Evidence map›Paper›PMID 31873806›Full record

Trial reportPharmaceutical research2019

Multicenter-Based Population Pharmacokinetic Analysis of Ciclosporin in Hematopoietic Stem Cell Transplantation Patients.

Ling Xue, Wen-Juan Zhang, Ji-Xin Tian, Lin-Na Liu, Hai-Hong Yan, Wen-Wen Zhang, Xiao-Liang Ding, Jing-Jing Zhang, Li-Yan Miao

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Pharmaceutical research, 2019. 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 29% 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, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Assessment of risk factors for acute graft-Therapeutic advances in hematology · 2023
    Article
  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

9 authors at 4 institutions in 1 country.

Ling XueDepartment of Clinical Pharmacology, the First Affiliated Hospital of Soochow University, Suzhou, China.
Wen-Juan ZhangDepartment of Pharmacy, the Second Affiliated Hospital of Air Force Medical University, Xi'an, China.
Ji-Xin TianDepartment of Pharmacy, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Lin-Na LiuDepartment of Pharmacy, the Second Affiliated Hospital of Air Force Medical University, Xi'an, China.
Hai-Hong YanDepartment of Pharmacy, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Wen-Wen ZhangDepartment of Clinical Pharmacology, the First Affiliated Hospital of Soochow University, Suzhou, China.
Xiao-Liang DingDepartment of Clinical Pharmacology, the First Affiliated Hospital of Soochow University, Suzhou, China.
Jing-Jing ZhangDepartment of Clinical Pharmacology, the First Affiliated Hospital of Soochow University, Suzhou, China.
Li-Yan MiaoDepartment of Clinical Pharmacology, the First Affiliated Hospital of Soochow University, Suzhou, China. miaolysuzhou@163.com.
First Affiliated Hospital of Soochow University · CNInstitute of Hematology & Blood Diseases Hospital · CNSoochow University · CNXi'an Medical University · CN

Funding

National Key New Drug Creation and Manufacturing Program, Ministry of Science and Technology 2017ZX09304-021Young Scientists Fund 81803628
6 · The paper itself

Abstract

purposeTo explore the contribution of physiological characteristics to variability in ciclosporin pharmacokinetics in hematopoietic stem cell transplantation patients.

methodsClinical data from 563 patients were collected from centers in three regions. Ciclosporin concentrations were measured using immunoassays. The patients' demographics, hematological and biological indicators, coadministered drugs, region, and disease diagnosis were recorded from medical records. Data analysis was performed using NONMEM based on a one-compartment model to describe the pharmacokinetics of ciclosporin. The reliability and stability of the final model were evaluated using bootstrap resampling, goodness-of-fit plots, and prediction-corrected visual predictive checks.

resultsThe population estimate of the clearance (CL) was 30.4 L/h, the volume of distribution (V) was 874.0 L and the bioavailability (F) was 81.1%. The between-subject variability in these parameters was 26.3, 68.0, and 110.8%, respectively. Coadministration of fluconazole, itraconazole, or voriconazole decreased CL by 17.6%, 28.4%, and 29.2%, respectively. Females' CL increased by approximately 12.0%. In addition, CL and V decreased with hematocrit, total protein, and uric acid increase, and CL also decreased with age and aspartate aminotransferase increase. However, CL increased with creatinine clearance increase.

conclusionsA multicenter-based population pharmacokinetic model of ciclosporin was established. The pharmacokinetics of ciclosporin exhibited discrepancies among different regions.

Indexed as

Hematopoietic Stem Cell TransplantationAdolescentAdultAgedBody WeightChildChild, PreschoolCyclosporineDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFluconazoleHematologic NeoplasmsHematopoietic Stem CellsHumansImmunosuppressive AgentsCyclosporineFluconazoleImmunosuppressive AgentsItraconazoleVoriconazoleciclosporinhematopoietic stem cell transplantationmulticenterpopulation pharmacokinetics

Identifiers

PMID31873806
OpenAlexW2997765013

What OpenQuestion holds

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Registered trials

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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.