关节内注射曲安奈德 10 毫克与 40 毫克治疗膝骨关节炎患者的疗效比较：一项非劣效性、随机、对照、双盲、多中心研究。
The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study.
机构信息
Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
Department of Orthopedics, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
出版信息
BMC Musculoskelet Disord. 2023 Feb 3;24(1):92. doi: 10.1186/s12891-023-06191-6.
BACKGROUND
Intra-articular (IA) corticosteroid injection is recommended in refractory knee osteoarthritis patients. However, 40-mg of triamcinolone IA every 3 months for 2 years reduces cartilage volume as compared to saline IA.
OBJECTIVE
To determine the non-inferiority of 10-mg versus 40-mg of triamcinolone acetonide (TA) for treatment of pain in symptomatic knee osteoarthritis at week 12.
METHODS
This was a double-blind, randomized, controlled trial conducted in 84 symptomatic knee osteoarthritis patients. The 10-mg or 40-mg of TA were 1:1 randomized and injected to the affected knees. The primary outcome was the 12-week difference from baseline in pain VAS, with a pre-specified lower margin for non-inferiority of 10 mm. The measuring instruments used were: Visual analog scale (VAS: 0-10), modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol Group 5 Dimensions (EQ5D), Knee Injuries and Osteoarthritis Outcome Score (KOOS) questionnaire, chair standing test and 20-m walking time at baseline, at week 4, and week 12 after randomization. Adverse events were recorded.
RESULTS
Baseline characteristics were similar between two groups. The mean differences of pain VAS (95% confidence interval: CI) between the two groups at baseline and week 12 were 0.8 (-0.8, 2.4) with p of 0.002 for non-inferiority. There were no differences in pain reduction and quality of life improvement between 10-mg and 40-mg groups. The mean differences (95%CI) of WOMAC, KOOS pain, EQ5D and KOOS quality of life between baseline and week 12 were 0.4 (-1.1, 1.9). -8.7 (-21.3, 3.9), 1.3(-7.1, 9.6) and 1.8 (-11.5, 15.0), respectively. There were significant improvements in pain and quality of life between baseline and week 12 in both groups.
CONCLUSION
The 10 mg of TA is non-inferior to 40 mg TA in improving pain in patients with symptomatic knee OA. Both 10 mg and 40 mg of TA significantly improved pain and quality of life in patients with symptomatic knee OA.
TRIAL REGISTRATION
TCTR, I TCTR20210224002. Retrospectively registered 24 February 2021, http://www.thaiclinicaltrials.org/show/TCTR20210224002.
背景
关节内（IA）皮质类固醇注射被推荐用于治疗难治性膝骨关节炎患者。然而，与生理盐水 IA 相比，每 3 个月给予 40 毫克曲安奈德 IA 可减少软骨体积。
目的
确定 10 毫克与 40 毫克曲安奈德（TA）治疗症状性膝骨关节炎疼痛的非劣效性，在第 12 周。
方法
这是一项在 84 例症状性膝骨关节炎患者中进行的双盲、随机、对照试验。10 毫克或 40 毫克 TA 以 1:1 的比例随机注射到受影响的膝关节。主要结局是从基线开始疼痛 VAS 在 12 周的差异，预先设定的非劣效性下限为 10 毫米。使用的测量仪器包括：视觉模拟量表（VAS：0-10）、改良的安大略西部大学和麦克马斯特大学骨关节炎指数（WOMAC）、欧洲五维健康量表（EQ5D）、膝关节损伤和骨关节炎结果评分（KOOS）问卷、椅子站立测试和 20 米步行时间，在基线时、第 4 周和随机分组后第 12 周进行测量。记录不良事件。
结果
两组的基线特征相似。两组在基线和第 12 周时疼痛 VAS（95%置信区间：CI）的平均差异为 0.8（-0.8, 2.4），p 值<0.002 表示非劣效性。10 毫克和 40 毫克组在疼痛减轻和生活质量改善方面没有差异。WOMAC、KOOS 疼痛、EQ5D 和 KOOS 生活质量在基线和第 12 周的平均差异（95%CI）分别为 0.4（-1.1, 1.9）、-8.7（-21.3, 3.9）、1.3（-7.1, 9.6）和 1.8（-11.5, 15.0）。两组患者在基线和第 12 周时疼痛和生活质量均有显著改善。
结论
10 毫克 TA 在改善症状性膝骨关节炎患者的疼痛方面不劣于 40 毫克 TA。10 毫克和 40 毫克 TA 均显著改善了症状性膝骨关节炎患者的疼痛和生活质量。
试验注册
TCTR，I TCTR20210224002。于 2021 年 2 月 24 日进行回顾性注册，网址为：http://www.thaiclinicaltrials.org/show/TCTR20210224002。
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