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静脉注射或肌肉注射帕瑞昔布用于成人术后急性疼痛。

Intravenous or intramuscular parecoxib for acute postoperative pain in adults.

作者信息

Lloyd Rosalind, Derry Sheena, Moore R Andrew, 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 Apr 15;2009(2):CD004771. doi: 10.1002/14651858.CD004771.pub4.

Abstract

BACKGROUND

Parecoxib was the first COX-2 available for parenteral administration, and may, given intravenously or intramuscularly, offer advantages over oral medication when patients have nausea and vomiting or are unable to swallow, such as in the immediate postoperative period.

OBJECTIVES

Assess the efficacy of single dose intravenous or intramuscular parecoxib in acute postoperative pain, the requirement for rescue medication, and any associated adverse events.

SEARCH STRATEGY

We searched Cochrane CENTRAL, MEDLINE, EMBASE in November 2008.

SELECTION CRITERIA

Randomised, double-blind, placebo-controlled clinical trials of parecoxib compared with placebo for relief of acute postoperative pain in adults.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed trial quality and extracted data. The area under the "pain relief versus time" curve was used to derive the proportion of participants with parecoxib and placebo experiencing at least 50% pain relief over 6 hours, using validated equations. The number-needed-to-treat-to-benefit (NNT) was calculated using 95% confidence intervals (CI). The proportion of participants using rescue analgesia over a specified time period, and time to use of rescue analgesia, were sought as additional measures of efficacy. Information on adverse events and withdrawals were also collected.

MAIN RESULTS

Seven studies (1446 participants) were included. There was no significant difference between doses, or between intravenous and intramuscular administration for 50% pain relief over 6 hours: NNTs compared with placebo were 3.1 (2.4 to 4.5), 2.4 (2.1 to 2.8), and 1.8 (1.5 to 2.3) for 10, 20, and 40 mg parecoxib respectively. Fewer participants required rescue medication over 24 hours with parecoxib than placebo: parecoxib 40 mg was significantly better than parecoxib 20 mg (NNTs to prevent use of rescue medication 7.5 (5.3 to 12.8) and 3.3 (2.6 to 4.5) respectively; P < 0.0007). Median time to use of rescue medication was 3.1 hours, 6.9 hours and 10.6 hours with parecoxib 10 mg, 20 mg and 40 mg respectively, and 1.5 hours with placebo. Adverse events were generally mild to moderate, rarely led to withdrawal, and did not differ in frequency between groups. No serious adverse events were reported with parecoxib or placebo.

AUTHORS' CONCLUSIONS: A single dose of parecoxib 20 mg or 40 mg provided effective analgesia for 50 to 60% of those treated compared to about 15% with placebo, and was well tolerated. Duration of analgesia was longer, and significantly fewer participants required rescue medication over 24 hours with the higher dose.

摘要

背景

帕瑞昔布是首个可用于胃肠外给药的环氧化酶-2(COX-2)抑制剂,当患者出现恶心、呕吐或无法吞咽时,如在术后即刻,静脉或肌内注射给药可能比口服给药更具优势。

目的

评估单剂量静脉或肌内注射帕瑞昔布治疗急性术后疼痛的疗效、急救药物的需求以及任何相关不良事件。

检索策略

我们于2008年11月检索了Cochrane中心对照试验注册库、医学期刊数据库(MEDLINE)和荷兰医学文摘数据库(EMBASE)。

选择标准

将帕瑞昔布与安慰剂进行比较,用于缓解成人急性术后疼痛的随机、双盲、安慰剂对照临床试验。

数据收集与分析

两名综述作者独立评估试验质量并提取数据。使用经过验证的公式,通过“疼痛缓解与时间”曲线下的面积,得出接受帕瑞昔布和安慰剂治疗的参与者在6小时内疼痛缓解至少50%的比例。使用95%置信区间(CI)计算治疗获益所需的人数(NNT)。寻求在特定时间段内使用急救镇痛药物的参与者比例以及使用急救镇痛药物的时间,作为疗效的额外衡量指标。还收集了不良事件和退出试验的信息。

主要结果

纳入了7项研究(1446名参与者)。在6小时内实现50%疼痛缓解方面,不同剂量之间以及静脉注射和肌内注射之间均无显著差异:与安慰剂相比,10mg、20mg和40mg帕瑞昔布的NNT分别为3.1(2.4至4.5)、2.4(2.1至2.8)和1.8(1.5至2.3)。与安慰剂相比,使用帕瑞昔布的参与者在24小时内需要急救药物的人数更少:40mg帕瑞昔布明显优于20mg帕瑞昔布(预防使用急救药物的NNT分别为7.5(5.3至12.8)和3.3(2.6至4.5);P<0.0007)。使用10mg、20mg和40mg帕瑞昔布时,使用急救药物的中位时间分别为3.1小时、6.9小时和10.6小时,而使用安慰剂时为1.5小时。不良事件一般为轻至中度,很少导致退出试验,且组间频率无差异。未报告帕瑞昔布或安慰剂的严重不良事件。

作者结论

与安慰剂组约15%的患者相比,单剂量20mg或40mg帕瑞昔布可为50%至60%的治疗患者提供有效的镇痛效果,且耐受性良好。镇痛持续时间更长,较高剂量组在24小时内需要急救药物的参与者明显更少。

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