AP-HP Saint-Antoine Hospital, 184 rue du faubourg Saint-Antoine, 75012 Paris, France.
Ann Rheum Dis. 2012 Sep;71(9):1454-60. doi: 10.1136/annrheumdis-2011-200972. Epub 2012 Jan 31.
To compare the effects of an intermediate molecular weight (MW) intra-articular hyaluronic acid (HA) with a low MW product on knee osteoarthritis (OA) symptoms.
Patients with symptomatic knee OA were enrolled inarandomised, controlled, double-blind, parallel-group, non-inferiority trial with the possibility to shift to superiority. Patients were randomised to GO-ON(MW 800-1500 kD, 25 mg/2.5 ml) or Hyalgan(MW 500-730 kD, 20 mg/2 ml) injected at 3-weekly intervals. The primary outcome was 6-month change in the WOMAC pain subscale (0-100 mm). Sample size was calculated on a non-inferiority margin of 9 mm, lower than the minimum perceptible clinical improvement. Secondary endpoints included OARSI-OMERACT responder rates
The intention-to-treat (ITT) and per-protocol (PP) populations consisted of 217 and 209 patients and 171 and 172 patients in the GO-ON and Hyalgan groups, respectively. ITT WOMAC pain of 47.5±1.0(SE) and 48.8±1.0 mm decreased by 22.9±1.4 mm with GO-ON and 18.4±1.5 mm with Hyalgan after 6 months. The primary analysis was conducted in the PP population followed by the ITT population.Mean (95% CI) differences in WOMAC pain change were 5.2 (0.9 to 9.6)mm and 4.5 (0.5 to 8.5)mm, respectively,favouring GO-ON, satisfying the claim for non-inferiority (lower limit>-9 mm) and for statistical superiority (95% CI all>0, p=0.021). Ahigher proportion of OARSI/OMERACT responders was observed with GO-ONthan with Hyalgan (73.3% vs58.4%, p=0.001). Both preparations were well tolerated.
Treatment with 3-weekly injections of intermediate MW HA may be superior to low MW HA on knee OA symptoms over 6 months, with similar safety.
比较中等分子量（MW）关节内透明质酸（HA）与低 MW 产品对膝骨关节炎（OA）症状的影响。
本研究纳入了症状性膝骨关节炎患者，进行了一项随机、对照、双盲、平行组、非劣效性试验，同时具备向优效性转换的可能性。患者被随机分配至 GO-ON（MW 800-1500 kD，25 mg/2.5 ml）或 Hyalgan（MW 500-730 kD，20 mg/2 ml），每 3 周注射一次。主要结局是 6 个月时 WOMAC 疼痛量表（0-100 mm）的变化。根据低于最小可感知临床改善的 9mm 非劣效性边界计算样本量。次要终点包括 OARSI-OMERACT 应答率。
意向治疗（ITT）和符合方案（PP）人群中，GO-ON 组和 Hyalgan 组分别有 217 例和 209 例患者，以及 171 例和 172 例患者进入 ITT 和 PP 分析。GO-ON 和 Hyalgan 治疗后 6 个月时，ITT WOMAC 疼痛分别为 47.5±1.0（SE）和 48.8±1.0 mm，下降 22.9±1.4 mm 和 18.4±1.5 mm。主要分析在 PP 人群中进行，然后在 ITT 人群中进行。WOMAC 疼痛变化的平均（95%CI）差异分别为 5.2（0.9 至 9.6）mm 和 4.5（0.5 至 8.5）mm，GO-ON 更优，满足非劣效性（下限>-9mm）和统计学优效性（95%CI 均>0，p=0.021）的要求。GO-ON 组 OARSI/OMERACT 应答者比例高于 Hyalgan 组（73.3% vs 58.4%，p=0.001）。两种制剂均具有良好的耐受性。
在 6 个月时，中等分子量 HA 每 3 周注射一次可能优于低分子量 HA，可改善膝骨关节炎症状，且安全性相当。
