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Article: A three-month, open-label, single-arm trial evaluating the safety and pharmacokinetics of oral lithium in patients with chronic spinal cord injury

TitleA three-month, open-label, single-arm trial evaluating the safety and pharmacokinetics of oral lithium in patients with chronic spinal cord injury
Authors
Keywordslithium
regeneration
safety
Issue Date2011
PublisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/sc
Citation
Spinal Cord, 2011, v. 49 n. 1, p. 94-98 How to Cite?
AbstractObjectives: Lithium has recently been found to enhance neuronal regeneration and differentiation. This arouses its potential use to treat spinal cord injury patients. The safety and pharmacokinetics of lithium are not verified for this group of patients as their internal organ functions may change. This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of lithium in spinal cord injury patients.Methods: A total of 20 chronic spinal cord injury subjects were recruited. Oral lithium carbonate was given in divided dose to maintain the serum lithium level 0.6-1.2 mmol l -1 for 6 weeks. Safety parameters, adverse events and pharmacokinetic data were carefully collected and monitored.Results: No severe adverse event was documented. All blood parameters remained stable. Nausea and vomiting were the most common complaints but tolerance was improved in 2 weeks for most subjects. A wide range of oral doses was required to maintain serum lithium level at the targeted range. However, the dose for individual subject was relatively constant.Conclusion: This phase 1 clinical trial is the first report indicating the safety of lithium in chronic spinal cord injury patients. It is well tolerated after the first 2 weeks. Individual titration of lithium is essential to maintain an optimal serum lithium level but once the desirable level is achieved, the oral dose remains relatively unchanged for maintenance. © 2011 International Spinal Cord Society All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/149756
ISSN
2023 Impact Factor: 2.1
2023 SCImago Journal Rankings: 0.826
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorWong, YWen_HK
dc.contributor.authorTam, Sen_HK
dc.contributor.authorSo, KFen_HK
dc.contributor.authorChen, JYHen_HK
dc.contributor.authorCheng, WSen_HK
dc.contributor.authorLuk, KDKen_HK
dc.contributor.authorTang, SWen_HK
dc.contributor.authorYoung, Wen_HK
dc.date.accessioned2012-06-26T05:58:09Z-
dc.date.available2012-06-26T05:58:09Z-
dc.date.issued2011en_HK
dc.identifier.citationSpinal Cord, 2011, v. 49 n. 1, p. 94-98en_HK
dc.identifier.issn1362-4393en_HK
dc.identifier.urihttp://hdl.handle.net/10722/149756-
dc.description.abstractObjectives: Lithium has recently been found to enhance neuronal regeneration and differentiation. This arouses its potential use to treat spinal cord injury patients. The safety and pharmacokinetics of lithium are not verified for this group of patients as their internal organ functions may change. This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of lithium in spinal cord injury patients.Methods: A total of 20 chronic spinal cord injury subjects were recruited. Oral lithium carbonate was given in divided dose to maintain the serum lithium level 0.6-1.2 mmol l -1 for 6 weeks. Safety parameters, adverse events and pharmacokinetic data were carefully collected and monitored.Results: No severe adverse event was documented. All blood parameters remained stable. Nausea and vomiting were the most common complaints but tolerance was improved in 2 weeks for most subjects. A wide range of oral doses was required to maintain serum lithium level at the targeted range. However, the dose for individual subject was relatively constant.Conclusion: This phase 1 clinical trial is the first report indicating the safety of lithium in chronic spinal cord injury patients. It is well tolerated after the first 2 weeks. Individual titration of lithium is essential to maintain an optimal serum lithium level but once the desirable level is achieved, the oral dose remains relatively unchanged for maintenance. © 2011 International Spinal Cord Society All rights reserved.en_HK
dc.languageengen_US
dc.publisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/scen_HK
dc.relation.ispartofSpinal Corden_HK
dc.subjectlithiumen_HK
dc.subjectregenerationen_HK
dc.subjectsafetyen_HK
dc.subject.meshAdministration, Oralen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshChronic Diseaseen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshLithium Carbonate - Administration & Dosage - Adverse Effects - Pharmacokineticsen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshNeuroprotective Agents - Administration & Dosage - Adverse Effects - Pharmacokineticsen_US
dc.subject.meshSpinal Cord - Drug Effects - Pathologyen_US
dc.subject.meshSpinal Cord Injuries - Drug Therapy - Metabolismen_US
dc.subject.meshYoung Adulten_US
dc.titleA three-month, open-label, single-arm trial evaluating the safety and pharmacokinetics of oral lithium in patients with chronic spinal cord injuryen_HK
dc.typeArticleen_HK
dc.identifier.emailSo, KF:hrmaskf@hkucc.hku.hken_HK
dc.identifier.emailLuk, KDK:hcm21000@hku.hken_HK
dc.identifier.authoritySo, KF=rp00329en_HK
dc.identifier.authorityLuk, KDK=rp00333en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1038/sc.2010.69en_HK
dc.identifier.pmid20531359-
dc.identifier.scopuseid_2-s2.0-78651314460en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-78651314460&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume49en_HK
dc.identifier.issue1en_HK
dc.identifier.spage94en_HK
dc.identifier.epage98en_HK
dc.identifier.isiWOS:000285996800016-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridWong, YW=34882411200en_HK
dc.identifier.scopusauthoridTam, S=7202037323en_HK
dc.identifier.scopusauthoridSo, KF=34668391300en_HK
dc.identifier.scopusauthoridChen, JYH=36945051000en_HK
dc.identifier.scopusauthoridCheng, WS=36945031600en_HK
dc.identifier.scopusauthoridLuk, KDK=7201921573en_HK
dc.identifier.scopusauthoridTang, SW=7403437221en_HK
dc.identifier.scopusauthoridYoung, W=8128819100en_HK
dc.identifier.citeulike7351603-
dc.identifier.issnl1362-4393-

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