甲强龙并不能减轻心脏手术患者术后急性术后疼痛

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Methylprednisolone Does Not Reduce Acute Postoperative Pain After Cardiac Surgery: Subanalysis of a Randomized Clinical Trial

背景与目的

一般心脏手术后的疼痛都是用阿片类药物治疗,但它们的不安全性使非阿片类药物作为多模式途径的一部分而具有吸引力。抗炎药物可减少急性术后疼痛,但类固醇在减少急性术后疼痛中的作用尚不清楚。我们评估了在心脏手术后24小时期间术中给甲强龙与术后镇痛的关系。

方  法

我们对一项临床试验进行了事后回顾性分析,在这项试验中,接受心脏手术的成年人按1:1的比例随机接受静脉滴注250mg甲强龙或者安慰剂。术后24小时评价疼痛评分并记录阿片类药物消耗量。与安慰剂相比,甲强龙被认为与术后更好的疼痛控制相关,如果其被证明是非劣的,那么疼痛评分为1分

结  果

在251例符合条件的患者中,127例接受了甲强龙,124例接受了安慰剂。甲强龙使用患者的疼痛不低于安慰剂,并且其中位疼痛评分为 -0.25 (-0.71~ 0.21,P<0.001)。然而,甲强龙在阿片类药物的使用上并不低于安慰剂(几何均值之比[C I]:1.11[0.64-1.91];P=0.37)。因为甲强龙在两种结果上都不低于安慰剂,所以我们没有进行基于先验停止规则的优势测试。

结  论

在这种事后分析中,我们无法确定与甲强龙给药相关的心脏手术后有益的镇痛作用。目前还没有数据表明甲强龙对心脏手术有明显的镇痛作用。

原始文献摘要

Alparslan Turan, MD, Barak Cohen, MD,Richard P. Whitlock, MD,et al.Methylprednisolone Does Not Reduce Acute Postoperative Pain After Cardiac Surgery: Subanalysis of a Randomized Clinical Trial.Anesth Analg 2019;129:1468–73.

BACKGROUND: Pain after cardiac surgery is largely treated with opioids, but their poor safety profile makes nonopioid medications attractive as part of multimodal pathways. Anti-inflammatory drugs reduce acute postoperative pain, but the role of steroids in reducing acute poststernotomy pain is unclear. We evaluated the association between the intraoperative administration of methylprednisolone and postoperative analgesia, defined as a composite of pain scores and opioid consumption, during the initial 24 hours after cardiac surgery.

METHODS: We conducted a post hoc retrospective analysis of a large clinical trial in which adults having cardiac surgery were randomized 1:1 to receive 2 intraoperative doses of 250 mg IV methylprednisolone or placebo. Pain scores and opioid consumption were collected during the initial 24 hours after

surgery.Methylprednisolone was considered to be associated with better pain control than placebo if proven noninferior (not worse) on both pain scores (defined a priori with delta of 1 point) and opioid consumption (delta of 20%) and superior to placebo in at least 1 of the 2 outcomes. This test was repeated in the opposite direction (testing whether placebo is better than methylprednisolone on postoperative pain management).

RESULTS: Of 251 eligible patients, 127 received methylprednisolone and 124 received placebo. Methylprednisolone was noninferior to placebo on pain with difference in mean (CI) pain scores of −0.25 (−0.71 to 0.21); P <0 .001. However, methylprednisolone was not noninferior to placebo on opioid consumption (ratio of geometric means [CI]: 1.11 [0.64–1.91]; P =0 .37). Because methylprednisolone was not noninferior to placebo on both outcomes, we did not proceed to superiority testing based on the a priori stopping rules. Similar results were found when

testing the opposite direction.

CONCLUSIONS: In this post hoc analysis, we could not identify a beneficial analgesic effect after cardiac surgery associated with methylprednisolone administration. There are currently no data to suggest that methylprednisolone has significant analgesic benefit in adults having cardiac surgery.

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