Moore R Andrew, Derry Sheena, 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 Oct 7;2009(4):CD007540. doi: 10.1002/14651858.CD007540.pub2.
Sulindac 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. This review sought to evaluate the efficacy and safety of oral sulindac in acute postoperative pain, using clinical studies of patients with established pain, and with outcomes measured primarily over 6 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 of single dose oral sulindac in acute postoperative pain, and any associated adverse events.
We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies up to June 2009.
Randomised, double-blind, placebo-controlled clinical trials of oral sulindac for relief of acute postoperative pain in adults.
Two review authors independently assessed trial quality and extracted data. We planned to use area under the "pain relief versus time" curve to derive the proportion of participants with meloxicam experiencing least 50% pain relief over 4 to 6 hours, using validated equations; to use number needed to treat to benefit (NNT); the proportion of participants using rescue analgesia over a specified time period; time to use of rescue analgesia; information on adverse events and withdrawals.
No studies were identified by the searches that examined oral sulindac in patients with established postoperative pain.
AUTHORS' CONCLUSIONS: In the absence of evidence of efficacy, at present, for oral sulindac in acute postoperative pain, its use in this indication is not justified. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies is lacking, use in other indications should be evaluated carefully. Given the large number of available drugs of this and similar classes, there is no urgent research agenda.
舒林酸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。本综述旨在通过对已有疼痛的患者进行临床研究,并主要使用标准方法在6小时内测量结果,来评估口服舒林酸治疗急性术后疼痛的疗效和安全性。这种类型的研究已经被用于确定药物的镇痛特性数十年了。
评估单剂量口服舒林酸治疗急性术后疼痛的疗效以及任何相关不良事件。
我们检索了Cochrane中心对照试验注册库、医学期刊数据库、荷兰医学文摘数据库以及牛津疼痛缓解数据库,检索截至2009年6月的研究。
口服舒林酸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。
两位综述作者独立评估试验质量并提取数据。我们计划使用“疼痛缓解与时间”曲线下面积,通过验证方程得出在4至6小时内美洛昔康治疗组中至少50%疼痛得到缓解的参与者比例;使用需治疗人数(NNT);特定时间段内使用解救镇痛药的参与者比例;使用解救镇痛药的时间;不良事件和退出研究的信息。
检索未发现研究口服舒林酸治疗术后已确诊疼痛患者的相关研究。
目前,由于缺乏口服舒林酸治疗急性术后疼痛疗效的证据,其在该适应症中的使用不合理。鉴于在最基本的急性疼痛研究中缺乏明确证明其镇痛疗效的试验,在其他适应症中的使用应谨慎评估。鉴于此类及类似类别有大量可用药物,没有紧迫的研究议程。