Population pharmacokinetics of cyclosporine in Chinese children receiving hematopoietic stem cell transplantation
Cyclosporine (CsA) is characterized by a narrow therapeutic window and high interindividual pharmacokinetic variability, particularly in juvenile patients. The aims of this study were to build a population pharmacokinetic model of CsA in Chinese children with hematopathy who received allogeneic hema...
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| Veröffentlicht in: | Acta pharmacologica Sinica 2019-12, Vol.40 (12), p.1603-1610 |
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| creator | Li, Tai-feng Hu, Lei Ma, Xiao-lu Huang, Lin Liu, Xue-mei Luo, Xing-xian Feng, Wan-yu Wu, Chun-fu |
| description | Cyclosporine (CsA) is characterized by a narrow therapeutic window and high interindividual pharmacokinetic variability, particularly in juvenile patients. The aims of this study were to build a population pharmacokinetic model of CsA in Chinese children with hematopathy who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and to identify covariates affecting CsA pharmacokinetics. A total of 86 Chinese children aged 8.4 ± 3.8 years (range 1.1–16.8 years) who received allo-HSCT were enrolled. Whole blood samples were collected before allo-HSCT. Genotyping was performed using an Agena MassARRAY system. A total of 1010 trough plasma concentration values of CsA and clinical data were collected. The population pharmacokinetic model of CsA was constructed using nonlinear mixed-effects modeling (NONMEM) software. The stability and performance of the final model were validated using bootstrapping and normalized prediction distribution errors. We showed that a one-compartment model with first-order elimination adequately described the pharmacokinetics of CsA. The typical values for clearance (CL) and volume of distribution (V) were 42.3 L/h and 3100 L, respectively. Body weight, postoperative days, CYP3A4*1 G genotype, estimated glomerular filtration rate and coadministration of triazole antifungal drugs were identified as significant covariates for CL. Weight and postoperative days were significant covariates for the V of CsA. Our model can be adopted to optimize the CsA dosing regimen for Chinese children with hematopathy receiving allo-HSCT. |
| doi_str_mv | 10.1038/s41401-019-0277-x |
| format | Article |
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The aims of this study were to build a population pharmacokinetic model of CsA in Chinese children with hematopathy who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and to identify covariates affecting CsA pharmacokinetics. A total of 86 Chinese children aged 8.4 ± 3.8 years (range 1.1–16.8 years) who received allo-HSCT were enrolled. Whole blood samples were collected before allo-HSCT. Genotyping was performed using an Agena MassARRAY system. A total of 1010 trough plasma concentration values of CsA and clinical data were collected. The population pharmacokinetic model of CsA was constructed using nonlinear mixed-effects modeling (NONMEM) software. The stability and performance of the final model were validated using bootstrapping and normalized prediction distribution errors. We showed that a one-compartment model with first-order elimination adequately described the pharmacokinetics of CsA. The typical values for clearance (CL) and volume of distribution (V) were 42.3 L/h and 3100 L, respectively. Body weight, postoperative days, CYP3A4*1 G genotype, estimated glomerular filtration rate and coadministration of triazole antifungal drugs were identified as significant covariates for CL. Weight and postoperative days were significant covariates for the V of CsA. Our model can be adopted to optimize the CsA dosing regimen for Chinese children with hematopathy receiving allo-HSCT.