Hamburger Max I, Lakhanpal Sharad, Mooar Pekka A, Oster David
Rheumatology Associates of Long Island, Melville, NY 11747, USA.
Semin Arthritis Rheum. 2003 Apr;32(5):296-309. doi: 10.1053/sarh.2002.50008.
Intra-articular (IA) hyaluronans (HAs) are indicated for pain relief of osteoarthritis (OA) of the knee. Hyalgan (sodium hyaluronate), Supartz (sodium hyaluronate), and Synvisc (hylan G-F 20) are Food and Drug Administration-approved HA products. They are derived from rooster combs; Hyalgan and Supartz are naturally derived (unmodified); Synvisc is chemically modified to increase its molecular weight. This article reviews and updates the safety data for IA HAs used for the treatment of knee OA.
References were taken from Medline through July 2002; respective product information services and information from the searchable United States Food and Drug Administration Manufacturer and User Facility Device Experience Database also were used.
All products demonstrated favorable safety profiles in clinical trials and practice compared to other standard therapies for management of OA knee pain. The most common adverse event associated with HAs is mild injection site pain and swelling. Each product has had rare reports of pseudogout and anaphylactoid reactions. Product-specific adverse events, severe acute inflammatory reactions (pseudoseptic knee), in patients receiving Synvisc have been reported. One such patient developed antibodies to chicken proteins and hylan, suggesting an immunologic basis for the severe acute inflammatory reaction. Data from an animal study support a possible immunogenic difference between Synvisc and Hyalgan.
Overall, HA therapy is a safe treatment for OA knee pain, although there may be interproduct variability in safety profiles.
关节内（IA）透明质酸（HA）可用于缓解膝关节骨关节炎（OA）的疼痛。Hyalgan（透明质酸钠）、Supartz（透明质酸钠）和Synvisc（交联透明质酸钠凝胶）是美国食品药品监督管理局批准的HA产品。它们来源于公鸡鸡冠；Hyalgan和Supartz是天然来源（未修饰）；Synvisc经过化学修饰以增加其分子量。本文回顾并更新了用于治疗膝关节OA的IA HA的安全性数据。
参考文献取自截至2002年7月的Medline；还使用了各自的产品信息服务以及可搜索的美国食品药品监督管理局制造商和用户设施设备经验数据库中的信息。
与其他治疗OA膝关节疼痛的标准疗法相比，所有产品在临床试验和实践中均显示出良好的安全性。与HA相关的最常见不良事件是轻度注射部位疼痛和肿胀。每种产品都有罕见的假性痛风和类过敏反应报告。有报告称接受Synvisc的患者出现特定产品的不良事件，即严重急性炎症反应（假性脓毒性膝关节）。一名此类患者产生了针对鸡蛋白和交联透明质酸钠的抗体，提示严重急性炎症反应存在免疫基础。一项动物研究的数据支持Synvisc和Hyalgan之间可能存在免疫原性差异。
总体而言，HA疗法是治疗OA膝关节疼痛的安全方法，尽管不同产品的安全性可能存在差异。
