最小疗效标准用于治疗个体患者荟萃分析的急性疼痛试验之间的比较：以第三磨牙拔除后依托考昔、对乙酰氨基酚、布洛芬和布洛芬/对乙酰氨基酚联合用药为例。

Minimum efficacy criteria for comparisons between treatments using individual patient meta-analysis of acute pain trials: examples of etoricoxib, paracetamol, ibuprofen, and ibuprofen/paracetamol combinations after third molar extraction.

机构信息

Pain Research and Nuffield Department of Anaesthetics, University of Oxford, Churchill Hospital, Oxford, UK Department of Occupational and Social Medicine, University Medical Center Göttingen, Göttingen, Germany Spreadsheet Factory, Stratfield Road, Oxford, UK.

出版信息

Pain. 2011 May;152(5):982-989. doi: 10.1016/j.pain.2010.11.030.

DOI:10.1016/j.pain.2010.11.030

PMID:21414722

Abstract

We defined response in acute pain trials according to percentage of maximum possible efficacy. Minimum efficacy criteria (MEC) of 0%, or at least 15%, 30%, 50%, and 70% pain relief were used to examine stability over time using total pain relief and summed pain intensity difference (SPID), sex differences, and sensitivity. We used individual patient data from placebo-controlled third molar extraction trials: 4 with single-dose oral etoricoxib 120 mg, and 2 with paracetamol, ibuprofen, and ibuprofen plus paracetamol combinations. With etoricoxib, numbers needed to treat (NNTs) were stable between response levels of at least 15% (MEC15) and 50% pain relief (MEC50), and similar for total pain relief and SPID. NNTs were higher (worse) at extremes of MEC, especially with SPID. Results for women and men were similar. NNTs of lower efficacy treatments (paracetamol 500 and 1000 mg) rose rapidly at higher MEC. NNTs of high efficacy treatments (ibuprofen plus paracetamol combinations) showed greater separation at higher MEC. The highest degree of discrimination between treatments was with MEC50 and MEC70. Etoricoxib 120 mg (NNT for ≥50% maximum 6-hour pain relief 1.7) and ibuprofen 200/400 mg plus paracetamol 500/1000 mg (NNTs 1.5 and 1.6, respectively) produced the lowest (best) NNTs in the dental pain model. Timing of patient request for additional analgesia is an alternative analgesic efficacy outcome measure.

摘要

我们根据最大疗效百分比定义了急性疼痛试验中的反应。最小疗效标准（MEC）为 0%，或至少 15%、30%、50%和 70%的疼痛缓解，用于使用总疼痛缓解和总和疼痛强度差（SPID）、性别差异和敏感性来检查随时间的稳定性。我们使用来自安慰剂对照第三磨牙拔除试验的个体患者数据：4 项单次口服依托考昔 120mg，2 项对乙酰氨基酚、布洛芬和布洛芬加对乙酰氨基酚组合。对于依托考昔，至少 15%（MEC15）和 50%疼痛缓解（MEC50）的反应水平之间的 NNT 稳定，总疼痛缓解和 SPID 也相似。在 MEC 的极端情况下，NNT 更高（更差），尤其是 SPID。女性和男性的结果相似。疗效较低的治疗（对乙酰氨基酚 500 和 1000mg）的 NNT 在较高的 MEC 时迅速上升。高疗效治疗（布洛芬加对乙酰氨基酚组合）的 NNT 在较高的 MEC 时显示出更大的分离。治疗之间的区分度最高的是 MEC50 和 MEC70。依托考昔 120mg（NNT 为≥50%最大 6 小时疼痛缓解 1.7）和布洛芬 200/400mg 加对乙酰氨基酚 500/1000mg（NNTs 分别为 1.5 和 1.6）在牙科疼痛模型中产生了最低（最佳）的 NNT。患者要求额外镇痛的时间是另一种镇痛疗效的衡量标准。