</description><identifier>ISSN: 1671-4083</identifier><identifier>EISSN: 1745-7254</identifier><identifier>DOI: 10.1038/s41401-019-0277-x</identifier><identifier>PMID: 31341257</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>Adolescent ; Antifungal Agents - therapeutic use ; Asian Continental Ancestry Group ; Biomedical and Life Sciences ; Biomedicine ; Body Weight ; Child ; Child, Preschool ; Children ; Cyclosporine - pharmacokinetics ; Cyclosporine - therapeutic use ; Cyclosporins ; Cytochrome P-450 CYP3A - genetics ; Drug Monitoring ; Female ; Fungicides ; Genotypes ; Genotyping ; Glomerular Filtration Rate ; Graft vs Host Disease - prevention & control ; Hematopoietic Stem Cell Transplantation - adverse effects ; Hematopoietic stem cells ; Humans ; Immunology ; Immunosuppressive agents ; Immunosuppressive Agents - pharmacokinetics ; Immunosuppressive Agents - therapeutic use ; Infant ; Internal Medicine ; Male ; Medical Microbiology ; Models, Biological ; Pharmacokinetics ; Pharmacology/Toxicology ; Polymorphism, Genetic ; Stem cell transplantation ; Stem cells ; Transplantation ; Transplantation, Homologous - adverse effects ; Triazoles ; Triazoles - therapeutic use ; Vaccine</subject><ispartof>Acta pharmacologica Sinica, 2019-12, Vol.40 (12), p.1603-1610</ispartof><rights>CPS and SIMM 2019</rights><rights>Copyright Nature Publishing Group Dec 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-799d6ac226575bfc031448e7e147c1aa4394038598702488d04d0d30f9ba9933</citedby><cites>FETCH-LOGICAL-c470t-799d6ac226575bfc031448e7e147c1aa4394038598702488d04d0d30f9ba9933</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471407/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471407/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27903,27904,53770,53772</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31341257$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Tai-feng</creatorcontrib><creatorcontrib>Hu, Lei</creatorcontrib><creatorcontrib>Ma, Xiao-lu</creatorcontrib><creatorcontrib>Huang, Lin</creatorcontrib><creatorcontrib>Liu, Xue-mei</creatorcontrib><creatorcontrib>Luo, Xing-xian</creatorcontrib><creatorcontrib>Feng, Wan-yu</creatorcontrib><creatorcontrib>Wu, Chun-fu</creatorcontrib><title>Population pharmacokinetics of cyclosporine in Chinese children receiving hematopoietic stem cell transplantation</title><title>Acta pharmacologica Sinica</title><addtitle>Acta Pharmacol Sin</addtitle><addtitle>Acta Pharmacol Sin</addtitle><description>Cyclosporine (CsA) is characterized by a narrow therapeutic window and high interindividual pharmacokinetic variability, particularly in juvenile patients. The aims of this study were to build a population pharmacokinetic model of CsA in Chinese children with hematopathy who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and to identify covariates affecting CsA pharmacokinetics. A total of 86 Chinese children aged 8.4 ± 3.8 years (range 1.1–16.8 years) who received allo-HSCT were enrolled. Whole blood samples were collected before allo-HSCT. Genotyping was performed using an Agena MassARRAY system. A total of 1010 trough plasma concentration values of CsA and clinical data were collected. The population pharmacokinetic model of CsA was constructed using nonlinear mixed-effects modeling (NONMEM) software. The stability and performance of the final model were validated using bootstrapping and normalized prediction distribution errors. We showed that a one-compartment model with first-order elimination adequately described the pharmacokinetics of CsA. The typical values for clearance (CL) and volume of distribution (V) were 42.3 L/h and 3100 L, respectively. Body weight, postoperative days, CYP3A4*1 G genotype, estimated glomerular filtration rate and coadministration of triazole antifungal drugs were identified as significant covariates for CL. Weight and postoperative days were significant covariates for the V of CsA. Our model can be adopted to optimize the CsA dosing regimen for Chinese children with hematopathy receiving allo-HSCT.