Crozer-Keystone Health System, Springfield, PA, USA.
Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
Cartilage. 2021 Dec;13(1_suppl):1619S-1636S. doi: 10.1177/19476035211017320. Epub 2021 May 28.
This literature review summarizes evidence on the safety and efficacy of intraarticular hyaluronic acid (IAHA) preparations approved in the United States for the treatment of osteoarthritis of the knee.
A systematic literature search was performed in PubMed, Ovid MEDLINE, and SCOPUS databases. Only studies in which clinical outcomes of individual IAHA preparations alone could be assessed when compared to placebo, no treatment, other standard knee osteoarthritis treatments, and IAHA head-to-head studies were selected.
One hundred nine articles meeting our inclusion criteria were identified, including 59 randomized and 50 observational studies. Hylan G-F 20 has been the most extensively studied preparation, with consistent results confirming efficacy in placebo-controlled studies. Efficacy is also consistently reported for Supartz, Monovisc, and Euflexxa, but not for Hyalgan, Orthovisc, and Durolane. In the head-to-head trials, high-molecular-weight (MW) Hylan G-F 20 was consistently superior to low MW sodium hyaluronate preparations (Hyalgan, Supartz) up to 20 weeks, whereas one study reported that Durolane was noninferior to Supartz. Head-to-head trials comparing high versus medium MW preparations all used Hylan G-F 20 as the high MW preparation. Of the IAHA preparations with strong evidence of efficacy in placebo-controlled studies, Euflexxa was found to be noninferior to Hylan G-F 20. There are no direct comparisons to Monovisc. One additional IAHA preparation (ie, Synovial), which has not been assessed in placebo-controlled studies, was also noninferior to Hylan G-F 20.
IAHA efficacy varies widely across preparations. High-quality studies are required to assess and compare the safety and efficacy of IAHA preparations.
本文献综述总结了已获美国批准用于治疗膝关节骨关节炎的关节内透明质酸（IAHA）制剂的安全性和疗效证据。
在 PubMed、Ovid MEDLINE 和 SCOPUS 数据库中进行了系统的文献检索。仅选择了能够单独评估单个 IAHA 制剂与安慰剂、无治疗、其他标准膝骨关节炎治疗以及 IAHA 头对头研究相比的临床疗效的研究。
确定了 109 篇符合纳入标准的文章，其中包括 59 项随机对照研究和 50 项观察性研究。Hylan G-F 20 是研究最广泛的制剂，一致的结果证实了安慰剂对照研究中的疗效。Supartz、Monovisc 和 Euflexxa 的疗效也得到了一致报告，但 Hyalgan、Orthovisc 和 Durolane 则不然。在头对头试验中，高分子量（MW）Hylan G-F 20 一直优于低 MW 透明质酸钠制剂（Hyalgan、Supartz）长达 20 周，而一项研究报告称 Durolane 与 Supartz 相当。比较高 MW 与中 MW 制剂的头对头试验均使用 Hylan G-F 20 作为高 MW 制剂。在安慰剂对照研究中具有明确疗效的 IAHA 制剂中，Euflexxa 被发现与 Hylan G-F 20 相当。与 Monovisc 没有直接比较。一种额外的 IAHA 制剂（即 Synovial）也没有在安慰剂对照研究中进行评估，但与 Hylan G-F 20 相当。
IAHA 的疗效在不同制剂之间差异很大。需要高质量的研究来评估和比较 IAHA 制剂的安全性和疗效。
