Evidence map›Paper›PMID 38167238›Full record

ArticleBMC pharmacology & toxicology2024

Pharmacokinetics and pharmacodynamics of perfluoropropane after intra-venous bolus injection of perflutren lipid microsphere injection (DEFINITY®) in healthy Chinese volunteers.

Pengfei Li, Ping Du, Jun Peng, Zhixia Zhao, Huiling Li, Weiyue Yu, Shumin Wang, Lihong Liu

Open access · goldAbstract read
In one paragraph

Article in BMC pharmacology & toxicology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Pengfei Li *Department of Pharmacy, Beijing An Ding Hospital, Capital Medical University, No.5 Ankang Hutong, Xicheng District, Beijing, 100088, China. lee-pf@163.com.
Ping Du *Phase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China.
Jun PengGuoke Excellence (Beijing) Medicine Technology Research Co., Ltd, No.18 Zhonghe street, Daxing District, Beijing, 100176, China.
Zhixia ZhaoDepartment of Pharmacy, China-Japan Friendship Hospital, No.2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China.
Huiling LiPhase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China.
Weiyue YuPhase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China.
Shumin WangPhase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China. shuminwang7000@163.com.
Lihong LiuDepartment of Pharmacy, China-Japan Friendship Hospital, No.2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China. hong@outlook.com.
Beijing Chao-Yang Hospital · CNCapital Medical University · CNChina-Japan Friendship Hospital · CNBeijing Zhongke Science and Technology (China) · CN

Funding

Capital's Funds for Health Improvement and Research 2020-1-2031
6 · The paper itself

Abstract

BACKGROUND AND

objectiveDefinity is an ultrasound contrast agent consisting of phospholipids-encapsulated perfluoropropane (PFP), also known as perflutren, microspheres, which is initially designed to enhance echocardiographic ultrasound images. With no pharmacologic action, Definity can increase the backscatter of ultrasound resulting enhanced ultrasound signals. The objective of this study was to determine the pharmacokinetics (PKs), Pharmacodynamics (PDs) and safety of Definity in healthy male and female Chinese volunteers.

methodsA simple GC-MS method was developed and applied to simultaneously quantify PFP both in human whole blood and in expired air using Perfluorobutane (PFB) as internal standard. Meanwhile, the blood microbubble Doppler intensities were continuously monitored as companion PDs by a Doppler ultrasonography system using a non-imaging method.

resultsAfter intravenous infusion of 10 µL/kg of PFP within 30 seconds, the mean AUC

conclusionThe pharmacokinetics and pharmacodynamics of Definity in blood and expired air were systematically evaluated for the first time in this study. The PK/PD analysis results of this trial showed that the change of blood concentration was related to the change process of Doppler signal intensity, the trend of the two was close and expired air are the main excretion pathways of Definity. Definity was well tolerated by all subjects in the trial.

trial registrationThis study was registered on 08 December 2017 at the Chinese Clinical Trial Registry (CTR20171087).

Indexed as

LipidsVolunteersArea Under CurveChinaFemaleFluorocarbonsHealthy VolunteersHumansMaleMicrospheresFluorocarbonsLipidsperflutrenDefinityDoppler ultrasonographyGC-MSPerfluoropropane (PFP)PharmacodynamicsPharmacokinetics

Identifiers

PMID38167238
PMCPMC10763448
OpenAlexW4390499833

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.