Amy Bronstone, Jacob T Neary, Todd H Lambert, Vinod Dasa
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引用次数: 11
摘要
由于担心膝关节骨关节炎(OA)的全身口服药物治疗的安全性,临床医生在治疗轻中度膝关节OA时增加了关节内透明质酸(IA-HA)的使用。透明质酸钠;Seikagaku Corporation, Tokyo, Japan)是世界上第一个获得批准的IA-HA产品,也是全球使用历史最长的产品。在这篇综述中,我们总结了支持Supartz有效性和安全性的证据,包括Supartz在美国和日本获得批准的关键临床试验数据,Supartz单疗程和重复疗程的安全性,以及Supartz在客观结果和特殊人群中的有效性。有强有力的证据表明,单次5周的Supartz疗程可以在临床上有意义的减轻疼痛和改善功能长达6个月,没有严重副作用或并发症的风险。重复疗程的Supartz与单疗程一样安全,感染风险极低。初步研究结果表明,Supartz可能改善肌肉力量、步态模式和平衡,这些结果应该在随机对照试验中得到证实。
Supartz (Sodium Hyaluronate) for the Treatment of Knee Osteoarthritis: A Review of Efficacy and Safety.
As concerns about the safety of systemic oral pharmacologic treatments for knee osteoarthritis (OA) mount, clinicians have increased the use of intra-articular hyaluronic acid (IA-HA) in managing mild-to-moderate knee OA. Supartz (sodium hyaluronate; Seikagaku Corporation, Tokyo, Japan) is the first IA-HA product to be approved in the world and has the longest history of global use. In this review, we summarize evidence supporting Supartz efficacy and safety, including data from pivotal clinical trials that resulted in approval of Supartz in the United States and Japan, the safety of single and repeated courses of Supartz, and Supartz efficacy using objective outcomes and in special populations. There is strong evidence that single 5-week courses of Supartz provide clinically meaningful reductions in pain and improved function for up to 6 months without risk of serious side effects or complications. Repeated courses of Supartz are as safe as single courses and have an extremely low risk of infection. Findings from promising initial studies, which suggest that Supartz may improve muscle strength, gait pattern, and balance, should be confirmed in randomized controlled trials.