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急性疼痛:个体患者荟萃分析显示了不同分析和呈现结果方式的影响。

Acute pain: individual patient meta-analysis shows the impact of different ways of analysing and presenting results.

作者信息

Moore R A, Edwards J E, McQuay H J

机构信息

Pain Research and Nuffield Department of Anaesthetics, University of Oxford, Oxford Radcliffe NHS Trust, The Churchill, Headington, Oxford OX3 7LJ, UK.

出版信息

Pain. 2005 Aug;116(3):322-331. doi: 10.1016/j.pain.2005.05.001.

Abstract

Individual patient meta-analysis using information from clinically homogeneous acute pain trials with observations over 24h was used to investigate different ways trials can be analysed and reported. There were 13 third-molar extraction trials, with 1,330 patients using rofecoxib 50mg, 303 using ibuprofen 400mg, and 570 using placebo. Pain relief scores were available at individual time points, plus time to remedication. Many more patients remedicated with placebo than ibuprofen 400mg, and more with ibuprofen than rofecoxib 50mg. Median time to remedication, the proportion remedicated at various times, or survival curves would be useful outcomes. In dealing with missing data points when patients remedicated, baseline observation carried forward was more conservative than last observation carried forward, resulting in higher (worse) NNTs and lower average pain scores after 12 and 24h. Results based on both methods might be sensible for trials longer than eight hours. The distribution of pain relief was highly skewed, especially at later times, when almost no patient was average. Different cut points for pain relief (at least 25, 50 or 75% maxTOTPAR) and longer duration changed the NNT for ibuprofen compared with placebo, but less for rofecoxib, reflecting longer duration of action of rofecoxib. Reporting for each treatment group the percentage of patients with 25, 50 and 75% pain relief at various times after dose, and reporting the proportion of patients with good or complete pain relief, and inadequate pain relief, at each time point, would improve acute pain trial reporting.

摘要

利用来自临床同质性急性疼痛试验且观察时间超过24小时的信息进行个体患者荟萃分析,以研究试验的不同分析和报告方式。有13项第三磨牙拔除试验,1330例患者使用50毫克罗非昔布,303例使用400毫克布洛芬,570例使用安慰剂。在各个时间点可获得疼痛缓解评分,以及再次用药时间。再次使用安慰剂的患者比使用400毫克布洛芬的患者多得多,使用布洛芬的患者比使用50毫克罗非昔布的患者多。再次用药的中位时间、不同时间再次用药的比例或生存曲线将是有用的结果。在处理患者再次用药时的缺失数据点时,向前结转基线观察比向前结转末次观察更为保守,导致12小时和24小时后的NNT更高(更差)且平均疼痛评分更低。对于超过8小时的试验,基于这两种方法的结果可能都是合理的。疼痛缓解的分布高度偏态,尤其是在后期,几乎没有患者处于平均水平。与安慰剂相比,不同的疼痛缓解切点(至少25%、50%或75%的最大总疼痛缓解率)和更长的持续时间改变了布洛芬的NNT,但罗非昔布的变化较小,这反映了罗非昔布的作用持续时间更长。报告每个治疗组在给药后不同时间疼痛缓解25%、50%和75%的患者百分比,以及报告每个时间点疼痛缓解良好或完全缓解以及疼痛缓解不足的患者比例,将改善急性疼痛试验的报告。

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