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局部非甾体抗炎药凝胶(依托那酯)治疗膝骨关节炎。一项将依托那酯与口服双氯芬酸及安慰剂凝胶进行比较的双盲研究。

Local NSAID gel (eltenac) in the treatment of osteoarthritis of the knee. A double blind study comparing eltenac with oral diclofenac and placebo gel.

作者信息

Sandelin J, Harilainen A, Crone H, Hamberg P, Forsskåhl B, Tamelander G

机构信息

Orton Hospital, Invalid Foundation, Helsinki, Finland.

出版信息

Scand J Rheumatol. 1997;26(4):287-92. doi: 10.3109/03009749709105318.

Abstract

In a randomized, double blind, multicentre study with 4 weeks follow-up of 290 patients with osteoarthritis of the knee joint, a topical NSAID (eltenac) was compared with oral diclofenac and placebo. The main outcome, Lequesne's Index and pain by VAS showed no statistically significant differences between neither of the active treatments and placebo for the total study population. However, in patients with more severe symptoms, both active groups showed statistically significant differences to placebo. No severe adverse drug reactions were seen but the number of GI reactions were three times higher in the diclofenac group compared to the topical treatment. Local skin reactions were twice as frequent in the eltenac than in the placebo group. Taking into account the nature of the treatment for a chronic disease like OA, our results indicate that eltenac gel could be a safe alternative to oral NSAIDs.

摘要

在一项针对290例膝关节骨关节炎患者的随机、双盲、多中心研究中,对一种外用非甾体抗炎药(依托那酯)与口服双氯芬酸及安慰剂进行了为期4周的随访比较。主要观察指标,即勒凯斯内指数和视觉模拟评分法测定的疼痛,在整个研究人群中,两种活性治疗组与安慰剂组之间均无统计学显著差异。然而,在症状较严重的患者中,两个活性组与安慰剂组相比均有统计学显著差异。未观察到严重药物不良反应,但双氯芬酸组胃肠道反应的数量比外用治疗组高两倍。依托那酯组局部皮肤反应的发生率是安慰剂组的两倍。考虑到骨关节炎这种慢性病的治疗性质,我们的结果表明,依托那酯凝胶可能是口服非甾体抗炎药的一种安全替代药物。

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