Hangody Laszlo, Szody Robert, Lukasik Piotr, Zgadzaj Wojciech, Lénárt Endre, Dokoupilova Eva, Bichovsk Daniela, Berta Agnes, Vasarhelyi Gabor, Ficzere Andrea, Hangody György, Stevens Gary, Szendroi Miklos
1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.
2 Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic, Budapest, Hungary.
Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. Epub 2017 May 23.
To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis.
This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks.
A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported.
Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.
评估关节腔内注射Cingal（阿妮卡治疗公司，贝德福德，马萨诸塞州）与Monovisc（阿妮卡治疗公司，贝德福德，马萨诸塞州）或生理盐水相比，用于治疗膝关节骨关节炎的疗效和安全性。
这项多中心、双盲、生理盐水对照的临床试验，将膝关节骨关节炎（凯尔格伦-劳伦斯分级I-III级）患者随机分为单次注射Cingal（4 mL，88 mg透明质酸[HA]加18 mg曲安奈德六乙酸酯[TH]）、Monovisc（4 mL，88 mg HA）或生理盐水（4 mL，0.9%）。主要疗效指标是Cingal与生理盐水相比，至12周时WOMAC（西安大略和麦克马斯特大学关节炎指数）疼痛评分的变化。次要指标包括患者和评估者整体评估、OMERACT-OARSI应答者指数，以及至26周时的WOMAC总分、僵硬和身体功能评分。
共治疗368例患者（Cingal组，n = 149；Monovisc组，n = 150；生理盐水组，n = 69）。Cingal组从基线的改善在12周（P = 0.0099）和26周（P = 0.0072）时均显著大于生理盐水组。使用Cingal时，WOMAC疼痛评分在12周时降低了70%，在26周时降低了72%。在至26周的大多数时间点，大多数次要终点的疼痛和功能均有显著改善。在1周和3周时，Cingal在大多数终点上显著优于Monovisc；从6周至26周，Cingal和Monovisc相似。报告的相关不良事件发生率较低。
与生理盐水相比，Cingal可立即并长期缓解骨关节炎相关的疼痛、僵硬和功能，这种效果在26周内均显著。与单独使用HA相比，Cingal有类似的即时优势，同时在6周及以后显示出与HA相当的益处。
