Multicenter study of hyaluronic acid obtained by biotechnology to evaluate clinical efficacy and safety in knee osteoarthritis.

A C Novaes, P Schaiquevich, G Nasswetter
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Abstract

Viscosuppplementation with intra-articular hyaluronic acid (hyaluronan [HA]) is a relatively new option for improving pain and articular function in patients with symptomatic knee osteoarthritis. An open multi-center study was performed in 365 patients with definite and symptomatic knee osteoarthritis from seven Latin American countries. Five doses of HA were administered once a week. The parameters studied were pain (six items), stiffness (two items) and functional capacity (17 items). The parameters were evaluated 1 week after the corresponding injection. Statistical differences were found when basal determinations of the three parameters were compared with the results of the first and fourth administration (p < 0.05). Intra-articular HA administration was well tolerated. Treatment-related nonserious adverse events were registered in 2.5% of administrations. Based on the results obtained, HA is a useful and well-tolerated symptomatic treatment for knee osteoarthritis with a rapid onset of action.

生物技术获得透明质酸的多中心研究评估膝关节骨关节炎的临床疗效和安全性。
关节内补充透明质酸(透明质酸[HA])是改善症状性膝骨关节炎患者疼痛和关节功能的一种相对较新的选择。一项开放的多中心研究对来自7个拉丁美洲国家的365例明确和有症状的膝关节骨关节炎患者进行了研究。每周给药一次,共5剂。研究的参数包括疼痛(6项)、僵硬(2项)和功能能力(17项)。注射后1周评估各项参数。与第1、4次给药组比较,3个参数的基础测定结果有统计学差异(p < 0.05)。关节内给药具有良好的耐受性。治疗相关的非严重不良事件发生率为2.5%。根据所获得的结果,透明质酸是一种有效且耐受性良好的治疗膝骨关节炎的对症治疗,起效迅速。
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