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单剂量口服噻洛芬酸用于成人急性术后疼痛

Single dose oral tiaprofenic acid for acute postoperative pain in adults.

作者信息

Moore R Andrew, Derry Sheena, Moore Maura, McQuay Henry J

机构信息

Pain Research and Nuffield Department of Anaesthetics, University of Oxford, West Wing (Level 6), John Radcliffe Hospital, Oxford, Oxfordshire, UK, OX3 9DU.

出版信息

Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD007542. doi: 10.1002/14651858.CD007542.pub2.

Abstract

BACKGROUND

Tiaprofenic acid is a a non-steroidal anti-inflammatory drug (NSAID). It is widely available around the world, with indications for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, periarticular disorders, and strains and sprains. This review sought to evaluate the efficacy and safety of oral tiaprofenic acid in acute postoperative pain, using clinical studies of patients with established pain, and with outcomes measured primarily over 6 hours using standard methods. This type of study has been used for many decades to establish that drugs have analgesic properties.

OBJECTIVES

To assess the efficacy of single dose oral tiaprofenic acid in acute postoperative pain, and any associated adverse events.

SEARCH STRATEGY

We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to June 2009.

SELECTION CRITERIA

Randomised, double blind, placebo-controlled trials of single dose orally administered tiaprofenic acid in adults with moderate to severe acute postoperative pain.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed trial quality and extracted data. We planned to use area under the "pain relief versus time" curve to derive the proportion of participants with tiaprofenic acid experiencing at least 50% pain relief over 4 to 6 hours, using validated equations; to use number needed to treat to benefit (NNT); the proportion of participants using rescue analgesia over a specified time period; time to use of rescue analgesia; information on adverse events and withdrawals.

MAIN RESULTS

Not one of eleven studies identified by the searches and examined in detail studied oral tiaprofenic acid against placebo in patients with established postoperative pain and therefore no results are available.

AUTHORS' CONCLUSIONS: In the absence of evidence of efficacy for oral tiaprofenic acid in acute postoperative pain, its use in this indication is not justified at present. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies is lacking, use in other indications should be evaluated carefully. Given the large number of available drugs of this and similar classes which are effective, there is no urgent research agenda for this particular drug.

摘要

背景

噻洛芬酸是一种非甾体抗炎药(NSAID)。它在全球广泛可得,适用于骨关节炎、类风湿性关节炎、强直性脊柱炎、关节周围疾病以及拉伤和扭伤。本综述旨在通过对已确诊疼痛患者的临床研究,并使用标准方法主要在6小时内测量结果,来评估口服噻洛芬酸治疗急性术后疼痛的疗效和安全性。这类研究已被用于数十年以确定药物是否具有镇痛特性。

目的

评估单剂量口服噻洛芬酸治疗急性术后疼痛的疗效以及任何相关不良事件。

检索策略

我们检索了考克兰中心对照试验注册库(Cochrane CENTRAL)、医学文献数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)以及牛津疼痛缓解数据库,检索截至2009年6月的研究。

入选标准

针对患有中度至重度急性术后疼痛的成年人,口服单剂量噻洛芬酸的随机、双盲、安慰剂对照试验。

数据收集与分析

两位综述作者独立评估试验质量并提取数据。我们计划使用“疼痛缓解与时间”曲线下面积,通过验证方程得出在4至6小时内经历至少50%疼痛缓解的噻洛芬酸参与者比例;使用需治疗获益人数(NNT);在特定时间段内使用解救镇痛药的参与者比例;使用解救镇痛药的时间;不良事件和退出研究的信息。

主要结果

检索到并详细审查的11项研究中,没有一项研究针对已确诊术后疼痛的患者将口服噻洛芬酸与安慰剂进行对比,因此没有可用结果。

作者结论

由于缺乏口服噻洛芬酸治疗急性术后疼痛疗效的证据,目前其在此适应症中的使用不合理。鉴于缺乏在最基础的急性疼痛研究中明确证明镇痛疗效的试验,在其他适应症中的使用应谨慎评估。鉴于有大量此类及类似类别的有效药物可用,对于这种特定药物没有紧迫的研究议程。

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