）糖皮质激素对特定亚组膝关节或髋关节骨关节炎（OA）患者的疗效。此外，本研究旨在评估基线疼痛阈值是否与IA糖皮质激素的临床重要疗效相关。这是OA试验库对IA糖皮质激素IPD荟萃分析的更新。
选取截至2018年5月发表的评估一种或多种IA糖皮质激素制剂用于髋关节和膝关节OA的随机试验。获取患者和疾病特征以及结局指标的IPD。主要结局是短期随访（最长4周）时的疼痛严重程度。采用两阶段方法，先使用一般线性模型，再使用随机效应模型，研究基线时严重疼痛（≥70分，0-100分制）和炎症体征的潜在交互作用。进行趋势分析，评估与安慰剂相比，基线疼痛阈值是否与IA糖皮质激素临床重要治疗效果的阈值相关。
16项符合条件的随机临床试验中有4项（n = 641）与OA试验库的现有研究（n = 620）合并，来自11项研究的1261名参与者纳入分析。与基线疼痛较轻的参与者相比，基线疼痛严重的参与者在中期（约12周）疼痛减轻更明显（平均减轻：-6.90（95%CI -10.91；-2.90）），但在短期和长期并非如此。在所有随访时间点，与安慰剂相比，炎症体征与IA糖皮质激素注射之间未发现交互作用。趋势分析表明，基线疼痛水平>50（0-100分制）及以上时，患者对IA糖皮质激素有治疗反应。
这项更新的IPD荟萃分析表明，与基线疼痛较轻的参与者相比，基线疼痛严重的参与者在中期使用IA糖皮质激素时，与安慰剂相比疼痛缓解明显更多。
