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单剂量口服氯诺昔康用于成人术后急性疼痛

Single dose oral lornoxicam for acute postoperative pain in adults.

作者信息

Hall Peter E, Derry Sheena, Moore R Andrew, McQuay Henry J

机构信息

Keble College, University of Oxford, Parks Road, Oxford, Oxfordshire, UK, OX1 3PG.

出版信息

Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD007441. doi: 10.1002/14651858.CD007441.pub2.

Abstract

BACKGROUND

Lornoxicam is one of the oxicam class of non-steroidal anti-inflammatory drugs (NSAIDs), producing analgesic and antipyretic effects in part through the non-selective inhibition of cyclo-oxygenase-1 and -2. It is prescribed for osteoarthritis, rheumatoid arthritis, acute lumbar-sciatica conditions and for postoperative pain management. Lornoxicam is available in 31 countries in Europe, the Middle East, Far East and South America, and is becoming more widely available.

OBJECTIVES

To assess the efficacy, the time to onset of analgesia, the time to use of rescue medication and any associated adverse events of single dose oral lornoxicam in acute postoperative pain.

SEARCH STRATEGY

We searched CENTRAL, MEDLINE, EMBASE and PubMed to June 2009.

SELECTION CRITERIA

Single oral dose, randomised, double-blind, placebo-controlled trials of lornoxicam for relief of established moderate to severe postoperative pain in adults.

DATA COLLECTION AND ANALYSIS

Studies were assessed for methodological quality and the data extracted by two review authors independently. Summed total pain relief over 6 hours (TOTPAR 6) was used to calculate the number of participants achieving at least 50% pain relief. These derived results were used to calculate, with 95% confidence intervals (CIs), the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over 6 hours. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.

MAIN RESULTS

Three studies, with 628 participants, met the inclusion criteria; 434 participants were treated with various doses (2 mg to 32 mg) of lornoxicam, 118 with placebo, and 76 with other active therapies. All the participants had pain following third molar extraction, and study duration was 8 to 24 hours. The NNT for at least 50% pain relief over 6 hours after a single dose of lornoxicam 8 mg was 2.9 (2.3 to 4.0). There were insufficient data to analyse other doses or use of rescue medication. No serious adverse events or withdrawals were reported by any of the studies.

AUTHORS' CONCLUSIONS: Oral lornoxicam is effective at treating moderate to severe acute postoperative pain, based on limited data. Adverse events did not differ significantly from placebo.

摘要

背景

氯诺昔康是昔康类非甾体抗炎药(NSAIDs)之一,部分通过非选择性抑制环氧化酶-1和-2产生镇痛和解热作用。它被用于治疗骨关节炎、类风湿性关节炎、急性腰腿痛以及术后疼痛管理。氯诺昔康在欧洲、中东、远东和南美洲的31个国家有售,并且越来越广泛地可得。

目的

评估单剂量口服氯诺昔康用于急性术后疼痛的疗效、镇痛起效时间、使用解救药物的时间以及任何相关不良事件。

检索策略

我们检索了截至2009年6月的Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库和美国国立医学图书馆医学期刊数据库。

选择标准

氯诺昔康单口服剂量、随机、双盲、安慰剂对照试验,用于缓解成人已确诊的中度至重度术后疼痛。

数据收集与分析

评估研究的方法学质量,由两位综述作者独立提取数据。使用6小时内的总疼痛缓解量(TOTPAR 6)来计算疼痛缓解至少50%的参与者数量。这些得出的结果用于计算95%置信区间(CIs)下与安慰剂相比的相对获益,以及一名参与者在6小时内疼痛缓解至少50%所需治疗人数(NNT)。寻求特定时间段内使用解救药物的参与者数量以及使用解救药物的时间,作为疗效的额外衡量指标。收集不良事件和退出研究的信息。

主要结果

三项研究,共628名参与者,符合纳入标准;434名参与者接受了不同剂量(2毫克至32毫克)的氯诺昔康治疗,118名接受安慰剂治疗,76名接受其他活性疗法治疗。所有参与者在拔除第三磨牙后均有疼痛,研究持续时间为8至24小时。单剂量8毫克氯诺昔康后6小时内疼痛缓解至少50%的NNT为2.9(2.3至4.0)。没有足够的数据来分析其他剂量或解救药物的使用情况。任何一项研究均未报告严重不良事件或退出研究情况。

作者结论

基于有限的数据,口服氯诺昔康对治疗中度至重度急性术后疼痛有效。不良事件与安慰剂相比无显著差异。

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