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口服美洛昔康治疗急性坐骨神经痛有效:两项与安慰剂或双氯芬酸对比的随机双盲试验

Oral meloxicam is effective in acute sciatica: two randomised, double-blind trials versus placebo or diclofenac.

作者信息

Dreiser R L, Le Parc J M, Vélicitat P, Lleu P L

机构信息

Service de Rhumatologie, H pital Ambroise Pare, Boulogne, France.

出版信息

Inflamm Res. 2001 Mar;50 Suppl 1:S17-23. doi: 10.1007/PL00022375.

Abstract

OBJECTIVE

Two randomised, double-blind, double-dummy trials evaluated the efficacy and tolerability of meloxicam compared with placebo or diclofenac in patients with acute sciatica.

SUBJECTS

1021 patients with acute sciatica.

TREATMENT AND METHODS

In the first study, 532 patients received meloxicam 7.5 mg, meloxicam 15 mg, or placebo for 7 days. The second study randomised 489 patients to meloxicam 7.5 mg, meloxicam 15 mg, or diclofenac 150 mg for 14 days.

RESULTS

Meloxicam 7.5 mg and 15 mg significantly improved overall pain between baseline and day 7 (p < 0.05) compared with placebo. Furthermore, both meloxicam doses showed similar improvements on all primary and secondary efficacy endpoints compared with diclofenac 150 mg. No significant differences in tolerability were observed between any of the treatment groups in either study.

CONCLUSIONS

Meloxicam (7.5 mg or 15 mg) was well tolerated and was more effective than placebo, and as effective as diclofenac, in acute sciatica.

摘要

目的

两项随机、双盲、双模拟试验评估了美洛昔康与安慰剂或双氯芬酸相比,在急性坐骨神经痛患者中的疗效和耐受性。

受试者

1021例急性坐骨神经痛患者。

治疗与方法

在第一项研究中,532例患者接受7.5毫克美洛昔康、15毫克美洛昔康或安慰剂治疗7天。第二项研究将489例患者随机分为接受7.5毫克美洛昔康、15毫克美洛昔康或150毫克双氯芬酸治疗14天。

结果

与安慰剂相比,7.5毫克和15毫克美洛昔康在基线至第7天期间显著改善了总体疼痛(p<0.05)。此外,与150毫克双氯芬酸相比,两种美洛昔康剂量在所有主要和次要疗效终点上均显示出相似的改善。在两项研究的任何治疗组之间,均未观察到耐受性的显著差异。

结论

在急性坐骨神经痛中,美洛昔康(7.5毫克或15毫克)耐受性良好,比安慰剂更有效,且与双氯芬酸疗效相当。

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