Richette Pascal, Ravaud Philippe, Conrozier Thierry, Euller-Ziegler Liana, Mazières Bernard, Maugars Yves, Mulleman Denis, Clerson Pierre, Chevalier Xavier
Hôpital Lariboisière, Assistance Publique Hôpitaux de Paris, Paris, France.
Arthritis Rheum. 2009 Mar;60(3):824-30. doi: 10.1002/art.24301.
To evaluate the efficacy and tolerability of a single intraarticular (IA) injection of hyaluronic acid (HA) for the treatment of hip osteoarthritis (OA).
A multicenter, randomized, parallel-group, placebo-controlled trial was conducted over 3 months. Patients (older than 30 years) with symptomatic hip OA (pain score of >40 mm on a visual analog scale [VAS]) and a Kellgren/Lawrence grade of 2 or 3 were randomly assigned to receive 1 fluoroscopically guided IA injection of HA (2.5 ml) or placebo (2.5 ml). Patients were followed up for 3 months. The main outcome measure was pain score on a VAS (100 mm) at month 3 compared with baseline. Secondary outcome measures were the proportion of responders defined by Osteoarthritis Research Society International criteria; Western Ontario and McMaster Universities Osteoarthritis Index subscores for pain, stiffness, and disability; and patient and physician global assessment. Randomization was computer generated. HA and placebo preparations were placed in numbered identical containers, and syringes were covered with masking tape. Physicians assessing outcomes were blinded with regard to group assignment.
Eighty-five patients were randomized to the HA group (n = 42) or placebo group (n = 43). Baseline characteristics were similar between the 2 groups. At 3 months, the decrease in pain score did not differ between the HA and placebo groups in the intent-to-treat analysis (mean +/- SD decrease 7.8 +/- 24.9 mm with HA versus 9.1 +/- 27.4 mm with placebo; P = 0.98). The responder rates were 33.3% and 32.6% in the HA and placebo groups, respectively (P = 0.94). Other secondary end points did not differ between the groups, nor did use of rescue medication or frequency of adverse events.
Our findings indicate that a single IA injection of HA is no more effective than placebo in treating the symptoms of hip OA.
评估单次关节内注射透明质酸(HA)治疗髋骨关节炎(OA)的疗效和耐受性。
进行了一项为期3个月的多中心、随机、平行组、安慰剂对照试验。有症状的髋OA患者(年龄大于30岁,视觉模拟量表[VAS]疼痛评分>40 mm)且Kellgren/Lawrence分级为2级或3级,被随机分配接受1次在荧光镜引导下关节内注射HA(2.5 ml)或安慰剂(2.5 ml)。对患者随访3个月。主要结局指标是与基线相比,第3个月时VAS(100 mm)上的疼痛评分。次要结局指标是根据国际骨关节炎研究学会标准定义的缓解者比例;西安大略和麦克马斯特大学骨关节炎指数中疼痛、僵硬和残疾的子评分;以及患者和医生的整体评估。随机分组由计算机生成。HA和安慰剂制剂放置在编号相同的容器中,注射器用胶带覆盖。评估结局的医生对分组情况不知情。
85例患者被随机分为HA组(n = 42)或安慰剂组(n = 43)。两组的基线特征相似。在3个月时,意向性分析中HA组和安慰剂组的疼痛评分下降无差异(HA组平均±标准差下降7.8±24.9 mm,安慰剂组为9.1±27.4 mm;P = 0.98)。HA组和安慰剂组的缓解率分别为33.3%和32.6%(P = 0.94)。其他次要终点在两组之间无差异,使用急救药物或不良事件发生率也无差异。
我们的研究结果表明,单次关节内注射HA在治疗髋OA症状方面并不比安慰剂更有效。