Traa Maria X, Derry Sheena, Moore R Andrew
Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 7LJ.
Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007556. doi: 10.1002/14651858.CD007556.pub2.
Fenoprofen is a non-steroidal anti-inflammatory drug (NSAID), available in several different countries, but not widely used.
To assess the efficacy of single dose oral fenoprofen in acute postoperative pain, and associated adverse events.
We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to December 2010.
Single oral dose, randomised, double-blind, placebo-controlled trials of fenoprofen for relief of established moderate to severe postoperative pain in adults.
Studies were assessed for methodological quality and data extracted by two review authors independently. Summed total pain relief (TOTPAR) or pain intensity difference (SPID) over 4 to 6 hours was used to calculate the number of participants achieving at least 50% pain relief. These derived results were used to calculate, with 95% confidence intervals, the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over 4 to 6 hours. 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 was collected.
Five studies (696 participants) met the inclusion criteria; 24 participants were treated with fenoprofen 12.5 mg, 23 with fenoprofen 25 mg, 79 with fenoprofen 50 mg, 78 with fenoprofen 100 mg, 146 with fenoprofen 200 mg, 55 with fenoprofen 300 mg, 43 with zomepirac 100 mg, 30 with morphine 8 mg, 77 with codeine 60 mg, and 141 with placebo. Participants had pain following third molar extraction, laparoscopy, minor day surgery and episiotomy. The NNT for at least 50% pain relief over 4 to 6 hours with a single dose of fenoprofen 200 mg compared to placebo was 2.3 (1.9 to 3.0). There were insufficient data to analyse other doses or active comparators, time to use of rescue medication, or numbers of participants needing rescue medication. There was no difference in numbers of participants experiencing any adverse events between fenoprofen 200 mg and placebo. No serious adverse events or adverse event withdrawals were reported in these studies.
AUTHORS' CONCLUSIONS: Oral fenoprofen 200 mg is effective at treating moderate to severe acute postoperative pain, based on limited data for at least 50% pain relief over 4 to 6 hours. Efficacy of other doses, other efficacy outcomes, and safety and tolerability could not be assessed.
非诺洛芬是一种非甾体抗炎药(NSAID),在多个不同国家有售,但使用并不广泛。
评估单剂量口服非诺洛芬治疗急性术后疼痛的疗效及相关不良事件。
我们检索了考克兰中心对照试验注册库(Cochrane CENTRAL)、医学期刊数据库(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2010年12月的研究。
针对非诺洛芬用于缓解成人已确诊的中度至重度术后疼痛的单口服剂量、随机、双盲、安慰剂对照试验。
由两位综述作者独立评估研究的方法学质量并提取数据。使用4至6小时内的总疼痛缓解量(TOTPAR)或疼痛强度差值(SPID)来计算实现至少50%疼痛缓解的参与者数量。这些得出的结果用于计算与安慰剂相比的相对获益以及95%置信区间,以及一名参与者在4至6小时内实现至少50%疼痛缓解所需的治疗人数(NNT)。收集特定时间段内使用解救药物的参与者数量以及使用解救药物的时间,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。
五项研究(696名参与者)符合纳入标准;24名参与者接受12.5毫克非诺洛芬治疗,23名接受25毫克非诺洛芬治疗,79名接受50毫克非诺洛芬治疗,78名接受100毫克非诺洛芬治疗,146名接受200毫克非诺洛芬治疗,55名接受300毫克非诺洛芬治疗,43名接受100毫克佐美酸治疗,30名接受8毫克吗啡治疗,77名接受60毫克可待因治疗,141名接受安慰剂治疗。参与者在拔除第三磨牙、腹腔镜检查、小型日间手术和会阴切开术后出现疼痛。与安慰剂相比,单剂量200毫克非诺洛芬在4至6小时内实现至少50%疼痛缓解的NNT为(2.3(1.9至3.0))。没有足够的数据来分析其他剂量或活性对照药、使用解救药物的时间或需要解救药物的参与者数量。200毫克非诺洛芬组和安慰剂组之间经历任何不良事件的参与者数量没有差异。这些研究中未报告严重不良事件或因不良事件退出研究的情况。
基于有限的数据表明,200毫克口服非诺洛芬在4至6小时内实现至少50%疼痛缓解,对治疗中度至重度急性术后疼痛有效。无法评估其他剂量的疗效、其他疗效指标以及安全性和耐受性。