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单剂量口服塞来昔布用于成人术后急性疼痛

Single dose oral celecoxib for acute postoperative pain in adults.

作者信息

Derry Sheena, Moore R Andrew

机构信息

Pain Research and Nuffield Department of Clinical Neurosciences, University of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 7LE.

出版信息

Cochrane Database Syst Rev. 2013 Oct 22;2013(10):CD004233. doi: 10.1002/14651858.CD004233.pub4.

Abstract

BACKGROUND

This is an update of a review first published in The Cochrane Library in Issue 4, 2008, and updated in Issue 3, 2012. Celecoxib is a selective cyclo-oxygenase-2 (COX-2) inhibitor usually prescribed for the relief of chronic pain in osteoarthritis and rheumatoid arthritis. Celecoxib is believed to be associated with fewer upper gastrointestinal adverse effects than conventional non-steroidal anti-inflammatory drugs (NSAIDs). Its effectiveness in acute pain was demonstrated in the earlier reviews.

OBJECTIVES

To assess analgesic efficacy and adverse effects of a single oral dose of celecoxib for moderate to severe postoperative pain in adults.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Database, and ClinicalTrials.gov. The most recent search was to 31 May 2013.

SELECTION CRITERIA

We included randomised, double-blind, placebo-controlled trials (RCTs) of adults prescribed any dose of oral celecoxib or placebo for acute postoperative pain.

DATA COLLECTION AND ANALYSIS

Two review authors assessed studies for quality and extracted data. We converted summed pain relief (TOTPAR) or pain intensity difference (SPID) into dichotomous information, yielding the number of participants with at least 50% pain relief over four to six hours. We used this to calculate the relative benefit (RB) and number needed to treat to benefit (NNT), for one patient to achieve at least 50% of maximum pain relief with celecoxib who would not have done so with placebo. We used information on use of rescue medication to calculate the proportion of participants requiring rescue medication and the weighted mean of the median time to use.

MAIN RESULTS

Ten studies (1785 participants) met the inclusion criteria. The two new studies in this update had been identified in the earlier update, but data were not available. There remain three potentially relevant unpublished studies for which data are not available at this time.The NNT for celecoxib 200 mg and 400 mg compared with placebo for at least 50% of maximum pain relief over four to six hours was 4.2 (95% confidence interval (CI) 3.4 to 5.6) and 2.6 (95% CI 2.3 to 3.0) respectively. The median time to use of rescue medication was 6.6 hours with celecoxib 200 mg, 8.4 hours with celecoxib 400 mg, and 2.3 hours with placebo. The proportion of participants requiring rescue medication over 24 hours was 74% with celecoxib 200 mg, 63% for celecoxib 400 mg, and 91% for placebo. The NNT to prevent one patient using rescue medication was 4.8 (95% CI 3.5 to 7.7) and 3.5 (95% CI 2.9 to 4.6) for celecoxib 200 mg and 400 mg respectively. Adverse events were generally mild to moderate in severity, and were experienced by a similar proportion of participants in the celecoxib and placebo groups. One serious adverse event that was probably related to celecoxib was reported.

AUTHORS' CONCLUSIONS: Single-dose oral celecoxib is an effective analgesic for postoperative pain relief. Indirect comparison suggests that the 400 mg dose has similar efficacy to ibuprofen 400 mg.

摘要

背景

本综述首次发表于《Cochrane图书馆》2008年第4期,并于2012年第3期更新。塞来昔布是一种选择性环氧化酶-2(COX-2)抑制剂,常用于缓解骨关节炎和类风湿关节炎的慢性疼痛。与传统非甾体抗炎药(NSAIDs)相比,塞来昔布被认为上消化道不良反应较少。其在急性疼痛中的有效性已在早期综述中得到证实。

目的

评估单剂量口服塞来昔布对成人中重度术后疼痛的镇痛效果及不良反应。

检索方法

我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、牛津疼痛数据库和ClinicalTrials.gov。最近一次检索截至2013年5月31日。

入选标准

我们纳入了针对急性术后疼痛给予任何剂量口服塞来昔布或安慰剂的成人随机、双盲、安慰剂对照试验(RCT)。

数据收集与分析

两位综述作者评估研究质量并提取数据。我们将总疼痛缓解(TOTPAR)或疼痛强度差异(SPID)转换为二分信息,得出在四至六小时内疼痛缓解至少50%的参与者人数。我们用此计算相对获益(RB)和需治疗获益人数(NNT),即使用塞来昔布能实现至少50%最大疼痛缓解而使用安慰剂则不能的患者人数。我们利用急救药物使用信息计算需要急救药物的参与者比例以及使用时间中位数的加权均值。

主要结果

十项研究(1785名参与者)符合纳入标准。本次更新中的两项新研究在早期更新中已被识别,但当时没有数据。目前仍有三项潜在相关的未发表研究,暂无数据。与安慰剂相比,塞来昔布200毫克和400毫克在四至六小时内实现至少50%最大疼痛缓解的NNT分别为4.2(95%置信区间(CI)3.4至5.6)和2.6(95%CI 2.3至3.0)。使用急救药物的中位数时间,塞来昔布200毫克组为6.6小时,塞来昔布400毫克组为8.4小时,安慰剂组为2.3小时。24小时内需要急救药物的参与者比例,塞来昔布200毫克组为74%,塞来昔布400毫克组为63%,安慰剂组为91%。塞来昔布200毫克和400毫克预防一名患者使用急救药物的NNT分别为4.8(95%CI 3.5至7.7)和3.5(95%CI 2.9至4.6)。不良反应一般为轻至中度,塞来昔布组和安慰剂组经历不良反应的参与者比例相似。报告了一例可能与塞来昔布相关的严重不良事件。

作者结论

单剂量口服塞来昔布是缓解术后疼痛的有效镇痛药。间接比较表明,400毫克剂量的塞来昔布与400毫克布洛芬疗效相似。

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