Back Pain Research Group, Faculty of Health Sciences, University of Sydney, NSW, Australia.
Clin J Pain. 2009 Oct;25(8):659-65. doi: 10.1097/AJP.0b013e3181a7ee3a.
The aim of this study was to determine whether certain patient characteristics could identify people with acute low back pain who were more likely to respond to nonsteroidal anti-inflammatory drugs (NSAIDs), when administered in combination with paracetamol.
This study involved a secondary analysis of a randomized controlled trial investigating the efficacy of diclofenac in 239 patients presenting to general practitioners for acute low back pain. All patients received advice to "stay active" and take regular paracetamol and then were randomized to receive either diclofenac (50 mg twice daily) or placebo. The primary outcome was days to recovery from pain. The ability of 14 patient characteristics to identify those who respond best to diclofenac was assessed using interaction terms in Cox regression models.
Most of the 14 baseline characteristics investigated were uninformative in identifying those who respond best to diclofenac when added to paracetamol. Patients' sex and levels of fear regarding movement and pain were both independent statistically significant predictors of response to NSAIDs for one definition of recovery but not for the other. The interaction between fear avoidance (physical activity) and NSAIDs treatment was statistically significant (P=0.042, hazard ratio=1.059, 95% confidence interval 1.002 to 1.118) for recovery defined as a pain score of 0 or 1. The interaction between sex and NSAID treatment was statistically significant (P=0.044, hazard ratio=1.755, 95% confidence interval 1.014 to 3.038) for recovery defined as a pain score of 0 or 1 maintained for 7 consecutive days.
This study did not find any baseline patient characteristics, which consistently identified patients with acute low back pain who respond best to NSAIDs when provided in addition to paracetamol and advice. A patient's sex and level of fear avoidance may be weak predictors and warrant further prospective investigation.
本研究旨在确定某些患者特征是否可以识别出那些在接受非甾体抗炎药（NSAIDs）联合扑热息痛治疗时更有可能对其产生反应的急性腰痛患者。
本研究是对一项针对 239 名因急性腰痛就诊于全科医生的患者的双氯芬酸疗效进行的随机对照试验的二次分析。所有患者均接受“保持活动”的建议，并定期服用扑热息痛，然后随机分为接受双氯芬酸（50mg，每日 2 次）或安慰剂。主要结局是疼痛恢复的天数。使用 Cox 回归模型中的交互项评估 14 项患者特征中哪些特征能够最好地识别出对双氯芬酸反应最佳的患者。
在所研究的 14 项基线特征中，大多数特征在添加扑热息痛后识别出对双氯芬酸反应最佳的患者时均无信息。患者的性别和对运动和疼痛的恐惧程度均是 NSAIDs 治疗反应的独立统计学显著预测因素，但对另一种定义的恢复则不是。恐惧回避（身体活动）和 NSAIDs 治疗之间的交互作用在疼痛评分为 0 或 1 的恢复定义方面具有统计学意义（P=0.042，危险比=1.059，95%置信区间 1.002 至 1.118）。性别和 NSAIDs 治疗之间的交互作用在疼痛评分持续 7 天且为 0 或 1 的恢复定义方面具有统计学意义（P=0.044，危险比=1.755，95%置信区间 1.014 至 3.038）。
本研究未发现任何基线患者特征能够一致地识别出在添加扑热息痛和建议后对 NSAIDs 反应最佳的急性腰痛患者。患者的性别和恐惧回避程度可能是较弱的预测因素，需要进一步进行前瞻性研究。
