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[JAMA发表论文]:静脉对乙酰氨基酚对腹部手术后低氧血症的影响
2020年08月05日 时讯速递, 进展交流 暂无评论

Original Investigation July 28, 2020

Effect of Intravenous Acetaminophen on Postoperative Hypoxemia After Abdominal Surgery: The FACTOR Randomized Clinical Trial

Alparslan Turan, Hani Essber,Wael Saasouh, et al

JAMA. 2020;324(4):350-358. doi:10.1001/jama.2020.10009

Abstract

Importance 背景

Opioid-induced ventilatory depression and hypoxemia is common, severe, and often unrecognized in postoperative patients. To the extent that nonopioid analgesics reduce opioid consumption, they may decrease postoperative hypoxemia.

阿片诱导呼吸抑制及低氧血症在术后患者非常普遍且很严重,常常没有被发现。非阿片类镇痛药物如果能够减少阿片的使用,有可能减少术后低氧血症。

Objective 目的

To test the hypothesis that duration of hypoxemia is less in patients given intravenous acetaminophen than those given placebo.

验证如下假设:静脉使用对乙酰氨基酚的患者较安慰剂减少低氧血症持续时间。

Design, Setting, and Participants 设计,场景及研究人群

Randomized, placebo-controlled, double-blind trial conducted at 2 US academic hospitals among 570 patients who were undergoing abdominal surgery, enrolled from February 2015 through October 2018 and followed up until February 2019.

在2个美国医院进行的随机、安慰剂对照、双盲试验,纳入2015年2月至2018年10月间接受腹部感染的570名患者,随访至2019年2月。

Interventions 干预措施

Participants were randomized to receive either intravenous acetaminophen, 1 g (n = 289), or normal saline placebo (n = 291) starting at the beginning of surgery and repeated every 6 hours until 48 postoperative hours or hospital discharge, whichever occurred first.

患者被随机分组,接受静脉对乙酰氨基酚1 g (n = 289)或生理盐水(n = 291),手术开始时开始使用,此后每6小时重复使用,直至术后48小时或出院。

Main Outcomes and Measures 主要预后指标

The primary outcome was the total duration of hypoxemia (hemoglobin oxygen saturation [Spo2] <90%) per hour, with oxygen saturation measured continuously for 48 postoperative hours. Secondary outcomes were postoperative opioid consumption, pain (0- 10-point scale; 0: no pain; 10: the most pain imaginable), nausea and vomiting, sedation, minimal alveolar concentration of volatile anesthetic, fatigue, active time, and respiratory function.

主要预后指标为每小时低氧血症(Spo2 <90%)总持续时间(氧饱和度监测持续到术后48小时)。次要预后指标包括术后阿片消耗量,疼痛(0-10分量表;0分:无疼痛;10分:可以想象的最严重的疼痛),恶心呕吐,镇静,可挥发麻醉药的最小肺泡浓度,乏力,呼吸功能。

Results 结果

Among 580 patients randomized (mean age, 49 years; 48% women), 570 (98%) completed the trial. The primary outcome, median duration with Spo2 of less than 90%, was 0.7 (interquartile range [IQR], 0.1-5.1) minutes per hour among patients in the acetaminophen group and 1.1 (IQR, 0.1-6.6) minutes per hour among patients in the placebo group (P = .29), with an estimated median difference of −0.04 (95% CI,−0.18 to 0.11) minutes per hour. None of the 8 secondary end points differed significantly between the acetaminophen and placebo groups. Mean pain scores within initial 48 postoperative hours were 4.2 (SD, 1.8) in the acetaminophen group and 4.4 (SD, 1.8) in the placebo group (difference, −0.28; 95% CI, –0.71 to 0.15); median opioid use in morphine equivalents was 50 mg (IQR, 18-122 mg) and 58 mg (IQR, 24-151 mg) , respectively, with a ratio of geometric means of 0.86 (95% CI, 0.61-1.21).

总共 580 名患者接受随机分组(平均年龄,49 岁;48%为女性),570名 (98%) 完成试验。主要预后指标,即Spo2 < 90%的中位时间在对乙酰氨基酚组为每小时 0.7(四分位区间 [IQR], 0.1-5.1)分钟,安慰剂组为每小时1.1 (IQR, 0.1-6.6) 分钟 (P = .29),差异中位数每小时 −0.04 (95% CI,−0.18 to 0.11) 分钟。对乙酰氨基酚组与安慰剂组间8项次要预后指标均无显著差异。术后最初48小时内,对乙酰氨基酚组平均疼痛评分为 4.2 (SD, 1.8),安慰剂组为 4.4 (SD, 1.8)(差异,−0.28; 95% CI, –0.71 to 0.15);阿片用量分别相当于50 mg (IQR, 18-122 mg) 和 58 mg (IQR, 24-151 mg)吗啡,几何平均值比值0.86 (95% CI, 0.61-1.21)。

Conclusions and Relevance 结论与意义

Among patients who underwent abdominal surgery, use of postoperative intravenous acetaminophen, compared with placebo, did not significantly reduce the duration of postoperative hypoxemia over 48 hours. The study findings do not support the use of intravenous acetaminophen for this purpose.

对于接受腹部手术的患者,与安慰剂相比,术后静脉使用对乙酰氨基酚不能显著缩短术后48小时内低氧血症持续时间。研究结果不支持出于此种目的静脉使用对乙酰氨基酚。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT02156154

[评论]

术后镇痛的一般想法:

  • 阿片类镇痛药物在临床得到普遍应用,是术后镇痛的常用药物
  • 任何药物都具有副作用。对于阿片类镇痛药物而言,呼吸抑制属于最为严重的副作用之一
  • 镇痛药物的临床使用应当基于医务人员对患者疼痛程度的判断(尽管疼痛的判断不可避免的具有主观性)
  • 临床经验告诉我们,在镇痛药物使用未过量时,出现呼吸抑制的情况其实并不多见

如果上述考虑是有道理的,那么再来评价本研究的阴性结果

  • 术后48小时总共减少相当于8 mg吗啡的阿片类药物用量,不可能观察到临床有意义的差异
  • 安慰剂组平均每小时1.1分钟的低氧血症临床意义其实很有限:即便研究药物能够把这一指标减少到0,也仅仅是数据上的差异,难以说明临床意义

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