一项多中心、随机对照试验，比较了新型交联透明质酸钠凝胶（Gel-200）与磷酸盐缓冲液单次关节内注射治疗膝关节骨关节炎的疗效。
A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee.
机构信息
Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
The Center for Rheumatology and Bone Research, Wheaton, MD, USA.
出版信息
Osteoarthritis Cartilage. 2012 May;20(5):350-356. doi: 10.1016/j.joca.2012.01.013. Epub 2012 Feb 1.
OBJECTIVE
To compare the safety and efficacy of a single intra-articular (IA) injection of a new cross-linked hyaluronic acid product, Gel-200, with phosphate buffered saline (PBS, control) in a multi-center randomized controlled trial in patients with symptomatic osteoarthritis (OA) of the knee.
DESIGN
Patients were randomized 2:1 to receive a single injection of Gel-200 or PBS, after joint aspiration. The primary measure of effectiveness was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores by 100-mm Visual Analog Scale (VAS); secondary outcomes included: total WOMAC, physical function, and stiffness subscores; patient and physician global assessments of disease activity, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responders, as well as safety of Gel-200.
RESULTS
Of 379 patients randomized, safety was evaluated in 377 and efficacy in 375 (98.9% randomized) in the intent-to-treat population. Effectiveness of Gel-200 by WOMAC pain subscores was statistically significant at week 13 (P=0.037). Mean improvements from baseline in WOMAC pain subscores consistently favored Gel-200 at each visit. Effectiveness of Gel-200 treatment was statistically significant over weeks 3-13 by WOMAC total score, physical function, and physician global evaluations (P<0.05). The number of "strict" OMERACT-OARSI responders was statistically significant from weeks 6 to 13 (P=0.022). Adverse events were not significantly different between treatment groups, including serious adverse events considered related to study treatment.
CONCLUSIONS
This trial demonstrated that a single injection of Gel-200 was well tolerated and relieved pain associated with symptomatic OA of the knee over 13 weeks.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov NTC 00449696.
目的
在一项多中心随机对照试验中，比较新型交联透明质酸钠产品 Gel-200 与磷酸盐缓冲盐水（PBS，对照）单次关节内（IA）注射治疗膝关节症状性骨关节炎（OA）患者的安全性和疗效。
设计
患者在关节抽吸后按 2:1 随机接受 Gel-200 或 PBS 单次注射。主要疗效测量指标为 100mm 视觉模拟量表（VAS）的西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）疼痛子评分；次要结局包括：WOMAC 总分、躯体功能和僵硬子评分；患者和医生对疾病活动的总体评估、疗效评估在风湿病临床试验中的应用（OMERACT-OARSI）严格应答者，以及 Gel-200 的安全性。
结果
在 379 例随机患者中，377 例患者进行了安全性评估，375 例患者（意向治疗人群中 98.9%的随机患者）进行了疗效评估。WOMAC 疼痛子评分显示 Gel-200 的疗效在第 13 周具有统计学意义（P=0.037）。WOMAC 疼痛子评分的基线改善平均值在每次就诊时均倾向于 Gel-200。WOMAC 总分、躯体功能和医生总体评估的疗效在第 3 周至第 13 周时，Gel-200 的疗效具有统计学意义（P<0.05）。从第 6 周到第 13 周，“严格”OMERACT-OARSI 应答者的数量具有统计学意义（P=0.022）。治疗组之间的不良事件无显著差异，包括被认为与研究治疗相关的严重不良事件。
结论
本试验表明，单次注射 Gel-200 耐受性良好，可缓解膝关节症状性 OA 患者 13 周内的疼痛。
试验注册号
ClinicalTrials.gov NTC 00449696。
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