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关节内注射透明质酸治疗膝骨关节炎:一项随机、双盲、安慰剂对照研究。

Intra-articular hyaluronan injections for the treatment of osteoarthritis of the knee: a randomized, double blind, placebo controlled study.

作者信息

Tamir E, Robinson D, Koren R, Agar G, Halperin N

机构信息

Department of Orthopedics, Assaf Harofe Hospital, Zerifin, Israel.

出版信息

Clin Exp Rheumatol. 2001 May-Jun;19(3):265-70.

Abstract

OBJECTIVE

Hyaluronic acid (HA) polymers have been found to be useful as viscosupplements for the treatment of osteoarthritis (OA) in a number of clinical studies. It appears that HA with high molecular weights (HMW) are more effective than low molecular weight HA polymers.

METHODS

A single blind, initial randomized study was conducted involving two randomly selected patient groups, which received injections of either placebo or BioHy, a highly purified HMW HA produced by bacterial fermentation. HA was administered intra-articularly and several functional tests, including pain level, stiffness, and physical function, were used to score efficacy at various intervals throughout the study.

RESULTS AND CONCLUSION

The results through week 20 indicate that BioHy provides relief for osteoarthritic patients without causing adverse effects, although the study was not sufficiently powered to obtain statistically significant differences between the treatment groups.

摘要

目的

在多项临床研究中,已发现透明质酸(HA)聚合物作为黏弹性补充剂用于治疗骨关节炎(OA)有效。高分子量(HMW)的HA似乎比低分子量HA聚合物更有效。

方法

进行了一项单盲、初始随机研究,涉及两个随机选择的患者组,分别接受安慰剂或BioHy(一种通过细菌发酵产生的高度纯化的HMW HA)注射。HA通过关节内给药,在整个研究过程中的不同时间间隔使用包括疼痛程度、僵硬程度和身体功能在内的多项功能测试来评估疗效。

结果与结论

到第20周的结果表明,BioHy可为骨关节炎患者提供缓解且不引起不良反应,尽管该研究的样本量不足以在治疗组之间获得具有统计学意义的差异。

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