Borrás-Verdera A, Calcedo-Bernal V, Ojeda-Levenfeld J, Clavel-Sainz C
Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Virgen Macarena, Sevilla, España.
Rev Esp Cir Ortop Traumatol. 2012 Jul-Aug;56(4):274-80. doi: 10.1016/j.recot.2012.02.004. Epub 2012 Apr 19.
To evaluate the safety and efficacy of a single intra-articular injection of 2% hyaluronic acid (HA)+mannitol in symptomatic knee osteoarthritis (KOA).
Pilot, multicentre, open, non-comparative study performed in eighty patients with painful KOA, of whom 79 completed the study. They received one injection of 2ml of 2% HA+0.5% mannitol (Day 0) and were followed-up for 6 months. On Days 0, 15, 30, 60, 90, 120, 150 and 180, pain and joint function were assessed using a visual analogue scale (VAS) and WOMAC index. Efficacy and safety by investigator and patient, and rescue medication, as an indirect measure of pain, were also recorded.
A significant reduction in joint pain, stiffness and functional disability compared with baseline was observed at every follow-up visit (P<.001). Joint function improved by 38.7% on Day 30, reaching 47.5% on Day 180. Rescue medication use decreased from 58.2% at baseline to 2.5% on Day 90, increasing in the last visits. Efficacy and safety were positively evaluated by investigators and patients. No serious adverse events were observed. Mild side effects were reported in 4 patients (local pain and swelling in the infiltration area).
There is evidence that repeated intra-articular injections of HA improve symptoms in KOA. However, studies with a single injection of HA have shown mixed results. This study demonstrates that one single intra-articular injection of non-cross-linked HA reduces joint pain and increases function in patients with KOA over a period of at least 6 months.
评估单次关节腔内注射2%透明质酸（HA）+甘露醇治疗症状性膝关节骨关节炎（KOA）的安全性和有效性。
对80例疼痛性KOA患者进行了一项先导性、多中心、开放性、非对照研究，其中79例完成了研究。他们接受了一次2ml的2%HA+0.5%甘露醇注射（第0天），并随访6个月。在第0、15、30、60、90、120、150和180天，使用视觉模拟量表（VAS）和WOMAC指数评估疼痛和关节功能。还记录了研究者和患者评估的疗效和安全性以及作为疼痛间接指标所使用的急救药物。
在每次随访时，与基线相比，关节疼痛、僵硬和功能障碍均有显著减轻（P<0.001）。关节功能在第30天改善了38.7%，在第180天达到47.5%。急救药物的使用从基线时的58.2%降至第90天的2.5%，在最后几次随访中有所增加。研究者和患者对疗效和安全性的评价均为阳性。未观察到严重不良事件。4例患者报告了轻微副作用（注射部位局部疼痛和肿胀）。
有证据表明，重复关节腔内注射HA可改善KOA的症状。然而，单次注射HA的研究结果不一。本研究表明，单次关节腔内注射非交联HA可在至少6个月的时间内减轻KOA患者的关节疼痛并改善其功能。
