Derry Sheena, Best Jessica, Moore R Andrew
Pain Research and Nuffield Department of Clinical Neurosciences, University of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 7LE.
Cochrane Database Syst Rev. 2013 Oct 23;2013(10):CD007550. doi: 10.1002/14651858.CD007550.pub3.
This review is an update of a previously published review in The Cochrane Database of Systematic Reviews Issue 3, 2009 on single dose oral dexibuprofen (S(+)-ibuprofen) for acute postoperative pain in adults.Dexibuprofen is a non-steroidal anti-inflammatory drug (NSAID) licensed for use in rheumatic disease and other musculoskeletal disorders in the UK, and widely available in other countries worldwide. It is an active isomer of ibuprofen. This review sought to evaluate the efficacy and safety of oral dexibuprofen in acute postoperative pain, using clinical studies in patients with established pain, and with outcomes measured primarily over four to six hours, using standard methods. This type of study has been used for many decades to establish that drugs have analgesic properties.
To assess the efficacy and adverse effects of single dose oral dexibuprofen for acute postoperative pain using methods that permit comparison with other analgesics evaluated in standardised studies using almost identical methods and outcomes.
Searches were run for the original review in 2009 and subsequent searches have been run in August 2013. We did not find any new published studies as a result of the updated search.We searched for randomised studies of dexibuprofen in acute postoperative pain in MEDLINE, EMBASE, and CENTRAL (The Cochrane LIbrary), and for clinical trial reports and synopses of published and unpublished studies from Internet sources.
Randomised, double blind, placebo-controlled clinical studies of oral dexibuprofen for relief of acute postoperative pain in adults.
Two review authors independently assessed study quality and extracted data. We extracted pain relief or pain intensity data and converted it 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. We collected information on adverse events and withdrawals.
New data were identified for this update in one unpublished trial synopsis (BR1160 1995) in addition to the single study (Dionne 1998) that was included in the original review. In both studies dexibuprofen gave high levels of response, with 51/96 (53%) participants experiencing at least 50% pain relief with dexibuprofen 200 mg and 35/50 (70%) with dexibuprofen 400 mg, compared with 75/147 (51%) with racemic ibuprofen 400 mg, and 12/62 (13%) with placebo. The numbers of participants was too small to calculate NNTs with any meaning. The median time to additional analgesic use was greater than four hours for all active therapies, but about two hours for placebo.Adverse events were generally of mild or moderate intensity and consistent with events normally associated with anaesthesia and surgery. There were no serious adverse events or deaths.Additional data did not alter the conclusions from the earlier review.
AUTHORS' CONCLUSIONS: The information from these two studies in acute postoperative pain suggested that dexibuprofen may be a useful analgesic, but at doses not very different from racemic ibuprofen, for which considerably more evidence exists.
本综述是对2009年第3期《Cochrane系统评价数据库》中一篇关于单剂量口服右布洛芬（S(+)-布洛芬）用于成人术后急性疼痛的已发表综述的更新。右布洛芬是一种非甾体抗炎药（NSAID），在英国被批准用于治疗风湿性疾病和其他肌肉骨骼疾病，在世界其他国家也广泛可得。它是布洛芬的活性异构体。本综述旨在通过对已有疼痛患者的临床研究，并使用标准方法，主要在4至6小时内测量结果，来评估口服右布洛芬治疗术后急性疼痛的疗效和安全性。这种类型的研究已经使用了几十年，以确定药物是否具有镇痛特性。
使用能够与采用几乎相同方法和结果的标准化研究中评估的其他镇痛药进行比较的方法，评估单剂量口服右布洛芬治疗术后急性疼痛的疗效和不良反应。
2009年对原始综述进行了检索，随后在2013年8月进行了后续检索。更新检索未发现任何新发表的研究。我们在MEDLINE、EMBASE和CENTRAL（Cochrane图书馆）中检索了右布洛芬用于术后急性疼痛的随机研究，并从互联网来源检索了已发表和未发表研究的临床试验报告及摘要。
口服右布洛芬用于缓解成人术后急性疼痛的随机、双盲、安慰剂对照临床研究。
两名综述作者独立评估研究质量并提取数据。我们提取了疼痛缓解或疼痛强度数据，并将其转换为在4至6小时内疼痛缓解至少50%的参与者数量这一二分结果，据此计算相对风险和需治疗获益人数（NNT）。寻求在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。我们收集了不良事件和退出研究的信息。
除了原始综述中纳入的一项研究（Dionne 1998）外，本次更新在一份未发表的试验摘要（BR1160 1995）中发现了新数据。在这两项研究中，右布洛芬均有较高的反应率，200 mg右布洛芬组有51/96（53%）的参与者疼痛缓解至少50%，400 mg右布洛芬组有35/50（70%），相比之下，400 mg消旋布洛芬组有75/1,47（51%），安慰剂组有十二/62（13%）。参与者数量过少，无法计算有意义的NNT。所有活性治疗组额外使用镇痛药的中位时间均大于4小时，而安慰剂组约为2小时。不良事件一般为轻度或中度，与通常与麻醉和手术相关的事件一致。没有严重不良事件或死亡。额外数据未改变早期综述的结论。
这两项关于术后急性疼痛的研究信息表明，右布洛芬可能是一种有用的镇痛药，但剂量与消旋布洛芬相差不大，而关于消旋布洛芬的证据要多得多。
