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美洛昔康的临床试验及获益/风险比综述。

Review of clinical trials and benefit/risk ratio of meloxicam.

作者信息

Barner A

机构信息

Boehringer Ingelheim, Ingelheim am Rhein, Germany.

出版信息

Scand J Rheumatol Suppl. 1996;102:29-37. doi: 10.3109/03009749609097228.

DOI:10.3109/03009749609097228
PMID:8628979
Abstract

Meloxicam is a new once daily non-steroidal anti-inflammatory drug (NSAID). Double-blind trials in over 5000 patients with osteoarthritis and rheumatoid arthritis have shown that meloxicam 7.5 mg and 15 mg are significantly more effective than placebo and comparable in efficacy to standard NSAIDs such as naproxen 750-1000 mg, piroxicam 20 mg and diclofenac 100 mg slow release. In a global safety analysis, both meloxicam doses produced significantly fewer gastrointestinal (GI) side effects than the comparators (p < 0/05). Severe GI side effects, discontinuations due to GI side effects and less serious events such as dyspepsia and abdominal pain were also significantly less frequent with meloxicam. Perforations, ulcerations and bleedings occurred in 0.1%, 0.2%, 1.2%, 0.6% and 2.1% of meloxicam 7.5 mg, 15 mg, piroxicam, diclofenac and naproxen patients respectively (p < 0.05 for piroxicam and naproxen compared with meloxicam). This improved safety profile is likely to be due to meloxicam's selective inhibition of COX-2 relative to COX-1.

摘要

美洛昔康是一种新型的每日一次服用的非甾体抗炎药(NSAID)。针对5000多名骨关节炎和类风湿关节炎患者进行的双盲试验表明,7.5毫克和15毫克的美洛昔康比安慰剂显著更有效,且在疗效上与标准NSAIDs相当,如750 - 1000毫克的萘普生、20毫克的吡罗昔康和100毫克缓释双氯芬酸。在一项全球安全性分析中,与对照药物相比,两种剂量的美洛昔康产生的胃肠道(GI)副作用显著更少(p < 0.05)。严重的GI副作用、因GI副作用导致的停药以及诸如消化不良和腹痛等不太严重的事件,在使用美洛昔康的患者中也明显更不常见。7.5毫克、15毫克美洛昔康、吡罗昔康、双氯芬酸和萘普生的患者中,穿孔、溃疡和出血的发生率分别为0.1%、0.2%、1.2%、0.6%和2.1%(与美洛昔康相比,吡罗昔康和萘普生的p < 0.05)。这种改善的安全性可能归因于美洛昔康相对于COX - 1对COX - 2的选择性抑制作用。

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Review of clinical trials and benefit/risk ratio of meloxicam.美洛昔康的临床试验及获益/风险比综述。
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