双氯芬酸透明质酸盐（双氯芬酸依托透明质酸盐）关节内注射治疗髋、踝、肩和肘骨关节炎：一项随机对照试验。
Diclofenac-hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial.
机构信息
Kyoto Interdisciplinary Research Institute, Nakagyo-ku, Kyoto, Japan.
Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan.
出版信息
BMC Musculoskelet Disord. 2022 Apr 20;23(1):371. doi: 10.1186/s12891-022-05328-3.
BACKGROUND
To evaluate the efficacy and safety of intra-articular injection of diclofenac etalhyaluronate (DF-HA) in patients with osteoarthritis (OA) of the hip, ankle, shoulder, or elbow.
METHODS
In this randomized, placebo-controlled, double-blind study in Japan, Japanese patients aged ≥20 years diagnosed with OA of the hip, ankle, shoulder, or elbow were randomly assigned 1:1 to DF-HA 30 mg or placebo (citric acid-sodium citrate buffered solution). Subjects received three injections of the study drug in each joint cavity every 4 weeks and were assessed for 12 weeks after the first injection. The primary endpoint was the mean change from baseline in a diary-based 11-point numerical rating scale (NRS) for pain over 12 weeks, analyzed for each joint. Treatment-emergent adverse events were recorded, and morphological changes in each joint were evaluated radiographically.
RESULTS
The study drug (DF-HA vs placebo) was injected into 90, 60, 90, or 50 subjects with OA of the hip, ankle, shoulder, or elbow (46 vs 44, 30 vs 30, 45 vs 45, and 25 vs 25, respectively). The group differences in the mean change from baseline in the pain NRS over 12 weeks were - 0.81 (95% confidence interval: - 1.48 to - 0.13), - 0.07 (- 1.03 to 0.89), 0.15 (- 0.48 to 0.78), and 0.61 (- 0.41 to 1.62) for the hip, ankle, shoulder, and elbow joints, respectively, with statistically significant differences observed only in the hip joint. The change from baseline in the hip joint was greater with DF-HA than placebo at all time points from Weeks 1-12. No clinically significant adverse events or radiographic changes were observed.
CONCLUSIONS
Intra-articularly administered DF-HA for hip OA produced a rapid response and was safe, with analgesia maintained for 12 weeks when administered every 4 weeks.
TRIAL REGISTRATION
JapicCTI-173,678 (First registered date: 21 August 2017).
背景
评估关节内注射双氯芬酸依托度酸（DF-HA）治疗髋关节、踝关节、肩关节或肘关节骨关节炎（OA）的疗效和安全性。
方法
本研究为日本的一项随机、安慰剂对照、双盲研究，纳入年龄≥20 岁、诊断为髋关节、踝关节、肩关节或肘关节 OA 的日本患者，按 1:1 随机分配至 DF-HA 30mg 或安慰剂（柠檬酸-柠檬酸钠缓冲溶液）组。受试者每 4 周在每个关节腔内接受 3 次研究药物注射，在首次注射后 12 周进行评估。主要终点为 12 周时基于日记的 11 点数字评分量表（NRS）疼痛评分的基线变化均值，每个关节均进行分析。记录治疗中出现的不良事件，并进行影像学评估。
结果
研究药物（DF-HA 组与安慰剂组）分别注射至髋关节、踝关节、肩关节或肘关节 OA 患者 90、60、90 或 50 例（46 例与 44 例、30 例与 30 例、45 例与 45 例和 25 例与 25 例）。12 周时疼痛 NRS 评分的基线变化均值组间差异分别为-0.81（95%置信区间：-1.48 至 -0.13）、-0.07（-1.03 至 0.89）、0.15（-0.48 至 0.78）和 0.61（-0.41 至 1.62），仅髋关节存在统计学显著差异。DF-HA 组与安慰剂组相比，在第 1-12 周的所有时间点，髋关节的改善均更为显著。未观察到有临床意义的不良事件或影像学变化。
结论
髋关节 OA 患者关节内注射 DF-HA 可迅速起效且安全，每 4 周给药 1 次可维持 12 周的镇痛效果。
临床试验注册
JapicCTI-173678（首次注册日期：2017 年 8 月 21 日）。
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