</description><subject>Adolescent</subject><subject>Antifungal Agents - therapeutic use</subject><subject>Asian Continental Ancestry Group</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Body Weight</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children</subject><subject>Cyclosporine - pharmacokinetics</subject><subject>Cyclosporine - therapeutic use</subject><subject>Cyclosporins</subject><subject>Cytochrome P-450 CYP3A - genetics</subject><subject>Drug Monitoring</subject><subject>Female</subject><subject>Fungicides</subject><subject>Genotypes</subject><subject>Genotyping</subject><subject>Glomerular Filtration Rate</subject><subject>Graft vs Host Disease - prevention & control</subject><subject>Hematopoietic Stem Cell Transplantation - adverse effects</subject><subject>Hematopoietic stem cells</subject><subject>Humans</subject><subject>Immunology</subject><subject>Immunosuppressive agents</subject><subject>Immunosuppressive Agents - pharmacokinetics</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Infant</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medical Microbiology</subject><subject>Models, Biological</subject><subject>Pharmacokinetics</subject><subject>Pharmacology/Toxicology</subject><subject>Polymorphism, Genetic</subject><subject>Stem cell transplantation</subject><subject>Stem cells</subject><subject>Transplantation</subject><subject>Transplantation, Homologous - adverse effects</subject><subject>Triazoles</subject><subject>Triazoles - therapeutic use</subject><subject>Vaccine</subject><issn>1671-4083</issn><issn>1745-7254</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp1UctOxCAUJUbj-wPcGBLXVS7QoWxMzMRXYqIL94ShdIq2UKFjxr-XcXwuXHHDPa_cg9ARkFMgrDpLHDiBgoAsCBWiWG6gXRC8LAQt-WaeJwIKTiq2g_ZSeiKEUQZyG-0wYBxoKXbRy0MYFp0eXfB4aHXstQnPztvRmYRDg82b6UIaQsx_2Hk8bfOQLDat6-poPY7WWPfq_By3ttdjGIJbkXEabY-N7To8Ru3T0Gk_ftgcoK1Gd8kefr776PHq8nF6U9zdX99OL-4KwwUZCyFlPdGG0kkpylljCAPOKysscGFAa84kzzcoZSUI5VVVE16TmpFGzrSUjO2j87XssJj1tjbW5xydGqLrdXxTQTv1d-Ndq-bhVQku8lVFFjj5FIjhZWHTqJ7CIvocWVFGAaqKlySjYI0yMaQUbfPtAEStSlLrklQuSa1KUsvMOf4d7Zvx1UoG0DUg5ZWf2_hj_b_qO4lNoGs</recordid><startdate>20191201</startdate><enddate>20191201</enddate><creator>Li, Tai-feng</creator><creator>Hu, Lei</creator><creator>Ma, Xiao-lu</creator><creator>Huang, Lin</creator><creator>Liu, Xue-mei</creator><creator>Luo, Xing-xian</creator><creator>Feng, Wan-yu</creator><creator>Wu, Chun-fu</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20191201</creationdate><title>Population pharmacokinetics of cyclosporine in Chinese children receiving hematopoietic stem cell transplantation</title><author>Li, Tai-feng ; Hu, Lei ; Ma, Xiao-lu ; Huang, Lin ; Liu, Xue-mei ; Luo, Xing-xian ; Feng, Wan-yu ; Wu, Chun-fu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-799d6ac226575bfc031448e7e147c1aa4394038598702488d04d0d30f9ba9933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Antifungal Agents - therapeutic use</topic><topic>Asian Continental Ancestry Group</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Body Weight</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children</topic><topic>Cyclosporine - pharmacokinetics</topic><topic>Cyclosporine - therapeutic use</topic><topic>Cyclosporins</topic><topic>Cytochrome P-450 CYP3A - genetics</topic><topic>Drug Monitoring</topic><topic>Female</topic><topic>Fungicides</topic><topic>Genotypes</topic><topic>Genotyping</topic><topic>Glomerular Filtration Rate</topic><topic>Graft vs Host Disease - prevention & control</topic><topic>Hematopoietic Stem Cell Transplantation - adverse effects</topic><topic>Hematopoietic stem cells</topic><topic>Humans</topic><topic>Immunology</topic><topic>Immunosuppressive agents</topic><topic>Immunosuppressive Agents - pharmacokinetics</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Infant</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Medical Microbiology</topic><topic>Models, Biological</topic><topic>Pharmacokinetics</topic><topic>Pharmacology/Toxicology</topic><topic>Polymorphism, Genetic</topic><topic>Stem cell transplantation</topic><topic>Stem cells</topic><topic>Transplantation</topic><topic>Transplantation, Homologous - adverse