Derry Christopher, Derry Sheena, Moore R Andrew, McQuay Henry J
Pain Research and Nuffield Department of Anaesthetics, University of Oxford, West Wing (Level 6), John Radcliffe Hospital, Oxford, Oxfordshire, UK, OX3 9DU.
Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD004234. doi: 10.1002/14651858.CD004234.pub3.
Naproxen, a non-steroidal anti-inflammatory drug, is used to treat various painful conditions including postoperative pain, and is often administered as the sodium salt to improve its solubility. This review updates a 2004 Cochrane review showing that naproxen sodium 550 mg (equivalent to naproxen 500 mg) was effective for treating postoperative pain. New studies have since been published.
To assess efficacy, duration of action, and associated adverse events of single dose oral naproxen or naproxen sodium in acute postoperative pain in adults.
We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to October 2008.
Randomised, double blind, placebo-controlled trials of single dose orally administered naproxen or naproxen sodium in adults with moderate to severe acute postoperative pain.
Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over four to six hours, from which relative risk and number-needed-to-treat-to-benefit (NNT) were calculated. 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 were collected.
The original review included 10 studies with 996 participants. This updated review included 15 studies (1509 participants); 11 assessed naproxen sodium and four naproxen. In nine studies (784 participants) using 500/550 mg naproxen or naproxen sodium the NNT for at least 50% pain relief over four to six hours was 2.7 (95% CI 2.3 to 3.2). No dose response was demonstrated over the range 200/220 mg to 500/550 mg, but limited data was identified. Median time to use of rescue medication was 8.9 hours for naproxen 500/550 mg and 2.0 hours for placebo. Use of rescue medication was significantly less common with naproxen than placebo. Associated adverse events were generally of mild to moderate severity and rarely led to withdrawal.
AUTHORS' CONCLUSIONS: Doses equivalent to 500 mg and 400 mg naproxen administered orally provided effective analgesia to adults with moderate to severe acute postoperative pain. About half of participants treated with these doses experienced clinically useful levels of pain relief, compared to 15% with placebo, and half required additional medication within nine hours, compared to two hours with placebo. Associated adverse events did not differ from placebo.
萘普生是一种非甾体抗炎药，用于治疗包括术后疼痛在内的各种疼痛病症，常以钠盐形式给药以提高其溶解度。本综述更新了2004年Cochrane综述，该综述表明550毫克萘普生钠（相当于500毫克萘普生）对治疗术后疼痛有效。此后发表了新的研究。
评估单剂量口服萘普生或萘普生钠对成人急性术后疼痛的疗效、作用持续时间及相关不良事件。
我们检索了Cochrane CENTRAL、MEDLINE、EMBASE和牛津疼痛缓解数据库，检索截至2008年10月的研究。
对患有中度至重度急性术后疼痛的成人进行单剂量口服萘普生或萘普生钠的随机、双盲、安慰剂对照试验。
两位综述作者独立评估试验质量并提取数据。提取疼痛缓解或疼痛强度数据，并转换为在四至六小时内疼痛缓解至少50%的参与者数量的二分结果，据此计算相对风险和需治疗获益人数（NNT）。收集在特定时间段内使用急救药物的参与者数量以及使用急救药物的时间，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。
原综述纳入了10项研究，共996名参与者。本次更新综述纳入了15项研究（1509名参与者）；11项评估萘普生钠，4项评估萘普生。在9项使用500/550毫克萘普生或萘普生钠的研究（784名参与者）中，四至六小时内疼痛缓解至少50%的NNT为2.7（95%CI 2.3至3.2）。在200/220毫克至500/550毫克范围内未显示出剂量反应，但可获取的数据有限。500/550毫克萘普生使用急救药物的中位时间为8.9小时，安慰剂为2.0小时。与安慰剂相比，萘普生使用急救药物的情况明显较少见。相关不良事件一般为轻度至中度严重程度，很少导致退出研究。
口服相当于500毫克和400毫克萘普生的剂量可为患有中度至重度急性术后疼痛的成人提供有效的镇痛作用。接受这些剂量治疗的参与者中约有一半经历了临床上有用的疼痛缓解水平，而安慰剂组为15%；一半在九小时内需要额外用药,而安慰剂组为两小时。相关不良事件与安慰剂组无差异。
