膝关节骨关节炎长期关节内注射类固醇的安全性和有效性：一项随机、双盲、安慰剂对照试验。

Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial.

作者信息

Raynauld Jean-Pierre, Buckland-Wright Chris, Ward Rupert, Choquette Denis, Haraoui Boulos, Martel-Pelletier Johanne, Uthman Imad, Khy Visithan, Tremblay Jean-Luc, Bertrand Carole, Pelletier Jean-Pierre

机构信息

Hôpital Notre-Dame, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.

出版信息

Arthritis Rheum. 2003 Feb;48(2):370-7. doi: 10.1002/art.10777.

DOI:10.1002/art.10777

PMID:12571845

Abstract

OBJECTIVE

To evaluate the safety and efficacy of long-term intraarticular (IA) steroid injections for knee pain related to osteoarthritis (OA).

METHODS

In a randomized, double-blind trial, 68 patients with OA of the knee received IA injections of triamcinolone acetonide 40 mg (34 patients) or saline (34 patients) into the study knee every 3 months for up to 2 years. The primary outcome variable was radiologic progression of joint space narrowing of the injected knee after 2 years. Measurements of minimum joint space width were performed by an automated computerized method on standardized fluoroscopically guided radiographs taken with the patient standing and with the knee in a semiflexed position. The clinical efficacy measure of primary interest was the pain subscale from the Western Ontario and McMaster Universities OA Index (WOMAC). Efficacy measures of secondary interest were the total score on the WOMAC, physician's global assessment, patient's global assessment, patient's assessment of pain, range of motion (ROM) of the affected knee, and 50-foot walking time. Clinical symptoms were assessed just before each injection.

RESULTS

At the 1-year and 2-year followup evaluations, no difference was noted between the two treatment groups with respect to loss of joint space over time. The steroid-injected knees showed a trend toward greater symptom improvement, especially at 1 year, for the WOMAC pain subscale, night pain, and ROM values (P = 0.05) compared with the saline-injected knees. Using area under the curve analyses, knee pain and stiffness were significantly improved throughout the 2-year study by repeated injections of triamcinolone acetonide, but not saline (P < 0.05).

CONCLUSION

Our findings support the long-term safety of IA steroid injections for patients with symptomatic knee OA. No deleterious effects of the long-term administration of IA steroids on the anatomical structure of the knee were noted. Moreover, long-term treatment of knee OA with repeated steroid injections appears to be clinically effective for the relief of symptoms of the disease.

摘要

目的

评估长期关节内（IA）注射类固醇治疗与骨关节炎（OA）相关的膝关节疼痛的安全性和有效性。

方法

在一项随机双盲试验中，68例膝关节OA患者每3个月接受一次膝关节IA注射40mg曲安奈德（34例患者）或生理盐水（34例患者），持续2年。主要结局变量是2年后注射膝关节关节间隙狭窄的影像学进展。通过自动计算机方法在患者站立且膝关节处于半屈曲位时标准化荧光透视引导下的X线片上测量最小关节间隙宽度。主要关注的临床疗效指标是西安大略和麦克马斯特大学OA指数（WOMAC）的疼痛子量表。次要关注的疗效指标是WOMAC总分、医生整体评估、患者整体评估、患者疼痛评估、患侧膝关节活动范围（ROM）和50英尺步行时间。每次注射前评估临床症状。

结果

在1年和2年的随访评估中，两个治疗组在关节间隙随时间的丢失方面没有差异。与注射生理盐水的膝关节相比，注射类固醇的膝关节在WOMAC疼痛子量表、夜间疼痛和ROM值方面显示出更大的症状改善趋势，尤其是在1年时（P = 0.05）。使用曲线下面积分析，通过反复注射曲安奈德，膝关节疼痛和僵硬在整个2年研究中得到显著改善，但注射生理盐水则没有（P < 0.05）。