Li Wan Po A, Petersen B
Centre for Evidence-Based Pharmacotherapy, Nottingham, UK.
J Clin Pharm Ther. 2006 Apr;31(2):161-5. doi: 10.1111/j.1365-2710.2006.00719.x.
A pain relief score 50% of the maximum is often used as a clinically meaningful outcome in meta-analyses of analgesic trials. This arbitrary value requires validation.
To determine the optimum pain relief score for predicting pain relief sufficient to obviate the need for analgesic remedication in acute post-surgical pain.
Individual-patient meta-analysis of randomized controlled trials and use of signal detection theory to identify the optimum cut-off point on the total pain relief score (TOTPAR). Analgesic remedication was used as the clinical outcome.
Seven parallel-group, active and placebo-controlled trials of minor analgesics.
The predictive value of the TOTPAR score [expressed as a percentage of the maximum score (%maxTOTPAR)] for remedication was excellent for all the trials. The pooled estimate of the area under the receiver operating curve, an index of discriminative power, was outstanding 0.96 (95% CI 0.95-0.97). The pooled estimate of the optimal %maxTOTPAR for predictive purposes was 44.11 (95% CI 44.00-44.23).
The analysis suggests that the arbitrary 50% cut-off point TOTPAR score often used in meta-analyses of analgesic trials in dental pain is reasonably acceptable. This is different to the 33% cut-off point reported for analgesic trials of acute breakthrough cancer pain and some chronic pain states such as diabetic neuropathy and postherpetic neuralgia. These differences deserve careful consideration when reading reports of analgesic trials and meta-analyses. Remedication itself should be considered as the preferred outcome measure for analgesic trials.
在镇痛试验的荟萃分析中,常将最大疼痛缓解评分的50%作为具有临床意义的结果。这个任意设定的值需要验证。
确定最佳疼痛缓解评分,以预测术后急性疼痛中足以避免使用镇痛补救药物的疼痛缓解情况。
对随机对照试验进行个体患者荟萃分析,并使用信号检测理论确定总疼痛缓解评分(TOTPAR)的最佳截断点。将使用镇痛补救药物作为临床结局。
7项关于小剂量镇痛药的平行组、活性药物与安慰剂对照试验。
在所有试验中,TOTPAR评分[以最大评分的百分比表示(%maxTOTPAR)]对补救药物使用情况的预测价值都非常好。受试者工作特征曲线下面积的合并估计值(一种鉴别能力指标)出色,为0.96(95%CI 0.95 - 0.97)。用于预测目的的最佳%maxTOTPAR的合并估计值为44.11(95%CI 44.00 - 44.23)。
该分析表明,在牙科疼痛镇痛试验的荟萃分析中常用的任意50%截断点TOTPAR评分是合理可接受的。这与急性突破性癌痛以及一些慢性疼痛状态(如糖尿病性神经病变和带状疱疹后神经痛)的镇痛试验中报告的33%截断点不同。在阅读镇痛试验和荟萃分析报告时,这些差异值得仔细考虑。对于镇痛试验,应将补救药物使用本身视为首选的结局指标。