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根据给药装置的组成比较硝酸甘油的药代动力学和药效学特性:一项初步研究。

A comparison of the pharmacokinetic and pharmacodynamic properties of nitroglycerin according to the composition of the administration set: A preliminary study.

作者信息

Kim Choon Ok, Song Jeongyun, Min Ji Young, Park Su Jung, Lee Hye Mi, Byon Hyo-Jin

机构信息

Department of Clinical Pharmacology and Clinical Trials Center, Severance Hospital, Yonsei University Health System, Seodaemun-gu, Seoul Department of Anesthesiology and Pain Medicine, Yeoncheon Public Health Center, Yeoncheon-gun, Gyeonggi-do Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Republic of Korea.

出版信息

Medicine (Baltimore). 2018 Mar;97(9):e9829. doi: 10.1097/MD.0000000000009829.

Abstract

BACKGROUND

There is a risk of drug sorption into an intravenous administration set composed of polyvinyl chloride (PVC), polyurethane (PU), or polyolefin (PO). This has implications on the dose of the active ingredient the patient receives, and thus therapeutic success. This study aimed to determine the plasma concentration of nitroglycerin and the effect of nitroglycerin on patients based on the composition of the administration set.

METHODS

Using a randomized, open-labeled, 3 × 3 crossover method, 9 volunteers were assigned to 3 groups. In period I, nitroglycerin (100 μg/mL) was infused via a PVC- (group A), PU- (group B), or PO-based (group C) administration set. In period II, PU- (group A), PO- (group B), and PVC-based (group C) administration sets were used, and in period III, PO- (group A), PVC- (group B), and PU-based (group C) administration sets were used. The rate of drug administration in all periods was 12 mL/hour for 30 minutes using an infusion pump. Blood samples were collected, and the plasma concentrations of nitroglycerin were analyzed using validated high-performance liquid chromatography coupled with tandem mass spectrometry. Blood pressure was determined using a sphygmomanometer applied to the other upper arm at an interval of 5 minutes.

RESULTS

We observed that the mean plasma concentration of nitroglycerin over time when administered using a PO-based tube was higher than that when using a PU- or PVC-based tube. When the percent change of the mean arterial pressure from baseline at each time point was compared among groups, there were statistically significant differences between PU and PO or PVC at most points during nitroglycerin infusion.

CONCLUSION

Our results showed higher nitroglycerin plasma concentration and lower arterial pressure when a PO-based administration set was used than when a PVC- or PU-based administration set was used. PO-based administration sets may be more appropriate for nitroglycerin administration compared to those composed of PVC or PU.

摘要

背景

药物存在被由聚氯乙烯(PVC)、聚氨酯(PU)或聚烯烃(PO)组成的静脉给药装置吸附的风险。这会影响患者所接受的活性成分剂量,进而影响治疗效果。本研究旨在根据给药装置的组成确定硝酸甘油的血浆浓度以及硝酸甘油对患者的影响。

方法

采用随机、开放标签的3×3交叉法,将9名志愿者分为3组。在第一阶段,通过基于PVC的(A组)、基于PU的(B组)或基于PO的(C组)给药装置输注硝酸甘油(100μg/mL)。在第二阶段,使用基于PU的(A组)、基于PO的(B组)和基于PVC的(C组)给药装置,在第三阶段,使用基于PO的(A组)、基于PVC的(B组)和基于PU的(C组)给药装置。在所有阶段,使用输液泵以12mL/小时的速度给药30分钟。采集血样,使用经过验证的高效液相色谱-串联质谱法分析硝酸甘油的血浆浓度。使用血压计在另一只上臂每隔5分钟测定一次血压。

结果

我们观察到,使用基于PO的导管给药时,硝酸甘油的平均血浆浓度随时间高于使用基于PU或PVC的导管时。当比较各组在每个时间点相对于基线的平均动脉压变化百分比时,在硝酸甘油输注期间的大多数时间点,PU与PO或PVC之间存在统计学显著差异。

结论

我们的结果表明,与使用基于PVC或PU的给药装置相比,使用基于PO的给药装置时硝酸甘油的血浆浓度更高,动脉压更低。与由PVC或PU组成的给药装置相比,基于PO的给药装置可能更适合用于硝酸甘油给药。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9502/5851736/d77e82a09177/medi-97-e9829-g002.jpg

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