Wasey Jack O, Derry Sheena, Moore R Andrew, McQuay Henry J
Magdalen College, University of Oxford, High Street, Oxford, Oxfordshire, UK, OX1 4AU.
Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD007440. doi: 10.1002/14651858.CD007440.pub2.
Diflunisal is a long-acting non-steroidal anti-inflammatory drug (NSAID) most commonly used to treat acute postoperative pain or chronic joint pain from osteoarthritis and rheumatoid arthritis. This review analyses the effectiveness and harm of different doses of diflunisal in the context of moderate to severe postoperative pain.
To assess efficacy, duration of action, and associated adverse events of single dose oral diflunisal in acute postoperative pain in adults.
We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to January 2010.
Randomised, double blind, placebo-controlled trials of single dose orally administered diflunisal 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 4 to 6 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.
Nine studies in dental, orthopedic and gynaecological surgery met the inclusion criteria, testing doses of diflunisal from 125 mg to 1000 mg.For diflunisal 1000 mg, the NNT for at least 50% pain relief over 4 to 6 hours was 2.1 (1.8 to 2.6) (6 studies, 391 participants); the NNT to prevent remedication within 6 hours was 1.9 (1.7 to 2.3), and within 12 hours was 2.2 (1.9 to 2.7) (6 studies, 409 participants). More participants experienced adverse events with diflunisal 100 mg than with placebo, but none were serious or led to withdrawal.For diflunisal 500 mg, the NNT for at least 50% pain relief over 4 to 6 hours was 2.6 (2.1 to 3.3) (6 studies, 357 participants); the NNT to prevent remedication within 6 hours was 2.6 (2.1 to 3.4) (6 studies, 390 participants), and within 12 hours was 2.9 (2.3 to 4.0) (5 studies, 329 participants). Adverse events did not differ significantly from placebo.
AUTHORS' CONCLUSIONS: Diflunisal has an analgesic effect similar to other NSAIDs in single dose, but benefits from providing significant analgesia for about twelve hours. This property may be useful when regular dosing is needed, or when taking several doses of a shorter acting analgesic is impractical.
双氯芬酸是一种长效非甾体抗炎药(NSAID),最常用于治疗急性术后疼痛或骨关节炎及类风湿关节炎引起的慢性关节疼痛。本综述分析了不同剂量双氯芬酸在中度至重度术后疼痛情况下的有效性和危害。
评估单剂量口服双氯芬酸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2010年1月的研究。
针对患有中度至重度急性术后疼痛的成人进行的单剂量口服双氯芬酸的随机、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,并将其转换为在4至6小时内疼痛缓解至少50%的参与者人数这一二分结果,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人数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试验的信息。
牙科、骨科和妇科手术的9项研究符合纳入标准,测试的双氯芬酸剂量为125毫克至1000毫克。对于1000毫克双氯芬酸,在4至6小时内疼痛缓解至少50%的NNT为2.1(1.8至2.6)(6项研究,391名参与者);在6小时内预防再次用药的NNT为1.9(1.7至2.3),在12小时内为2.2(1.9至2.7)(6项研究,409名参与者)。与安慰剂相比,服用100毫克双氯芬酸的参与者出现不良事件的更多,但均不严重,也未导致退出试验。对于500毫克双氯芬酸,在4至6小时内疼痛缓解至少50%的NNT为2.6(2.1至3.3)(6项研究,357名参与者);在6小时内预防再次用药的NNT为2.6(2.1至3.4)(6项研究,390名参与者),在12小时内为2.9(2.3至4.0)(5项研究,329名参与者)。不良事件与安慰剂无显著差异。
双氯芬酸单剂量时的镇痛效果与其他非甾体抗炎药相似,但能提供约12小时的显著镇痛效果。当需要规律给药或服用几剂短效镇痛药不切实际时,这一特性可能有用。