Division of Pulmonary and Critical Care Medicine, Department of Medicine, The Miller School of Medicine at the University of Miami, Jackson Memorial Hospital, Miami, Florida, USA.
Clin Pharmacol Ther. 2011 Jul;90(1):32-9. doi: 10.1038/clpt.2011.98. Epub 2011 May 4.
This randomized, double-blind, placebo-controlled study evaluated the antipyretic effect and safety of intravenous (i.v.) acetaminophen using an endotoxin-induced fever model. Subjects exhibiting sufficient fever response following administration of reference standard endotoxin (RSE) were randomly assigned to receive i.v. acetaminophen 1,000 mg (n = 31) or matching placebo (n = 29). The primary efficacy end point was the weighted sum of temperature differences from baseline through 6 h. Relative to placebo, i.v. acetaminophen administration produced a rapid decrease in temperature that persisted throughout the 6-h study period. The primary end point favored i.v. acetaminophen over placebo (P < 0.001). Temperature differences from baseline reached statistical significance at T30 min after endotoxin administration (15 min after completing the study medication infusion). Acetaminophen administered i.v. was well tolerated, and the frequency of adverse events was comparable to that after administration of i.v. placebo. This study shows that i.v. acetaminophen in a single 1,000-mg dose is safe and effective in reducing fever.
这项随机、双盲、安慰剂对照的研究评估了静脉注射（i.v.）对乙酰氨基酚在内毒素诱导发热模型中的退热效果和安全性。在给予参考标准内毒素（RSE）后表现出足够发热反应的受试者被随机分配接受 i.v.对乙酰氨基酚 1000mg（n=31）或匹配的安慰剂（n=29）。主要疗效终点是从基线到 6 小时的体温差异的加权总和。与安慰剂相比，静脉注射对乙酰氨基酚可迅速降低体温，并在整个 6 小时研究期间持续。主要终点支持 i.v.对乙酰氨基酚优于安慰剂（P<0.001）。在给予内毒素后 30 分钟（完成研究药物输注后 15 分钟）达到统计学意义。静脉注射给予对乙酰氨基酚耐受性良好，不良事件的频率与静脉注射安慰剂后相当。这项研究表明，单次 1000mg 剂量的静脉注射对乙酰氨基酚可安全有效降低发热。
