《A three-month》.pdfVIP

Spinal Cord (2011) 49, 94–98 2011 International Spinal Cord Society All rights reserved 1362-4393/11 $32.00 /sc ORIGINAL ARTICLE A three-month, open-label, single-arm trial evaluating the safety and pharmacokinetics of oral lithium in patients with chronic spinal cord injury 1 2 3 4 4 1 5 3 YW Wong , S Tam , KF So , JYH Chen , WS Cheng , KDK Luk , SW Tang and W Young 1Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong, China; 2Clinical Trials Centre, The University of Hong Kong, Hong Kong, China; 3Department of Anatomy, The University of Hong Kong, Hong Kong, China; 4China Spinal Cord Injury Network, Ltd., Hong Kong, China and 5Department of Psychiatry, The University of Hong Kong, Hong Kong, China Objectives: 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 l1 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. Na