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没有证据表明布洛芬中添加咖啡因会影响血压。

Lack of Evidence for Blood Pressure Effects of Caffeine Added to Ibuprofen.

机构信息

CHC Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

出版信息

Curr Drug Saf. 2023;18(1):97-102. doi: 10.2174/1574886317666220414125027.

DOI:10.2174/1574886317666220414125027
PMID:35430997
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10173466/
Abstract

BACKGROUND

Caffeine enhances the efficacy of non-opioid analgesics. Data on the cardiovascular health effects of caffeine intake are controversial, and studies on the cardiovascular effects of medical caffeine use are lacking.

OBJECTIVE

The study aims to explore the cardiovascular effects of an ibuprofen/caffeine combination in comparison to ibuprofen alone.

METHODS

Secondary analysis of a previously reported bioequivalence study of a single dose of a fixed dose ibuprofen/caffeine combination (400/100 mg) vs. ibuprofen alone in a randomized, cross-over design in 36 healthy volunteers. Plasma catecholamines were analyzed to enhance mechanistic interpretation of the data.

RESULTS

After exclusion of 10 protocol violators (pre-dosing intake of caffeine), vital signs were comparable over a 24-h period in the absence and presence of caffeine. Plasma catecholamine levels were also comparable.

CONCLUSION

These data do not support the hypothesis that occasional intake of a small dose of caffeine as part of pain medication imposes a health risk due to vital sign changes. Based on the proven increase in efficacy, the addition of caffeine to non-opioid analgesics such as IBU has a favorable risk/benefit profile for occasional use.

摘要

背景

咖啡因能增强非阿片类镇痛药的疗效。关于咖啡因摄入对心血管健康影响的数据存在争议,而且缺乏关于医用咖啡因使用对心血管影响的研究。

目的

本研究旨在探讨布洛芬/咖啡因复方与布洛芬单药相比的心血管效应。

方法

对先前报告的一项单次固定剂量布洛芬/咖啡因复方(400/100mg)与布洛芬单药的生物等效性研究进行二次分析,该研究采用随机、交叉设计,纳入 36 例健康志愿者。为了增强对数据机制的解释,分析了血浆儿茶酚胺。

结果

排除 10 例(预服咖啡因)方案违反者后,在无咖啡因和有咖啡因的情况下,24 小时内生命体征无差异。血浆儿茶酚胺水平也无差异。

结论

这些数据不支持偶尔摄入小剂量咖啡因作为止痛药物的一部分会因生命体征变化而带来健康风险的假设。基于已证实的疗效增加,偶尔使用时,将咖啡因添加到非阿片类镇痛药(如 IBU)中具有有利的风险/获益比。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/02ff/10173466/9b0f7889ea65/CDS-18-97_F2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/02ff/10173466/559066d9878a/CDS-18-97_F1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/02ff/10173466/9b0f7889ea65/CDS-18-97_F2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/02ff/10173466/559066d9878a/CDS-18-97_F1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/02ff/10173466/9b0f7889ea65/CDS-18-97_F2.jpg

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本文引用的文献

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A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain.一项随机、安慰剂和活性药物对照、多国家、多中心平行组试验,旨在评估400毫克布洛芬与100毫克咖啡因固定剂量组合,相较于400毫克布洛芬和安慰剂,对急性下背部或颈部疼痛患者的疗效和安全性。
J Pain Res. 2019 Sep 23;12:2771-2783. doi: 10.2147/JPR.S217045. eCollection 2019.
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Caffeine and blood pressure: a critical review perspective.咖啡因与血压:批判性综述视角。
Nutr Res Rev. 2019 Dec;32(2):169-175. doi: 10.1017/S0954422419000015. Epub 2019 Apr 5.
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Pharmacokinetic Properties of Ibuprofen (IBU) From the Fixed-Dose Combination IBU/Caffeine (400/100 mg; FDC) in Comparison With 400 mg IBU as Acid or Lysinate Under Fasted and Fed Conditions-Data From 2 Single-Center, Single-Dose, Randomized Crossover Studies in Healthy Volunteers.
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Clin Pharmacol Drug Dev. 2019 Aug;8(6):742-753. doi: 10.1002/cpdd.672. Epub 2019 Mar 21.
4
Long-term coffee consumption, caffeine metabolism genetics, and risk of cardiovascular disease: a prospective analysis of up to 347,077 individuals and 8368 cases.长期喝咖啡、咖啡因代谢基因与心血管疾病风险:对多达 347077 名个体和 8368 例病例的前瞻性分析。
Am J Clin Nutr. 2019 Mar 1;109(3):509-516. doi: 10.1093/ajcn/nqy297.
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