effects</topic><topic>Triazoles</topic><topic>Triazoles - therapeutic use</topic><topic>Vaccine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Li, Tai-feng</creatorcontrib><creatorcontrib>Hu, Lei</creatorcontrib><creatorcontrib>Ma, Xiao-lu</creatorcontrib><creatorcontrib>Huang, Lin</creatorcontrib><creatorcontrib>Liu, Xue-mei</creatorcontrib><creatorcontrib>Luo, Xing-xian</creatorcontrib><creatorcontrib>Feng, Wan-yu</creatorcontrib><creatorcontrib>Wu, Chun-fu</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Acta pharmacologica Sinica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Li, Tai-feng</au><au>Hu, Lei</au><au>Ma, Xiao-lu</au><au>Huang, Lin</au><au>Liu, Xue-mei</au><au>Luo, Xing-xian</au><au>Feng, Wan-yu</au><au>Wu, Chun-fu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Population pharmacokinetics of cyclosporine in Chinese children receiving hematopoietic stem cell transplantation</atitle><jtitle>Acta pharmacologica Sinica</jtitle><stitle>Acta Pharmacol Sin</stitle><addtitle>Acta Pharmacol Sin</addtitle><date>2019-12-01</date><risdate>2019</risdate><volume>40</volume><issue>12</issue><spage>1603</spage><epage>1610</epage><pages>1603-1610</pages><issn>1671-4083</issn><eissn>1745-7254</eissn><abstract>Cyclosporine (CsA) is characterized by a narrow therapeutic window and high interindividual pharmacokinetic variability, particularly in juvenile patients. The aims of this study were to build a population pharmacokinetic model of CsA in Chinese children with hematopathy who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and to identify covariates affecting CsA pharmacokinetics. A total of 86 Chinese children aged 8.4 ± 3.8 years (range 1.1–16.8 years) who received allo-HSCT were enrolled. Whole blood samples were collected before allo-HSCT. Genotyping was performed using an Agena MassARRAY system. A total of 1010 trough plasma concentration values of CsA and clinical data were collected. The population pharmacokinetic model of CsA was constructed using nonlinear mixed-effects modeling (NONMEM) software. The stability and performance of the final model were validated using bootstrapping and normalized prediction distribution errors. We showed that a one-compartment model with first-order elimination adequately described the pharmacokinetics of CsA. The typical values for clearance (CL) and volume of distribution (V) were 42.3 L/h and 3100 L, respectively. Body weight, postoperative days, CYP3A4*1 G genotype, estimated glomerular filtration rate and coadministration of triazole antifungal drugs were identified as significant covariates for CL. Weight and postoperative days were significant covariates for the V of CsA. Our model can be adopted to optimize the CsA dosing regimen for Chinese children with hematopathy receiving allo-HSCT.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>31341257</pmid><doi>10.1038/s41401-019-0277-x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Antifungal Agents - therapeutic use Asian Continental Ancestry Group Biomedical and Life Sciences Biomedicine Body Weight Child Child, Preschool Children Cyclosporine - pharmacokinetics Cyclosporine - therapeutic use Cyclosporins Cytochrome P-450 CYP3A - genetics Drug Monitoring Female Fungicides Genotypes Genotyping Glomerular Filtration Rate Graft vs Host Disease - prevention & control Hematopoietic Stem Cell Transplantation - adverse effects Hematopoietic stem cells Humans Immunology Immunosuppressive agents Immunosuppressive Agents - pharmacokinetics Immunosuppressive Agents - therapeutic use Infant Internal Medicine Male Medical Microbiology Models, Biological Pharmacokinetics Pharmacology/Toxicology Polymorphism, Genetic Stem cell transplantation Stem cells Transplantation Transplantation, Homologous - adverse effects Triazoles Triazoles - therapeutic use Vaccine |
| title | Population pharmacokinetics of cyclosporine in Chinese children receiving hematopoietic stem cell transplantation |
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