Jones A C, Pattrick M, Doherty S, Doherty M
Rheumatology Unit, City Hospital, Nottingham, UK.
Osteoarthritis Cartilage. 1995 Dec;3(4):269-73. doi: 10.1016/s1063-4584(05)80018-4.
The aim of this study was to determine the comparative efficacy and safety of intra-articular (i/a) triamcinolone. hexacetonide (TH) and i/a hyaluronic acid (HA) in inflammatory knee osteoarthritis. A randomized double-blind comparative trail was carried out in a rheumatology outpatient department. There were 63 patients (24 male, 39 female, mean age 70.5 years) with bilateral symptomatic knee osteoarthritis with effusion. Each was given five HA injections at weekly intervals; or 20 mg TH followed by four placebo (saline) injections. Patients were examined weekly during the treatment period and then at monthly intervals for a further 6 months. Assessment included recording of: visual analog scores (VAS) for pain; duration of stiffness; range of movement; joint effusion; local heat; synovial thickening; joint-line and periarticular tenderness. The principal outcome measure was pain on a self-selected activity assessed by Vas. The two groups were comparable at entry and no significant differences between the groups developed at any time during the treatment period. However, there was a high drop-out rate and intention to treat analysis failed to demonstrate statistically significant differences between the groups. In patients remaining in the study, significantly less pain was experienced by the HA group during the 6 month follow-up period. Other parameters showed a similar trend in favor of experienced by the HA group during the 6 month follow-up period. Other parameters showed a similar trend in favor of HA. We could not, however, demonstrate significant differences between the placebo and active treatments. HA may therefore be a useful additional therapy for symptomatic knee osteoarthritis and may have a long duration of action.
本研究旨在确定关节腔内注射曲安奈德己酸酯（TH）和透明质酸（HA）治疗炎性膝关节骨关节炎的相对疗效和安全性。在一个风湿病门诊进行了一项随机双盲对照试验。共有63例双侧有症状的膝关节骨关节炎伴积液患者（男性24例，女性39例，平均年龄70.5岁）。每位患者每周接受5次HA注射；或先注射20mg TH，随后注射4次安慰剂（生理盐水）。在治疗期间每周对患者进行检查，之后每间隔1个月再检查6个月。评估内容包括记录：疼痛的视觉模拟评分（VAS）；僵硬持续时间；活动范围；关节积液；局部发热；滑膜增厚；关节线及关节周围压痛。主要结局指标是通过VAS评估的自选活动时的疼痛。两组在入组时具有可比性，在治疗期间的任何时间两组之间均未出现显著差异。然而，脱落率较高，意向性分析未能显示两组之间存在统计学上的显著差异。在继续参与研究的患者中，HA组在6个月随访期内疼痛明显减轻。其他参数也显示出类似的趋势，有利于HA组。然而，我们未能证明安慰剂治疗和活性治疗之间存在显著差异。因此，HA可能是治疗有症状膝关节骨关节炎的一种有用的辅助疗法，并且可能具有长效作用。
