膝关节骨关节炎患者重复使用玻璃酸钠G-F 20疗程的有效性和安全性。

Effectiveness and safety of repeat courses of hylan G-F 20 in patients with knee osteoarthritis.

作者信息

Raynauld J P, Goldsmith C H, Bellamy N, Torrance G W, Polisson R, Belovich D, Pericak D, Tugwell P

机构信息

Department of Medicine, University of Montreal, Montreal, Quebec, Canada.

出版信息

Osteoarthritis Cartilage. 2005 Feb;13(2):111-9. doi: 10.1016/j.joca.2004.10.018.

DOI:10.1016/j.joca.2004.10.018

PMID:15694572

Abstract

OBJECTIVE

To compare the effectiveness and safety of repeat treatment with hylan G-F 20 based on data from a randomized, controlled trial [Raynauld JP, Torrance GW, Band PA, Goldsmith CH, Tugwell P, Walker V, et al. A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results. Osteoarthritis Cartilage 2002;10:506-17]. The hypotheses tested were whether the single-course and repeat-course subgroups would be superior to appropriate care and not different from each other.

METHOD

A total of 255 patients with knee osteoarthritis were randomized to "appropriate care with hylan G-F 20" or "appropriate care without hylan G-F 20". The hylan G-F 20 group was partitioned into two subgroups: (1) patients who received a single course of hylan G-F 20; and (2) patients who received two or more courses of hylan G-F 20.

RESULTS

For the primary effectiveness measure, change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score as a percent of baseline, the single-course subgroup improved by 41%, the repeat-course subgroup by 35%, and the appropriate care group by 14%. Both subgroups improved significantly more than the appropriate care group (P<0.05), and were not statistically significantly different from each other (70% power to detect a 20% difference). Secondary effectiveness measures showed similar results. In the repeat-course subgroup, no statistically significant differences were found in the number of local adverse events, the number of patients with local adverse events, or arthrocentesis rates between the first and repeat courses of treatment.

CONCLUSIONS

Although the study was neither designed nor powered to examine repeat treatment, this a posteriori analysis provides support for a favorable effectiveness and safety profile of hylan G-F 20 in repeat course patients.

摘要

目的

基于一项随机对照试验的数据，比较重复使用透明质酸钠凝胶G-F 20治疗的有效性和安全性[雷纳尔德·J·P、托伦斯·G·W、班德·P·A、戈德史密斯·C·H、塔格韦尔·P、沃克·V等人。一项前瞻性、随机、实用、健康结局试验，评估将透明质酸钠凝胶G-F 20纳入膝骨关节炎患者治疗模式（第1部分，共2部分）：临床结果。骨关节炎与软骨2002；10：506 - 17]。所检验的假设为单疗程和重复疗程亚组是否优于适当治疗且彼此无差异。

方法

总共255例膝骨关节炎患者被随机分为“使用透明质酸钠凝胶G-F 20的适当治疗”组或“不使用透明质酸钠凝胶G-F 20的适当治疗”组。透明质酸钠凝胶G-F 20组又分为两个亚组：（1）接受单疗程透明质酸钠凝胶G-F 20的患者；（2）接受两个或更多疗程透明质酸钠凝胶G-F 20的患者。

结果

对于主要有效性指标，即西安大略和麦克马斯特大学骨关节炎指数（WOMAC）疼痛评分相对于基线的变化百分比，单疗程亚组改善了41%，重复疗程亚组改善了35%，适当治疗组改善了14%。两个亚组的改善均显著优于适当治疗组（P<0.05），且彼此之间无统计学显著差异（检测20%差异的效能为70%）。次要有效性指标显示了类似结果。在重复疗程亚组中，首次治疗和重复治疗之间在局部不良事件数量、发生局部不良事件的患者数量或关节穿刺率方面未发现统计学显著差异。