Clarke Rachel, Derry Sheena, Moore R Andrew
Pain Research and Nuffield Department of Clinical Neurosciences, University of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 9LE.
Cochrane Database Syst Rev. 2014 May 8;2014(5):CD004309. doi: 10.1002/14651858.CD004309.pub4.
This is an updated version of the original Cochrane review first published in Issue 2, 2009, and updated in Issue 4, 2012.Etoricoxib is a selective cyclo-oxygenase-2 (COX-2) inhibitor licensed for the relief of chronic pain in osteoarthritis and rheumatoid arthritis, and acute pain in some jurisdictions. This class of drugs is believed to be associated with fewer upper gastrointestinal adverse effects than conventional non-steroidal anti-inflammatory drugs (NSAIDs).
To assess the efficacy and adverse effects of single dose etoricoxib for acute postoperative pain using methods that permit accurate comparison with other analgesics evaluated in the same way, using criteria of efficacy recommended by in-depth studies at the individual patient level.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Database, www.clinicaltrials.gov, and reference lists of articles. The date of the most recent search was 31 January 2014.
Randomised, double-blind, placebo-controlled clinical trials of single dose, oral etoricoxib for acute postoperative pain in adults.
Two review authors independently considered studies for inclusion in the review, assessed quality, and extracted data. We used the area under the pain relief versus time curve to derive the proportion of participants prescribed etoricoxib or placebo with at least 50% pain relief over six hours, using validated equations. We calculated relative risk (RR) and number needed to treat to benefit (NNT). 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. We also collected information on adverse events.
We identified no new studies for this updated review, which includes six studies with 1214 participants in comparisons of etoricoxib with placebo. All six studies reported on the 120 mg dose (798 participants in a comparison with placebo). Sixty-six per cent of participants with etoricoxib 120 mg and 12% with placebo reported at least 50% pain relief (NNT 1.8 (1.7 to 2.0); high-quality evidence). For dental studies only, the NNT was 1.6 (1.5 to 1.8). A single dose of 90 mg produced similar results in one large trial. Other doses (60, 180, and 240 mg) were each studied in only one treatment arm.Significantly fewer participants used rescue medication over 24 hours when taking etoricoxib 120 mg than placebo (NNT to prevent remedication 2.2 (1.9 to 2.8)), and the median time to use of rescue medication was 20 hours for etoricoxib and two hours for placebo. Adverse events were reported at a similar rate to placebo (moderate-quality evidence), with no serious events.
AUTHORS' CONCLUSIONS: Single-dose oral etoricoxib produces high levels of good quality pain relief after surgery, and adverse events did not differ from placebo in these studies. The 120 mg dose is as effective as, or better than, other commonly used analgesics.
这是对最初发表于2009年第2期并于2012年第4期更新的Cochrane系统评价的更新版本。依托考昔是一种选择性环氧化酶-2(COX-2)抑制剂,已获许可用于缓解骨关节炎和类风湿关节炎的慢性疼痛,以及在某些司法管辖区用于缓解急性疼痛。据信,这类药物与传统非甾体抗炎药(NSAIDs)相比,上消化道不良反应较少。
采用能够与以相同方式评估的其他镇痛药进行准确比较的方法,依据个体患者层面深入研究推荐的疗效标准,评估单剂量依托考昔用于急性术后疼痛的疗效和不良反应。
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、www.clinicaltrials.gov以及文章的参考文献列表。最近一次检索日期为2014年1月31日。
单剂量口服依托考昔用于成人急性术后疼痛的随机、双盲、安慰剂对照临床试验。
两位综述作者独立考虑纳入综述的研究、评估质量并提取数据。我们使用疼痛缓解与时间曲线下面积,通过验证方程得出服用依托考昔或安慰剂的参与者在6小时内疼痛缓解至少50%的比例。我们计算相对风险(RR)和需治疗获益人数(NNT)。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急救药物的中位时间加权均值。我们还收集了不良事件信息。
本次更新综述未纳入新的研究,其包括6项研究,共1214名参与者,比较了依托考昔与安慰剂。所有6项研究均报告了120mg剂量(798名参与者与安慰剂进行比较)。服用120mg依托考昔的参与者中有66%报告疼痛缓解至少50%,服用安慰剂的参与者中有12%报告疼痛缓解至少50%(NNT 1.8(1.7至2.0);高质量证据)。仅对于牙科研究,NNT为1.6(1.5至1.8)。在一项大型试验中,单剂量90mg产生了相似结果。其他剂量(60、180和240mg)每个仅在一个治疗组中进行了研究。服用120mg依托考昔的参与者在24小时内使用急救药物的人数显著少于服用安慰剂者(预防再次用药的NNT 2.2(1.9至2.8)),依托考昔使用急救药物的中位时间为20小时,安慰剂为2小时。不良事件报告率与安慰剂相似(中等质量证据),无严重事件。
单剂量口服依托考昔术后可产生高水平的良好疼痛缓解,且在这些研究中不良事件与安慰剂无差异。120mg剂量与其他常用镇痛药效果相当或更好。