McAlindon Timothy E, LaValley Michael P, Harvey William F, Price Lori Lyn, Driban Jeffrey B, Zhang Ming, Ward Robert J
Division of Rheumatology, Tufts Medical Center, Boston, Massachusetts.
Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.
JAMA. 2017 May 16;317(19):1967-1975. doi: 10.1001/jama.2017.5283.
Synovitis is common and is associated with progression of structural characteristics of knee osteoarthritis. Intra-articular corticosteroids could reduce cartilage damage associated with synovitis but might have adverse effects on cartilage and periarticular bone.
To determine the effects of intra-articular injection of 40 mg of triamcinolone acetonide every 3 months on progression of cartilage loss and knee pain.
DESIGN, SETTING, AND PARTICIPANTS: Two-year, randomized, placebo-controlled, double-blind trial of intra-articular triamcinolone vs saline for symptomatic knee osteoarthritis with ultrasonic features of synovitis in 140 patients. Mixed-effects regression models with a random intercept were used to analyze the longitudinal repeated outcome measures. Patients fulfilling the American College of Rheumatology criteria for symptomatic knee osteoarthritis, Kellgren-Lawrence grades 2 or 3, were enrolled at Tufts Medical Center beginning February 11, 2013; all patients completed the study by January 1, 2015.
Intra-articular triamcinolone (n = 70) or saline (n = 70) every 12 weeks for 2 years.
Annual knee magnetic resonance imaging for quantitative evaluation of cartilage volume (minimal clinically important difference not yet defined), and Western Ontario and McMaster Universities Osteoarthritis index collected every 3 months (Likert pain subscale range, 0 [no pain] to 20 [extreme pain]; minimal clinically important improvement, 3.94).
Among 140 randomized patients (mean age, 58 [SD, 8] years, 75 women [54%]), 119 (85%) completed the study. Intra-articular triamcinolone resulted in significantly greater cartilage volume loss than did saline for a mean change in index compartment cartilage thickness of -0.21 mm vs -0.10 mm (between-group difference, -0.11 mm; 95% CI, -0.20 to -0.03 mm); and no significant difference in pain (-1.2 vs -1.9; between-group difference, -0.6; 95% CI, -1.6 to 0.3). The saline group had 3 treatment-related adverse events compared with 5 in the triamcinolone group and had a small increase in hemoglobin A1c levels (between-group difference, -0.2%; 95% CI, -0.5% to -0.007%).
Among patients with symptomatic knee osteoarthritis, 2 years of intra-articular triamcinolone, compared with intra-articular saline, resulted in significantly greater cartilage volume loss and no significant difference in knee pain. These findings do not support this treatment for patients with symptomatic knee osteoarthritis.
ClinicalTrials.gov Identifier: NCT01230424.
滑膜炎很常见，且与膝关节骨关节炎的结构特征进展相关。关节内注射皮质类固醇可减少与滑膜炎相关的软骨损伤，但可能对软骨和关节周围骨骼产生不良影响。
确定每3个月关节内注射40mg曲安奈德对软骨丢失进展和膝关节疼痛的影响。
设计、设置和参与者：一项为期两年的随机、安慰剂对照、双盲试验，比较关节内注射曲安奈德与生理盐水对140例有滑膜炎超声特征的症状性膝关节骨关节炎患者的疗效。采用具有随机截距的混合效应回归模型分析纵向重复结局指标。符合美国风湿病学会症状性膝关节骨关节炎标准、Kellgren-Lawrence分级为2级或3级的患者于2013年2月11日开始在塔夫茨医疗中心入组；所有患者均于2015年1月1日前完成研究。
每12周关节内注射曲安奈德（n = 70）或生理盐水（n = 70），共2年。
每年进行膝关节磁共振成像以定量评估软骨体积（尚未确定最小临床重要差异），每3个月收集西安大略和麦克马斯特大学骨关节炎指数（Likert疼痛子量表范围为0[无疼痛]至20[极度疼痛]；最小临床重要改善为3.94）。
在140例随机分组的患者中（平均年龄58[标准差8]岁，75例女性[54%]），119例（85%）完成了研究。关节内注射曲安奈德导致指数隔室软骨厚度的平均变化为-0.21mm，而生理盐水组为-0.10mm，曲安奈德组的软骨体积丢失明显大于生理盐水组（组间差异为-0.11mm；95%可信区间为-0.20至-0.03mm）；疼痛方面无显著差异（-1.2对-1.9；组间差异为-0.6；95%可信区间为-1.6至0.3）。生理盐水组有3例与治疗相关的不良事件，曲安奈德组有5例，且生理盐水组糖化血红蛋白水平有小幅升高（组间差异为-0.2%；95%可信区间为-0.5%至-0.007%）。
在症状性膝关节骨关节炎患者中，与关节内注射生理盐水相比，关节内注射曲安奈德2年导致软骨体积丢失明显更大，膝关节疼痛无显著差异。这些发现不支持对症状性膝关节骨关节炎患者采用这种治疗方法。
ClinicalTrials.gov标识符：NCT01230424。
