一项关于透明质酸钠凝胶G-F 20（施沛特）治疗有症状的踝关节（距小腿关节）骨关节炎患者安全性和有效性的前瞻性多中心开放性研究。
A prospective multi-centre, open study of the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic ankle (talo-crural) osteoarthritis.
作者信息
Witteveen Angelique G H, Giannini Sandro, Guido Giulio, Jerosch Joerg, Lohrer Heinz, Vannini Francesca, Donati Leonardo, Schulz Axel, Scholl Jakob, Sierevelt Inger N, van Dijk C Niek
机构信息
Orthopaedic Research Centre Amsterdam, Academic Medical Center, 1105 AZ Amsterdam, The Netherlands.
出版信息
Foot Ankle Surg. 2008;14(3):145-52. doi: 10.1016/j.fas.2008.01.001. Epub 2008 Mar 4.
BACKGROUND
To evaluate the safety and efficacy of hylan G-F 20 in patients with ankle osteoarthritis.
METHODS
A prospective, open study in patients with symptomatic (>or=50 mm and <or=90 mm on a 100 mm VAS) ankle osteoarthritis. Patients received 1 ml x 2 ml intra-articular injection of hylan G-F 20, plus an optional, second injection if pain remained at baseline levels after 1, 2 or 3 months. The primary efficacy endpoint was the change from baseline in the pain VAS score at 3 months.
RESULTS
Fifty-five patients received the first injection; 24 patients received a second. There were no serious or severe adverse events (AEs) related to the treatment. Seventeen patients experienced mild or moderate local, treatment-related AEs. The mean pain VAS score decreased from 68.0 mm (baseline) to 33.8 mm at 3 months (p<0.001), which was maintained to 6 months (34.2 mm, p<0.001).
CONCLUSIONS
Hylan G-F 20 is well-tolerated and effective for up to 6 months in the treatment of symptomatic ankle osteoarthritis.
背景
评估透明质酸钠凝胶G-F 20治疗踝关节骨关节炎患者的安全性和有效性。
方法
对有症状的（视觉模拟评分法[VAS]100mm量表上≥50mm且≤90mm）踝关节骨关节炎患者进行一项前瞻性开放性研究。患者接受2ml（1ml×2）关节腔内注射透明质酸钠凝胶G-F 20，若在1、2或3个月后疼痛仍维持在基线水平，则可选择进行第二次注射。主要疗效终点为3个月时疼痛VAS评分相对于基线的变化。
结果
55例患者接受了首次注射；24例患者接受了第二次注射。未出现与治疗相关的严重不良事件。17例患者出现轻度或中度局部治疗相关不良事件。疼痛VAS评分的平均值从基线时的68.0mm降至3个月时的33.8mm（p<0.001），并维持至6个月（34.2mm，p<0.001）。
结论
透明质酸钠凝胶G-F 20耐受性良好，治疗有症状的踝关节骨关节炎长达6个月有效。
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