Intraarticular sodium hyaluronate (Hyalgan) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. Hyalgan Study Group.
Intraarticular sodium hyaluronate (Hyalgan) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. Hyalgan Study Group.
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发表时间：
1998-11
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通讯作者：
R. Altman;R. Moskowitz
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作者：
R. Altman;R. Moskowitz
目的：比较关节内透明质酸（HA; Hyalgan）与安慰剂和一种非甾体抗炎药治疗膝关节骨关节炎（OA）的疗效和安全性。方法：对495例特发性OA患者进行为期26周、双盲、蒙面观察、多中心试验，将HA连续5周注射（每次20 mg）与安慰剂或口服萘普生进行比较。对乙酰氨基酚用于逃逸镇痛。主要测量方法是对完成研究的参与者（完成者）进行50英尺步行测试时所经历的疼痛，以10厘米视觉模拟量表（VAS）测量。还测量了西安大略和麦克马斯特大学（WOMAC）骨关节炎指数（疼痛、僵硬、功能）和疼痛分类评估。结果：在第26周，与安慰剂相比，接受HA治疗的患者在50英尺步行时的疼痛得到了更多的改善(HA与安慰剂的差异为8.8 mm；从第5周持续到第26周，VAS减少了20 mm （p=0.031）。在26周时，与安慰剂组（33.1%,p=0.039）或萘普生组（36.9%,p=0.22）相比，更多的HA组患者（47.6%）有轻微疼痛或无疼痛。与安慰剂组相比，HA组在次要结局变量的改善总体上优于安慰剂组，并且在第26周时，在WOMAC疼痛（p=0.041）和WOMAC身体功能（p=0.047）亚量表方面明显更好。与萘普生组相比，HA组在初级和次级评估中也倾向于有更好的结果。对于所有随机分配的患者，28%的安慰剂治疗患者在50英尺行走时疼痛改善bb0或= 20毫米，而36%的HA治疗患者（p=0.127； 67%的患者完成了试验）。HA组（38/164=23%）比安慰剂组（22/168=13%,p < 0.001）更常报告注射部位疼痛，导致6例患者（4%）停药。1例停药与HA注射相关（< 1%）。胃肠道不良事件在萘普生组明显比HA组或安慰剂组更常见，14名萘普生治疗患者（8.3%）因这些事件过早停药。结论：这项大型随机对照临床试验证实，对于膝关节OA患者，每周5次IA注射HA （Hyalgan）通常耐受性良好，可持续缓解疼痛，改善患者功能，至少与连续26周服用萘普生一样有效，不良反应更少。
OBJECTIVE To determine efficacy and safety of intraarticular (IA) hyaluronic acid (HA; Hyalgan) versus placebo and a nonsteroidal antiinflammatory drug for osteoarthritis (OA) of the knee. METHOD A series of 5 weekly IA injections of HA (20 mg each) was compared to placebo or oral naproxen in a 26 week, double blind, masked observer, multicenter trial of 495 patients with idiopathic OA. Acetaminophen was permitted for escape analgesia. The primary measurement was pain experienced on a 50 foot walk test for those completing the study (completers) as measured on a 10 cm visual analog scale (VAS). Also measured were the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index (pain, stiffness, function) and categorical assessments of pain. RESULTS Patients receiving HA improved more with respect to pain on the 50 foot walk compared to placebo at Week 26 (HA vs placebo difference 8.8 mm; p or = 20 mm reduction in the VAS from Week 5 continuously through Week 26 (p=0.031). At 26 weeks, more HA treated patients (47.6%) had slight pain or were pain-free in contrast to placebo treated (33.1%; p=0.039) or naproxen treated (36.9%; p=0.22) [corrected] patients. Improvement in secondary outcome variables was generally superior in the HA group compared to those receiving placebo and was significantly better at Week 26 with respect to the WOMAC pain (p=0.041) and WOMAC physical function (p=0.047) subscales. The HA group also tended to have better results relative to the naproxen group in both primary and secondary assessments. For all randomized patients, there was a > or = 20 mm improvement in pain experienced on the 50 foot walk in 28% [corrected] of placebo treated patients vs 36% [corrected] of the HA treated patients (p=0.127; 67% of patients completed the trial). Injection site pain, more commonly reported in the HA group (38/164=23%) than in the placebo group (22/168=13%; p < 0.001), resulted in withdrawal in 6 patients (4%). One withdrawal was associated with the HA injection (< 1%). Gastrointestinal adverse events were significantly more common in the naproxen group than the HA or the placebo groups and 14 naproxen treated patients (8.3%) discontinued prematurely due to these events. CONCLUSION This large, controlled randomized clinical trial confirms that 5 weekly IA injections of HA (Hyalgan) in patients with OA of the knee are generally well tolerated, provide sustained relief of pain and improved patient function, and were at least as effective with fewer adverse reactions as continuous treatment with naproxen for 26 weeks.