Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year
Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year
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DOI：
10.1136/ard.2009.118042
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发表时间：
2010-06-01
影响因子：
27.4
通讯作者：
Frimer-Larsen, Helle
中科院分区：
文献类型：
--
作者：
Jorgensen, Anette;Stengaard-Pedersen, Kristian;Frimer-Larsen, Helle
目的探讨5种关节内注射透明质酸治疗膝骨关节炎的长期疗效和安全性。方法一项多中心、随机、安慰剂对照的双盲研究，纳入337例符合美国风湿病学会（ACR）膝骨关节炎（临床和实验室）标准的患者，Lequesne功能指数评分（LFI）≥ 10。患者接受透明质酸产品（透明质酸钠; Hyalgan）（n= 167）或生理盐水（n= 170）关节内每周一次，持续5周，并随访1年。至复发时间是主要疗效参数。LFI、基于视觉模拟量表的步行50 m疼痛（VAS疼痛50 m）、对乙酰氨基酚消耗量、患者总体评估、诺丁汉健康状况、关节积液和应答者数量是次要疗效参数。按意向治疗（ITT）和符合方案（PP）分析疗效参数。所有不良事件（AE）记录为安全性参数。结果复发时间显示没有显着的治疗效果（ITT分析，p = 0.26）。ITT人群中LFI和VAS疼痛50 m较基线的变化显示无治疗效应。根据ITT和PP分析，治疗组间对乙酰氨基酚消耗量、患者总体评估、应答率和AE无显著差异。透明质酸组的治疗依从性为95%，安慰剂组为99%。结论在符合ACR标准的中度至重度疾病活动度（LFI >= 10）的膝关节骨关节炎患者中，5次关节内注射透明质酸在治疗后3、6、9和12个月并没有改善疼痛、功能、扑热息痛消耗或其他疗效参数。
Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis.Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n= 167) or saline (n= 170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters.Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered.Conclusion In patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI >= 10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment.