Tenti Sara, Pascarelli Nicola Antonio, Giannotti Stefano, Galeazzi Mauro, Giordano Nicola, Fioravanti Antonella
Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Viale Bracci 1, 53100, Siena, Italy.
Section of Orthopedics and Traumatology, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
BMC Musculoskelet Disord. 2017 Nov 13;18(1):444. doi: 10.1186/s12891-017-1809-5.
Osteoarthritis (OA) of the trapeziometacarpal joint (TMJ) is a disabling condition with a significant impact on quality of life. The optimal management of hand OA requires a combination of non-pharmacological and pharmacological treatments that include intra-articular (i.a.) therapy. EULAR experts recommend corticosteroid injections in TMJ OA and underline the usefulness of hyaluronic acid (HA). The aim of this study was the assessment of the efficacy and tolerability of i.a. injections of a hybrid formulation of HA (Sinovial H-L®) in comparison to triamcinolone in patients with TMJ OA.
This 6-months observational comparative study, retrospective analyzed the medical records of 100 patients with monolateral or bilateral TMJ OA, treated with two injections of Sinovial H-L® (Sinovial H-L Group) or of triamcinolone acetonide (Triamcinolone Group). Clinical assessments were recorded at the time of the first and second injection and after one, 3 and 6 months. The primary outcomes were the change in global pain on a Visual Analogue Scale (VAS) and in hand function evaluated by the Functional Index for Hand OA (FIHOA) from baseline to month 6. Secondary outcomes were the improvement of the duration of morning stiffness, Health Assessment Questionnaire (HAQ) and the Medical Outcomes Study 36-Item Short Form (SF-36). The comparison between the two groups of treatment were performed with the Wilcoxon rank-sum test for continuous variables and with chi-square or Fisher exact test for categorical variables. Statistical significance was set at p < 0.05.
Both therapies provided effective pain relief and joint function improvement, but the benefits achieved were statistically significantly superior in the Sinovial H-L Group than the Triamcinolone Group after one month (p < 0.01) from the beginning of the therapy and during the 6-months follow-up (p < 0.001). Furthermore, Sinovial H-L® was associated with a significant decrease in the duration of morning stiffness and with a significant improvement in the HAQ score and physical component summary (PCS)-SF-36.
Our results suggested that the hybrid formulation of HA may be more effective than triamcinolone in pain relief and joint function improvement with a rapid and persistent effect, resulting a valid alternative to steroid in the management of TMJ OA.
ClinicalTrials.gov, date of registration: June 14, 2017, NCT03200886 . The present trial was retrospectively registered.
第一掌腕关节(TMJ)骨关节炎(OA)是一种致残性疾病,对生活质量有重大影响。手部OA的最佳治疗需要非药物和药物治疗相结合,其中包括关节内(i.a.)治疗。欧洲抗风湿病联盟(EULAR)专家推荐在TMJ OA中注射皮质类固醇,并强调透明质酸(HA)的有效性。本研究的目的是评估与曲安奈德相比,i.a.注射混合配方的HA(Sinovial H-L®)对TMJ OA患者的疗效和耐受性。
这项为期6个月的观察性比较研究,回顾性分析了100名单侧或双侧TMJ OA患者的病历,这些患者接受了两次Sinovial H-L®注射(Sinovial H-L组)或曲安奈德注射(曲安奈德组)。在第一次和第二次注射时以及1、3和6个月后记录临床评估结果。主要结局指标是从基线到第6个月,视觉模拟量表(VAS)上的总体疼痛变化以及通过手部OA功能指数(FIHOA)评估的手部功能变化。次要结局指标是晨僵持续时间、健康评估问卷(HAQ)和医学结局研究36项简短形式(SF-36)的改善情况。两组治疗之间的比较,对于连续变量采用Wilcoxon秩和检验,对于分类变量采用卡方检验或Fisher精确检验。设定统计学显著性为p < 0.05。
两种疗法均能有效缓解疼痛并改善关节功能,但从治疗开始1个月后(p < 0.01)以及6个月随访期间(p < 0.001),Sinovial H-L组所获得的益处在统计学上显著优于曲安奈德组。此外,Sinovial H-L®与晨僵持续时间显著缩短、HAQ评分和身体成分总结(PCS)-SF-36显著改善相关。
我们的结果表明,HA混合配方在缓解疼痛和改善关节功能方面可能比曲安奈德更有效,具有快速且持久的效果,是TMJ OA管理中类固醇的有效替代方案。
ClinicalTrials.gov,注册日期:2017年6月14日,NCT03200886。本试验为回顾性注册。