Clinical Rheumatology Unit, Department of Rheumatology and Medical Sciences, ASST Centro Traumatologico Ortopedico G. Pini-CTO, Milan, Italy.
Orthopedic Department, Johanna Étienne Hospital, Am Hasenberg 46, 41462, Neuss, Germany.
Clin Rheumatol. 2021 Jun;40(6):2133-2142. doi: 10.1007/s10067-020-05477-7. Epub 2020 Oct 27.
The aim of this study was to evaluate the long-term efficacy and safety of single or 1-3 weekly injections of hylan G-F 20 at 1 year following the first injection for knee osteoarthritis (OA). Searches were conducted in PubMed/MEDLINE, Embase, and CENTRAL and included relevant conference proceedings (January 1, 1995-August 17, 2020). Randomized controlled trials (RCTs), non-randomized trials, and observational studies investigating 1-year efficacy and safety of 1-3 weekly injections or single hylan G-F 20 injection for knee OA were included. Primary outcomes were WOMAC pain, physical function, and stiffness. Meta-analyses of RCTs and non-randomized studies were conducted separately. Our search identified 24 eligible studies. Hylan G-F 20, in the meta-analyses of RCTs, showed statistically significant improvement in WOMAC pain (SMCC - 0.98, 95% CI - 1.50, - 0.46), physical function (SMCC - 1.05, 95% CI - 1.28, - 0.83), and stiffness (SMCC - 1.07, 95% CI -1.28, -0.86). Improvement was also seen for VAS pain, SF-36 MCS (mental component summary), and SF-36 PCS (physical component summary). Analyses of non-randomized studies showed similar efficacy estimates. There were no significant differences in efficacy based on injection schedule, nor between RCT and non-randomized studies. Rates of adverse events (AEs) were low for most types of AEs. Hylan G-F 20 (either as single or 1-3 weekly injections) showed improvement in 1-year efficacy outcomes in comparison to baseline and was generally well tolerated. While further research will inform the medical field regarding viscosupplementation treatment options for knee OA, these findings show that hylan G-F 20 at both frequencies/dosages are efficacious and generally well tolerated for long-term use.
本研究旨在评估玻璃酸钠 G-F 20 单次或每周 1-3 次注射治疗膝关节骨关节炎(OA)的长期疗效和安全性,随访时间为首次注射后 1 年。在 PubMed/MEDLINE、Embase 和 CENTRAL 中进行了检索,并包括相关会议论文(1995 年 1 月 1 日至 2020 年 8 月 17 日)。纳入了评估 1 年疗效和安全性的每周 1-3 次注射或单次玻璃酸钠 G-F 20 注射治疗膝关节 OA 的随机对照试验(RCT)、非随机试验和观察性研究。主要结局为 WOMAC 疼痛、躯体功能和僵硬度。对 RCT 和非随机研究分别进行了荟萃分析。我们的检索共确定了 24 项符合条件的研究。玻璃酸钠 G-F 20 在 RCT 的荟萃分析中,在 WOMAC 疼痛(SMCC -0.98,95%CI-1.50,-0.46)、躯体功能(SMCC-1.05,95%CI-1.28,-0.83)和僵硬度(SMCC-1.07,95%CI-1.28,-0.86)方面显示出统计学显著改善。VAS 疼痛、SF-36 MCS(精神健康量表)和 SF-36 PCS(躯体健康量表)也有改善。非随机研究的分析显示出相似的疗效估计。根据注射方案、RCT 和非随机研究之间,疗效没有显著差异。大多数类型的不良事件(AE)发生率较低。与基线相比,玻璃酸钠 G-F 20(无论是单次还是每周 1-3 次注射)在 1 年的疗效结局方面均有改善,且通常具有良好的耐受性。虽然进一步的研究将为膝关节骨关节炎的滑液补充治疗选择提供信息,但这些发现表明,玻璃酸钠 G-F 20 无论在何种频率/剂量下,均具有疗效,且长期使用通常具有良好的耐受性。