Methotrexate nanoparticle delivery system for treatment of inflammatory bowel disease in pediatric patients|
Liu, Gang; Li, Dun-Chen; Li, Ping-Ping; Li, Ran-Ran & Chen, Shu-Ying
Purpose: To evaluate the efficacy and safety of methotrexate (MTX) nanoparticles in pediatric patients
with inflammatory bowel disease (IBD).
Methods: In this randomized, open-label clinical study, 28 pediatric patients with moderate to severe
IBD were randomly assigned to treatment (MTX nanoparticles,15 mg/week) or control (azathioprine,
AZA, 2 mg/kg/day) group. Nanoparticles were synthesized by adding calcium chloride to sodium
alginate solution containing MTX, and was further treated with poly-L-lysine aqueous solution. The
nanoparticles were evaluated for particle size, zeta potential and drug encapsulation efficacy.
Erythrocyte sedimentation rate, C-reactive protein, aspartate aminotransferase, alanine transaminase,
and disease activity scores were used to assess IBD remission.
Results: Nanoparticle size, zeta potential and encapsulation efficacy were 164.4 ± 6.9 nm, -32.6 ± 3.7
mV, and 97.8 ± 4.2 %, respectively. After 12 weeks of therapy, the mean Pediatric Crohn\'s Disease
Activity Index (PCDAI) scores for control and treatment groups were 22.3 ± 2.14 and 16.8 ± 1.87,
respectively, while mean Pediatric Ulcerative Colitis Activity (PUCAI) Index scores were 24.3 ± 1.47 and
18.7 ± 1.92, respectively. Eight patients in the treatment and five patients in the control group achieved
remission. Biochemical parameters varied significantly between the groups.
Conclusion: MTX nanoparticles are safe and more effective than standard first-line IBD therapy.
However, further studies are required to determine the suitability of the formulation for therapeutic use.
Pediatric patient; Methotrexate nanoparticle; Inflammatory bowel disease; Azathioprine